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Republic Act No.

166 June 20, 1947

AN ACT TO PROVIDE FOR THE REGISTRATION AND PROTECTION OF TRADE-MARKS, TRADE-NAMES AND
SERVICE-MARKS, DEFINING UNFAIR COMPETITION AND FALSE MARKING AND PROVIDING REMEDIES AGAINST
THE SAME, AND FOR OTHER PURPOSES

CHAPTER I - Powers, Duties and Functions of Patent Office

Section 1. Transfer of powers from Bureau of Commerce to Patent Office. - The powers, duties and functions vested in, or performed and exercised
by, the Bureau of Commerce in connection with the registration of trade-marks, trade-names and other marks are hereby transferred to the
Patent Office. The administration of this Act shall devolve upon the Patent Office.

All books, records, documents and files of the Bureau of Commerce relating to trade-marks, trade-names and other marks, and such
personnel of the said Bureau as is now discharging the functions or performing the duties of the Bureau of Commerce in connection with
the registration of trade-marks, trade-names and other marks together with the corresponding appropriation, are transferred to the Patent
Office, and the Budget Commissioner shall make immediate provision for such transfer.

CHAPTER II - Registration of Marks and Trade-Names

Section 2. What are registrable. - Trade-marks, trade-names and service-marks may be registered in accordance with the provisions of this
Act.

Section 3. Application by non-residents. - Any person filing an application for the registration of a mark or trade-name, who is not a resident of
the Philippines, must appoint an agent or representative in the Philippines upon whom notice or process relating to the application or
registration of the mark or trade-name may be served. In the event of death, absence or inability of the agent or representative, a new agent
or representative must be appointed, and notice thereof must be filed in the Patent Office. Upon failure to maintain an agent or
representative of record in the Patent Office, service on the Director shall be deemed sufficient.

Section 4. Registration of trade-marks, trade-names and service-marks. - The owner of a trade-mark, trade-name or service-mark used to distinguish
his goods, business or services from the goods, business or services of others shall have the right to register the same, unless it:

(a) Consists of or comprises immoral, deceptive or scandalous matter; or matter which may disparage or falsely suggest a
connection with persons, living or dead, institutions, beliefs, or national symbols, or bring them into contempt or disrepute;

(b) Consists of or comprises the flag or coat of arms or other insignia of the Philippines or any of its political subdivisions, or of
any foreign nation, or any simulation thereof;

(c) Consists of or comprises a name, portrait, or signature identifying a particular living individual except by his written consent,
or the name, signature, or portrait of a deceased President of the Philippines, during the life of his widow, if any, except by the
written consent of the widow;

(d) Consists of or comprises a mark or trade-name which so resembles a mark or trade-name registered in the Philippines or a
mark or trade-name previously used in the Philippines by another and not abandoned, as to be likely, when applied to or used in
connection with the goods, business or services of the applicant, to cause confusion or mistake or to deceive purchases; or

(e) Consists of a mark or trade-name which, when applied to or used in connection with the goods, business or services of the
applicant is merely descriptive or deceptively misdescriptive of them, or when applied to or used in connection with the goods,
business or services of the applicant is primarily geographically descriptive or deceptively misdescriptive of them, or is primarily
merely a surname.

(f) Except as expressly excluded in paragraphs (a), (b), (c) and (d) of this section, nothing herein shall prevent the registration of a
mark or trade-name used by the applicant which has become distinctive of the applicant's goods, business or services. The
Director may accept as prima facie evidence that the mark or trade-name has become distinctive, as applied to or used in
connection with the applicant's goods, business or services, proof of substantially exclusive and continuous use thereof as a mark
or trade-name by the applicant in connection with the sale of goods, business or services for the five years next preceding the date
of the filing of the application for its registration.

Section 5. Requirements of the application. - The application for the registration of a mark or trade-name shall be in English or Spanish, or in
the national language, with its corresponding English translation, and signed by the applicant, and shall include:

(a) Sworn statement of the applicant's domicile and citizenship, the date of the applicant's first use of the mark or trade-name, the
date of the applicant's first use of the mark or trade-name in commerce or business, the goods, business or services in connection
with which the mark or trade-name is used and the mode or manner in which the mark is used in connection with such goods,
business or services, and that the person making the application believes himself, or the firm, corporation or association on whose
behalf he makes the verification, to be the owner of the mark or trade-name sought to be registered, that the mark or trade-name
is in use in commerce or business, and that to the best of his knowledge no person, firm, corporation or association has the right
to use such mark or trade-name in commerce or business either in the identical form thereof or in such near resemblance thereto
as might be calculated to deceive;

(b) Such number of specimens or facsimiles of the mark or trade-name as actually used as may be required by the Director;

(c) Power of attorney, if the filing is through attorney;

(d) The appointment of an agent or representative, if the applicant is not domiciled in the Philippines; and

(e) The required fee.

Section 6. Classification of goods and services. - The Director shall establish a classification of goods and services, for the convenience of the
Patent Office administration, but not to limit or extent the applicant's rights. The applicant may register his mark or trade-name in one
application for any of all the goods or services included in one class, upon or in connection with which he is actually using the mark or
trade-name. The Director may issue a single certificate for one mark or trade-name registered in a plurality of classes upon payment of a fee
equaling the sum of the fees for each registration in each class.

Section 7. Examination and publication. - Upon the filing of an application for registration and the payment of the required fee, the Director
shall cause an examination of the application to be made, and, if on such examination it shall appear that the applicant is entitled to
registration, the Director, upon payment of the required fee, shall cause the mark or trade-name to be published in the Official Gazette.

If the applicant is found not entitled to registration, the Director shall advise the applicant thereof and of the reasons therefor. The
applicant shall have a period of three months in which to reply or amend his application, which shall then be re-examined. This procedure
may be repeated until the Director finally refuses registration or the applicant fails within the required period to reply or amend or appeal,
whereupon the application shall be deemed to have been abandoned, unless it can be shown to the satisfaction of the Director that the
delay in responding was unavoidable, in which event such time may be extended in the discretion of the Director. An abandoned
application may be revived as a pending application within three months from the date of abandonment, upon good cause shown and the
payment of the required fee.

Section 8. Opposition. - Any person who believes that he would be damaged by the registration of a mark or trade-name may, upon payment
of the required fee and within thirty days after the publication under the first paragraph of section seven hereof, file with the Director as
opposition to the application. Such opposition shall be in writing and verified by the oppositor, or by any person on his behalf who knows
the facts, and shall specify the grounds on which it is based and include a statement of the facts relied upon. Copies of certificates of
registration of marks or trade-names registered in other countries or other supporting documents mentioned in the opposition shall be
filed therewith, together with the translation thereof into English, if not in the English language. For good cause shown and upon payment
of the required surcharge, the time for filing an opposition may be extended for an additional thirty days by the Director, who shall notify
the applicant of such extension.

Section 9. Notice and hearing. - Upon the filing of an opposition, the Director shall forthwith serve notice of the filing on the applicant, and
of the date of the hearing thereof upon the applicant and the oppositor and all other persons having any right, title or interest in the mark
or trade-name covered by the application, as appear of record in the Patent Office.

Section 10. Issuance and publication of certificates. - When the period for filing the opposition has expired, or when the Director shall have
denied the opposition, the Director, upon payment of the required fee, shall issue the certificate of registration. Upon issuance of a
certificate of registration, notice thereof making reference to the publication of the application shall be published in the Official Gazette.

Section 11. Issuance and contents of the certificate. - Certificates of registration shall be issued in the name of the Republic of the Philippines
under the seal of the Patent Office, and shall be signed by the Director, and a record thereof together with a copy of the specimen or
facsimile and the statement of the applicant, shall be kept in books for that purpose. The certificate shall reproduce the specimen or
facsimile of the mark or trade-name, contain the statement of the applicant and state that the mark or trade-name is registered under this
Act, the date of the first use, the date of the first use in commerce or business, the particular goods or services for which it is registered, the
number and date of the registration, the term thereof, the date on which the application for registration was received in the Patent Office, a
statement of the requirement that in order to maintain the registration, periodical affidavits of use within the specified times hereinafter in
section twelve provided, shall be filed, and such other data as the rules and regulations may from time to time prescribe.

Section 12. Duration. - Each certificate of registration shall remain in force for twenty years:

Provided, That registrations under the provisions of this Act shall be cancelled by the Director, unless within one year following
the fifth, tenth and fifteenth anniversaries of the date of issue of the certificate of registration, the registrant shall file in the Patent
Office an affidavit showing that the mark or trade-name is still in use or showing that its non-use is due to special circumstances
which excuse such non-use and is not due to any intention to abandon the same, and pay the required fee.

The Director shall notify the registrant who files the above-prescribed affidavits of his acceptance or refusal thereof and, if a refusal, the
reasons therefor.
Section 13. Disclaimers before issue. - The Director shall require unregistrable matter to be disclaimed, but such disclaimer shall not prejudice
or affect the applicant's or owner's rights then existing or thereafter arising in the disclaimed matter, nor shall such disclaimer prejudice or
affect the applicant's or owner's rights of registration on another application of later date if the disclaimed matter has become distinctive of
the applicant's or owner's goods, business or services.

Section 14. Voluntary surrender, cancellation, amendment and disclaimer after registration. - At any time, upon application of the registrant and
payment of the required fee, the Director may permit any registration to be surrendered, cancelled, or for good cause shown to be
amended, he may permit any registered mark or trade-name to be disclaimed in whole or in part:

Provided, That the registration when so amended shall still contain registrable matter and the mark or trade-name as amended
shall still be registrable as a whole, and that such amendment or disclaimer does not involve such changes in the registration as to
alter materially the character of the mark or trade-name. The Director shall make appropriate entry upon the records of the Patent
Office and upon the certificate of registration or, if said certificate is lost or destroyed, upon a certified copy thereof. The Director
in his discretion and upon payment of the required fee, may issue a substitute certificate limited to the term of the original
certificate and incorporating such amendment or correction.

CHAPTER III - Renewals of Certificate of Registration

Section 15. Renewal. - Each certificate of registration may be renewed for periods of twenty years from the end of the expiring period upon
the filing of an application therefor and the payment of the required fee. Such application for renewal shall include a sworn statement of
the applicant's domicile and citizenship, the specific goods, business or services in connection with which the mark or trade-name is still in
use, the period of any nonuse in reference to the specific goods, business or services covered by original or renewed certificates of
registration and any rights granted third parties for the use of the mark or trade-name, any additional goods, business or services to which
the mark or trade-name has been extended during the period of the original or renewed certificates of registration, and any material
variation in the manner of display of the mark or trade-name from that shown in the original or renewed certificate of registration. The
applicant shall file the application within six months before the expiration of the period for which the certificate of registration was issued
or renewed, or it may be made within three months after such expiration for good cause shown and upon payment of the required
surcharge.

In the event the applicant for renewal be not domiciled in the Philippines, he shall be subject to and comply with the provisions of
paragraph (d), section five, Chapter II hereof.

Section 16. Effect of failure to renew registration. - Mere failure to renew any registration shall not affect the right of the registrant to apply for
and obtain a new registration under the provisions of this Act, nor shall such failure entitle any other person to register a mark or trade-
name unless he is entitled thereto in accordance with the provisions of this Act.

CHAPTER IV - Cancellation of Registration

Section 17. Grounds for cancellation. - Any person, who believes that he is or will be damaged by the registration of a mark or trade-name,
may, upon the payment of the prescribed fee, apply to cancel said registration upon any of the following grounds:

(a) That the registered mark or trade-name becomes the common descriptive name of an article or substance on which the patent
has expired;

(b) That it has been abandoned;

(c) That the registration was obtained fraudulently or contrary to the provisions of section four, Chapter II hereof;

(d) That the registered mark or trade-name has been assigned, and is being used by, or with the permission of, the assignee so as
to misrepresent the source of the goods, business or services in connection with which the mark or trade-name is used; or

(e) That cancellation is authorized by other provisions of this Act.

Section 18. Requirements of petition; notice and hearing. - Insofar as applicable, the petition herein shall be in the same form as that provided in
section eight, Chapter II hereof, and notice and hearing shall be as provided in section nine, Chapter II hereof.

Section 19. Cancellation of registration. - If the Director finds that a case for cancellation has been made out he shall order the cancellation of
the registration. The order shall not become effective until the period for appeal has elapsed, or if appeal is taken, until the judgment on
appeal becomes final. When the order or judgment becomes final, any right conferred by such registration upon the registrant or any
person in interest of record shall terminate. Notice of cancellation shall be published in the Official Gazette.

CHAPTER V - Rights and Remedies

Section 20. Certificate of registration prima facie evidence of validity. - A certificate of registration of a mark or trade-name shall be prima facie
evidence of the validity of the registration, the registrant's ownership of the mark or trade-name, and of the registrant's exclusive right to
use the same in connection with the goods, business or services specified in the certificate, subject to any conditions and limitations stated
therein.

Section 21. Requirements of notice of registration of trade-mark. - The registrant of a trade-mark, heretofore registered or registered under the
provisions of this Act, shall give notice that his mark is registered by displaying with the same as used the words "Registered in the
Philippines Patent Office" or "Reg. Phil. Pat. Off."; and in any suit for infringement under this Act by a registrant failing so to mark the
goods bearing the registered trade-mark, no damages shall be recovered under the provisions of this Act unless the defendant has actual
notice of the registration.

Section 22. Infringement, what constitutes. - Any person who shall use, without the consent of the registrant, any reproduction, counterfeit,
copy or colorable imitation of any registered mark or trade-name in connection with the sale, offering for sale, or advertising of any goods,
business or services on or in connection with which such use is likely to cause confusion or mistake or to deceive purchasers or others as to
the source or origin of such goods or services, or identity of such business; or reproduce, counterfeit, copy or colorably imitate any such
mark or trade-name and apply such reproduction, counterfeit, copy, or colorable imitation to labels, signs, prints, packages, wrappers,
receptacles or advertisements intended to be used upon or in connection with such goods, business or services, shall be liable to a civil
action by the registrant for any or all of the remedies herein provided.

Section 23. Actions, and damages and injunction for infringement. - Any person entitled to the exclusive use of a registered mark or trade-name
may recover damages in a civil action from any person who infringes his rights, and the measure of the damages suffered shall be either the
reasonable profit which the complaining party would have made, had the defendant not infringed his said rights, or the profit which the
defendant actually made out of the infringement, or in the event such measure of damages cannot be readily ascertained with reasonable
certainty, then the court may award as damages a reasonable percentage based upon the amount of gross sales of the defendant of the value
of the services in connection with which the mark or trade-name was used in the infringement of the rights of the complaining party. In
cases where actual intent to mislead the public or to defraud the complaining party shall be shown, in the discretion of the court, the
damages may be doubled.

The complaining party, upon proper showing, may also be granted injunction.

Section 24. Power of court to order infringing material destroyed. - In any action arising under this Act, in which a violation of any right of the
registrant shall have been established, the court may order that all labels, sign, prints, packages, wrappers, receptacles and advertisements in
the possession of the defendant, bearing the registered mark or trade-name or any reproduction, counterfeit, copy or colorable imitation
thereof, and all plates, molds, matrices and other means of making the same, shall be delivered up and destroyed.

Section 25. Authority to determine right to registration. - In any action involving a registered mark or trade-name the court may determine the
right to registration, order the cancellation of registrations, in whole or in part, restore cancelled registration, and otherwise rectify the
register with respect to the registration of any party to the action. Judgments and orders shall be certified by the court to the Director, who
shall make appropriate entry upon the records of the Patent Office, and shall be controlled thereby.

Section 26. Action for false or fraudulent declaration. - Any person who shall procure registration in the Patent Office of a mark or trade-name
by a false or fraudulent declaration or representation, oral or in writing, or by any false means, shall be liable in a civil action by any person
injured thereby for any damages sustained in consequence thereof.

Section 27. Jurisdiction of Court of First Instance. - All actions under this Chapter and Chapters VI and VII hereof shall be brought before the
proper Court of First Instance.

Section 28. Appeal. - Appeal may be taken from any judgment or final order of the Court of First Instance in the same manner as in other
actions.

CHAPTER VI - Unfair Competition

Section 29. Unfair competition, rights and remedies. - A person who has identified in the mind of the public the goods he manufactures or deals
in, his business or services from those of others, whether or not a mark or trade-name is employed, has a property right in the goodwill of
the said goods, business or services so identified, which will be protected in the same manner as other property rights. Such a person shall
have the remedies provided in section twenty-three, Chapter V hereof.

Any person who shall employ deception or any other means contrary to good faith by which he shall pass off the goods manufactured by
him or in which he deals, or his business, or services for those of the one having established such goodwill, or who shall commit any acts
calculated to produce said result, shall be guilty of unfair competition, and shall be subject to an action therefor.

In particular, and without in any way limiting the scope of unfair competition, the following shall be deemed guilty of unfair competition:

(a) Any person, who in selling his goods shall give them the general appearance of goods of another manufacturer or dealer, either
as to the goods themselves or in the wrapping of the packages in which they are contained, or the devices or words thereon, or in
any other feature of their appearance, which would be likely to influence purchasers to believe that the goods offered are those of
a manufacturer or dealer other than the actual manufacturer or dealer, or who otherwise clothes the goods with such appearance
as shall deceive the public and defraud another of his legitimate trade, or any subsequent vendor of such goods or any agent of
any vendor engaged in selling such goods with a like purpose;

(b) Any person who by any artifice, or device, or who employs any other means calculated to induce the false belief that such
person is offering the services of another who has identified such services in the mind of the public;

(c) Any person who shall make any false statement in the course of trade or who shall commit any other act contrary to good faith
of a nature calculated to discredit the goods, business or services of another.

CHAPTER VII - False Designation of Origin and False Description

Section 30. False designation of origin and false description forbidden. - Any person who shall affix, apply, annex or use in connection with any
goods or services, or any container or containers for goods, a false designation of origin, or any false description or representation,
including words or other symbols tending falsely to describe or represent the same, and shall cause such goods or services to enter into
commerce, and any person who shall with knowledge of the falsity of such designation of origin or description or representation cause or
procure the same to enter into commerce, shall be liable to a civil action for damages and injunction provided in section twenty-three,
Chapter V hereof, by any person doing business in the locality falsely indicated as that of origin or in the region in which said locality is
situated, or by any person who believes that he is or is likely to be damaged by the use of any such false description or representation.

CHAPTER VIII - Assignment and Transmission of Rights

Section 31. Rights assignable and form of assignment. - A registered mark or trade-name, or one for which application to register has been filed
shall be assignable with the goodwill of the business in which the mark or trade-name is used, or with that part of the goodwill of the
business connected with the use of and symbolized by the mark or trade-name, and in any such assignment it shall not be necessary to
include the goodwill of the business connected with the use of and symbolized by any other mark or trade-name used in the business or by
the name or style under which the business is conducted. Upon payment of the required fee, the Director shall record assignments in due
form in books kept for that purpose.

The assignment must be in writing, acknowledged before a notary public or other officer authorized to administer oaths or perform other
notarial acts and certified under the hand and official seal of the notary or other officer.

An assignment shall be void as against any subsequent purchaser for a valuable consideration without notice, unless it is recorded in the
Patent Office within three months after the date thereof or prior to such subsequent purchase.

Section 32. Issuance of certificate of registration to assignee. - A certificate of registration of a mark or trade-name may be issued to the assignee of
the applicant, but the assignment must first be recorded in the Patent Office. In case of change of ownership the Director shall, at the
request of the owner and upon proper showing and payment of the required fee, issue to such assignee a new certificate of registration of
the said mark or trade-name in the name of such assignee, and for the unexpired part of the original period.

CHAPTER IX - Review of Orders or Decisions of Director

Section 33. Appeal from action of Director. - Any party who has been denied registration of a mark or trade-name, or to the renewal of the
registration, or to any cancellation proceeding in the Patent Office, may appeal to the Supreme Court from the final order or decision of
the Director.

Section 34. Procedure on appeal. - Sections sixty-three to seventy-three, inclusive, Chapter VIII, of Republic Act No. _____ entitled "An Act
creating a Patent Office, prescribing its powers and duties, regulating the issuance of patents, and appropriating funds therefor," shall be
applicable to the appeals herein provided.

CHAPTER X - Importations Prohibited

Section 35. Goods bearing infringing marks or trade-names. - No article of imported merchandise which shall copy or simulate the name of any
domestic product, or manufacturer, or dealer, or of any manufacturer or dealer located in any foreign country which, by treaty, convention
or law affords similar privileges to citizens of the Philippines, or which shall copy or simulate a mark or trade-name registered in
accordance with the provisions of this Act, or shall bear a mark or trade-name calculated to induce the public to believe that the article is
manufactured in the Philippines, or that it is manufactured in any foreign country or locality other than the country or locality where it is in
fact manufactured, shall be admitted to entry at any customhouse of the Philippines. In order to aid the officers of the customs service in
enforcing this prohibition, any person who is entitled to the benefits of this Act, may require his name and residence, and the name of the
locality in which his goods are manufactured, a copy of the certificate of registration of his mark or trade-name to be recorded in books
which shall be kept for this purpose in the Bureau of Customs, under such regulations as the Collector of Customs with the approval of the
Secretary of Finance shall prescribe, and may furnish to the said Bureau facsimiles of his name, the name of the locality in which his goods
are manufactured, or of his registered mark or trade-name, and thereupon the Collector of Customs shall cause one or more copies of the
same to be transmitted to each collector or other proper officer of the Bureau of Customs.
Section 36. Goods with false designation of origin and false description. - Any goods marked or labeled in contravention of the provisions of section
thirty, Chapter VII hereof, shall not be imported into the Philippines or admitted to entry at any customhouse in the Philippines.

CHAPTER XI - Provisions in Reference to Foreign Industrial Property

Section 37. Rights of foreign registrants. - Persons who are nationals of, domiciled in, or have a bona fide or effective business or commercial
establishment in any foreign country, which is a party to any international convention or treaty relating to marks or trade-names, or the
repression of unfair competition to which the Philippines may be a party, shall be entitled to the benefits and subject to the provisions of
this Act to the extent and under the conditions essential to give effect to any such convention and treaties so long as the Philippines shall
continue to be a party thereto, except as provided in the following paragraphs of this section.

No registration of a mark or trade-name in the Philippines by a person described in the preceding paragraph of this section shall be granted
until such mark or trade-name has been registered in the country of origin of the applicant, unless the applicant alleges use in commerce.

For the purposes of this section, the country of origin of the applicant is the country in which he has bona fide and effective industrial or
commercial establishment, or if he has not such an establishment in the country in which he is domiciled, or if he has not a domicile in any
of the countries described in the first paragraph of this section, the country of which he is a national.

An application for registration of a mark or trade-name under the provisions of this Act filed by a person described in the first paragraph
of this section who has previously duly filed an application for registration of the same mark or trade-name in one of the countries
described in said paragraph shall be accorded the same force and effect as would be accorded to the same application if filed in the
Philippines on the same date on which the application was first filed in such foreign country:

Provided, That -

(a) The application in the Philippines is filed within six months from the date on which the applicant was first filed in the foreign
country; and within three months from the date of filing or within such time as the Director shall in his discretion grant, the
applicant shall furnish a certified copy of the application for or registration in the country of origin of the applicant, together with
a translation thereof into English, if not in the English language;

(b) The application conforms as nearly as practicable to the requirements of this Act, but use in commerce need not be alleged;

(c) The rights acquired by third parties before the date of the filing of the first application in the foreign country shall in no way
be affected by a registration obtained on an application filed under this paragraph; and

(d) Nothing in this paragraph shall entitle the owner of a registration granted under this section to sue for acts committed prior to
the date on which his mark or trade-name was registered in this country unless the registration is based on use in commerce.

The registration of a mark under the provisions of this section shall be independent of the registration in the country of origin and the
duration, validity or transfer in the Philippines of such registration shall be governed by the provisions of this Act.

Trade-names of persons described in the first paragraph of this section shall be protected without the obligation of filing or registration
whether or not they form parts of marks.

Any person designated in the first paragraph of this section as entitled to the benefits and subject to the provisions of this Act shall be
entitled to effective protection against unfair competition, and the remedies provided herein for infringement of marks and trade-names
shall be available so far as they may be appropriate in repressing acts of unfair competition.

Citizens or residents of the Philippines shall have the same benefits as are granted by this section to persons described in the first
paragraph hereof.

CHAPTER XII - Construction and Definitions

Section 38. Words and terms defined and construed. - In the construction of this Act, unless the contrary is plainly apparent from the context -

The term "trade-name" includes individual names and surnames, firm names, trade-names, devices or words used by manufacturers,
industrialists, merchants, agriculturists, and others to identify their business, vocations or occupations; the names or titles lawfully adopted
and used by natural or juridical persons, unions, and any manufacturing, industrial, commercial, agricultural or other organizations engaged
in trade or commerce.

The term "trade-mark" includes any word, name, symbol, emblem, sign or device or any combination thereof adopted and used by a
manufacturer or merchant to identify his goods and distinguish them from those manufactured, sold or dealt in by others.

The term "service-mark" means a mark used in the sale or advertising of services to identify the services of one person and distinguish
them from the services of others and includes without limitation the marks, names, symbols, titles, designations, slogans, character names,
and distinctive features of radio or other advertising.
The word "business" includes vocations or occupations.

The term "mark" includes any trade-mark or service-mark entitled to registration under this Act whether registered or not.

The word "registrant" includes the owner of a registered mark or trade-name.

Section 39. Fees. - The following fees shall be paid:

For filing application for registration for each class included in the application, fifty pesos;

For filing application for revival of abandoned application for registration, twenty-five pesos;

For publication in the Official Gazette of allowance of application, fifty pesos;

For filing of opposition, fifty pesos;

For issuance and publication of certificate of registration, twenty-five pesos;

For filing each affidavit required by section twelve, Chapter II hereof, twenty-five pesos;

For filing disclaimer, amendment, surrender or cancellation after registration, twenty pesos;

For issuance of a substitute certificate of registration following correction of a registrant's mistake, twenty-five pesos;

For issuance of a new certificate of registration following change of ownership of mark, twenty-five pesos;

For filing petition for renewal of certificate of registration for each class, fifty pesos;

For filing petition for cancellation, fifty pesos;

For surcharge for any delayed payment or any delayed action of an applicant or registrant, twenty-five pesos;

For notice of appeal from orders or decisions of Commissioner, twenty-five pesos;

For recording assignments for each mark or trade-name, ten pesos;

For issuance of a certificate regarding the registration or non-registration of each mark or trade-name, ten pesos;

For issuance of an affirmative or negative certificate regarding the registration of any document in connection, with a mark or
trade-name, ten pesos;

For filing any other documents in connection with marks or trade-names not required by law to be filed, ten pesos;

For certifying a copy to be a true and exact copy, one peso;

For copies of records, two pesos per photostat sheet; one peso per one hundred words of typewritten copy; and

For services not otherwise specified, the Director shall, by regulation, provide the fees therefor.

Section 40. Collective marks and collective trade-names. - Collective marks and collective trade-names belonging to cooperatives, associations or
other collective groups or organization may also be registered under the provisions of this Act, even though the said collectivities may not
possess an industrial, commercial or agricultural establishment. Foreign collectivities may not, however, procure such registration if the
existence of such collectivities is contrary to the laws of the country of origin.

Such collective marks and collective trade-names, when registered, shall be entitled to the protection provided herein in the case of marks
and trade-names, except when used so as to represent falsely that the owner or a user makes or sells the goods on which the mark or trade-
name is used, or so as to represent falsely the origin of the goods or services.

The other provisions of this Act relating to marks and trade-names shall apply to collective marks and collective trade-names, except that
the part of paragraph (e), section four, Chapter II hereof, relating to geographically descriptive marks or trade-names shall not be applicable
in appropriate cases.

A "collective mark" or collective trade-name" is a mark or trade-name used by the members of a cooperative, an association or other
collective group or organization.

CHAPTER XIV - Miscellaneous Provisions


Section 41. Reservation in favor of prior registration. - Owners of marks or trade-names registered under the provisions of the laws in force prior
hereto, the registrations of which are still subsisting under the said laws are hereby granted the right:

(a) Within one year after the taking effect of this Act to surrender their certificates of registration and procure the issuance of new
certificates, in which event they shall be entitled to the benefits and subject to the provisions of this Act; or

(b) Within one year before the expiration of the period for which the certificates of registration was issued or renewed, the
registrant may renew the registration upon filing an application therefor, as provided in section fifteen, Chapter III hereof. If said
application is granted a renewal certificate shall be issued by the Director in accordance with the provisions of this Act.

Section 42. Renewal of registrations which expired during the war. - The provisions of this Act to the contrary notwithstanding, registrations under
prior laws which expired after the eighth day of December, nineteen hundred forty-one, and which the owners were not able to renew for
causes arising out of the war, may be renewed within one year after this Act takes effect, and non-use of the mark or trade-name may be
shown to be due to special circumstances. If the application for renewal is granted, a renewal certificate to commence from the date of the
expiration of the prior registration shall be issued by the Director in accordance with the provisions of this Act.

Section 43. Pending applications. - All applications for registration pending on the effective date of this Act may be amended, if practicable, to
bring them under the provisions of this Act, without the payment of any additional fee. The prosecution of such applications whether
amended or not and the grant of registrations thereon shall conform to the provisions of this Act.

Section 44. Repealing clause. - Act Numbered Six hundred and sixty-six of the Philippine Commission, approved March six, nineteen
hundred and three, and all laws amendatory thereto; Act Numbered Thirty hundred and seventy of the Philippine Legislature, approved
March sixteen, nineteen hundred and twenty-three; Act Numbered Thirty-two hundred and two, approved December three, nineteen
hundred and twenty-four, and all other acts, or parts of acts inconsistent herewith, are hereby repealed.

Section 45. Effective date. - This Act shall take effect on its approval.

Approved: June 20, 1947


Republic Act No. 165 June 20, 1947

AN ACT CREATING A PATENT OFFICE, PRESCRIBING ITS POWERS AND DUTIES, REGULATING THE
ISSUANCE OF PATENTS, AND APPROPRIATING FUNDS THEREFOR

CHAPTER I - Organization and Operation

Section 1. Patent Office. - There is hereby created a "Patent Office" under the executive supervision of the Department of Justice, where
all records, books, drawings, specifications, and other papers and things pertaining to patents shall be safely kept and preserved.

Section 2. Officers and employees of the Patent Office. - The Patent Office shall be under the direction of a Director who shall have
an assistant to be known as Assistant Director. The Director and Assistant Director shall be appointed by the President with the consent of
the Commission on Appointments of the Congress of the Philippines, and shall hold office during good behavior. The Director shall
receive a salary of seven thousand two hundred pesos a year, and the Assistant Director a salary of six thousand pesos a year.

To carry into effect the provisions of this Act, there shall also be in said office such other officers and employees as may be appointed by
the Secretary of Justice upon recommendation of the Director.

The term "Office" used in this Act means that Patent Office.

The term "Director" used in this Act refers to the Director of Patents or the Assistant Director of Patents when acting as or performing
the duties of the Director.

Section 3. Special technical and scientific assistance. - The Director is empowered to obtain the assistance of technical, scientific or
other qualified officers or employees of other departments, bureaus, offices, agencies and instrumentalities of the Government, including
corporations owned, controlled or operated by the Government, when deemed necessary in the consideration of any matter submitted to
the Office relative to the enforcement of the provisions of this Act.

Section 4. Seal of Office. - The Office shall have a seal with which patents and other papers issued by it shall be authenticated. The form
and design of the seal shall be approved by the President of the Philippines.

Section 5. Publication of laws and rules. - The Director shall print, or cause to be printed, and make available for distribution, pamphlet
copies of the laws and of the rules and regulations of the Office, and may print circulars of information relating to matters within the
jurisdiction of the Office.

Section 6. Publication of certain matters in the Official Gazette. - There shall be published in the Official Gazette a suitable view of
the drawing, if there be a drawing, and the claims of each patent issued; the rules and regulations duly promulgated and the amendments
thereto; an annual index of the names of investors and patentees and the title of the inventions covered by the patents issued during each
fiscal year; all notices and decisions required under this Act to be published; and such other information relating to patents and other
matters within the jurisdiction of the Office, as may, in the discretion of the Director, be useful to the public.

CHAPTER II - Inventions Patentable

Section 7. Inventions patentable. - Any invention of a new and useful machine, manufactured product or substance, process, or an
improvement of any of the foregoing, shall be patentable.

Section 8. Inventions not patentable. - An invention shall not be patentable if it is contrary to public order or morals, or to public health
or welfare, or if it constitutes a mere idea, scientific principle or abstract theorem not embodied in an invention as specified in section
seven hereof, or any process not directed to the making or improving of a commercial product.

Section 9. Invention not considered new or patentable. - An invention shall not be considered new or capable of being patented if it
was known or used by others in the Philippines before the invention thereof by the inventor named in an application for patent for the
invention; or if it was patented or described in any printed publication in the Philippines or any foreign country more than one year before
the application for a patent therefor; or if it had been in public use or on sale in the Philippines for more than one year before the
application for a patent therefor; or if it is the subject matter of a validly issued patent in the Philippines granted on an application filed
before the filing of the application for patent therefor.

CHAPTER III - Application for Patent

Section 10. Right to patent. - The right to the patent belongs to the true and actual inventor, his heirs, legal representatives or assigns. If
two or more persons have an invention jointly, the right to the patent belongs to them jointly. If two or more persons have made the
invention separately and independently of each other, the right to the patent shall belong to the person who is the first to file an application
for such invention, unless the contrary is shown.

Section 11. Applications by non-residents. - Any person filing an application for patent who is not a resident of the Philippines must
appoint an agent or representative in the Philippines upon whom notice or process relating to the application for patent may be served. In
the event of death, absence or inability of the agent or representative, a new agent or representative must be appointed and notice thereof
must be filed in the Office. Upon failure to maintain an agent or representative of record in this Office, service on the Director shall be
deemed sufficient.

Section 12. Who may apply for patent. - An application for patent may be filed only by the inventor, his heirs, legal representatives or
assigns.

Section 13. The application. - The application for patent shall be in English or Spanish, or in the national language with its corresponding
English translation, and signed by the applicant, and shall include a statement giving the name, address, and citizenship or nationality of the
applicant and of the inventor, if the applicant is not the inventor, and:

(a) A specification;

(b) Drawings, where the invention can be shown by drawings;

(c) Power of attorney if the filing is through an attorney;

(d) The assignment or a certified copy of the assignment of the invention for recording, where the application is filed by one who
derives his title from the inventor, or proof of title if the derivation is not by assignment;

(e) A sworn statement by the inventor of his inventorship; or such sworn statement may be made by his heirs or legal
representatives in case of death or incapacity of the inventor; however, such sworn statement will not be required if a certified
copy of a previously filed foreign application containing the same is filed;

(f) The appointment of a resident agent or representative in cases coming under section eleven hereof; and

(g) The required fee.

Section 14. The specification. - The specification shall include:

(a) The title of the invention;

(b) A brief statement of its nature and purpose;

(c) A brief explanation of the drawings, where there are drawings;

(d) A complete and detailed description of the invention in such full, clear, concise and exact terms as to enable any person skilled
in the art or science to which the invention relates to make and practice the invention; and

(e) A distinct and explicit claim or claims of the subject matter which the applicant claims as new and seeks to have patented.

Section 15. Applications previously filed abroad. - An application for patent for an invention filed in this country by any person who
has previously regularly filed an application for a patent for the same invention in a foreign country which, by treaty, convention, or law,
affords similar privileges to citizens of the Philippines shall have the same force and effect as the same applicant would have if filed in this
country on the date on which the application for patent for the same invention was first filed in such foreign country:

Provided, That the application in this country is filed within twelve months from the earliest date on which any such foreign
application was filed, and a certified copy of the foreign application together with a translation thereof into English, if not in the
English language, is filed within six months from the date of filing in the Philippines, unless the Director for good cause shown
shall extend the time for filing such certified copy.

CHAPTER IV - Issuance of Patent

Section 16. Formal examination of the application. - When an application for patent has been filed the Director shall determine
whether it complies with the formal requirements. If the application is defective in this respect the applicant shall be notified on the
specific defects and a time fixed, not less than four months, within which such defects may be remedied.

If the applicant fails to request reconsideration or to remedy the defects within the time fixed by the Director, or within such additional
time, not exceeding four months, as may be granted, the application shall be denied.

Section 17. Multiple inventions in one application. - If several independent inventions which are not so closely related as to be proper
in one application are claimed, the Director may require the application to be restricted to a single invention in the same manner as
notifications of defects in the application. A later application filed for an invention divided out shall be considered as having been filed on
the same day as the first application provided the later application is filed within four months after the requirement to divide becomes final,
or within such additional time, not exceeding four months, as may be granted.
Section 18. Issuance of patent. - If the original or corrected application is in order, the Director shall issue the patent and shall, as soon
as practicable, make the publication required by section six, Chapter I hereof.

Section 19. How issued. - The patent shall be issued in the name of the Republic of the Philippines under the seal of the Office and shall
be signed by the Director, and registered together with the specification and drawings, if any, in books and records of the Office to be kept
for the purpose.

Section 20. Content of patent. - The patent shall contain the patent number, the title of the invention, the name and residence of the
inventor and of the patentee if the patentee be other than the inventor, the date on which the application was filed, the date on which it is
issued, and a grant to the patentee, his heirs or assigns, of the exclusive right to the invention throughout the Republic of the Philippines
for the term thereof. A copy of the specification and drawings shall be annexed to the patent and be a part thereof.

CHAPTER V - Term of Patent

Section 21. Term of patent. - The term of a patent shall begin on the date when the patent is issued as shown on the face thereof and
shall expire seventeen years thereafter. However, a patent shall cease to be in force and effect of the patentee fails to pay the prescribed
annual fees within the prescribed times hereinafter provided or if the patent is cancelled in accordance with the provisions of this Act.

Section 22. Annual fees. - The first annual fee on a patent shall be due and payable on the expiration of four years from the date of issue.
In a similar manner, annual fees on subsisting patents shall be due and payable on the fifth and each subsequent anniversary of the date of
issue. If any annual fee is not paid within the prescribed time, a notice of the non-payment shall be published in the Official Gazette and
the patentee shall have six months from the date of the publication to pay the fee together with the surcharge required for the delayed
payment. A notice of the lapsing of a patent for non-payment of any annual fee shall be published in the Official Gazette.

Section 23. Reinstatement of a lapsed patent. - Within two years from the date on which the first unpaid annual fee was due, a patent
which has lapsed for non-payment of any annual fee may be reinstated upon payment of all annual fees then due and the surcharge for
reinstatement, and upon proof satisfactory to the Director that such non-payment was due to fraud, accident, mistake or excusable
negligence:

Provided, however, That such reinstatement shall not prejudice the rights acquired by a third person while the patent was not in
force.

CHAPTER VI - Surrender, Correction and Amendments of Patent

Section 24. Surrender of patent. - Any patentee, with the consent of all persons having grants or licenses or other right, title or interest in
and to the patent and the invention covered thereby, which have been recorded in the Office, may surrender his patent or any claim or
claims forming part thereof to the Director for cancellation.

Section 25. Correction of mistakes of Office. - The Director shall have the power to correct without fee any mistake in a patent incurred
through the fault of the Office when clearly disclosed by the records thereof, to make the patent conform to the records.

Section 26. Correction of mistake of application. - On payment of the prescribed fee the Director is authorized to correct any mistake
in a patent of a formal or clerical nature, not incurred through the fault of the Office.

Section 27. Form and publication of amendment. - Amendment or correction of a patent as provided in sections twenty-five and
twenty-six hereof, shall be accomplished by a certificate of such amendment or correction authenticated by the seal of the Office and
signed by the Director, which certificate shall be attached to the patent if the patent has been returned to the Director. Notice of such
amendment or correction shall be published in the Official Gazette, and copies of the patent furnished by the Office shall include a copy of
the certificate of the amendment or correction.

CHAPTER VII - Cancellation of Patents

Section 28. General grounds for cancellation. - Any person may on payment of the required fee petition the Director within three years
from the date of publication of the issue of the patent in the Official Gazette, to cancel the patent or any claim thereof, on any of the
following grounds:

(a) That the invention is not new or patentable in accordance with sections seven, eight and nine, Chapter II hereof;

(b) That the specification does not comply with the requirement of section fourteen, Chapter III hereof; or

(c) That the person to whom the patent was issued was not the true and actual inventor or did not derive his rights from the true
and actual inventor.

Section 29. When patent may be cancelled at any time. - A petition to cancel a patent on any of the grounds specified in the next
preceding section may be filed at any time by the Solicitor General.
Section 30. Requirements of the petition. - The petition for cancellation must be in writing and verified by the petitioner or by any
person on his behalf who knows the facts, and shall specify the grounds upon which it is based, and include a statement of the facts to be
relied upon. Copies of printed publications or of patents of other countries, or other supporting documents mentioned in the petition shall
be filed therewith, together with the transaction thereof into English, if not in the English language.

Section 31. Notice and hearing. - Upon the filing of a petition for cancellation, the Director shall forthwith serve notice of the filing
thereof upon the patentee and all persons having grants or licenses, or any other right, title or interest in and to the patent and the
invention covered thereby, as appears of record in the Office, and of notice of the date of hearing thereon on such persons and the
petitioner. Notice of the filing of the petition shall be published in the Official Gazette.

Section 32. Cancellation of the patent. - If the Director finds that a case for cancellation has been made out he shall order the patent or
any specified claim or claims thereof cancelled. The order shall not become effective until the time for appeal has elapsed or, if appeal is
taken, until the judgment on appeal becomes final. When the order or judgment becomes final, any rights conferred upon the patentee by
the patent or any specified claim or claims cancelled thereby shall terminate. Notice of cancellation shall be published in the Official
Gazette.

Section 33. Cancellation for fraud on the inventor. - In the case of the ground specified in paragraph (c), section twenty-eight hereof, if
the petition for cancellation is made by or on behalf of the true and actual inventor from whom the patentee fraudulently derived the
invention and is successful on this ground, a patent may be obtained by such inventor, if he does not have a patent, notwithstanding any
knowledge or use or publication of the patent cancelled:

Provided, That the true and actual inventor shall file an application for patent for such invention within six months after the order
of cancellation has become final. The term of such patent, however, shall expire seventeen years from the date of issue of the
patent cancelled.

CHAPTER VIII - Compulsory Licensing

Section 34. Grounds for compulsory license. - Any person may apply to the Director for the grant of a license under a particular patent
at any time after the expiration of three years from the date of the grant of the patent, under any of the following circumstances:

(a) If the patented invention is not being worked within the Philippines on a commercial scale, although capable of being so
worked, without satisfactory reason;

(b) If the demand for the patented article in the Philippines is not being met to an adequate extent and on reasonable terms,
without satisfactory reason;

(c) If by reason of the refusal of the patentee to grant a license or licenses on reasonable terms, or by reason of the conditions
attached by the patentee to licenses or to the purchase, lease or use of the patented article or working of the patented process or
machine of production the establishment of any new trade or industry in the Philippines is prevented, or the trade of industry
therein is unduly restrained; or

(d) If the patented invention relates to food or medicine or is necessary for public health or public safety.

The term "worked" or "working" as used in this section means the manufacture and sale of a patented article, or the carrying on of a
patented process or the use of a patented machine for production, in or by means of a definite and substantial establishment or
organization in the Philippines and on a scale which is adequate and reasonable under the circumstances.

Section 35. Notice and hearing. - Upon the filing of a petition under section thirty-four hereof, notice shall be given in the same manner
and form as that provided in section thirty-one, Chapter VII hereof.

Section 36. Grant of license. - If the Director finds that a case for the grant of a license under section thirty-four hereof has been made
out, he may order the grant of an appropriate license and in default of agreement among the parties as to the terms and conditions of the
license he shall fix the terms and conditions of the license in the order.

The order of the Director granting a license under this Chapter, when final, shall operate as a deed granting a license executed by the
patentee and the other parties in interest.

CHAPTER IX - Rights of Patentees and Infringement of Patents

Section 37. Rights of patentees. - A patentee shall have the exclusive right to make, use and sell the patented machine, article or product,
and to use the patented process for the purpose of industry or commerce, throughout the territory of the Philippines for the term of the
patent; and such making, using, or selling by any person without the authorization of the patentee constitutes infringement of the patent.

Section 38. Experimental use of invention. - The making or using of a patented invention when not conducted for profit and solely for
the purpose of research or experiment, or for instruction, shall not constitute infringement.
Section 39. Temporary presence in the country. - No patent shall prevent the use of any invention in any ship, vessel, aircraft, or land
vehicle of any other country entering the territory of the Philippines temporarily or accidentally, and such use shall not constitute
infringement of the patent, provided such invention is used exclusively for the needs of the ship, vessel, aircraft, or land vehicle and not
used for the manufacture of anything to be sold within or exported from the Philippines.

Section 40. Rights of third parties prior to application. - Any person who has purchased or acquired of the inventor, his legal
representatives, or assigns, or who, with their knowledge and consent, constructs any newly invented device or other patentable article,
prior to the filing of the application therefor, shall have the right to use and sell the specific thing purchased, acquired or made, without
liability therefor.

Section 41. Use of invention by the Government. - The Government of the Philippines may use any patented invention at any time for
governmental purposes, and the manufacture or use of the invention by or for the Government for such purposes shall not constitute
infringement of the patent, but the patentee shall be entitled to receive a reasonable compensation for the use of the invention.

CHAPTER X - Actions and Remedies for Infringement

Section 42. Civil action for infringement. - Any patentee, or anyone possessing any right, title or interest in and to the patented
invention, whose rights have been infringed, may bring a civil action before the proper Court of First Instance, to recover from the
infringer damages sustained by reason of the infringement and to secure an injunction for the protection of his rights.

If the damages are inadequate or cannot be readily ascertained with reasonable certainty, the court may award as damages a sum amounting
to a reasonable royalty.

The court may, according to the circumstances of the case, award damages in a sum above the amount found as actual damages sustained
provided the award does not exceed three times the amount of such actual damages.

Section 43. Limitation of action for damages. - No damages can be recovered for acts of infringement committed more than four years
before the institution of the action for infringement.

Section 44. Damages not recoverable for want of notice or marking. - Damages cannot be recovered for acts of infringement
committed before the infringer had actual notice of the patent, unless the patentee or those exploiting the invention on his behalf or under
his authorization have given notice to the public that the machine, device, articles or process is patented either by placing thereon the
words "Philippines Patent" with the number of the patent, or when from the nature of the article this cannot reasonably be done, by
placing such notice on the package or container in which the device or article is supplied to the public, or is descriptive or advertising
matter used in connection with the patented machine, device, article or process.

Section 45. Defenses in action for infringement. - In an action for infringement the defendant, in addition to other defenses available to
him, may show the invalidity of the patent or any claim thereof on any of the grounds on which a petition of cancellation can be brought
under section twenty-eight, Chapter VII hereof.

Section 46. Patent found invalid to be cancelled. - If the court shall find the patent or any claim thereof invalid, the Director shall, on
certification of the final judgment to the Office, issue an order cancelling the patent or the claims found invalid, and shall publish a notice
thereof in the Official Gazette.

Section 47. Assessors in infringement action. - Two or more assessors may be appointed by the court. The assessors shall be so
qualified by the necessary scientific and technical knowledge required by the subject matter in suit. Either party may, as a preliminary
question, challenge the fitness of any assessor to sit in an action.

Each assessor shall receive a compensation in an amount to be fixed by the court and advanced by the complaining party, and thereafter to
be taxed as costs in favor of the prevailing party.

Section 48. Criminal action for repetition of infringement. - If infringement is repeated by the infringer or by anyone in connivance
with him after final judgment of the court against the infringer, the parties liable shall, without prejudice to further civil action, be punished
by a fine not exceeding ten thousand pesos and imprisonment not exceeding five years, or both such fine and imprisonment in the
discretion of the court, in a criminal action instituted for the purpose. The criminal action herein provided shall prescribed in two years.

Section 49. Appeal. - Appeal may be taken from the judgment of the court in the civil and criminal actions herein provided in the same
manner as in other actions.

CHAPTER XI - Assignment and Transmission of Rights

Section 50. Transmission of rights. - Patents and the inventions covered thereby shall be protected as and have the applicable rights of
other property. Inventions and any rights, title or interest in and to patents and inventions covered thereby may be assigned, or transmitted
by inheritance or bequest.
Section 51. Assignment of inventions. - An assignment may be on the entire right, title or interest in and to the patent and the invention
covered thereby, or of an undivided share of the entire patent and invention in which event the parties become joint owners thereof. An
assignment may be limited to a specified territory.

Section 52. Form of assignment. - The assignment must be in writing, acknowledged before a notary public or other officer authorized
to administer oaths or perform notarial acts and certified under the hand and official seal of the notary or other officer.

Section 53. Recording. - The Director shall record assignment, licenses and other instruments relating to any right, title or interest in and
to inventions, and patents or inventions covered thereby, which are presented in due form to the Office for registration, in books and
records kept for the purpose. The original document together with a signed duplicate thereof shall be filed, but if the original is not
available, an authenticated copy thereof in duplicate may be filed. Upon recording, the Director shall retain the duplicate, and return the
original or the authenticated copy to the party filing with a notation of the fact of record. Notice of the recording shall be published in the
Official Gazette.

Such instruments shall be void as against any subsequent purchaser or mortgagee for a valuable consideration and without notice unless it
is recorded in the Office within three months from the date thereof, or prior to the subsequent purchase or mortgage.

Section 54. Rights of joint owners. - If two or more persons jointly own a patent and the invention covered thereby either by the issuing
of the patent to them jointly or by reason of the assignment of an undivided share in the patent and invention or by reason of the
succession in title to such share, each of the joint owners, shall be entitled to personally make, use, or sell the invention for his own profit,
subject to any contract or agreement, but neither of the owners shall be entitled to grant licenses or to assign his right, title or interest or
part thereof without the consent of the other owner or owners, or without proportionately dividing the proceeds with the other owner or
owners.

CHAPTER XII - Designs

Section 55. Industrial designs. - Any new and original creation relating to the features of shape, pattern, configuration, ornamental, or
artistic appearance of an article or industrial product may be protected as an industrial design by the author in the same manner and subject
to the same provisions and requirements as relate to patents for inventions insofar as they are applicable, except as otherwise hereinafter
provided.

Section 56. Six months publication. - The period of one year specified in section nine, Chapter II, and section fifteen, Chapter III,
hereof, for inventions shall be six months in the case of designs.

Section 57. Notice of registration shall be published. - Notice of the registration of the design shall be published in the Official
Gazette.

Section 58. Term and extension thereof . - The term of the design registration shall be five years from the date of registration.

Before the expiration of the five-year term upon payment of the required fee, or within a further time thereafter not to exceed six months
upon payment of the surcharge, the owner of the registration may apply for an extension for an additional five years. The application for
extension must be accompanied by an affidavit showing that the design is in commercial or industrial use in the Philippines or satisfactorily
explaining non-use. In a similar manner an extension for a third five-year period may be obtained.

Section 59. Marking. - The marking required by section forty-four, Chapter X, hereof, shall be "Philippines Design Registration," or
appropriate abbreviation, and the number of the registration.

Section 60. Infringement. - Infringement of a design registration shall consist in unauthorized copying of the registered design for the
purpose of trade or industry in the article or product and in the making, using or selling of the article or product copying the registered
design. Identity or substantial identity with the registered design shall constitute evidence of copying.

CHAPTER XIII - Review of Orders or Decisions of Director

Section 61. Appeal from the action of Director. - The applicant for a patent or for the registration of a design, any party to a proceeding
to cancel a patent or to obtain a compulsory license, and any party to any other proceeding in the Office may appeal to the Supreme Court
from any final order or decision of the Director.

Section 62. Stay. - A petition for review of any order or decision of the Director rejecting in whole or in part an application for a patent or
registration of a design, shall not stay any order or decision of the Director in respect of any other applications then pending for a patent or
design registration; but the Director shall proceed to act on such other applications without regard to such petition unless the Supreme
Court shall otherwise direct.

Section 63. How appeal is perfected. - An appeal from an order or decision of the Director shall be perfected by filing with the Director
a notice of appeal and the payment of the required appeal fee and filing with the Supreme Court a petition for review, within thirty days
from notice of the order or decision appealed from.
Section 64. Contents and notice of petition. - The petition shall contain a summary statement of the issues involved and the reasons
relied upon for allowance of a review. Copies of the petition shall be served upon the Director and all other parties in interest.

Section 65. Docketing fee and deposits for costs. - Upon filing the petition for review, the petitioner shall pay to the clerk of the
Supreme Court the docketing fee and shall deposit the sum of one hundred pesos for costs.

Section 66. Elevation of copy of record. - Upon the filing of the petition, notice thereof shall be served by the clerk of the Supreme
Court upon the Director, who, within thirty days thereafter, shall certify and forward to the Supreme Court a copy of the record as the
same appears in this Office.

Section 67. Answer of respondent. - Upon receipt of the record, the clerk of the Supreme Court shall serve notice upon the Director and
all other parties in interest, requiring them to answer within ten days from service. Copies of such answer shall served upon the petitioner.

Section 68. Power of court. - The Supreme Court may, on petition filed within five days after the filing of the answer, allow the parties to
adduce additional evidence material to the matter at issue, which shall constitute a supplementary record to be considered in connection
with the record on appeal.

Section 69. Representation by Solicitor General. - In all appeals from an order or decision of the Director the Solicitor General shall
appeal on behalf of the Director.

Section 70. Briefs on appeal. - Upon receipt of the answer to the petition or upon conclusion of the presentation of additional evidence,
the clerk of the Supreme Court shall notify the parties, and the petitioner, within thirty days from such notice, shall file twenty copies of his
brief upon the adverse parties and, within thirty days from such service, the adverse parties shall file twenty copies of their brief together
with proof of service of five copies thereof upon the petitioner.

Section 71. Inclusion in calendar. - Upon the filing of the respondent's brief, or after the expiration of the time for its filing, the case
shall be included in the regular calendar, unless the court advances the hearing for special cause shown.

Section 72. Oral argument, its duration. - Each party is entitled to one hour for oral argument, extendible in the discretion of the court.

Section 73. Rules of Court applicable. - In all other matters not herein provided, the applicable provisions of the Rules of Court shall
govern.

CHAPTER XIV - Penalty for False Marking

Section 74. Penalty for false marking. - Any person who falsely represents or indicates that any device, article or product made or sold
by him is patented, or is the subject of a registered design, by making or having on the device, article or product, or on their containers or
packages, or using in advertising or displays used in connection with them, or with any process, words expressing or implying that the
device, article, product or process is patented or registered, shall be subject to a fine of not less than one hundred pesos nor more than one
thousand pesos, or imprisonment for not less than one month nor more than one year, or both, in the discretion of the court. Actions
hereunder shall prescribe in two years.

Section 75. Fees. - The following fees shall be paid:

For filing an application for patent, which shall include the cost of publication in the Official Gazette, two hundred pesos;

For annual fees due at the beginning of the fifth and each succeeding year, one hundred pesos each year;

For surcharge for delayed payment of an annual fee, twenty-five pesos;

For reinstating lapsed patent, one hundred pesos;

For filing a petition for cancellation, except when filed by the Solicitor General, fifty pesos;

For filing a petition for a compulsory license, one hundred pesos;

For copies of records of the Office, two pesos per photostat sheet, one peso per hundred words of typewritten copy;

For each certification of copy of any records, ten pesos;

For recording assignments, and other documents relating to title, and license, ten pesos;

For notice of appeal from the order or decision of the Director; twenty-five pesos;

For filing application for registration of a design, fifty pesos;


For renewing design registration, fifty pesos;

For surcharge for delayed renewal of design registration, twenty pesos; and

For services not otherwise specified, the Director shall provide, by regulation, the fees therefor.

CHAPTER XVI - Miscellaneous

Section 76. Certain priority for filing application extended. - The rights of priority provided by section nine, Chapter II; section
fifteen, Chapter III; and section fifty-six, Chapter XII hereof for the filing of applications for patent for inventions and designs, which
rights had not expired on the eighth day of December, nineteen hundred and forty-one, or which rights have arisen since the eighth day of
December, nineteen hundred and forty-one, are extended until the first day of July, nineteen hundred and forty-eight, in favor of the
citizens of the Philippines or citizens or subjects of countries which have extended, or which now extend, or which within said period
ending the first day of July, nineteen hundred and forty-eight, shall extend substantially reciprocal privileges to citizens of the Philippines.

Section 77. Disqualification of officers and employees from acquiring patents and design registrations . - All officers and
employees of the Office shall not, during their employment or for one year thereafter, apply for a grant of patent or for the registration of a
design, or acquire, directly or indirectly, except by hereditary succession, any patent of invention or design registration, or any right, title or
interest therein.

Section 78. Rules and regulations. - The Director subject to the approval of the Secretary of Justice, shall promulgate the necessary rules
and regulations, not inconsistent with law, for the conduct of all business in the Patent Office.

Section 79. Records to be public. - The records of the Office shall be open to public inspection, and any person may obtain an
authenticated copy thereof on payment of the prescribed fees.

Section 80. Repealing clause. - Acts Numbered Twenty-two hundred and thirty-five, Twenty-seven hundred and ninety-three, as
amended, and all other acts, or parts of acts, inconsistent herewith, are hereby repealed.

Section 81. Reservation of prior rights. - Any rights acquired under laws existing prior to the taking effect of this Act are hereby
respected and preserved.

Section 82. Appropriation. - The sum of seventy-five thousand pesos, or so much thereof as may be necessary, is hereby appropriated out
of any funds in the National Treasury not otherwise appropriated, for the initial expenses of the Office, including organization expenses,
salaries, supplies, equipment, and other sundry expenses until June thirtieth, nineteen hundred and forty-eight.

Section 83. Effective date. - This Act shall take effect on its approval.

Approved: June 20, 1947


REPUBLIC ACT No. 3720

AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS, AND COSMETICS BEING MADE
AVAILABLE TO THE PUBLIC BY CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALL
ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO.

CHAPTER I
Title

Section 1. This Act shall be known as the "Food, Drug, and Cosmetic Act."

CHAPTER II
Declaration of Policy

Section 2. It is hereby declared the policy of the State to insure safe and good quality supply of food, drug and cosmetic, and to regulate
the production, sale, and traffic of the same to protect the health of the people.

Section 3. In the implementation of the foregoing policy, the Government shall in accordance with the provisions of this Act:

(a) Establish standards and quality measures for food, drug, and cosmetic.

(b) Adopt measures to insure pure and safe supply of food, drug, and cosmetic in the country.

CHAPTER III
Creation of the Food and Drug Administration

Section 4. To carry out the provisions of this Act, there is hereby created an office to be called the Food and Drug Administration in the
Department of Health. Said Administration shall be under the Office of the Secretary and shall have the following functions, powers and
duties:

(a) To administer and supervise the implementation of this Act and of the rules and regulations issued pursuant to the same.

(b) To provide for the collection of samples of food, drug and cosmetic.

(c) To analyze and inspect food, drug and cosmetic in connection with the implementation of this Act.

(d) To establish analytical data to serve as basis for the preparation of food, drug and cosmetic standards, and to recommend
standards of identity, purity, quality and fill of container.

(e) To issue certificate of compliance with technical requirements to serve as basis for the issuance of license and spot-check for
compliance with regulations regarding operation of food, drug and cosmetic manufacturers and establishments.

(f) To levy, assess and collect fees for inspection, analysis and testing of products and materials submitted in compliance with the
provisions of this Act.

(g) To certify batches of anti-biotic and anti-biotic preparations in compliance with the provisions of this Act.

Section 5. The Food and Drug Administration shall have the following Divisions:

(a) Inspection and Licensing Division, which shall have charge of the inspection of food, drug, and cosmetic establishments
engaged in their manufacture and sale.

(b) Laboratory Division, which shall conduct all the tests, analyses and trials of products covered by this Act.

Section 6. The Food and Drug Administration shall have a Food and Drug Administrator who shall be appointed by the Secretary of
Health subject to the Civil Service rules and regulations. The compensation of said official shall be determined by the Secretary of Health.

Section 7. The Secretary of Health shall provide for the additional personnel needed to carry out the functions and duties of the Food and
Drug Administration.

Section 8. The powers, functions and duties of the Division of Food and Drug Testing of the Bureau of Research and Laboratories and
the Board of Food Inspection, all personnel in the Bureau of Health Services who are engaged in food and drug control work, together
with all their equipment, supplies, records, files, personnel and balance of appropriations are transferred to the Food and Drug
Administration.
CHAPTER IV
Board of Food and Drug Inspection

Section 9. The Board of Food Inspection is hereby converted into the Board of Food and Drug Inspection which shall consist of:

(a) A representative of the Department of Health to be designated by the Secretary of Health, as Chairman;

(b) A representative of the Department of Agriculture and Natural Resources;

(c) A representative of the Department of Commerce and Industry;

(d) An authorized designate of the Commissioner of Customs;

(e) An authorized representative of the Office of the Solicitor-General;

(f) A technical member to be designated by the Food and Drug Administrator with the approval of the Secretary of Health.

(g) The President of the Philippine Medical Association of his authorized representative;

(h) The President of the Philippine Dental Association or his authorized representative; and

(i) The President of the Philippine Pharmaceutical Association or his authorized representative.

Each member of the Board as well as the Board secretary shall receive a per diem of twenty pesos per meeting, hearing or investigation
actually attended, but in no case shall the total per diem exceed two hundred pesos each per month.

It shall be the duty of the Board, conformably with the rules and regulations, to hold hearings and conduct investigations relative to matters
touching the administration of this Act, to investigate processes of food, drug and cosmetic manufacture and to submit reports to the Food
and Drug Administrator, recommending food and drug standards for adoption. Said Board shall also perform such additional functions,
properly within the scope of the administration hereof, as may be assigned to it by the Food and Drug Administrator. The decisions of the
Board shall be advisory to the Food and Drug Administrator.

CHAPTER V
Definitions

Section 10. For the purposes of this Act, the term:

(a) "Board" means the Board of Food and Drug Inspection.

(b) "Secretary" means the Secretary of Health.

(c) "Department" means the Department of Health.

(d) "Person" includes individual, partnership, corporation and association.

(e) "Food" means (1) articles used for food or drink for man, (2) chewing gum, and (3) articles used for components of any such
article.

(f) "Drug" means

(1) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United
States, or official National Formulary, or any supplement to any of them; and

(2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other
animals; and

(3) articles (other than food) intended to affect the structure or any function of the body of man or animals; and

(4) articles intended for use as a component of any articles specified in clauses (1), (2), or (3), but not include devices or
their components, parts, or accessories.

(g) "Device" means instruments, apparatus, or contrivances, including their components, parts, and accessories, intended

(1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; or

(2) to affect the structure or any function of the body of man or animals.
(h) "Cosmetic" means

(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human
body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and

(2) articles intended for use as a component of any such articles.

(i) "Label" means a display of written, printed, or graphic matter upon the immediate container of any article and a requirement
made by or under authority of this Act that any word, statement, or other information appearing on the label shall not be
considered to be complied with unless such word, statement, or other information also appears on the outside container or
wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.

(j) "Immediate container" does not include package liners.

(k) "Labeling" means all labels and other written, printed, or graphic matter

(1) upon any article or any of its containers or wrappers, or

(2) accompanying such article.

(l) "New drugs" mean:

(1) any drug the composition of which is such that said drug is not generally recognized, among experts qualified by
scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed,
recommended, or suggested in the labeling thereof.

(2) any drug the composition of which is such that said drug, as a result of investigations to determine its safety for use
under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to
a material extent or for a material time under such conditions.

(m) If an article is alleged to be misbranded because the labeling is misleading, then in determining whether the labeling is
misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word,
design, device, or any combination thereof, but also the extent to which the labeling fails to reveal facts material in the light of
such representations or material with respect to consequences which may result from the use of the article to which the labeling
relates under the conditions of use prescribed in the labeling thereof or under such conditions of use as are customary or usual.

(n) "Food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or
indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended
for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and
including any source of radiation intended for any such use), if such substance is not generally recognized, among experts
qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures
to be safe under the conditions of its intended use.

CHAPTER VI
Prohibited Acts and Penalties

PROHIBITED ACTS

Section 11. The following acts and the causing thereof are hereby prohibited:

(a) The manufacture, sale, offering for sale or transfer of any food, drug, device or cosmetic that is adulterated or misbranded.

(b) The adulteration or misbranding of any food, drug, device, or cosmetic.

(c) The refusal to permit entry or inspection as authorized by Section twenty-seven hereof or to allow samples to be collected.

(d) The giving of a guaranty or undertaking referred to in Section twelve (b) hereof which guaranty or undertaking is false, except
by a person who relied upon a guaranty or undertaking to the same effect signed by, and containing the name and address of, the
person residing in the Philippines from whom he received in good faith the food, drug, device, or cosmetic or the giving of a
guaranty or undertaking referred to in Section twelve (b) which guaranty or undertaking is false.

(e) Forging, counterfeiting, simulating, or falsely representing or without proper authority using any mark, stamp, tag label, or
other identification device authorized or required by regulations promulgated under the provisions of this Act.
(f) The using by any person to his own advantage, or revealing, other than to the Secretary or officers or employees of the
Department or to the courts when relevant in any judicial proceeding under this Act, any information acquired under authority of
Section nine, or concerning any method or process which as a trade secret is entitled to protection.

(g) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any
other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not
the first sale) and results in such article being adulterated or misbranded.

(h) The use, on the labeling of any drug or in any advertising relating to such drug, of any representation or suggestion that an
application with respect to such drug is effective under Section twenty-one hereof, or that such drug complies with the provisions
of such section.

(i) The use, in labeling, advertising or other sales promotion of any reference to any report or analysis furnished in compliance
with Section twenty-six hereof.

PENALTIES

Section 12.

(a) Any person who violates any of the provisions of Section eleven hereof shall, upon conviction, be subject to imprisonment of
not less than six months and one day, but not more than five years, or a fine of not less than one thousand pesos, or both such
imprisonment and fine, in the discretion of the Court.

(b) No person shall be subject to the penalties of subsection (a) of this section

(1) for having sold, offered for sale or transferred any article and delivered it, if such delivery was made in good faith,
unless he refuses to furnish on request of the Board of Food and Drug Inspection or an officer or employee duly
designated by the Secretary, the name and address of the person from whom he purchased or received such article and
copies of all documents, if any there be, pertaining to the delivery of the article to him;

(2) for having violated Section eleven (a) if he established a guaranty or undertaking signed by, and containing the name
and address of, the person residing in the Philippines from whom he received in good faith the article, or

(3) for having violated Section eleven (a), where the violation exists because the article is adulterated by reason of
containing a coal-tar color not permissible under regulations promulgated by the Secretary under this Act, if such person
establishes a guaranty or undertaking signed by, and containing the name and address, of the manufacturer of the coal-
tar color, to the effect that such color is permissible, under applicable regulations promulgated by the Secretary under
this Act.

(c) Any article of food, drug, device, or cosmetic that is adulterated or misbranded when introduced into the domestic commerce
may be seized and held in custody pending proceedings pursuant to Section twenty-six (d) hereof, without a hearing or court
order, when the Secretary has probable cause to believe from facts found by him or any officer or employee of the Food and
Drug Administration that the misbranded article is dangerous to health, or that the labeling of the misbranded articles is
fraudulent, or would be in a material respect misleading to the injury or damage of the purchaser or consumer.

CHAPTER VII
Definition and Standards for Food

Section 13. Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he
shall, upon recommendation of the Food and Drug Administrator, promulgate regulations fixing and establishing for any food, under its
common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, and/or
reasonable standards of fill of container:

Provided, That no definition and standard of identity and no standard of quality shall be established for fresh or dried fruits, fresh
or dried vegetables.

ADULTERATED FOOD

Section 14. A food shall be deemed to be adulterated:

(a)

(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the
substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of
such substance in such food does not ordinarily render it injurious to health;
(2) if it bears or contains any added poisonous or added deleterious substance other then one which is a pesticide
chemical in or a raw agricultural commodity for which tolerances have been established and it conforms to such
tolerances;

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food:

(4) if it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with
filth, or whereby, it may have been rendered injurious to health;

(5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by
slaughter;

(6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the
contents injurious to health.

(b)

(1) If any valuable constituent has been, in whole or in part, omitted or abstracted therefrom and same has not been
substituted by any healthful equivalent of such constituent;

(2) if any substance injurious to health has been added or substituted;

(3) if damage or inferiority has been concealed in any manner; and

(4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce
its quality or strength, or make it appear better or of greater value than it is.

(c) If it bears or contains a coal-tar color other than one which is permissible under existing regulations;

(d) If it is confectionery, and it bears or contains any alcohol or non-nutritive article or substance except harmless coloring,
harmless flavoring, harmless resinous glass less coloring, harmless flavoring, harmless resinous glass not in excess of four-tenths
of one per centum, natural gum and pectin:

Provided, That this paragraph shall not apply to any confectionery by reason of its containing less than one-half of one
per centum by volume of alcohol derived solely from the use of flavoring extracts, or to any chewing gum by reason of
its containing harmless non-nutritive masticatory substances;

(e) If it is oleomargarine or margarine or butter and any of the raw material used therein consists in whole or in part of any filthy,
putrid or decomposed substance, or such oleomargarine, margarine or butter is otherwise unfit for food.

MISBRANDED FOOD

Section 15. A food shall be deemed to be misbranded:

(a) If its labeling is false or misleading in any particular;

(b) If it is offered for sale under the name of another food;

(c) If it is an imitation of another food, unless its label bears in types of uniform size and prominence, the word "imitation" and,
immediately thereafter, the name of the food imitated;

(d) If its container is so made, formed, or filled as to be misleading;

(e) If in package form unless it bears a label containing

(1) the name and place of business of the manufacturer, packer, distributor; and

(2) an accurate statement of the quantity of the contents in terms of weight, measure, numerial count:

Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to
small packages shall be established, by regulations prescribed by the Secretary.

(f) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not
prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the
labeling), and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions
of purchase and use.
(g) If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed unless

(1) it conforms to such definition and standard, and

(2) its label bears the name of the food specified in the definition and standard, and, insofar as may be required by such
regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food.

(h) If it purports to be or is represented as

(1) A food for which a standard of quality has been prescribed by regulations as provided by Section thirteen, and its
quality falls below such standard, unless its label bears, in such manner and form as such regulations specify, a statement
that it falls below such standard; or

(2) a food for which a standard or standards of fill of container have been prescribed by regulations as provided by
Section thirteen and it falls below the standard of fill of container applicable thereto, unless its label bears, in such
manner and form as such regulations specify, statement that if falls below such standard.

(i) If it is not subject to the provisions of paragraph (g) of this section unless its label bears

(1) the common or usual name of the food, if there be any, and

(2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that
spices, flavorings, and colorings, other than those sold as such, may be designated as spices, flavorings and colorings
without naming each:

Provided, That to the extent that compliance with the requirements of clause (2) of this paragraph is
impracticable or results in deception or unfair competition, exemptions shall be established by regulations
promulgated by the Secretary.

(j) If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin,
mineral and other dietary properties as the Secretary determined to be, and by regulations prescribes as necessary in order fully to
inform purchasers as to its value for such uses.

(k) If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that
fact:

Provided, That to the extent that compliance with the requirements of this paragraph is impracticable, exemptions shall be
established by regulations promulgated by the Secretary. The provisions of this paragraph or paragraphs (g) and (i) with
respect to artificial coloring shall not apply in the case of butter, cheese or ice cream.

Emergency Permit Control

Section 16.

(a) Whenever the Secretary finds after investigation that the sale or distribution in domestic commerce of any class of food may
be injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered domestic
commerce, he shall promulgate regulations also in accordance with the recommendations of the Food and Drug Administrator
providing for the issuance, to manufacturers, processors, or packers of such class of food in such locality, of permits to which
shall be attached such conditions governing the manufacture, processing, or packing of such class of food, for such temporary
period of time, as may be necessary to protect the public health; and after the effective date of such regulations, and during such
temporary period, no person shall manufacture, sell or offer for sale or transfer any such food manufactured, processed, or
packed by any such manufacturer, processor, or packer unless such manufacturer, processor or packer holds a permit issued by
the Secretary as provided by such regulations.

(b) The Secretary is authorized to suspend immediately upon notice any permit issued under authority of this section if it is found
that any of the conditions of the permit have been violated.

(c) Any officer or employee duly designated by the Secretary shall have access to any factory or establishment, the operator of
which holds a permit from the Secretary, for the purpose of ascertaining whether or not the conditions of the permit are being
complied with, and denial of access for such inspection shall be ground for suspension of the permit until such access is freely
given by the operator.

Tolerances for Poisonous Ingredients in Food

COAL-TAR COLOR FOR FOOD


Section 17.

(a) Any poisonous or deleterious substance added to any food, shall be deemed to be unsafe except when such substance is
required or cannot be avoided in its production or manufacture. In such case the Secretary shall promulgate, upon
recommendation of the Food and Drug Administrator, regulations limiting the quantity therein to such extent as he finds
necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe. In
determining the quantity of such added substance to be tolerated in different articles of food the Secretary shall take into account
the extent to which the use of such article is required or cannot be avoided in the production or manufacture of such article and
the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.

(b) The Secretary shall, upon recommendation of the Food and Drug Administrator, promulgate regulations providing for the
listing of coal-tar colors which are harmless and suitable for use in food.

CHAPTER VIII
Drug and Devices

ADULTERATED DRUGS AND DEVICES

Section 18. A drug or device shall be deemed to be adulterated:

(a)

(1) If it consists in whole or in part of any filthy, putrid, decomposed substance; or

(2) if it has been prepared, packed, or held under insanitary conditions contaminated with filth or whereby it may have
been rendered injurious to health; or

(3) if it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may
render the contents injurious to health; or

(4) if it is a drug and it bears or contains, for purposes of coloring only, a coal-tar color other than a permissible one.

(b) If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength
differs from, or its quality or purity falls below, the standard set forth in such compendium, except that whenever tests or
methods of assay as are prescribed are, in the judgment of the Secretary, insufficient for the making of such determination the
Secretary, shall promulgate, upon recommendation of the Food and Drug Administrator, regulations prescribing appropriate tests
or methods of assay in accordance with which such determination as to strength, quality or purity shall be made. No drug defined
in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength,
quality or purity in strength, quality, or purity from such standards is plainly stated on its label.

(c) If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or its purity of quality falls
below, that which it purports or its represented to possess.

(d) If it is a drug and any substance has been

(1) mixed or packed therewith so as to reduce its quality or strength or

(2) substituted wholly or in part therefor.

MISBRANDED DRUGS AND DEVICES

Section 19. A drug or device shall be deemed to be misbranded:

(a) If its labeling is false or misleading in any particular.

(b) If in a package form unless it bears a label containing

(1) the name and place of business of the manufacturer, packer, or distributor;

(2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count:

Provided, That reasonable variations shall be permitted and exemptions as to small packages shall be established by
regulations prescribed by the Secretary.

(c) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not
prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the
labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions
of purchase and use.

(d) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-
eucaine, bromal, cannabis, cabromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, or
sulfonmethane; or any chemical derivative of such substance, which derivative has been recommended by the Secretary, after
investigation, and by regulations, designated as, habit forming; unless its label bears the name, and quantity or proportion of such
substance or derivative and in juxtaposition therewith the statement "Warning May be habit forming."

(e) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears

(1) the common or usual name of the drug, if such there be; and

(2) in case it is fabricated from two or more ingredients, the common or usual name of each active ingredient, including
the quantity, kind, and proportion of any alcohol, and also including whether active or not, the name and quantity of
proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine,
hyoscyamine, arsenic, digitalis, digitalis glucosides mercury, ouabain, strophantin, strychnine, thyroid, or any derivative or
preparation of any such substances, contained therein:

Provided, That where compliance with this paragraph in impracticable, exemptions shall, upon recommendation
of the Food and Drug Administrator, be established by regulations promulgated by the Secretary.

(f) Unless its labeling bears

(1) adequate directions for use; and

(2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to
health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as
necessary for the protection of users:

Provided, That where any requirement of clause (1) of this paragraph, as applied to any drug or device, is not
necessary for the protection of the public health, the Secretary shall, upon recommendation of the Food and
Drug Administrator, promulgate regulations exempting such drug or device from such requirement.

(g) If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as
prescribed therein:

Provided, That the method of packing may be modified with the consent of the Secretary.

(h) If it has been found by the Secretary to be a drug liable to determination, unless it is packaged in such form and manner, and
its label bears a statement of such precautions, as the Secretary shall by regulations require as necessary for the protection of the
public health.

(i)

(1) If it is a drug and its container is so made, formed, or filled as to be misleading; or

(2) if it is an imitation of another drug; or

(3) if it is offered for sale under the name of another drug.

(j) If it is dangerous to health when used in the dosage, or with the frequency of duration prescribed, recommended or suggested
in the labeling thereof.

(k) If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin, streptomycin,
chlortetracycline, chloramphenicol, bacitracin, or any other anti-biotic drug, or any derivative thereof, unless

(1) it is from a batch with respect to which a certificate of release has been issued pursuant to Section twenty-two (a),
and

(2) such certificate of release is in effect with respect to such drug:

Provided, That this paragraph shall not apply to any drug or class of drugs exempted by regulations promulgated
under Section twenty-one (a), (b) and (c).

EXEMPTION IN CASE OF DRUGS AND DEVICES


Section 20.

(a) The Secretary is hereby directed to promulgate regulations exempting from any labeling or packaging requirement of this Act
drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial
quantities at establishments other than those where originally processed or packed, on condition that such drugs and devices are
not adulterated or misbranded, under the provisions of this Act upon removal from such processing, labeling, or repacking
establishment.

(b)

(1) Drugs intended for use by man which:

(A) are habit-forming

(B) because of its toxicity or other potentiality for harmful effect, or the method of its use is not safe for use
except under the supervision of a practitioner licensed by law to administer such drug;

(C) are new drugs whose application are limited to investigational use shall be dispensed only (1) upon a written
prescription of a practitioner licensed by law to administer such drug, or (2) upon an oral prescription of such
practitioner which is reduced promptly to writing and filed by the pharmacist, or (3) by refilling any such
written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or
by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug
contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being
misbranded while held for sale.

(2) Any drug dispensed by filling or refilling a written prescription of a practitioner licensed by law to administer such
drug shall be exempt from the requirements of Section nineteen, except paragraphs (a), (1), (2) and (3), and the
packaging requirements of paragraphs (g) and (h), if the drug bears a label containing the name and address of the
dispenser, the serial number and date of the prescription or of its filling, the name of prescriber, and, if stated in the
prescription the name of the patient, and the directions of use and cautionary statements, if any, contained in such
prescription.

(3) The Secretary may by regulation remove drugs subject to Section nineteen (d) and Section twenty-one from the
requirements of Subsection (b) (1) of this Section, when such requirements are not necessary for the protection of the
public health.

(4) A drug which is subject to subsection (b) (1) of this section shall be deemed to be misbranded if at any time prior to
dispensing, its label fails to bear the statement "Caution: Food, Drug and Cosmetics Law prohibits dispensing without
prescription." A drug to which subsection (b) (1) of this Section does not apply shall be deemed to be misbranded if at
any time prior to dispensing, its label bears the caution statement quoted in the preceding sentence.

NEW DRUGS

Section 21.

(a) No person shall manufacture, sell, offer for the sale or transfer any new drug, unless an application filed pursuant to
subsection (b) is effective with respect to such drug.

(b) Any person may file with the Secretary, thru the Food and Drug Administration, an application with respect to any drug
subject to the provisions of subsection (a). Such persons shall permit to the Secretary thru the Food and Drug Administration as a
part of the application

(1) full reports of investigations which have been made to show whether or not such drug is safe for use;

(2) a full list of the articles used as components of such drug;

(3) a full statement of the composition of such drug;

(4) a full description of the methods used in and the facilities and controls used for the manufacture, processing, and
packing of such drug;

(5) such samples of such drug and of the articles used as components hereof as the Secretary may require; and

(6) specimens of the labeling proposed to be used for such drug.


(c) Within one hundred and eighty days after the filing of an application under this subsection, or such additional period as may
be agreed upon by the Secretary and the applicant, the Secretary shall either

(1) approve the application if he then finds that none of the grounds for denying approval specified in subsection (d)
applies, or

(2) give the applicant notice of an opportunity for a hearing before the Secretary under subsection (d) on the question
whether such application is approvable.

(d) If the Secretary finds, after due notice to the applicant and giving him an opportunity for a hearing, that

(1) the investigation, reports of which are required to be submitted to the Secretary pursuant to subsection (b), do not
include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the
conditions prescribed, recommended, or suggested in the proposed labeling thereof;

(2) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is
safe for use under such conditions;

(3) the methods used in, and the facilities and controls used for the manufacture, processing, and packing of such drug
are inadequate to preserve its identity, strength, quality, and purity; or

(4) upon the basis of the information submitted to him as part of the application, or upon the basis of any other
information before him with respect to such drug, he has insufficient information to determine whether such drug is
safe for use under such conditions; or

(5) evaluated on the basis of the information submitted to him as part of the application, and any other information
before him with respect to such drug, there is a lack of substantial evidence that the drug will have the effect it purports
or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling
thereof; or

(6) based on a fair evaluation of all material facts, such labeling is false or misleading in any particular; he shall issue an
order refusing to approve the application.

(e) The effectiveness of an application with respect to any drug shall, after due notice and opportunity for hearing to the applicant,
by order of the Secretary be suspended if the Secretary finds

(1) that clinical experience, tests by new methods, or tests by methods not deemed reasonably applicable when such
application became effective show that such drug is unsafe for use under the conditions of use upon the basis of which
the application became effective, or

(2) that the application contains any untrue statement of a material fact. The order shall state the findings upon which it
is based.

(f) An order refusing to permit an application with respect to any drug to become effective shall be revoked whenever the
Secretary finds that the facts so require.

(g) The Secretary shall promulgate regulations for exempting from the operation of this section drugs intended solely for
investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs.

CHAPTER IX
Certification of Drugs containing Penicillin, Streptomycin, Chlortetracycline, Chloramphenicol or Bacitracin.

Section 22.

(a) The Secretary, pursuant to regulations promulgated by him shall provide for the certification of batches of drugs composed
wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any anti-biotic drug, or
any derivative thereof. A batch of such drug shall be certified if such drug has such characteristics of identity, strength, quality and
purity, as the Secretary prescribes in such regulations as necessary to adequately insure safety and efficacy of use, but shall not
otherwise be certified. Prior to the effective date of such regulations the Secretary, in lieu of certification, shall issue a release for
any batch which, in his judgment, may be released without risk as to the safety and efficacy of its use. Such release shall prescribe
the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as to portions
thereof. For purposes of this section and of Section nineteen (k), the term "anti-biotic drug" means any drug intended for use by
man containing any quantity of any chemical substance which is produced by micro-organism and which has the capacity to
inhibit or destroy micro-organism in dilute solution (including the chemically synthesized equivalent of any such substance).
(b) Whenever in the judgment of the Secretary, the requirements of this section and of Section nineteen (k) with respect to any
drug or class of drugs are not necessary to insure safety and efficacy of use, the Secretary shall promulgate regulations exempting
such drug or class of drugs from such requirements.

(c) The Secretary shall promulgate regulations exempting from the requirement of this section and of Section nineteen (k), (1)
drugs which are to be stored, processed labeled, or repacked at establishments other than those where manufactured, on
condition that such drugs comply with all such requirements upon removal from such establishments; (2) drugs which conform to
applicable standards of identity, strength, quality, and purity prescribed by these regulations and are intended for use in
manufacturing other drugs; and (3) drugs which are intended for investigational use by experts qualified by scientific training and
experience to investigate the safety and efficacy of drugs.

CHAPTER X
Cosmetics

ADULTERATED COSMETICS

Section 23. A cosmetic shall be deemed to be adulterated:

(a) If it bears or contains any poisonous or deleterious substances which may render it injurious to users under the conditions of
use prescribed in the labeling thereof, or under the conditions of use as are customary or usual:

Provided, That this provision shall not apply to coal-tar hair dye, the label of which bears the following legend
conspicuous displayed thereon: "Caution: This product contains ingredients which may cause skin irritation on certain
individuals and a preliminary test according to accompanying directions should first be made. This product must not be
used for dyeing the eyelashes or eyebrows; to do so may cause blindness", and the labeling of which bears adequate
directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term "hair dye" shall
not include eyelash dyes or eyebrow dyes.

(b) If it consists in whole or in part of any filthy, putrid, or decomposed substance.

(c) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health.

(d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents
injurious to health.

(e) If it is not a hair dye and it bears or contains a coal-tar color other than one which is permissible.

MISBRANDED COSMETIC

Section 24. A cosmetic shall be deemed to be misbranded:

(a) If its labeling is false or misleading in any particular.

(b) If in package form unless it bears a label containing

(1) the name and place of business of the manufacturer, packer, or distributor; and

(2) an accurate statement of the quantity of the contents in terms of weight, measure, of numerical count:

Provided, That under reasonable variations shall be permitted and exemptions as to small packages shall be
established by regulations prescribed by the Secretary.

(c) If any word, statement, or other information required by or under authority of this Act, to appear on the label or labeling is
not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the
labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions
of purchase and use.

(d) If its container is so made, formed, or filled as to be misleading.

REGULATIONS MAKING EXEMPTIONS

Section 25. The Secretary shall promulgate regulations exempting from any labeling requirements of this Act cosmetic which are, in
accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those
where originally processed or packed, on condition that such cosmetics are not adulterated or misbranded under the provisions of this Act
upon removal from such processing, labeling, repacking establishment.
CHAPTER XI
General Administration Provisions, Regulations, Hearings and Institution of Criminal Action

Section 26.

(a) Except as otherwise provided in this section, the Secretary of Health shall, upon recommendation of the Food and Drug
Administrator, issue rules and regulations as may be necessary to enforce effectively the provisions of this Act.

(b) The Commissioner of Customs, the Commissioner of Internal Revenue and the Secretary of Health shall jointly prescribe
regulations for the efficient enforcement of the provisions of Section thirty, except as otherwise provided therein. Such
regulations shall be promulgated upon the recommendation of the Food and Drug Administrator and shall take effect at such
time, after due notice, as the Secretary of Health shall determine.

(c) Hearings authorized or required by this Act shall be conducted by the Board of Food and Drug Inspection which shall submit
its recommendation to the Food and Drug Administrator.

(d) When it appears to the Food and Drug Administrator from the report of the Food and Drug Laboratory that any article of
food or any drug, or cosmetic secured pursuant to Section twenty-eight of this Act is adulterated or misbranded, he shall cause
notice thereof to be given to the person or persons concerned and such person or persons shall be given an opportunity to be
heard before the Board of Food and Drug Inspection and to submit evidence impeaching the correctness of the finding or charge
in question.

(e) When a violation of any provisions of this Act comes to the knowledge of the Food and Drug Administrator of such character
that a criminal prosecution ought to be instituted against the offender, he shall certify the facts to the Secretary of Justice through
the Secretary of Health, together with the chemist's report, the findings of the Board of Food and Drug Inspection, or other
documentary evidence on which the charge is based.

(f) Nothing in this Act shall be construed as requiring the Food and Drug Administrator to certify for prosecution pursuant to
sub-paragraph (e) hereof, minor violations of this Act whenever he believes that public interest will be adequately served by a
suitable written notice or warning.

FACTORY INSPECTION

Section 27.

(a) For purposes of enforcement of this Act, officers or employees duly designated by the Secretary, upon presenting appropriate
credentials to the owner, operator, or agent in charge, are authorized

(1) to enter, at reasonable hours, any factory, warehouse, or establishment in which food, drugs, devices or cosmetics are
manufactured, processed, packed or held, for introduction into domestic commerce or are held after such introduction,
or to enter any vehicle being used to transport or hold such food, drugs, devices, or cosmetics, in domestic commerce;
and

(2) to inspect, in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment,
finished and unfinished materials, containers, and labeling therein.

Section 28.

(a) If the officer or employee making any such inspection of a factory, warehouse or other establishment has obtained any sample
in the course of the inspection, upon completion of the inspection and prior to leaving the premises he shall give to the owner,
operator, or agent in charge a receipt describing the samples obtained.

(b) Whenever in the course of any such inspection of a factory or other establishment where food is manufactured, processed, or
packed, the officer or employee making the inspection obtains a sample of any such food, and an analysis is made of such sample
for the purpose of ascertaining whether such food consists in whole or in part of any filthy, putrid or decomposed substance, or is
otherwise unfit for food, a copy of the results of such analysis shall be furnished promptly to the owner, operator, or agent in
charge.

PUBLICITY

Section 29.

(a) The Secretary may cause to be disseminated information regarding food, drugs, devices, or cosmetics in situations involving, in
the opinion of the Secretary, imminent danger to health, or gross deception of the consumer. Nothing in this Section shall be
construed to prohibit the Secretary from collecting, reporting, and illustrating the results of the investigations of the Department.
CHAPTER XII
Imports and Exports

Section 30.

(a) The Commissioner of Customs shall cause to be delivered to the Food and Drug Administration samples taken at random
from every incoming shipment of food, drugs, devices, and cosmetics which are being imported or offered for import into the
Philippines giving notice thereof to the owner or consignee. The quantity of such samples shall be fixed by regulation issued by
the Secretary. If it appears from the examination of such samples or otherwise that

(1) such article has been manufactured, processed, or packed under insanitary conditions, or

(2) such article is forbidden or restricted from sale in the country in which it was produced or from which it was
produced or from which it was exported, or

(3) such article is adulterated, misbranded, or in violation of Section twenty-one, then the Food and Drug Administrator
shall so inform the Commissioner of Customs and such article shall be refused admission, except as provided in
subsection (b) of this section. The Commissioner of Customs shall then cause the destruction of any such article refused
admission unless such article is exported, under regulations prescribed by the Commissioner of Customs, within ninety
days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such
regulations. If the food, drugs, devices, and cosmetics being imported or offered for import into the Philippines arrives
at a port of entry other than Manila, the collection of such samples shall be the responsibility of the Regional Health
Director having jurisdiction over the port of entry and such samples shall be forwarded to the Food and Drug
Administration.

(b) Pending decision as to the admission of an article being imported or offered for import, the Commissioner of Customs may
authorize delivery of such article to the owner or consignee upon execution by him of a good and sufficient bond providing for
the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the Commissioner
of Customs. If it appears to the Secretary that an article included within the provisions of clause (3) of subsection (a) of this
section can, by relabeling or other action, be brought into compliance with the Act or rendered other than a food, drug, device, or
cosmetic, final determination as to admission of such article may be deferred, and upon filing to timely written application by the
owner or consignee, and the execution by him of a bond as provided in the preceding provisions of this subsection, the Secretary
may, in accordance with regulations, authorize the applicant to perform such relabeling or other actions specified in such
authorization with regulations (including destruction or export of rejected articles or portions thereof, as may be specified in the
Secretary's authorization). All such relabeling or other action pursuant to such authorization shall be in accordance with
regulations and be under the supervision of an office or employee of the Bureau of Customs designated by the Commissioner of
Customs and a duly authorized representative of the Food and Drug Administrator.

(c) All expenses (including travel, per diem or subsistence, and salaries) of officers or employees of the Philippines in connection
with the destruction provided for in subsection (a) of this section and the supervision of the relabeling or other action authorized
under the provisions of subsection (b) of this section, the amount of such expenses to be determined in accordance with
regulations, and all expenses in connection with the storage, cargo, or labor with respect to any article refused admission under
subsection (a) of this section, shall be paid by the owner or consignee, and in default of such payment, shall constitute a lien
against any future importations made by such owner or consignee.

(d) A food, drug, device, or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this Act if it

(1) conforms with the specifications of the foreign purchaser,

(2) is not conflict with laws of the country to which it is intended for export, and

(3) is labelled on the outside of the shipping package to show that it is intended for export. But if such article is sold or
offered for sale in domestic commerce, this subsection shall not exempt it from any of the provisions of this Act.

CHAPTER XIII
Financing

Section 31. The amount of one million pesos is hereby appropriated from any funds in the National Treasury not otherwise appropriated
to augment the funds transferred to this Office under Section eight for the implementation of this Act. All income derived from fees
authorized in Section Four of this Act shall accrue to the General Fund.

CHAPTER XIV
Repealing Clause and Effectivity
Section 32. If any provision of this Act or the application of such provision to any person or circumstance is held invalid, the remainder of
this Act or the application of such provision to other persons of circumstances should not be affected thereby.

Section 33. Section eleven hundred and nine to Section eleven hundred twenty-nine of the Administrative Code, and such other laws,
executive orders, rules and regulations inconsistent with the provisions of this Act are repealed.

Section 34. This Act shall take effect upon its approval.

Approved: June 22, 1963.

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