5.

DISCLOSURE AND ENABLEMENT

TRIPS Agreement - Article 29
Conditions on Patent Applicants
1. Members shall require that an applicant for a patent
shall disclose the invention in a manner sufficiently clear
and complete for the invention to be carried out by a
person skilled in the art and may require the applicant to
indicate the best mode for carrying out the invention
known to the inventor at the filing date or, where priority
is claimed, at the priority date of the application.

2. Members may require an applicant for a patent to

provide
information
concerning
the
applicant's
corresponding foreign applications and grants.
IP Code - Section 35. Disclosure and Description of the
Invention. - 35.1. Disclosure. - The application shall
disclose the invention in a manner sufficiently clear and
complete for it to be carried out by a person skilled in the
art. Where the application concerns a microbiological
process or the product thereof and involves the use of a
micro-organism which cannot be sufficiently disclosed in
the application in such a way as to enable the invention to
be carried out by a person skilled in the art, and such
material is not available to the public, the application shall
be supplemented by a deposit of such material with an
international depository institution.
35.2. Description. - The Regulations shall prescribe the
contents of the description and the order of presentation.
(Sec. 14, R.A. No. 165a)

5.2 Speculation and Prophesy

Janssen Pharmaceutica v. Teva Pharms. (2009)
-

5.1 Undue Experimentation

Incandescent Lamp Patent (1985)
-

Sawyer and Man made a broad claim for every

fibrous or textile material, when in fact an
examination of over 6000 vegetable growths
showed that none of them possessed the peculiar
qualities that fitted them for that purpose.
If the description be so vague and uncertain that
no one can tell, except by independent
experiments, how to construct the patent device,
the patent is void.
How would it be possible for a person to know
what fibrous or textile material was adapted to the
purpose of an incandescent conduct except by the
most careful and painstaking experimentation?

DEPOSIT necessary for enablement where the

starting materials (i.e., living cells used to practice
the invention, or cells from which the required
cells can be produced) are (1) not readily available

Patent granted without the result of the animal

testing experiments
Enablement is determined as of the effective filing
date of the patents application.
If the patent claim fails to meet the utility
requirement because it is not useful or operative,
then it also fails to meet the how-to-use aspect of
the enablement requirement.
Only an unproved hypothesis - the specification,
even read in light of the knowledge of those
skilled in the art, does no more than state a
hypothesis and propose testing to determine the
accuracy of that hypothesis

5.3 Doctrine of Sound Prediction

Apotex v. Wellcome Foundation (2002)
-

In re Wands (1988)
-

to the public; OR (2) readily available but it would

require undue experimentation to make the cells of
the invention from the starting materials.
The keyword is undue, not experimentation.
Factors to be considered in determining whether a
disclosure would require undue experimentation:
1. Quantity of the experimentation necessary;
2. Amount of the direction and guidance
presented;
3. Presence or absence of working examples;
4. Nature of the invention;
5. State of the prior art;
6. Relative skill in the art
7. Predictability or unpredictability of the art;
and
8. Breadth of the claims
Not undue experimentation methods needed to
practice the invention were well known

The doctrine balances (1) the public interest in

early disclosure of new and useful inventions,
even before their utility has been fully verified by
tests; and (2) public interest in avoiding the
cluttering of the public domain with useless
patents and granting monopoly rights in exchange
for speculation or misinformation.
Three components:
1. Factual basis for the prediction;
2. Inventor must have at the date of the patent
application an articulable and sound line of
reasoning from which the desired result can be
inferred from the factual basis; and
3. Proper disclosure
Presupposes that further work remains to be done

5.4 Uses of examples in the specification

In re Strahilevitz (1982)
-

We recognize that working examples are desirable

in complex technologies and that detailed
examples can satisfy the statutory enablement
requirement.
Nevertheless, examples are not required to satisfy
enablement.

5.5 Written Description Requirement

Gsell v. Yap-Jue (1909)
-

Doctrine of mechanical equivalents An alteration

in a patented combination which merely
substitutes another old ingredient in the patented
combination, is an infringement of the patent, if
the substitute performs the same function and was
well known at the date of the patent as a proper
substitute for the omitted ingredient.

Godines v. Court of Appeals (1993)

-

Tests to determine infringement:

1. Literal infringement juxtapose the claims of
the patent and the accused product within the
overall context of the claims and
specifications, to determine whether there is
exact identity of all material elements
2. Doctrine of equivalent when a device
appropriates a prior invention by incorporating
its innovative concept and, albeit with some
modification
and
change,
performs
substantially the same function in
substantially the same way to achieve
substantially the same result.

Frank v. Kosuyama (1933)

-

It is obvious that the spindle is not an integral

part of the machine patented by the plaintiffs on
the ground that it was eliminated in their
application.
No infringement no essential part of the machine
manufactured and sold by him, which was
unknown to the public

The Gentry Gallery v. Berkline Corporation (1998)

-

5.7 Definite Claims

Orthokinetics v. Safety Travel (1986)
-

Drawings alone may be sufficient to provide the

written description of the invention.

5.6 Limitations on Amendments

Section 49. Amendment of Application. - An applicant may
amend the patent application during examination:
Provided, That such amendment shall not include new
matter outside the scope of the disclosure contained in the
application as filed. (n)

wherein said front leg portion is so dimensioned

A decision on whether a claim is invalid under
enablement requires a determination of whether
those skilled in the art would understand what is
claimed when the claim is read in light of the
specification.
The phrase so dimensioned is as accurate as the
subject matter permits, automobile being of
various sizes
As long as those of ordinary skill in the art
realized that the dimensions could be easily
obtained, Section 112 required nothing more.

6. OWNERSHIP OF PATENT AND TRANSFER OF RIGHTS

Albana v. Director of Patents (1953)
-

Assignments of patents and inventions covered

thereby may be recorded in books and records kept
for the purposes in the Patent Office if presented
in due form; but the appellant does not ask for the
registration of the alleged agreement, because as it
is not in due form it cannot be recorded, but prays
that the Director compel the applicant-inventor to
acknowledge it

8.1 Priority Date

Boothe v. Director of Patents (1980)
-

Vas-Cath Incorporated v. Mahurkar (1991)

-

Determination of infringement requires: (1) claim

must be properly construed to determine its scope
and meaning; and (2) claims as properly construed
must be compared to the accused devise or
process.

It is imperative that the application be complete in

order that it may be accepted. It is essential to the
validity of Letters Patent that the specifications be
full, definite, and specific.
Petition only complete when they submitted the
additional pages on the Specifications and Claims.

12. PATENT DRAFTING AND CLAIMS ANALYSIS

Merrill v. Yeomans, 94 U.S. 568 (1877)
-

new manufacture of the deodorized heavy

hydrocarbon oils
Prior to Merill claims played a primary role
Court looked into the specifications in
determining the meaning of the claims

Philips v. Awh Corporation (2005)

-

Expert background:

1. Background
2. How invention works
3. Consistent with POSA
4. Particular meaning in the pertinent field
Hierarchy of evidentiary sources
Intrinsic evidence:

1. Words of the claims

2. Specifications
3. Prosecution history and other documents in
the file wrapper
Extrinsic evidence:
1. Not part of the patent; does not have the
specifications virtue of being created at
the time of patent prosecution for the
purpose of explaining the patents scope
and meaning
2. Extrinsic publications may not be written
by a skilled artisan hence will not reflect
the understanding of a skilled artisan in
the field;
3. Expert reports and testimony not
objective since generated at the time of
and for the purpose of litigation;
4. Universe of potential extrinsic evidence of
some marginal relevance that could be
brought to bear on any claim construction
question
5. May be used to change the meaning of
claims in derogation of the intrinsic
evidence, thereby undermining the public
notice functions of patent

Markman v. Westview Instruments, Inc. (1996)

- Prior to Markman patent construction done by
juries
- According to Markman, must be done by the judge
patent claims are legal instruments
- District courts now use specific hearings known as
Markman hearings
- 2-step process
1. Court must construe or interpret the patent
claims - judge
2. Construed claims must be evaluated against
the alleged infringing device or process jury
Teva Pharmaceuticals USA, Inc v. Sandoz, Inc. (2015)
- Claim construction is a question of law
- Lower court decision may be reviewed by
appellate court but if it involves subsidiary factual
facts, then if appealed, the standards applied shall
be for the question of fact

Intrinsic evidence:
1. Claims given their ordinary and customary
meaning for the person ordinarily skilled in the art;
what was actually invented and what the inventor
intended them to cover; preserve the claims
validity (except where the invalidating claim
construction is consistent with the claim language
and specification)
2. Specifications dispositive when the proposed
construction most naturally aligns with the claim;
- describe the manner and process of making and
using the patented invention
a. Described the inventions preferred or sole
embodiment or specifically excludes an
embodiments from the
b. Distinguish prior art or cites particular
advantages over
c. Defines certain terms
3. Prosecution history written record of the
correspondence between the examiner and the
applicant/agent
during
the
examination
(amendments);
- Analogous to the journals of the Congress
- Less helpful compared to the two others
because represents the on-going the
negotiation
- may aid in claim construction in these cases:
a. disclaimed broad definition to overcome
prior art;
b. patentee may have dropped certain claim;
c. amended claims either to broaden or limit
the scope
Extrinsic Evidence not obligatory to be used; only when
helpful
1. Relevant scientific principles
2. Meaning of technical terms
3. State of the prior art
4. Dictionaries
5. Treaties
6. Expert testimony
19. COMPULSORY LICENSING
Price v. United Laboratories (1988)
- The terms and conditions of the compulsory
license were fixed by the Director after a hearing
and careful consideration of the evidence of the
parties and in default of an agreement between
them as to the terms of the license.
- Directors findings that UNILAB has the
capability to use the patented compound in
manufacture is a factual finding supported by a
substantial evidence

The important thing is that such capability was

proven to exist during the hearing of the petition.

Smith Kline v. Court of Appeals (2003)

-

The doctrine of equivalents requires satisfaction of

the function-means-result test, the patentee
having the burden to show that all three
components of such equivalency test are met.

III. PATENTS AND PUBLIC HEALTH

Roma Drug v. Regional Trial Court (2009)
- The unqualified right of private third parties to
import or possess unregistered imported drugs in
the Philippines confirmed by the IRR of the RA
9502.
- The drugs and medicines are deemed introduced
when they have been sold and offered for sale
anywhere else in the world.
- Otherwise, it discriminates, at the expense of
health, against poor Filipinos without means to
travel abroad to purchase less expensive medicines
in favor of their wealthier brethren able to do so.
Less urgently perhaps, but still within the range of
constitutionally protected behavior, it deprives
Filipinos to choose a less expensive regime for
their health case by denying them a plausible and
safe means of purchasing medicines at a cheaper
cost.
Merck KGaA v. Inegra Lifesciences (2005)
- Exemption from infringement extends to all uses
of patented inventions that are reasonable related
to the development and submission of any
information under the FDCA.
- Necessarily includes preclinical studies of
patented compounds that are appropriate
submission to the FDA in the regulatory process.
There is simply no room in the state in excluding
certain information from the exemption on the
basis of the phase of research in which it is
developed or the particular submission in which it
could be included.

V. PATENT AND UNFAIR COMPETITION

Illinois Tool Works v. Independent Ink (2006)
-

Patent does not necessarily confer market

power
Without proof that the patentee had market
power in the relevant market, its conduct at
issue in this case was neither misuse nor an
illegal extension of the patent right.
While price discrimination may provide
evidence of market power, particularly if
buttressed by evidence that the patentee has
charged an above-market price for the tied
package, it is generally recognized that it also
occurs in fully competitive markets.
In all cases involving a tying arrangement, the
plaintiff must prove that the defendant has
market power in the tying product.

Federal Trade Commission v. Actavis (2013)

-

reverse payment settlement agreement

Five set of considerations lead us to conclude
that the FTC should have been given the
opportunity to prove its anti-trust claim:
1. Specific restraint at issue has the
potential for genuine adverse effects on
competition.
2. These anticompetitive consequences will
at least sometimes prove unjustified
3. Where a reverse payment threatens to
work unjustified anticompetitive harm, the
patentee likely possesses the power to
bring that harm about in practice strong
indication of market power
4. Antitrust action is likely prove more
feasible administratively
5. What are the reasons for the settlement? If
the basic reason is a desire to maintain and
to share patent-generated monopoly
profits, then, in the absence of some other
justification, the antitrust laws are likely to
forbid the arrangement.