Introduction: IPR

Introduction:
NDA ANDA Generics

Orange Book
The Electronic Orange Book Query enables searching of the approved drug list by active ingredient, proprietary name, applicant holder or applicant number.

NDA vs. ANDA Review Process Brand Name Drug NDA Requirements 1. 2. 3. 4. 5. 6. 7. 8. Chemistry Manufacturing Controls Labeling Testing Animal Studies Clinical Studies Bioavailability Generic Drug ANDA Requirements 1. Chemistry 2. Manufacturing 3. Controls 4. Labeling 5. Testing 6. Bioequivalence

APPLICANT

Generic Drug Review Process

ANDA
Application Review

Refuse to Receive Letter

Acceptable & Complete

Y Request for Plant Inspection

PreApproval Inspection Results OK?

Chemistry & Micro Review

Labeling Review

Bioequivalence Review

Chem/Micro OK?

Labeling OK?

Bioequivalence OK?

Approval Withheld until Results Satisfactory

Not Approvable Letter

Bio Deficiency Letter

APPROVED ANDA

Orange Book
All FDA approved drug products listed (NDAs, OTCs & ANDAs)
Therapeutic equivalence codes
A = Substitutable B = Inequivalent, NOT Substitutable

Expiration dates: patent and exclusivity Reference Listed Drugs/brand drugs identified by FDA for generic companies to compare with their proposed products

Hatch-Waxman Amendments to FFD&C Act - 1984

Allowed generic firms to rely on findings of safety and efficacy of innovator drug after expiration of patents and exclusivities (do not have to repeat expensive clinical and pre-clinical trials) Allowed patent extensions and exclusivities to innovator firms
6

What is Intellectual Property?

The principal rights governing the ownership and disposition of technology are known as intellectual property rights which are derived primarily from legislation granting patent, copyright, trademark, and integrated circuit mask work protection.

Intellectual property rights are the rights given to persons over the creations of their minds. They usually give the creator an exclusive right over the use of his/her creation for a certain period of time.

Do intellectual property rights matter?

If you are in the business of making money, intellectual property rights are very important If you are going to spend resources on developing ideas and concepts, you want a return on your investment.IPR

Intellectual Capital
Intellectual Assets Human Resources Intellectual Property

The IP Chain of Activities

Creation Innovation Commercialization Protection Enforcement

IP as a property
Can be sold Can be bought Can be lease or rent Can pass under a will Can be assigned

International Convention for IP

Paris Convention for Protection of Industrial Property 1967 ( 1989) Berne Convention for the Protection of Literary and Artistic Works 1971 ( 1990) Trade-related aspects of Intellectual Property Agreement 1994 ( 1995) WCT ( digital agenda) PCT 2004

Overview of IP Management
IP Strategy Aligned with business strategy. Competitive advantage. Forward-looking. Measure/Monitor Value creation Accessibility Awareness IP Assets Patents Copyrights Trademarks, trade dress Designs Trade secretes Confidential info,know-how Investment Pursue R&D License-in Create alliance

License out Sell Donate

Protection Asset definition Asset maintenance

Assessment Evaluate competivity Identify additional uses

Elements of effective patent/IP management

Adopt a IP strategy The IP strategy must be aligned with the companys vision. The IP strategy must have full support of the top management. IP assets must be involved in value creation and extraction. There must be continuous evaluation of inventions. IP Innovations must be measured periodically.

Acts Governing IP rights: INDIA

The Patents Act 1970
Amended by various Acts until The Patents (Amendment) Act, 2005.

The Trade Marks Act, 1999

Came into force with effect from Sept. 15, 2003.

Geographical Indications of Goods Registration Protection Act 1999.

Came into force with effect from Sept. 15, 2003.

The Copyright Act, 1957

Amended by The Copyright Act, 1999 with from Jan. 15,2000.

Semiconductor Integral Circuits Layout Designs Act, 2000

(Yet to come into force)

The Industrial Designs Act, 2000.

Came into force with effect from May 11,2001.

The Protection of Plant Varieties and Farmers Rights Act, 2001

Came into force with effect from March 4th, 2005.

Biological Diversity Act, 2002

Came into force with effect from July 1,2004

Types of Intellectual Property Protection

Patents: .. Inventions Trademarks..Distinguishing Words or Designs Copyright: Expressive Works Designs .. Aesthetic Features of Articles Trade Secrets Confidential Information

Geographical indications
Layout of Designs of Integrated Circuits

Patents
An exclusive right granted by a government to an inventor to prevent others from making, selling or using a new product or a new process; therefore it is a negative right. Term of the patent in INDIA is 20 years from the date of filing of the application.

PATENTS ARE TERRITORIAL. Patent infringement Only Civil remedies.

Patents Provide A Wealth Of Information

Commercial : - Activity of Competitors - Owners of Patented Technology - Trends in Technology development Technical: - Prior Art - Deficiencies in Prior Art -Solution offered by the Invention

Legal: - Scope of the Claims - Ownership & Assignment Rights - Validity, Maintenance Status

Patents
Contract between the inventor, the assignee, and the state
Full disclosure in return for a time & geographically limited monopoly Terms are state specific but subject to international conventions

What Value is the Patent Right?

It may be asserted to enforce a monopoly
It may be licensed to others for a royalty It may be sold, or used a collateral It may prevent others from obtaining a patent It may be a bargaining chip in commercial or legal negotiations (infringement)

Two parallel processes

Patent process
Prior Art Search Generation of further examples in support of claim 1 year Technical Examination by Patent Office Acceptance and Publication in Gazette Grant and Sealing of the patent

1-2 years

Drug Development
Pre Clinical Testing Initial Synthesis Animal Testing Clinical Trials Phase I Phase II Phase III 1 month 2-3 years 1-2 months

6 months

Sales and Distribution

1-3 years

1-2 months

The companies with the most drugs (RLD NDAs) tend to be big pharma firms
Company Name Total RLD NDAs by Company Total Number of Patents Covering all of Companys RLD NDAs 98 67 35 46 62 46 50 52 36 24 Number (Percentage) of Those Patents that is Owned by Company 1 (1.0%) 19 (28.4%) 6 (17.1%) 23 (50.0%) 8 (12.9%) 4 (8.7%) 28 (56.0%) 41 (78.8%) 1 (2.8%) 21 (87.5%)

GlaxoSmithKline Novartis Bristol Myers Squibb Pfizer AstraZeneca Pharmacia and Upjohn Co. Abbott Laboratories Merck Aventis Eli Lilly

58 38 30 29 25 24 23 23 18 16

Total By Top 10:

284

516

152 (29.5%)

* Subsidiaries and mergers ARE NOT considered

Subsidiary companies and mergers play an important role in the pharmaceutical industry
Company Name Total RLD NDAs by Company Total Number of Patents Covering all of Companys RLD NDAs 122 103 71 67 38 63 51 50 52 28 Number (Percentage) of Those Patents that is Owned by Company 78 (63.9%) 75 (72.8%) 51 (71.8%) 35 (52.2%) 13 (34.2%) 38 (60.3%) 32 (62.7%) 32 (64.0%) 41 (78.8%) 18 (64.3%)

Pfizer GlaxoSmithKline Johnson and Johnson Novartis Bristol Myers Squibb AstraZeneca Sanofi-Aventis Abbott Laboratories Merck Roche

64 60 39 38 33 26 26 23 23 19

Total By Top 10:

351

645

413 (64.0%)

* Subsidiaries and mergers ARE considered

In-licensing plays a significant role for more than 50% of drugs

Name: Pfizer GlaxoSmithKline Johnson and Johnson Novartis Schering Plough Sanofi-Aventis NDAs filed: 42 36 23 21 15 14 Total RLD NDAs by firm: 64 60 39 38 18 26 Percentage of Total NDAs by Firm: 65.6% 60.0% 59.0% 55.3% 83.3% 53.8%

Eli Lilly
Merck Roche Abbott Laboratories

13
12 12 11

16
23 19 23

81.3%
52.2% 63.2% 47.8%

Total by Top 10

199

326

61.0%

* Firms with the most drugs (RLD NDAs) where the drug maker owns all the patents protecting the drug

Out-licensing varies significantly by firm

Name: Total patents owned by firm in Orange Book (cover RLD NDAs): Patents owned by firm in Orange Book that cover firms own drugs (RLD NDAs)
(% of total patents owned) GlaxoSmithKline Pfizer Johnson and Johnson Merck Sanofi-Aventis Novartis Takeda Chemical Industries AstraZeneca Abbott Laboratories 109 86 83 63 49 45 43 42 34 75 (68.8%) 78 (90.7%) 71 (85.5%) 41 (65.1%) 32 (65.3%) 35 (77.8%) 11 (25.6%) 38 (90.5%) 32 (94.1%)

Roche

34

18 (52.9%)

Total by Top 10:

588

451 (76.7%)

* Firms by most patents owned on RLD NDAs in the Orange Book

Copyright
Narrow Protection: expression not ideas
Inexpensive: free rights, low cost to register Quick: automatic

Lengthy: term is 50-60 years from death of author

Easy to Obtain: no ingenuity is required Expensive to Enforce: litigation is costly Infringement of Copyright Civil and Criminal remedies

Copyright
Microsoft

WORD

Copyright. (kprt) the exclusive legal right to the publication, sale, etc. of a literary or artisitic work.

Trademarks
Variable Protection: depends on distinctiveness Moderate Cost: 1.5 - 3K per country Time Consuming: 1 - 2 years to obtain Lengthy: Indefinitely renewable

Easy to Obtain: if distinctive mark chosen

Expensive to Enforce: litigation is costly

Trademark

Trademark. (trdmrk) a symbol, word, etc. used by a manufacturer or dealer to distinguish his product.

Microsoft

Trademarks
Words, Letters, Symbols, logo, combination of words and letters, Colors, Shapes, Slogans Corporate Name, Pictures , Collective marks Domain names Unlimited right. To be renewed every ten years Infringement of Trade Mark. Criminal + Civil Remedies Application Examination Publication Opposition Registration

Renewal
Rectification

Trade Secrets
Known by a limited number of persons, all of whom are under an obligation to maintain the confidentiality of the information Take measures to ensure that the information remains confidential Employee and Contractor agreements The information cannot be determined by examination or analysis of the final product (reverse engineering destroys a trade secret)

Trade Secrets

Trade Secerets. (trd skrit) A trade secret is any information that can be used in the operation of a business or other enterprise and that is sufficiently valuable and secret to afford an actual or potential economic advantage over others. A trade secret can consist of a formula, pattern, combination of data, computer program, device, method, technique, process, or other form or embodiment of economically value information.

Patent vs. Trade Secret

Patents
Disclose invention sufficient so others can make and use the invention

Duration20 years from filing

Protection against independent discovery

Trade secrets
Confidentiality
Potentially indefinite Protection lost if independent discovery or reverse engineered

Designs
Shape, Aesthetic features, Configuration, Surface pattern of an Article. New and original. Does not cover mechanical working of the article. 15 years right. Piracy of Design--- Only Civil Remedies.

Patent Law Disputes

Supreme Court

Discretionary Court of Appeals for the District Circuit

Mandatory

Federal District Court

Dispute Alternative Dispute Resolution Mediation Arbitration Negotiation

What is a U.S. Patent?

Quid pro quoin exchange for 20 years of exclusive rights, the inventor must explain how to make and use the invention in sufficient detail IMPORTANT!A U.S. Patent provides protection only in the United States IMPORTANT!The patent owner enforces the patent, not the U.S. government

Types of U.S. Patents

Utility patent Protects articles of manufacture, compositions of matter, machines, or processes, or improvements Term: 20 years from the application filing date Plant patent Protects most asexually reproduced plants Term: 20 years from the application filing date Design patent Protects new, original and ornamental designs Term: 14 years from the date of grant

Primary Patentability Considerations

35 U.S.C. 101: Patentable subject matter and utility 35 U.S.C. 102: Novelty and Loss of Right

35 U.S.C. 103: Non-obviousness

35 U.S.C. 112, first paragraph: Sufficient disclosure

Timeline for ANDA Patent Litigation

(1) A files ANDA with Para. IV (3) P files Complaint (5) Discovery/Scheduling Conference (6) Fact Discovery Closes

July 06
June 06 20 days

45 days Aug 06 20 days

Aug 06

Nov 06
20-30 days Oct 06 6 12 months May / Nov 07

Sept 07 / Mar 08 3 4 months

(2) A mails Notice to patent holder and NDA holder

(4) A files Answer

Scheduling Order

(7) Expert Discovery Closes

(9) Dispositive Motions (Summary Judgment)

3 5 months Jan 08 / Aug 08 May 08 / Dec 08

(11) Trial Begins

(13) Court Decision / Beginning of Appeals Process / Expiration of Statutory 30 Month Stay
12 18 months 3 - 4 months/ 8-12 months Nov 08 / May 10 Nov 09 / May 11

May 08/Dec 08

2 weeks

Jun 08 /Jan 09

(8) Markman Hearing

(10) Pre-trial Submission

(12) Trial Ends/ Post-trial Briefing

(14) CAFC Decision

P: Patent holder/NDA holder A: ANDA filer