1. PATENTS Introduction and International Regime Victor H. Bouganim WCL, American University

2. Victor H. Bouganim, WCL, American University, Spring 2001 U.S. Constitution The United States Constitution provides Congress with the following power: “to promote the Progress of Science and useful Arts, by securing for limited Times to…Inventors the exclusive Right to their…Discoveries.” Article I, section 8, clause 8

3. Victor H. Bouganim, WCL, American University, Spring 2001 Historical Background F 1790: First U.S. patent statute passed F 1793: The 1793 Act instituted a registration system F 1836: The 1836 Act introduced formal examination and examiners F 1952: The Patent Act of 1952, inter alia, replaced the subjective invention test with an objective test for non- obviousness F 1970: The Paris Convention F 1978: Patent Cooperation Treaty in force F 1982: Congress passed the Federal Courts Improvement Act, creating the Court of Appeals for the Federal Circuit (C.A.F.C.) F 1999: American Inventors Act of 1999

4. Victor H. Bouganim, WCL, American University, Spring 2001 TRIPS Amendments to the US Patents Act, 1994 F The patent term is now 20 years from the date of filing. 35 U.S.C. Sec. 154 F WTO members may introduce evidence of pre-patent filing in their home country when requesting a U.S. patent. 35 U.S.C. Sec. 104 F Definition of infringement expanded to include the acts of unauthorized offering for sale or importing. 35 U.S.C. Sec. 271 F Provisional applications permitted. 35 U.S.C. Sec. 111

5. Victor H. Bouganim, WCL, American University, Spring 2001 Theory of Patents Incentives Disclosure Legal Protection for limited period

6. Victor H. Bouganim, WCL, American University, Spring 2001 Types of Patents F Utility Patents F Design Patents F Plant Patents

7. Victor H. Bouganim, WCL, American University, Spring 2001 Obtaining a Patent Requirements F Patentable Subject Matter F Utility F Novelty F Nonobviousness F Enablement Rights The right to exclude others from: F making F using F selling F offering for sale F importing

8. Victor H. Bouganim, WCL, American University, Spring 2001 Patent Protection - International F Patents are granted to inventors according to national law F Patents represent territorial grants of exclusive rights F Each jurisdiction provides varying patent protections –Example – many developing nations refuse to grant patents on pharmaceuticals –Countries like South Africa introduces ‘compulsory licensing’ of certain drugs, e.g. for treatment of AIDS. Currently, a lawsuit is discussed in Pretoria.

9. Victor H. Bouganim, WCL, American University, Spring 2001 International Patent Regime F TRIPS, Art. 27-34 –Reference to the Paris Convention [TRIPS, Art. 2] F Paris Convention, 1883 as amended in 1967. F Patent Cooperation Treaty, 1970. F European Patent Convention –Designed to permit a single office at Munich and The Hague to issue patents of all countries party to the treaty F European Union Patent Convention –Designed to create a single patent valid throughout the EU

10. Victor H. Bouganim, WCL, American University, Spring 2001 Paris Convention - Overview Paris Convention - Overview F 160 States are members (The Paris Union), including: EU, USA and Japan (as in January 2001) F Concluded in 1883. Amended and revised several times, last in 1979. F Governed by WIPO - World Intellectual Property Organization F Subject matters covered: –Patents and Utility Models –Trademarks, Service and Collective Marks –Industrial Designs –Trade Names and Geographical Indications –Unfair Competition

11. Victor H. Bouganim, WCL, American University, Spring 2001 Paris Convention - Principles F National Treatment F Right of Priority F Common Rules

12. Victor H. Bouganim, WCL, American University, Spring 2001 PCT - Patent Cooperation Treaty F Established in 1970, Amended in 1979, modified 1984. F Open to members of the Paris Union. F Facilitates international patent search and registration.

13. Victor H. Bouganim, WCL, American University, Spring 2001 Patent Conventions F Paris Convention –“right of national treatment” –“rights of priority”patent applications in foreign jurisdictions are not dependent upon success in home country –Does not reduce the need for individual patent applications F Patent Cooperation Treaty (PCT) –40 countries including U.S. –Designed for greater uniformity and less cost in the international patent filing process –Filings can be done in selected countries instead of in each individual country –International Searching Authorities (ISA) –Allows applicant to have an international preliminary examination

14. Victor H. Bouganim, WCL, American University, Spring 2001 Drugs & Health Patents F North v. South debate: Do drug patents unfairly keep needed medications out of the hands of indigent populations? F Should the duration of patent protection be reduced for prescription drugs, so more affordable generic versions can be produced in less than 20 years? F Should health procedures, e.g., a surgical technique be patentable? F What is the relationship between drug patents and the health and well-being of individuals?

15. Victor H. Bouganim, WCL, American University, Spring 2001 Patents - Exclusions F Members may exclude from patentability inventions … necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment … F TRIPS, Art. 27.2 F Members may also exclude from patentability: F (a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals; F (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals … F TRIPS, Art. 27.3

16. Victor H. Bouganim, WCL, American University, Spring 2001 Class Discussion F Should drug patents receive the same protection in developing countries? F Compulsory licensing of drugs - is it justified? In what conditions? F South African AIDS drugs example –The Pharmaceutical Manufacturers' Association (PMA) challenged the Medicines and Related Substances Control Amendment Act in a bid to stop the South African government from making cheaper generic drugs available.

17. Victor H. Bouganim, WCL, American University, Spring 2001 South African Patent Case F The trial in Pretoria, South Africa which opened on 5 March, 2001 was adjourned to 18 April, 2001. F Parties ultimately settled out of court. F What role does TRIPS play in this dispute?

18. Victor H. Bouganim, WCL, American University, Spring 2001 Patents - Compulsory Licensing F Article 31 of the TRIPS sets outs the framework for national laws on use without authorization of the patent owner. F Article 31 gives countries broad discretion on government use of compulsory licensing. –For example, there are no limitations on the grounds upon which a government can authorize use of a patent by third parties, only a set of procedures to follow.

19. Victor H. Bouganim, WCL, American University, Spring 2001 Compulsory Licensing TRIPS Rules - 1 F Governments consider cases on their individual merits F Prior to authorizing third party use, there should be an effort to negotiate a voluntary license on reasonable commercial terms F Government must provide for "adequate remuneration... taking into account the economic value of the authorization."

20. Victor H. Bouganim, WCL, American University, Spring 2001 Compulsory Licensing TRIPS Rules - 2 F ”Use shall be authorized predominantly for the supply of the domestic market." [ TRIPS, Art. 31(f)] F There are many exceptions to the general rules. [ TRIPS, Art. 31] –For example, the requirements for negotiation for a voluntary license on reasonable commercial terms may be waived: u in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use.

21. Victor H. Bouganim, WCL, American University, Spring 2001 CIPRO Patent F The need for generic Cipro antibiotics for Anthrax infection depends upon -- –Can terrorists deliver Anthrax to large numbers of people? –Could an attack take place before Bayer could deliver large quantities of Cipro? F The probability of any of the above happening is unknown. F Scientists presume that 100 kilos of Anthrax could kill 1 to 3 million persons.

22. Victor H. Bouganim, WCL, American University, Spring 2001 The Need for Generic Cipro F The Health Authorities presume a need for medications for 10 million persons. –At the 120 pill recommended course of treatment for Cipro, this is 1.2 billion pills. –Bayer says it can produce 2 million per day. At this rate it would take 600 days to supply 1.2 billion pills. –5 generic companies have already received US FDA clearance for the quality of their generic Cipro, and could immediately be asked to manufacture the drug.

23. Victor H. Bouganim, WCL, American University, Spring 2001 U.S. Legal Framework F The US government already has the right to use patents without a license, under 28 US 1498, an authority which is often used for other patents. F HR 1708: Affordable Prescription Drugs and Medical Inventions Act –Amends the Patents Act to provide for compulsory licensing of certain patented inventions relating to health. –Introduced in the House on May 3, 2001

24. Victor H. Bouganim, WCL, American University, Spring 2001 28 USC 1498 F Deals with uses of patents or copyrights, when the use is by or for the US government. –Under this statute the US government does not have to seek a license or negotiate for use of a patent or copyright in certain circumstances. –Any federal employee can use or authorize the use of a patent or a copyright. –The right owner is entitled to compensation, but cannot enjoin the government or a third party authorized by the government, to prevent the use.