International Intellectual Property

1. International Intellectual Property June 26, 2009 Class 10 Patents: Multilateral Agreements (Patent Cooperation Treaty, [Proposed] Substantive Patent Law Treaty); Convention on Biological Diversity

2. Patent Cooperation Treaty (1978) • Patent Cooperation Treaty (PCT) was the first major step post-Paris Convention toward an internationalized patent system • Use of PCT does not result in an “international patent” • PCT is procedural in nature • Facilitates the grant of national/regional patents, which remain substantively governed by national/regional patent laws

3. PCT – Primary Provisions • PCT streamlines patent application process • Applicant files application in a Receiving Office (RO) • a national/regional office where first filing takes place • Applicant designates the countries in which inventor intends to seek a patent • Limited Fees • once applicant designates a certain number of countries, all PCT countries may be designated at no extra charge • Priority period extended to 30 months • This gives patent applicants more time to evaluate invention and potential for commercialization before entering “National Phase” • i.e., more time to decide whether it is worth the investment of translating patent application, appointing foreign agent, and paying fees at national/regional patent offices

4. Substantive Patent Law Treaty • In 2000, WIPO began preparing a draft Substantive Patent Law Treaty (SPLT), but it’s unlikely to be adopted in the near future • There is significant resistance from DCs and LDCs to patent law harmonization • Perception that the SPLT would solidify the dominance of developed countries with respect to technology • Fear of loss of flexibility in implementation of patent laws • There are some significant differences among developed countries with respect to substantive patent law • E.g., the United States uses a “first to invent” system, while the EU and Japan use a “first to file” system

5. Diamond v. Chakrabarty 447 U.S. 303 (1980) • U.S. Supreme Court held that Chakrabarty’s invention, a micro-organism, was patentable subject matter because: • The invention was a new, non-naturally occurring bacterium • The bacterium was different than anything found in nature and it had the potential for significant utility

6. Patentable Subject Matter • Discovery vs. Invention • Discoveries of properties of nature are NOT patentable • New mineral/plant • E=mc²; law of gravity • But if a human intervenes to make use of or alter naturally-occurring phenomena, that is considered an “invention” and IS patentable

7. Biological Research • Diamond is often seen as a turning point with respect to biological research • The decision opened the door to ever-broader biological patents • OncoMouse (which we previously discussed) • Transgenic Cotton – cotton modified through the introduction of foreign genes • This turning point in the law also increased the pharmaceutical industry’s interest in exploring (or some would say exploiting) the resources of indigenous peoples • Genetic Resources (GR) • Traditional Knowledge (TK)

8. Genetic Resources • What do we mean by GR? • Any form of life • i.e., genetic material of any kind • Examples • Plants • Animals • Terrestrial • Marine • Invertebrates • Microbes

9. What is traditional knowledge? • WIPO defines “traditional knowledge” as • “tradition-based literary, artistic or scientific works; performances; inventions; scientific discoveries; designs; marks, names and symbols; undisclosed information; and all other tradition-based innovations and creations resulting from intellectual activity in the industrial, scientific, literary or artistic fields” • “Tradition-based” refers to knowledge systems, creations, innovations and cultural expressions that have generally • been transmitted from generation to generation • been regarded as pertaining to a particular people or territory • evolve in response to a changing environment

10. Examples -- Patenting of GR & TK • Patent issued to Texas company for Basmati rice • India claims the rice was developed from GR originating in South Asia • POD-NERS, a Colorado seed company, was issued a patent for a yellow variety of a field bean called Enola • Bean producers from N. Mexico contend that the seeds were purchased in Mexican markets and the bean is not novel • Shaman Pharmaceuticals was issued numerous patents for inventions based on substances derived from plants found in various parts of the world

11. Convention on Biological Diversity • Convention on Biological Diversity (CBD) • Adopted in 1992 at the Rio Conference • Virtually all countries are parties, with the notable exception of the U.S. • Advances the concept of sustainable development • Economic development should be pursued in a way that preserves the environment, and not at its expense • In other words, development that meets the needs of the present without compromising the ability of future generations to meet their own needs • Although the concept of sustainable development is also reflected in the preamble to the WTO Agreement (of which TRIPS is a part), there have always been questions about the compatibility of CBD and TRIPS

12. Primary Objectives of CBD • Preservation of biological diversity, which means • “variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species and of ecosystems.” • Article 2 of CBD • Recognizes state ownership and control over genetic resources located within territory • Provides economic incentive to countries for preserving biological diversity • Improves economic situations in DCs and LDCs, where most genetic resources are concentrated

13. GR/TK and Disclosure Requirements • Should int’l patent system include a mandatory requirement for disclosure of source and origin of GR/TK in patent applications? • Yes – mandatory disclosure is necessary to assure that patent examiners consider information relevant to assessment of patentability (e.g., novelty, inventive step, inventorship) • Country/region where the GR/TK originated likely best source for prior art • No – source/origin of GR/TK not relevant to patentability; these additional requirements would be overburdensome and create uncertainty re the enforceability of patents • Any disputes between countries housing GR/TK and bio-prospecting firms can by addressed through contractual arrangements

14. Novelty Requirement in U.S. • Under U.S. law, an invention is not novel if it was • “known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent” • “patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States.” • 35 U.S.C. § 102(a)-(b)