© 2008 International Intellectual Property June 26, 2009 Class 10 Patents: Multilateral Agreements (Patent Cooperation Treaty, [Proposed] Substantive Patent Law Treaty); Convention on Biological Diversity

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 © 2008

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 © 2008

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 © 2008

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 © 2008

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 © 2008

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) © 2008

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 © 2008

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 © 2008

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 © 2008

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 © 2008

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 © 2008

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 © 2008

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) © 2008