BIOPIRACY: FACT OR FICTION? INTERNATIONAL TREATY NEGOTIATIONS COULD AFFECT YOUR IP RIGHTS AND YOUR BOTTOM LINE
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1 BIOPIRACY: FACT OR FICTION? INTERNATIONAL TREATY NEGOTIATIONS COULD AFFECT YOUR IP RIGHTS AND YOUR BOTTOM LINE BRYAN J. VOGEL 2013 ANNUAL IPO MEETING SEPTEMBER 15-17, 2013 BOSTON, MASSACHUSETTS
2 AGENDA Overview of bioprospecting and biopiracy Rules, laws, conventions, treaties Impact on patents and R&D 2
3 WHAT IS BIOPROSPECTING? Bioprospecting: process of discovery and commercialization of new products based on biological resources; often draws on indigenous knowledge about uses and characteristics of plants and animals 3
4 WHAT IS BIOPIRACY? Biopiracy: commercial development of naturally occurring biological materials, such as plant substances or genetic cell lines, by a technologically advanced country or organization without fair compensation to the peoples or nations in whose territory the materials were originally discovered 4
5 HISTORY OF BIOPROSPECTING A couple decades ago, take-and-run describes the approach to collecting Researcher could simply arrive at a field site, collect samples, and take them home No applicable law Today, rules for biodiversity prospecting and natural products research derive from three sources: International treaties National laws Professional self-regulation 5
6 EXAMPLES Recorded history of international plant collecting missions goes back at least 3500 years when Egyptian rulers began bringing plants home after military expeditions Last century, the British Empire instituted regular plant collections Voyage of the Beagle, Charles Darwin simply took what interested him, from the Galapagos and elsewhere, and brought it home The Royal Botanical Gardens took rubber trees from Brazil, and planted them in Southeast Asia Commodore Perry s naval mission to Japan collected a wide variety of plants to bring back to the United States Adventures of Richard Schultes during the mid-twentieth century befriended local shamans, who allowed him to collect thousands of specimens of medicinal plants, hundreds of which had never previously been identified taxonomically 6
7 EXAMPLES (CONT D) Maya ICBG controversy The rosy periwinkle The neem tree The Enola bean Basmati rice Hoodia 7
8 RULES International treaties Convention on Biological Diversity (CBD) National laws Through laws and regulations, countries have exercised their sovereign rights over biological resources as established in the CBD. Professional self-regulation Institutions and professional organizations have implemented natural products research policies for their members. 8
9 CONSEQUENCES OF BREAKING RULES Cancelled patent Loss of profits Lack of clean title to biological material Denial of access to material Blacklisting Criminal penalties 9
10 CONVENTION ON BIOLOGICAL DIVERSITY (CBD) Multinational agreement arising from 1992 Earth Summit in Rio de Janiero State sovereignty over genetic resources / traditional knowledge (GR/TK) Three objectives: Conservation of biodiversity Sustainable use of components of biodiversity Sharing benefits of commercialization or other use of genetic resources in a fair and equitable way US signed the treaty in 1994, but has not ratified it 10
11 WHAT IS THE DEBATE OVER GR/TK? Access to genetic resources and/or traditional knowledge is uncontrolled Developing countries and their indigenous communities share no benefit from commercialization of their genetic resources and/or traditional knowledge Biopiracy is rampant Taking genetic resources without consent is biopiracy Mere act of filing a patent application is not biopiracy 11
12 HOW DOES IT RELATE TO PATENTS? Increasing focus on a binding international treaty that would require patent applicants to disclose: Origin of genetic resources and/or traditional knowledge in patent applications Evidence that the applicant had prior informed consent to use the genetic resources and/or traditional knowledge Evidence of fair and equitable benefit-sharing arising from use of genetic resources and/or traditional knowledge 12
13 THIS LIKELY FALLS UNDER SOUTH AFRICA S BIODIVERSITY ACT There is still no product; and thus, no benefits to be shared. 13
14 BUT THIS LIKELY DOES NOT ABS Laws targeting only research (i.e., patented) use of the resource result in: No benefit sharing, but also, No conservation No sustainable use 14
15 WHAT S WRONG WITH DISCLOSURE? The Principle: Use of the patent system to monitor and enforce CBD Current proposals are potentially ambiguous in scope: Lack of clarity as to when disclosure would be required Human genetic resources are excluded from scope of CBD, but not from patent proposals What is the meaning of used in or directly based on the invitation? What if publicly-available traditional knowledge is used to create an entirely new/inventive compound? Retroactive effect How far back in time does obligation to determine origin extend? What if there is more than a single country of origin? Likely no impact on genetic resources and/or traditional knowledge if no patent application is filed 15
16 POTENTIAL CONSEQUENCES Failure to examine patent application Revocation of patent Obligation to share benefits, even for public genetic resources and/or traditional knowledge But all inventions are incremental improvements on publicly available prior art Deterrent to filing patent applications Or possibly even a deterrent to undertaking research? 16
17 PERCEIVED BENEFITS OF DISCLOSURE? International requirement for patent disclosure may: Prevent issuance of bad patents Provide mechanism to ensure benefit sharing Avoid need for costly litigation to revoke bad patents Address jurisdiction concerns after genetic resources and/or traditional knowledge leaves national boundaries Address limited resources to implement CBD at national level Address unfair negotiating position of developing countries (or their indigenous groups) with regard to access/benefit sharing agreements 17
18 DISCLOSURE OBLIGATIONS IN EXISTENCE National Patent disclosure requirements: Norway Sweden Denmark Andean Countries Brazil India South Africa Pressure for international disclosure requirements: Brazil India African Group European Union ( disclosure light ) 18
19 WIPO INTERGOVERNMENTAL COMMITTEE ON GR/TK/FOLKLORE Negotiations ongoing to protect GR, TK, and traditional cultural expressions (TCEs) Three separate texts under negotiation for each subject area Developing countries press for conclusion of negotiations, including binding obligations for disclosure of GR/TK, and revocation as a sanction for incorrect or incomplete disclosure 19
20 NAGOYA PROTOCOL ON ACCESS AND BENEFIT- SHARING TO THE CBD Negotiated in 2010 in Nagoya, Japan Requires countries to implement mechanisms for ABS, including checkpoints to monitor uses of GR/TK No specific reference to patent disclosure However, many countries continue to view disclosure as a means to monitor use of GR/TK Their preferred checkpoints include patent offices and marketing authorization bodies 20
21 ARTICLE 10 OF NAGOYA PROTOCOL Global Multilateral Benefit-sharing Mechanism Parties to consider the need for and modalities of a mechanism to address benefit-sharing from utilization of GR/TK that occur in trans-boundary situations. Benefits shared shall be used to support conservation and sustainable use. 21
22 WHAT IS A POTENTIALLY BETTER SOLUTION? Patent disclosure may not meet the goals National experience is likely required Calls for a binding disclosure requirement may be premature States should provide legal mechanism for access and prior informed consent Genetic resources and/or traditional knowledge databases can potentially assist patent examiners ensure granted patents are novel and non-obvious Contract-based approach will likely ensure benefit-sharing, even if commercialization is never realized 22
23 THANKS! BRYAN J. VOGEL ROBINS, KAPLAN, MILLER & CIRESI L.L.P. 601 LEXINGTON AVENUE, SUITE 3400 NEW YORK, NY TEL: (212) The opinions expressed are only those of the author/speaker and do not necessarily reflect the opinions of Robins, Kaplan, Miller & Ciresi L.L.P. or its attorneys. 23
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