experience of the united states related to access to...
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2008/SOM3/IPEG/SEM/012
Experience of the United States Related to Access to Genetic Resources
Submitted by: United States
Seminar on Genetic Resources and Protection of Traditional Knowledge
Lima, Peru13-14 August 2008
Jeffrey SiewAttorney - AdvisorOffice of IP Policy and EnforcementUS Patent & Trademark Office
APEC Seminar “Raising Awareness and Providing Policy Insights on Appropriate Access to Genetic Resources and Protection of
Traditional Knowledge in APEC Economies,” Session 4
Experience of the United States Related to Access
to Genetic Resources
August 13-14, 2008 CENTRO NAVAL DEL PERU
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Topics• The United States has significant biological diversity. Examples of US
entities that promote access:– US National Plant Germplasm System– National Park Service
• The United States Patent Law Sets Standards to Prevent Misappropriation– Finding Evidence Can be Difficult
• Examples of Common Art Situations• Searching for Prior Art
• Many United States Companies and Universities seek to Study Genetic Resources Worldwide
• Ideas to Handle International Issues
The United States has Significant Biological Diversity
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• Genetic Resources in the U.S. are handled by a variety of national, tribal, state and local entities. Two National entities are:– U.S. National Plant Germplasm System– U.S. National Park System Access Regime
Uses Cooperative Research and Development Agreements (CRADA)
• Easily adaptable to other legal regimes• See U.S. Submission to IGC- GRTK/IC/4/13
The US has significant Genetic Resources
U. S. National Plant Germplasm System (NPGS)
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U. S. National Plant Germplasm System (NPGS)
• One of the largest national genebank systems.
• More than 460,000 samples of more than 11,300 plant species.
• Large collections of the major staples important to U. S. and world agriculture.
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National Plant Germplasm System Genebanks
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Genetic Resource Management
• Distribution: NPGS annually distributes an average of about 120,000 samples to researchers worldwide.
• An average of about 25% are distributed internationally.
• Samples are distributed free-of-charge and without restriction, with the exception of those with an accompanying SMTA per the FAO ITPGRFA.
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NPGS Promotes Access to GR
• Current 6:1 ratio of NPGS accessions annually distributed internationally, vs. annually collected internationally, may increase.
• An increasing number of elite, previously proprietary, varieties and hybrids will be in the public domain and conserved and distributed by the NPGS because their limited-duration IPR will expire.
National Park Service
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YELLOWSTONE . . .YELLOWSTONE . . .
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. . . established in 1872
World’s first national park . . .
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10,000 hot springs, geysers, mud pots & fumaroles . . .
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Greatest concentrationand diversityof terrestrial thermal habitatson Earth . . .
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RESEARCH AT YELLOWSTONE1804 : Lewis & Clark expedition
first visits the Yellowstone region & collects biological samples . . .
with scientific expeditions continuing through 1870s resulting in the park’s establishment (1872)
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RESEARCH AT YELLOWSTONE
First research specimen collection permit at Yellowstone issued in August 1898
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Approximately 400 national park units covering 84.4 million acres located in every terrestrial ecoregion found in North America . . .
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Balancing of Interests
• How to encourage ‘access’ but also protect ‘benefit-sharing’ rights & interests in potentially valuable discoveries & inventions
• NPS Director asks YNP to develop a pilot ‘benefit-sharing’approach that . . .– Does not chill scientific research . . .– But captures benefits . . .– To be used for science / natural resource conservation
• Legal instruments that can address these issues at different stages of the research & development process . . .
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Current Status of ABS in NPS ?
• Benefit-Sharing negotiations between NPS & researchers authorized by US Congress
• Initial ‘CRADA’ approach undertaken by YNP upheld on federal judicial review as consistent with NPS and other applicable laws & regulations
• NPS currently completing EIS of potential impacts of BSAs on entire US National Park System
• Draft EIS released for public comment and the period for comment is now closed (includes standardized draft CRADA and MTA (consistent with CBD/Bonn Guidelines))
• http://www.nature.nps.gov/benefitssharing
The United States Patent Law Sets Standards to Prevent Misappropriation
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Standards to Prevent Misappropriation: Relevance of Patents
• Create benefits– Generate wealth– Stimulate innovation– Disseminate new ideas– Encourage investment– Promotes technology transfer
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Standards to Prevent Misappropriation
• 35 U.S.C. § 112, 2nd paragraph: Indefinite claims
• 35 U.S.C. § 101: Products of Nature • 35 U.S.C. § 112, 1st paragraph: Enablement • 35 U.S.C. § 102(a) and (b): Novelty• 35 U.S.C. § 102(f): Lack of inventorship• 37 CFR 1.56: Duty to Disclose Material
Information
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35 U.S.C. 112(2): Definite
1. It is helpful when applicants use the official botanical name(s) in the claim language.
2. If a common name of a plant is used in the claims, the claims might be objected to, to clarify the identity of the plant.
3. Common names for the claimed plants should be disclosed in the specification.
4. If the identity of the plant named in the claims is particularly unclear, then a rejection of the claims under 35 USC 112, 2nd paragraph is warranted.
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Products of Nature are not Patentable under 35 U.S.C. § 101
“A composition comprising phytochemical X.”reads on the plant itself.
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An Enabling Disclosure
Under U.S. law, the application is required to sufficiently describe how to make and use the claimed extract or herbal medicine. • The plant name/names• The part/parts of the plant used• The type/types of solvent used • Extraction temperature and pH• Material used fresh or dried and/or chopped or
powdered• Separation/fractionation/recovery/isolation
steps
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Novelty: Must be New
An example of an extract. Webster’s dictionary defines ‘extract’ as follows:
1 a : to draw forth (as by research) <extract data> b : to pull or take out forcibly <extracted a wisdom tooth> c : to obtain by much effort from someone unwilling <extracted a confession> 2 : to withdraw (as a juice or fraction) by physical or chemical process; also : to treat with a solvent so as to remove a soluble substance …
Plant Extracts are Ubiquitous:• An extract of Coffea arabica: Coffee• An extract of Camillia sinensis: Tea• An extract of broccoli: Soup• An extract of orange: Orange juice
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Derivation under 35 U.S.C. § 102(f)
Under U.S. law, only the inventor may obtain a patent on an invention.
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37 CFR 1.56
Applicants are required to disclose information that is necessary for an enabling disclosure, the best mode and:information that would be material to patentability.
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Some Common Prior Art Situations
Plant Nomenclature: Many words/terms for the same plant even within the same language!
• Harpagophytum procumbens, also known as devil’s claw, grapple plant, or wood spider.
• Larrea divaricata, also known as chaparral, creosote bush, greasewood, stinkweed.
• Azadirachta indica, commonly known as neem and also known as margosa, nim, nimba.
Searching for Prior Art
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Searching for Prior Art:Alternative search terms
• Arbre aux quarante ecus (forty coin tree) • eun-haeng (fossil tree) • ginan • icho • ityo • kew tree • maidenhair tree • pei-wen • Pterophyllus salisburiensis Nelson • Salisburia adiantifolia Smith • Salisburia macrophylla C. Koch • temple balm • tempeltrae • yin guo • yinhsing • olium ginkgo • Ginkgo folium ... gin-nan • ginkgoblatter • ginkgo balm• Ginkgo biloba
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This is the TK and Medicine Intranet Website that US Examiners Use, as part of their search, when Searching TK-GR Inventions
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Enhance Ability to Identify Prior Art
• Eliminating Erroneously Issued Patents– Increase disclosure of public domain
traditional knowledge and genetic resources
– Use of databases – Post-grant correction or opposition, such
as re-examination procedures
Patent Disclosure Requirements
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Patent Disclosure Requirements-Is there a benefit?
• Disclosure Requirement of the Source or Origin of GR or TK will neither ensure prior informed consent nor that benefits are equitably shared
• Requirement will not prevent misappropriation
• Will Not Apply to TK/GR that are Commercialized, But Not Patented
• At best, an ineffective monitoring system
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Patent Disclosure: Mechanism to Undermine a Patent
• Will create new uncertainties in patent rights– New Avenue for Litigation – Negative Effects on Innovation and
Economic Development Incentives– Negative Effects on Benefit Sharing –
contrary to our goals• Indeed, if requirement were adopted and a
patent invalidated, there would be no benefits to share
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Patent Disclosure Requirement
• Poses More Questions Than It Resolves– Scope of Claims Define the Invention
• What is “derived material?”• When and how much disclosure?
– Who Determines if Disclosure Proper?– What is the Consequence of Non-
Compliance?
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Patent Claim Example:What does it mean to be developed from a biological resource?
•1. A process for preparing potato chips consisting essentially of the steps of: slicing peeled potatoes to a thickness in the range of about 1.3 mm to about 2.8 mm; washing said potato slices to remove surface starch thereon; and frying said washed potato slices for a time period sufficient to reduce the moisture content of the potato slices to about 3% to 30%.
Many United States Companies andUniversities seek to Study Genetic Resources Worldwide
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To Create a Climate to Promote Research so that Benefits may be Created and Shared
• Establish Effective National Systems Separate From Patent Laws– Authorize access and Equitable Benefit-
Sharing• Provide point of contact (e.g. government and
indigenous reps., when appropriate)• May provide conditions for research• May require use of contracts for collecting
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To Create a Climate to Promote Research so that Benefits may be Created and Shared
• National Laws May provide civil and/or criminal penalties for misappropriation
• Contract-Based System– May provide for benefit sharing
• Monetary or non-monetary benefits– May contain regular reporting requirements
• At regular intervals, as to uses• Reporting of any inventions derived from the GR or TK• Reporting any filed patent applications derived from the
GR or TK– May include “choice of law” provisions or dispute
settlement procedures
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To Create a Climate to Promote Research so that Benefits may be Created and Shared
• Provide Legal Certainty!• Review Procedures to Confirm that
Researchers are not Hampered• Clear Points of Contact!
Conclusion
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Shared Objectives
• Provide Authorized Access While Assuring Conservation of Biodiversity
• Guarantee Equitable Benefit Sharing for Use of TK/GR– Prevent Misappropriation of TK/GR
• Eliminate Erroneously Issued Patents by Enhancing Ability to Search Prior Art
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Conclusion
Patent System is effective for promoting innovation and economic development, not regulating misconduct
• Shared objectives include access and equitable benefit sharing, as well as reducing misappropriation.
• We can achieve these objectives best through effective national systems outside of patent laws.
