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IAAE Conference Symposium Gold Coast QLD :: 13 August 2006 Carol Nottenburg PhD JD Restraints on anti- commons: is it enough?
Anti-commons in biotechnology A resource prone to under use when multiple owners each have a right to exclude others from a scarce resource and no one has an effective privilege of use. “Tragedy” of anti-commons refers to complex obstacles that arise when a user needs access to multiple patented inputs to create a single useful product Patents granted on upstream technology will stymie further downstream R&D of useful products
Is there an anti-commons? Original proposal was theoretical, supported only by anecdotes Anecdotal evidence for: plant transformation technologies Anecdotal vidence against: cloning and eukaryotic transformation technologies, SNP consortium, EST database Empirical studies differ but favor no anti-commons one study found at most a modest anti-commons effect (Murray and Stern, NBER, 2005) extensive survey of academic researchers found no anti- commons effect (Walsh, Science, 2005) European study also did not find anti-commons problem (Thumm, 2003)
Restraints on anti-commons Anti-trust law Patent pools and industry standards Post-grant patent challenges Patent grants tend to be narrow De facto research exemption Statutory exemptions to infringement Limited patent term (patent grant delay) Geographical limits of patents Difficulty of obtaining injunctions (EBay)
Anti-trust law Natural counterpoint to patents Mergers companies may have to divest or license some of its IP – compulsory licensing e.g.,Ciba-Geigy / Sandoz merger had to license TK and other gene therapy patents
Patent pools An agreement between 2 or more patent owners to license their collective patents to others In U.S., oversight of patent pools by DOJ, FTC; strict req’ts Used in multimedia industry (DVD, MPEG) PIPRA collective for agricultural biotechnology
Patent procedures Utility requirement e.g., can’t patent gene sequences wo known function Enablement / written description req’t difficult to obtain protection broader than what is reduced-to-practice Post-grant challenges re-examination / opposition
Limits on patents Patent term 20 yrs, but patent grant may take 3-8 yrs. Geographic limits most patents only filed in a few countries
Recourse against infringers Statutory exemptions De facto research exemption ignore patents and infringe no likely ramification (low damages; bad PR) Injunctions difficult to obtain recent EBay case in U.S. removed “automatic” injunctions in patent cases post-EBay :: no injunctions in several cases
Is it enough? is there an anti-commons problem? if there is a problem, are the restraints enough? are legislative / substantive changes needed?