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?

thank you