tag:blogger.com,1999:blog-10000891.post115686428227789277..comments2024-02-21T19:56:57.057-08:00Comments on California Stem Cell Report: A 'Good Citizen" Research ExemptionDavid Jensenhttp://www.blogger.com/profile/00077329461962729362noreply@blogger.comBlogger3125tag:blogger.com,1999:blog-10000891.post-1156896349476050082006-08-29T17:05:00.000-07:002006-08-29T17:05:00.000-07:00Of the text --A RUE that would address many of ind...Of the text --A RUE that would address many of industry concerns, and in fact reflect<BR/>the <B>"good citizen" practices of many universities</B> today (practices incidentally that industry readily accepts) would simply provide that<BR/>"CIRM Grantee organizations shall allow Non-Profit Organizations,<BR/>without payment, to practice CIRM-funded patented inventions in<BR/>California for any non-profit purpose."--<BR/><BR/>one notes that the case Madey v. Duke University, which impacted the common law research exemption, involved a university professor (Madey) suing a university (Duke) over a patent Madey obtained through the Bayh-Dole Act while working at Stanford University (you know, the one in California). Although the case Merck v. Integra "sounds like" it involves two companies, the underlying problems arose between two research institutions. ACT was involved in a patent interference based on rights it obtained from the "Dolly the Sheep" research group.<BR/><BR/>The issue may be the meaning of <B>for any non-profit purpose</B>.Lawrence B. Eberthttps://www.blogger.com/profile/05616776187293753324noreply@blogger.comtag:blogger.com,1999:blog-10000891.post-1156893486704987732006-08-29T16:18:00.000-07:002006-08-29T16:18:00.000-07:00Of the specific text --the Wisconsin Alumni Resear...Of the specific text --the Wisconsin Alumni Research Foundation (WARF), insisted that all academic and non-profit researchers pay substantial license<BR/>fees for the right to experiment with hESC or to create new hESC lines-- one has to make further inquiry as to whether or not the magnitude of the WARF licensing demands arose because of possible commercialization by the academics/nonprofits and/or partners thereof. Is WARF impeding research per se, or is WARF an obstacle to those who do research <B>AND</B> plan to commercialize? It is hard to see that WARF would be going after people who are ONLY doing research. Separately, someone doing research in the "therapeutic cloning" area (implementation of which does require FDA approval) will, with high probability, enjoy the statutory research exemption under 35 USC 271(e)(1). For more, see 88 JPTOS 239 (March 2006) and IPBiz.blogspot.comLawrence B. Eberthttps://www.blogger.com/profile/05616776187293753324noreply@blogger.comtag:blogger.com,1999:blog-10000891.post-1156892817360922712006-08-29T16:06:00.000-07:002006-08-29T16:06:00.000-07:00Of the text --A research use exemption (RUE) allow...Of the text --A research use exemption (RUE) allows researchers to use patented inventions without obtaining licenses and paying license fees, royalties<BR/>and other payments to the inventor. Courts have recently concluded that contrary to widely held belief, there is no automatic research use exemption under U.S. patent law. Many universities and non-profit<BR/>institutions, however, frequently allow other academic researchers to<BR/>use patented inventions for non-commercial research without paying the<BR/>university or institution any fees. This has not been the case with<BR/>human embryonic stem cell (hESC) research. The holder of the very broad<BR/>patents over human embryonic stem cells and the core process for<BR/>creating them, the Wisconsin Alumni Research Foundation (WARF), insisted that all academic and non-profit researchers pay substantial license<BR/>fees for the right to experiment with hESC or to create new hESC lines.--<BR/><BR/>one has to distinguish between the common law research exemption (at issue in Madey v. Duke University) and the statutory research exemption under 35 USC 271(e)(1) (for things requiring government approval).Lawrence B. Eberthttps://www.blogger.com/profile/05616776187293753324noreply@blogger.com