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Patenting Life Sciences by James F. Kamp

See Patenting Life Sciences in the September issue of MichBio Link – IP & Legal Review HERE .

To be successful, Michigan life science businesses must leverage their intellectual capital. Patenting is one way to do so.

Obtaining a U.S. patent requires, among other factors:
• An invention that is patentable subject matter;
• An invention that is useful, novel, and non-obvious; and
• A patent application that shows that the inventor is in possession of the claimed invention and enables one to practice the invention without undue experimentation, so-called “written description” requirements. Meeting these requirements, and rebuffing challenges to issued patents, can be challenging even for seemingly novel, promising discoveries.

Public debate continues over where the line for patentable subject matter should be drawn. For example, in Association for Molecular Pathology v. USPTO (S.D.N.Y. 2010), a federal trial court decided that isolated BRCA1/2 genes and related methods to evaluate breast cancer susceptibility were not patentable subject matter and consequently that the challenged patents were invalid. The decision is on appeal

Assertions of public interest also underlie a recent challenge to certain stem cell patents on “obviousness” grounds based on the U.S. Supreme Court’s decision in KSR v. Teleflex (2007). In April 2010, the USPTO Board of Patent Appeals and Interferences agreed with a consumer watchdog group that certain stem cell patent claims held by the Wisconsin Alumni Research Foundation were invalid. The Board found in relevant part that claims at issue were “obvious” under KSR because in the Board’s view, it was “obvious to try” to derive the stem cells in view of existing “significant guideposts” to follow in doing so. The examination and the controversy continue.

Finally, in Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (2010), the Federal Circuit Court of Appeals reversed a multimillion-dollar infringement verdict in Ariad’s favor, finding that the patent at issue was invalid for failure to meet “written description” requirements. The Ariad inventors had obtained broad patent claims for reducing potentially harmful activity of NF-kB, a transcription factor they had discovered. However, the patent did not identify any specific compound for reducing NF-kB activity. In invalidating the patent, the Court essentially agreed with Eli Lilly’s contention that the patent language was little more than a research plan. Responding to criticism that a finding of invalidity would impair incentives to do basic research, the Court emphasized public policy underlying patents:

“…Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others. ‘[A] patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.’…Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of ‘invention’ — that is, conceive of the complete and final invention with all its claimed limitations…”[Emphasis added].

To patent in the life sciences, one must have an informed, cogent strategy for meeting the requirements for patentability. In addition, translating promising academic work into patentable inventions will, in many cases, require entrepreneurial collaboration between public and private entities. Those who pursue a patent strategy with these factors in mind increase their chances of success in capitalizing on Michigan’s substantial life science resources and in diversifying its economy.

James F. Kamp is a partner at Rader Fishman & Grauer PLLC (www.raderfishman.com) where he practices patent litigation and patent prosecution in the biotech/life sciences and other areas. Contact him at (248) 594-0656 or jfk@raderfishman.com.