Gene patenting dramatically altered by U.S. case
QUOTE: "We again seem to be in a period... of frank hostility to patents and patent law from the Supreme Court." - biotech lawyer, Kevin E. Noonan
"This decision, along with 'In re Gleave'.., represents an ongoing trend reflected in the Federal Circuit's jurisprudence that makes patenting of classic biotechnology inventions more challenging."- Astrid R. Spain, patent law specialist and partner in the law firm McDermott Will & Emery
Federal Circuit Limits Patentability Of Genetic Sequences
William L. Warren
IP Frontline, 15 May 2009 [extracts only]
On April 3, 2009, the U.S. Court of Appeals for the Federal Circuit issued 'In re Kubin' (Fed. Cir., No. 2008-1184), perhaps the most significant patent law decision affecting the genetic engineering industry in over a decade. At issue is the patentability of isolated genetic sequences, in this case encoding a previously identified, but unsequenced, protein.
Kubin's Impact On Gene Patenting
The Federal Circuit's decision in Kubin generally means that to the extent a protein has been previously identified, its nucleotide sequence is no longer patentable. The broader application of Kubin will include attempts to reject or invalidate claims directed to biotech inventions which claim an outcome of experimentation from among a range of expected results, even though not expressly predictable. There will undoubtedly be an increase in invalidity challenges to existing gene patents by those seeking to market generic and follow-on biologics prior to patent expiration, in view of the likelihood that pending regulatory legislation also passes. Clearly, the patentability standard for gene sequences and the commercial exclusivity available for such biotech inventions have been dramatically altered by the Federal Circuit's 'In re Kubin' decision.