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The Kubrin case, 16 May 2009
Kubinís Impact on Gene Patenting
The Federal Circuitís 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 that 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 Circuitís In re Kubin decision.
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Ernst Max Nielsen - MaxInno: www.icnet.dk; Aldersrovej 31; DK 8200 Aarhus N
Denmark, Tel +45-4040-3264 (mobile) ; +45-8616-6218
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