The Federal Circuit Cracks Down on DNA Inventions of Uncertain Utility: The Fisher Case
Research institutions and certain biotechnology companies may breathe a bit easier now. That's because, in September, the Federal Circuit affirmed a decision of the Board of Patent Appeals and Interferences finding patent claims for "expressed sequence tags" unpatentable for lack of utility and lack of enablement.
The case, In re Fisher, No. 04-1465, 2005 WL 2139421 (Fed. Cir. Sept. 7, 2005), was closely followed in biotech circles. By affirming the finding of unpatentability, the Federal Circuit has likely ended a rush to patent certain small pieces of DNA sequence that can give researchers a quick and cheap way to discover new genes, get data on gene expression and regulation, and construct genome maps. The Federal Circuit has also laid down important new precedent governing the utility requirement of 35 U.S.C. §?101, a provision often forgotten in other areas of patent law.
The result: Some patent applicants in the biotech field will have to work harder to attain allowable subject matter. Also, biotech companies that are working on identifying expressed sequence tags will have to reap the rewards of this work through something other than patent law, unless they can show the utility of the underlying genes.
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