July 30, 2011

Federal Circuit Endorses Patent Eligibility of Genes

The long-awaited Federal Ciruit decision on the patent eligibility challenge from assorted plaintiffs (patients, physicians, medical organizations) to the BRCA1 and BRCA2 patents has issued. In 2010, the lower federal court in New York had declared that genes are not patentalbe subject matter, relying on product and law of nature doctrines for its ruling. Now, the appellate court has rejected that conclusion, reasoning that the isolated DNA claimed in the patents has a "distinctive chemical identity" that is different from the native DNA, thus reflecting an inventive intervention which allows the compositions to be patentable subject matter. My own view of the eligibility question relies on an examination of the gene as a molecule with a bifurcated legal identity that complicates its patent eligibility; I conclude that the patent of genes results in effective preemption of the genetic code, thus violating the prohibition on patenting laws of nature. For more exposition of this argument, my amicus brief is available: Kane Amicus Brief AMP v USPTO 2010. The Court did further decide that the method claims in the case were ineligible; more analysis will be forthcoming of the method claims.

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