Court Invalidates Gene Patent
By Elizabeth Akerman – Edited By Davis Doherty
Assn. for Molecular Pathology, et al. v. USPTO, et al. Case no. 09-CV-4514 (S.D.N.Y. Mar. 29, 2010)
Slip Opinion (hosted by PatentlyO)
The United States District Court for the Southern District of New York held the patents issued to Myriad Genetics for isolated versions of two human genes to be “directed to a law of nature,” and therefore invalid pursuant to 35 U.S.C. § 101.
Judge Sweet granted the Plaintiffs’ motion for summary judgment to invalidate 15 claims in 7 patents relating to the BRCA1 and BRCA2 genes. The court reasoned that isolated DNA containing naturally occurring sequences is not markedly different from the native DNA, and thus falls within the “product of nature” exception to patentable subject matter under § 101. Additionally, Judge Sweet held that the claims regarding comparisons of BRCA sequences to determine whether a mutation is present are invalid under § 101, as they only refer to “abstract mental process.” The court further notes that even if the claims-in-suit included the physical transformations associated with isolating DNA, this would merely constitute a data-gathering step and would not satisfy § 101.
A brief review of the decision is available at Patent Docs Biotech & Pharma Patent Law & News Blog. PatentlyO suggests that this decision is likely to be reversed by the Federal Circuit. (more…)