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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.

Gene sequencing is the process of examining the order of nucleotides within a DNA molecule to determine what traits exist within an individual’s genome. Because gene sequencing does not alter the information contained in a DNA sequence, the court described the process as analogous to using a microscope to see something “that exists in nature but is too small to be seen otherwise.” While the techniques required for gene sequencing are well-known, the process requires knowledge of a reference sequence of the portion of DNA targeted by the scientists. Mutations in the BRCA genes correlate to an increased risk of breast and ovarian cancer; Myriad’s patent allows it to offer the sole test for such BRCA mutations at a cost of over $3,000. The court acknowledged that while effort and ingenuity were necessary for Myriad and its collaborators to isolate the BRCA reference sequences, the techniques used to do so are widely used in the scientific community.

The court did not reach the constitutional issue presented by the plaintiffs of whether the USPTO’s policy permitting the grant of the Myriad patents violates Article I, Section 8, Clause 8 and the First Amendment of the Constitution. Judge Sweet noted that a holding by the Federal Circuit or Supreme Court affirming this decision would not only apply to the patents at issue in this case, but to all future patent applications as well, thereby avoiding the constitutional issue.

If it stands, this decision could have negative effects on the willingness of companies to invest in identifying gene sequences. But as the court discussed, other companies and research foundations have been eager to use the BRCA genes in their own research; this decision could reignite such research.  Additionally, it would allow other companies to develop a competing test for BRCA mutations, increasing women’s access to genetic testing.

Posted On Apr - 3 - 2010 Comments Off

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