Myriad Genetics Loses at Partial Summary Judgment Against Patent Claims to BRCA1 Genes

On March 29, 2010, the Southern District of New York ruled in favor of the plaintiffs (Association of Molecular Pathology) and granted partial summary judgment ruling that claims of several patents on BRCA1 (U.S. Patent  Nos. 5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,710,001; 5,753,441; and 6,033,857) were invalid. The BRCA1 are genes linked to an increased risk of breast and ovarian cancer. The patents in suit are assigned to Myriad Genetics, the University of Utah Research Foundation, and the National Institutes of Health (the ‘282, ‘001 and ‘441 patents).

The court stated that the claims were directed to non-statutory subject matter.  In a lengthy 156-page opinion, the District Court entered a narrow ruling that was damaging to the University of Utah and its licensee, Myriad Genetics. However, the District Court did not address the Constitutional issue of whether genetic information and material is proper patent subject matter pursuant to 35 U.S.C. § 101.

The Court granted summary judgment on the composition of matter claims, based on its reading of 19th century Supreme Court precedent as well as several old “product of nature” cases from several district courts and regional circuit Courts of Appeal.  The method claims were found invalid under the Federal Circuit’s “machine or transformation” test from In re Bilski.  The Supreme Court will shortly release its Bilski opinion, and thus this case may not have general application.

Legally, Judge Sweet tested whether the subject matter of the claims is patentable under 35 USC § 101.  Judge Sweet relied, appropriately, on a long line of Supreme Court cases affirming the patentability of various inventions derived from nature.  Diamond v. Chakrabarty, for example, stated that “the patent laws [should] be given wide scope” in upholding the patentability of genetically modified bacteria as “manufactures” or “compositions of matter.”  However, the scope of patentable subject matter is not unlimited, and because scientific principles and laws of nature “define the relationship of man with his environment [they] ought not to be the subject of exclusive rights to any one person.”  In re Meyer (CCPA 1982) (citing Leroy v. Tatham (1852)).

A great blog post further discussing this ruling is found at 37Thoughts.