HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Wednesday, August 22, 2012

Myriad's gene patents redux

Herewith my update on the Myriad gene patent case.

In response to the Supreme Court's remand in light of the Mayo v. Prometheus decision (132 S.Ct. 1289 (2012)), the Federal Circuit held oral argument on July 20 and issued its decision on August 16, 2012, Ass'n for Molecular Pathology v. United States PTO, 2012 U.S. App. LEXIS 17679 (August 16, 2012). At issue were fifteen composition and method patent claims held by Myriad with respect to the BRCA1 and BRCA2 genes, genes implicated in breast cancer.  The district court had held the claims invalid under section 101 of the Patent Act as patent-ineligible products of nature or scientific laws. The Supreme Court's remand had asked the Federal Circuit to reconsider its reversal of the district court in light of Mayo.

In its most recent decision, the Federal Circuit largely reaffirmed its earlier analysis. One type of patent at issue was Myriad's composition claims to isolated DNA molecules.  The Federal Circuit's earlier decision had concluded that Myriad's composition claims were valid, Association for Molecular Pathology v. United States PTO, 653 F.3d 1329 (2011). In the new judgment of the Federal Circuit, Mayo did not question composition patents generally; the question for resolution was whether the Myriad patents claimed patent-ineligible products of nature.  The Federal Circuit held that they did not, that although they were made from biological materials they were non-naturally occurring and man-made. Nor are they laws of nature. In reaching this conclusion, the Federal Circuit reasoned that the isolated genes were not merely "purified" versions of natural substances, but "distinct chemical entities." The Federal Circuit rejected the government's suggested "magic microscope" test under which if an imaginary microscope could focus on the claimed isolated bit of DNA, it was not patent eligible. Instead, relying on Charkrabarty, it analyzed whether the isolated molecules were "markedly different" from what is found in nature.  Whether chemical entities that convey genetic information warrant special treatment under the patent law, the court said, was a question for the legislature, not for the courts under the current statutory regime.

One set of Myriad's method patent claims consisted of analyzing and comparing DNA sequences.  For these patents, the analytic question is whether these patents merely state scientific laws and thus are ineligible for patenting. The Federal Circuit had earlier concluded that these patent claims were invalid and this decision also did not change. These were patents consisting of comparing one sequence to another and merely reflected abstract mental processes and thus were ineligible.  However, the Federal Circuit continued to hold that a different type of method claim, that of screening potential cancer therapeutics through changes in cell growth rates of transformed cells, was patentable. The Federal Circuit's reasoning was that this patent used "transformed" cells with "enhanced function and utility" to draw the therapeutic conclusion and hence did not simply apply a law of nature.

Stay tuned.


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