Wednesday, July 25, 2012
Myriad Genetics holds a number of patents on two genes implicated causally in breast cancer, BRCA1 and BRCA2. In 2009, scientific organizations devoted to genetics and pathology, genetics researchers, clinicians, genetics counselors, patients, and breast cancer and civil liberties advocacy groups filed a complaint seeking to have the patents declared invalid. In addition to Myriad, defendants in the suit are the US Patent and Trademark Office (USPTO) and the University of Utah Research Foundation (in this spirit of full disclosure, I teach at Utah and have colleagues who have appeared as amici in the case but otherwise have no relationships with Myriad). The patients claimed that the patents harmed them medically, as they were unable to obtain testing because of its high cost. Plaintiffs also contended that Myriad's test did not include additional variants of these genes that might be clinically relevant for them. Clinicians contended that they were unable to offer testing that differed from Myriad's, except under license from Myriad. The researchers claimed that Myriad had withheld scientifically important information and that they were unable to engage in research that could develop further understanding of the etiology of breast cancer and testing for it.
Central to the case is whether the patents come within the "law" or "product" of "nature" exception to 35 USC 101, or whether the DNA Myriad had "isolated" is a patentable discovery. The district court held that the patents were invalid and granted summary judgment for the plaintiffs, Association for Molecular Pathology v. United States Patent and Trademark Office, 702 F. Supp.2d 181 (S.D.N.Y.2010). On the merits of the patent claims, the U.S. Court of Appeals for the Federal Circuit affirmed in part and reversed in part. Myriad's patents on methods for comparing DNA sequences were held invalid as covering only an abstract analytic method. Myriad's other patents, on the "isolated" DNA molecules were held valid, as the molecules in the judgment of the court do not exist in nature. Finally, the Federal Circuit concluded that Myriad's method claim for screening potential cancer therapeutics through changes in cell growth rates was not a law of nature and was thus patent eligible, Association for Molecular Pathology v. US Patent and Trademark Office, 653 F.3d 1329 (Fed. Cir. 2011).
In March, 2012, the US Supreme Court decided the Prometheus Labs case, invalidating a patent on a process for determining the proper dosage of thiopurine drugs in treating autoimmune disease, Mayo Collaborative Services v. Prometheus Labs, Inc, 132 S.Ct. 1289 (2012). The goal of the Prometheus test was to tell physicians how to adjust dosages so that they would be at a level high enough to be therapeutic but without causing patients harm. The test did this by measuring metabolites in the patient's blood. In invalidating the patents, the Court concluded that the algorithm for adjusting dosage merely stated known laws of nature and did not add anything inventive to the application of these laws.
Six days later, the Court granted cert. in the Myriad case, vacated the decision of the Federal Circuit, and remanded for further consideration in light of Prometheus Labs., Association for Molecular Pathology v. Myriad Genetics, 132 S.Ct. 1794 (2012).
This past Friday, the case was re-argued in the Federal Circuit, before the same panel that upheld the Myriad patent (it was a 2-1 decision). According to the Bloomberg News report of the oral argument, http://www.businessweek.com/news/2012-07-20/myriad-defends-patent-claims-on-genetic-material-in-court-case#p1, at issue were patents concerning the isolated DNA molecule. Lawyers from the ACLU argued for the plaintiffs, contending that the patents come under the law or product of nature exception as understood in Prometheus. The Department of Justice also argued for the invalidity of the patents, analogizing the DNA extraction to taking coal from the ground. Myriad argued that the patent claims refer to human-made compositions, not natural products. Circuit Judge Bryson (the judge in the minority in the original panel decision) reportedly analogized the molecule to a piece of marble with the non-essential bits chopped away, like Michelangelo's David. As Circuit Judge Moore, noted, there's lots of money at stake in the decision--as well as important consequences for genetics research, clinicians, and patients.
In subsequent posts, I'll note updates to the case as they occur.