Supreme Court Tells Federal Circuit to Reconsider Patent Eligibility of Isolated DNA Claims
On the heels of its unanimous decision holding that the personalized medicine method claims at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (S. Ct. 2012), cannot be patented under 35 USC § 101 because they effectively claim a law of nature, the Supreme Court has asked the Federal Circuit to reconsider its decision in Association for Molecular Pathology v. Myriad Genetics, Inc. No. 10-1406 (Fed. Cir. 2011) (also known as the “ACLU gene patent” case). Rather than taking up Myriad’s isolated DNA claims for review on the merits, the U.S. Supreme Court granted certiorari, vacated the Federal Circuit’s decision, and remanded the case back to the Federal Circuit for reconsideration in view of Prometheus. (Among Supreme Court practitioners, this resolution is referred to as a GVR.) This turn of events is not surprising, but means that the patent-eligibility of claims directed to isolated DNA will remain undecided for at least several more months. For detailed analysis of the Prometheus decision, please refer to our article that was posted last week, Unanimous Supreme Court Invalidates Prometheus Personalized Medicine Claims.”
A divided panel of the Federal Circuit upheld Myriad’s isolated DNA claims. Judge Lourie found that the claims are not disqualified under § 101 as “products of nature,” because isolated DNA molecules are “markedly different” from molecules found in nature. Judge Moore concurred in that result, but wrote a separate opinion explaining the significance of a “new utility” to distinguish a product of nature, and also discussed the importance of not disrupting “[t]he settled expectations of the inventing community with respect to [the patent-eligibility of] isolated DNA claims.” Judge Bryson dissented, finding that the claims indeed were directed to products of nature, because isolated DNA is “the same, structurally and functionally” to the sequence in the native gene.
The GVR could signal to the Federal Circuit that it should give more consideration to the Supreme Court’s 1948 decision in Funk Bros. Seed Co. v. Kalo Inoculant Co. The patent at issue in Funk Brothers was directed to a composition comprising a mixture of different nitrogen-fixing strains of bacteria, used in agriculture to inoculate the seeds of leguminous plants, and was found to not be patentable. However, scholars disagree as to whether the issue was decided on principles analogous to today’s § 101 patent-eligibility jurisprudence or to today’s § 102/103 prior art jurisprudence. The Federal Circuit also could read sections of Prometheus as a reminder that policy considerations should not be elevated over the statutory prohibition against patenting a product of nature. Still, it is not clear how the Federal Circuit will decide this case on remand, and whether the case will again make its way to the Supreme Court.
On remand, the Federal Circuit also may have to revisit the standing issue. This case arose from a declaratory judgment action, and Myriad has not made any counterclaims of infringement. Although the court found that one of the 20 plaintiffs had a sufficiently immediate controversy to support a declaratory judgment action against Myriad’s patents, Myriad has questioned whether that plaintiff’s subsequent change in employment has eliminated his dispute. If no plaintiff has standing, the case should be dismissed as moot.
For a discussion of the Federal Circuit’s Myriad decision, see our July 29, 2011 Legal News Alert, “Federal Circuit Decides Highly Anticipated ‘ACLU/Myriad’ Gene Patenting Case — Subject Matter Patent-Eligibility of Isolated DNA and Diagnostic Methods Addressed Head-On.”
For detailed analysis of the Prometheus decision, please refer to our March 20, 2012 Legal News Alert, “Unanimous Supreme Court Invalidates Prometheus Personalized Medicine Claims.”
For on-going discussion of these and other issues, subscribe to our Personalized Medicine Bulletin and our PharmaPatents Blog.
Legal News Alert is part of our ongoing commitment to providing up-to-the-minute information about pressing concerns or industry issues affecting our clients and our colleagues. If you have any questions about this update or would like to discuss this topic further, please contact your Foley attorney or the following:
Courtenay C. Brinckerhoff
Washington, D.C.
202.295.4094
[email protected]
Jeanne M. Gills
Chicago, Illinois
312.832.4583
[email protected]
