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In a decision that is already attracting plenty of controversy, comments, compliments and complaints, the Court of Appeals for the Federal Circuit has held that isolated human DNA molecules are patentable, and were validly patented by Myriad, under the (US) Patents Act.  See Association for Molecular Pathology et al. v. Myriad Genetics, Inc et al. (Case No 2010-1406, Decided July 29, 2011).  The decision reverses in part and affirms in part the decision of Judge Sweet, sitting in the District Court for the Southern District of New York (Case No. 09-CV-4515).

Regarding the claims to isolated DNA molecules, the Court reversed Judge Sweet because “the molecules as claimed do not exist in nature”, but affirmed his decision that Myriad’s method claims directed to comparing or analyzing DNA sequences disclosed only non-transformative, abstract, mental steps, and therefore are ineligible for patent protection.

According to Judge Lourie:

Myriad Genetics, Inc. and the Directors of the Univer- sity of Utah Research Foundation (collectively, “Myriad”) appeal from the decision of the United States District Court for the Southern District of New York holding that an assortment of medical organizations, researchers, genetic counselors, and patients (collectively, “Plaintiffs”) have standing under the Declaratory Judgment Act to challenge Myriad’s patents. Assoc. for Molecular Pathology v. U.S. Patent & Trademark Office, 669 F. Supp. 2d 365 (S.D.N.Y. 2009) (“DJ Op.”). Myriad also appeals from the district court’s decision granting summary judgment that all of the challenged claims are drawn to non-patentable subject matter under 35 U.S.C. § 101. Assoc. for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010) (“SJ Op.”). We affirm in part and reverse in part.

On the threshold issue of jurisdiction, we affirm the district court’s decision to exercise declaratory judgment jurisdiction because we conclude that at least one plaintiff, Dr. Harry Ostrer, has standing to challenge the validity of Myriad’s patents. On the merits, we reverse the district court’s decision that Myriad’s composition claims to “isolated” DNA molecules cover patent-ineligible products of nature under § 101 since the molecules as claimed do not exist in nature. We also reverse the district court’s decision that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates is directed to a patent-ineligible scientific principle. We, however, affirm the court’s decision that Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent-ineligible abstract, mental steps.

I attended a talk about this case in late 2010 and I don’t think this decision will come as a huge surprise to any of the parties involved.  I am sure they have their eyes on a Supreme Court hearing, so this decision will serve to direct the form of their pleadings more than anything else.

There is a discussion of the case on the Patently-O blog which you can access here.

The decision, all 105 pages of it, is set out below.

 

Association for Molecular Pathology et al. v. Myriad Genetics, Inc et al. (Case No 2010-1406, Decided July …