Myriad Urges Dismissal of "Gene Patenting" Case

31 May 2012 Personalized Medicine Bulletin Blog

Yesterday Myriad urged the Federal Circuit to dismiss the “gene patenting” case on the ground that subject matter jurisdiction no longer exists. Myriad argued that in the alternative, the case should be remanded to the district court to address whether declaratory-judgment jurisdiction exists under the current facts of the dispute. 

 Background and Issue

As we reported in our March 26, 2012 post, the U.S. Supreme Court sent the ACLU “gene patenting” case back to the Federal Circuit for reconsideration in light of its unanimous decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012), (“Prometheus”) which held that claims directed to methods of optimizing the dose of specific drugs used in the treatment of specific conditions are invalid under 35 U.S.C. Section 101 because they impermissibly claim laws of nature. 

Whether or not the Plaintiff-Appellees retained standing was first raised in  a letter to the Federal Circuit delivered just two days prior to the Federal Circuit’s now vacated decision, and the issue was not addressed in the court’s decision. The Federal Circuit also did not include the issue in the questions to be addressed by the parties on remand.  

Myriad set up its argument by first noting that in the initial appellate proceedings, the Federal Circuit sustained declaratory-judgment jurisdiction as to only one of twenty plaintiffs – Dr. Harry Ostrer, who was then at New York University (“NYU”). This jurisdictional holding was based upon the controversy supposedly created when Myriad offered NYU a collaborative license in 1998, and the further finding that “the relevant circumstances remain unchanged” since Myriad proposed the license. After the Federal Circuit’s decision, Dr. Ostrer ended his employment at NYU. Myriad has not pursued any activity against the institutions (the Albert Einstein College of Medicine and Montefiore Medical Center) that now employ Dr. Ostrer. Thus, Dr. Ostrer’s voluntary change in his employment, it was argued, moots any real or immediate dispute that might otherwise have been before the court.

Supreme Court and Federal Circuit Precedent

Myriad cited the 2007 U.S. Supreme Court decision, MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), for the proposition that to establish jurisdiction in a declaratory-judgment action, the factual allegations must show that there is a substantial controversy between the parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment. Myriad also noted that in applying MedImmune, the Federal Circuit has held that a “case or controversy” arises under the Declaratory Judgment Act “where a patentee asserts rights under a patent based on certain identified ongoing or planned activity of another party … and where that party contends that it has the right to engage in the accused activity without license” citing SanDisk Corp. v. STMicroelecs., Inc. 480 F.3d 1372, 1381 (Fed. Cir. 2007) and 3M Co. v. Avery Dennison Corp., 673 F.3d 1372, 1377 (Fed. Cir. 2012). Plaintiffs bear the burden of proving the existence of a controversy throughout the litigation. Dow Jones & Co. v. Ablaise Ltd., 606 F.3d 1338, 1345 (Fed. Cir. 2010) and Benitec Australia Ltd. v. Nucleonics, Inc., 495 F.3d 1340, 1344 (Fed. Cir. 2007). In a footnote, Myriad also noted that the U.S. Supreme Court recently granted the Solicitor General’s petition for certiorari to review a case where, as in this case, an assortment of organizational and recruited plaintiffs represented by the ACLU were found to have Article III standing, even though they asserted only self-imposed injury and not any action directed at them by the defendant. See Amnesty Int’l USA v. Clapper, 638 F.3d 118 (2d Cir. 2011), cert. granted, Clapper v. Amnesty Int’l USA, 566 U.S. __ (May 21, 2012)(No. 11-1025).

Looking Ahead

After the recent U.S. Supreme Court “Prometheus” decision, many in the biotechnology and pharmaceutical industry are watching this case carefully and with some nervousness. Although the facts of the case are directed to the patent-eligibility of isolated DNA molecules, the repercussions of any decision could extend far beyond so called “gene patents” as many in the industry rely on technologies isolated from natural sources. An ultimate dismissal of the suit would at least maintain the status quo until such time the ACLU or other like-minded individuals create another suitable controversy for judicial review.

Initial briefings by the parties and interested amici are due June 15th.

A copy of Myriad’s filing is attached. [Myriad's Suggestion]




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