Category: Biotechnology

In Ariosa Diagnostics Inc. v. Sequenom Inc., 788 F.3d 1371 (Fed. Cir. 2015), a Federal Circuit panel held that Sequenom Inc.’s noninvasive prenatal diagnosis patent claims patent ineligible subject matter under the two-step test of Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012).  Sequenom petitioned the court for rehearing en banc, arguing that the panel failed to consider the claimed method as a whole and that its analysis was therefore contrary to Supreme Court precedent.  Sequenom’s petition received strong support from amici from numerous organizations, companies and academic groups. There were 12 amicus briefs in total, raising a variety of additional arguments in support of en banc review.  On September 3, 2015, the court invited appellees to file a response to the petition for rehearing en banc.

In a victory for holders of method patents, the Federal Circuit issued an en banc decision yesterday expanding the scope of direct infringement when multiple parties perform different steps of an invention.  In its unanimous Akamai Techs. v. Limelight Networks decision, the appeals court provided a fact-based test for determining when “all method steps can be attributed to a single entity” such that direct infringement can be found under 35 U.S.C. § 271(a).  Unlike the earlier panel decision that was overturned, the en banc court held that infringement can, in some circumstances, be attributed to a single entity even when there is an arms-length business relationship between that entity and the other parties that perform steps of the patented method.  

The Federal Circuit recently handed down a long-awaited Section 101 decision, one with potentially far-reaching consequences for biotech diagnostic patents. In Ariosa Diagnostics Inc. v. Sequenom Inc., No. 14-1139 (Fed. Cir. June 12, 2015), the Federal Circuit, applying the U.S. Supreme Court’s test for patent eligibility set out in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 132 S. Ct. 1289 (2012), invalidated Sequenom’s breakthrough patent on noninvasive prenatal diagnosis through the amplification and detection of paternally inherited cell-free fetal DNA (“cffDNA”) in the blood of pregnant women.  According to the court, “even such valuable contributions can fall short of statutory subject matter” under the test set out in Mayo.  In addition to its implications for other biotech patents and investment in diagnostics, the Federal Circuit’s decision illustrates the potentially unintended consequences of Mayo and the need for a legislative solution so that breakthrough manmade inventions remain patent-eligible.

On May 13, the FDA released additional draft question-and-answer guidance on the implementation of the BPCIA.  The draft document resurrects a number of the questions from FDA’s original 2012 draft guidance that were omitted from last month’s final version of the 2012 document.  As a result, FDA’s final answers to important questions from three years ago may not be forthcoming for some time. 

Yesterday the Federal Circuit granted Amgen’s motion for an injunction pending appeal in Amgen v. Sandoz, the first appeal to squarely address the patent litigation provisions of the Biologics Price Competition and Innovation Act (BPCIA).  While this is an interim decision without a substantive opinion, it indicates that the court is taking Amgen’s arguments seriously.

On March 31, the Supreme Court heard oral argument in Commil USA LLC v. Cisco Systems Inc.  The Supreme Court considered the Federal Circuit’s holding that a belief in a patent’s invalidity is a defense to inducing infringement under 35 U.S.C. § 271(b).  The Justices posed tough questions to both sides.  But the ultimate outcome of this case should not impact litigation under the BPCIA where inducing infringement of method of treatment and manufacturing patents offers important protection to innovators since the validity of such patents is typically determined prior to launch of a biosimilar product.

In Gilead Sciences v. Natco Pharma, the Federal Circuit held that for post-GATT patents, i.e., patents filed after June 8, 1995 and subject to a 20 year term from the filing of the patent applications under the General Agreement on Tariffs and Trade (GATT),...

In a recent case, the Federal Circuit held that short synthetically created DNAs are not patentable after the Supreme Court’s decision in Association for Molecular Pathology v. Myriad.