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.
A number of biosimilar makers have turned to inter partes review (IPR) proceedings to challenge innovator patents prior to submitting their biosimilar applications to FDA. IPRs have been attractive to biosimilar makers because in addition to offering procedural and substantive advantages for challenging patents they do not require the filing of a biosimilar application. As a result, they make it possible for biosimilar makers to obtain patent certainty at a time when litigation under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is premature and, depending on the results of the IPRs, may be avoided entirely. The first such IPRs, however, are yielding mixed results, leaving potential patent disputes for later BPCIA litigation.
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 BPCIA created an abbreviated pathway for FDA approval of biological medicinal products that are “biosimilar” to an already FDA-approved product. The FDA recently approved the first U.S. biosimilar – Sandoz’s biosimilar of Amgen’s Neupogen – and is currently reviewing at least four other proposed biosimilars. Many innovators and biosimilars manufacturers are responding to the changing landscape for biologics by developing “biobetters”: new and improved versions of biologic medicinal products. While biobetters require discovery and an original Biologics License Application (BLA) with a full complement of pre-clinical and clinical data for marketing approval, they also offer many advantages. By offering superior and longer-acting medicine, biobetters provide a competitive advantage over biosimilar products. In addition, unlike biosimilars, they generally would be entitled to patent protection and 12 years of non-patent exclusivity under the BPCIA.
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 26, 2015, the Supreme Court reversed the Federal Circuit’s decision in Commil USA, LLC v Cisco Systems, Inc. and held that a defendant’s belief regarding patent validity is not a defense to an induced infringement claim. The Supreme Court’s Decision is a big win for the pharmaceutical industry, where method of treatment patents provide important protection for innovative medical therapies. The Federal Circuit’s good-faith belief in invalidity defense gutted liability for inducing infringement of such patents. The Supreme Court’s reversal allows these valuable patents to be enforced against the companies that induce infringement. It also deters “at risk” launches prior to a district court decision on the validity of the patents.
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.
A number of biosimilar makers have turned to inter partes review (IPR) proceedings in order to litigate the validity of patents that cover their proposed products in advance of submitting their regulatory applications to FDA. Since IPRs, unlike district court proceedings, do not require a case or controversy, they allow biosimilar applicants to resolve potential patent disputes long prior to being able to litigate these disputes in district court and to potentially avoid the patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA) of 2009 entirely.
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.
Amgen v. Sandoz, the first full-fledged dispute under the Biologics Price Reduction and Innovation Act, is headed to the Federal Circuit on an expedited briefing schedule, with oral argument to be held on June 3. The Federal Circuit’s decision is likely to answer basic questions about how the statute operates.
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.
Zarxio is the first biosimilar approved under the 351(k) pathway, but it is not the first “biosimilar” to be approved in the U.S. For a small category of follow-on biologics, there is another pathway for marketing approval -- and it is only available for the next five years.
Welcome to the Biologics Blog, which will track and analyze developments in intellectual property law related to biologic medical products as well as regulatory and legislative changes. Our impetus for starting the blog is the recent onset of regulatory activity and litigation under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which created a new regulatory and legal framework for biosimilar and interchangeable biologic products.
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.
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