In a final written decision, the Patent Trial and Appeal Board (PTAB) cancelled claims 1 and 2 of MiMedx’s U.S. Patent No. 8,372,437 directed to a product-by-process for producing placental tissue grafts. Claim 1, which is representative, recited (i) isolating intact amnion and chorion layers from placental tissue, (ii) washing the two layers, (iii) laminating the two layers together, and (iv) dehydrating the laminated graft.
On July 5, 2016, the Federal Circuit held the 180-day notice requirement set forth in the commercial marketing provision of the Biologics Price Competition and Innovation Act (BPCIA) is mandatory and enforceable by injunction even if a biosimilar applicant participates in the process of information exchange and patent litigation provided in the Act. This decision supplements a previous decision in Amgen, Inc. v. Sandoz, Inc. in which the Federal Circuit held the notice requirement of the commercial marketing provision applies to parties who forego the information exchange procedures in the BPCIA. 794 F.3d 1347 (Fed. Cir. 2015)
On Monday, March 21, 2016, Sequenom, Inc. filed a petition for writ of certiorari in Sequenom, Inc. v. Ariosa Diagnostics, Inc., et al., No. 14-1139 (Fed. Cir. June 12, 2015). The question posed to the Supreme Court centers around the patentability of diagnostic claims applied to newly-discovered natural phenomena.
The claimed work dates back to 1996, when two doctors discovered paternal cell-free fetal DNA (cffDNA) in maternal blood serum and plasma. With that discovery, the doctors developed a method of testing fetal DNA to determine, among other things, the risk of certain birth defects in a manner far less invasive than conventional techniques, which required DNA samples to be taken directly from the fetus or placenta. The doctors obtained U.S. Patent No. 6,258,540 covering the methods.
In granting a summary determination motion, ALJ Lord found that the patent owner’s (Owner) patents were directed to ineligible subject matter under 35 U.S.C. § 101. This was the first successful challenge to patentability under Section 101 at the International Trade Commission (ITC) since the Supreme Court’s decision in Alice Corporation Pty. Ltd. v. CLS Bank International.
Judge Freeman of the Northern District of California issued an order on February 1, 2016, denying plaintiff Gilead Sciences, Inc.’s motion for summary judgment of invalidity of two patents assigned to Merck Sharp and Dohme Corp. and alleged to cover Gilead’s blockbuster Hepatitis C (HCV) drug sofosbuvir. Sofosbuvir is a key component of Gilead’s Sovaldi(R) and Harvoni(R) products. Gilead argued that the asserted claims were invalid for failure to satisfy “the utility prong of enablement.” This theory is based on the requirement that “the how to use prong of section 112 [requires] that the specification disclose as a matter of fact a practical utility for the invention,”—designed to “prevent the patenting of mere ideas, research proposals, and hypotheses.”
On December 2, 2015, the Federal Circuit denied a petition for rehearing en banc to consider whether a three-judge panel had correctly affirmed a judgment of invalidity under 35 U.S.C. § 101. The court determined that although the nature of the claimed invention is such that it should be patentable, the Federal Circuit’s hands are tied by the Supreme Court’s two-part test in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012). The court also expressed concern about the implications of decisions like this on medical diagnostics patents: Judge Lourie stated, “[i]t is said that the whole category of diagnostic claims is at risk. It is also said that a crisis of patent law and medical innovation may be upon us, and there seems to be some truth in that concern.”
The claims-at-issue were “directed to methods for detecting paternally-inherited fetal DNA in maternal blood samples, and performing a prenatal diagnosis based on such DNA.” Applying the Supreme Court’s two-step framework to § 101, the court found that the claims were directed to a natural phenomenon and failed to include an “inventive concept sufficient to ‘transform’ the claimed naturally occurring phenomenon into a patent-eligible application.” Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1376 (Fed. Cir. 2015) (quoting Mayo).