On February 15, 2017, the Patent Trial and Appeal Board (PTAB) terminated a patent interference between the Broad Institute and the University of California, finding the parties’ respective claims to CRISPR-Cas9 systems and methods patentably distinct and therefore not interfering.
In a November 21, 2016, order, the Honorable Janis L. Sammartino of the Southern District of California dismissed The Scripps Research Institute’s (TSRI) patent infringement claims without prejudice because TSRI failed to satisfy the recently heightened pleading standard for direct infringement. In setting out the relevant standard, the court noted that “Form 18”—a basic patent infringement form complaint that was previously appended to the Federal Rules of Civil Procedure, but eliminated on December 1, 2015—no longer applied. Instead, as the court had previously held, the pleading standard set out in the Supreme Court’s Twombly and Iqbal decisions now governed claims for patent infringement. The court held that, under Twombly, a complaint for patent infringement “must plausibly allege that a defendant directly infringes each limitation in at least one asserted claim.” The court did not elaborate on how much specificity is required to demonstrate that each limitation of an asserted claim is “plausibly met” by the accused products, but it did clarify that its holding “does not require a patentee to plead with the specificity required in its infringement contentions.” Notably, the court also held that a plaintiff need only plausibly allege infringement of a single claim for the complaint to survive, and it is not required to identify all asserted claims and all infringing products in its initial pleading. However, “all of a patentee’s asserted claims for infringement must eventually appear in its complaint, amended or otherwise.”
On September 20, 2016, the Federal Circuit issued an opinion affirming a judgment by the District Court for the District of Columbia finding the claims of Abbott GMBH & Co. KG’s (“Abbott”) U.S. Patent No. 5,344,915 (the “’915 patent”) valid over prior art. The court held the patent properly claims priority to an earlier filed application that was found, under the doctrine of inherent disclosure, to provide adequate written description support for the invention claimed in the ’915 patent.
A Patent Trial and Appeal Board (PTAB) panel has denied institution of inter partes review proceedings because the petitioner did not establish a patent qualified as prior art under 35 U.S.C. § 102(e). PTAB was not persuaded that the putative 102(e) patent’s issued claims had written description support in the provisional application from which the patent claimed priority.
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.
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).
On January 14, 2016, a PTAB panel denied institution of petitions for inter partes review of two patents owned by AbbVie and alleged by AbbVie to cover the pharmaceutical product HUMIRA®, the best-selling brand-name drug of 2015. The petitions, filed by Amgen, preceded the company’s submission of a Biologics License Application for a biosimilar alternative to HUMIRA®. According to the Board, the petitions challenging the patentability of the claims of U.S. Patent Nos. 8,916,157 and 8,916,158 failed to show “that there [was] a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition[s]” as required under 35 U.S.C. § 314. Petitioner challenged claims in both patents under 35 U.S.C. § 103(a) as obvious over two sets of prior art references and the state of the art at the time of the inventions. The Board was not persuaded in either instance, and determined that the first set of references did not provide “sufficient guidance such that a skilled artisan would have had a reasonable expectation of success…” The Board further found the combination of the references to “be exercises in impermissible hindsight reconstruction,” citing to Grain Processing Corp. v. Am.-Maize prods. Co., 840 F.2d 902, 907 (Fed. Cir. 1988). In also rejecting the patentability arguments over the second set of references, the Board agreed with the Patent Owner that a “lack of teachings . . . would have left one of ordinary skill in the art ‘with an utter lack of guidance…’” After determining that Petitioner had “not established a reasonable likelihood of prevailing with respect to” the challenged independent claims, the petitions were denied and no trial was instituted.