IP Newsflash

In its latest decision in a series of interferences related to the CRISPR gene-editing system, the Patent Trial and Appeal Board (PTAB) granted priority to The Broad Institute, MIT and Harvard (collectively, “Broad”) for inventions generally covering the use of a CRISPR-Cas9 system in eukaryotes. The PTAB found that Broad was the first to actually reduce the invention to practice and that the University of California, University of Vienna and Emmanuelle Charpentier (collectively, CVC) could not establish earlier conception or reduction to practice dates. As a result of its decision, the PTAB refused CVC’s pending patent claims to eukaryotic cells comprising a CRISPR-Cas9 system.

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.

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).