IP Newsflash

On September 10, 2018, the Federal Circuit affirmed a decision by the Patent Trial and Appeal Board (PTAB) determining that there was no interference in fact between the University of California’s (“UC”) U.S. Patent Application No. 13/842,859 and multiple patents and applications owned by the Broad Institute, MIT and Harvard College (collectively “Broad Institute”) that claim technologies related to the CRISPR-Cas9 gene-editing technology.

In a Report and Recommendation issued December 7, 2017, Magistrate Judge Burke in the District of Delaware recommended that Amgen’s BPCIA complaint for infringement against Coherus Biosciences Inc. be dismissed with prejudice on the ground that prosecution history estoppel barred Amgen from bringing claims for infringement under the doctrine of equivalents.

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 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).