Just over two months have elapsed since the Supreme Court rejected the Federal Circuit’s patent venue jurisprudence. TC Heartland LLC v. Kraft Foods Grp. Brands LLC, 137 S. Ct. 1514 (2017). The Supreme Court held that venue for patent cases is proper in (1) the defendant’s state of incorporation or (2) “where the defendant has…
Last week, in Novartis, et al., v. West-Ward Pharmaceuticals International Limited, the District of Delaware denied Defendant’s motion in limine seeking to exclude “post art” evidence, i.e. references published after the critical date, as irrelevant and prejudicial. In its order, the court remarked that though there are some limitations, post art can be offered for…
Yesterday in Sandoz Inc. v. Amgen Inc., et al., the Supreme Court ruled that biosimilar makers may give 180-day notice of sales before product approval, and that the failure of a biosimilar maker to provide its application and manufacturing information to the RLD drug maker under the Biologics Price Competition and Innovation Act (“BPCIA”) is…
The Federal Circuit recently reversed and remanded an Examiner’s rejection of a claim that involved an element requiring both structural and functional limitations. See In re Chudik, No. 2016-1487 (Fed. Cir. Jan. 9, 2017). Specifically, the Federal Circuit reversed the Examiner’s rejection because the record failed to establish that a single prior art reference contained…
Last week, the Federal Circuit held in Phigenix, Inc. v. Immunogen, Inc. that a party must be able to prove injury in fact in order to challenge an inter partes review decision in Federal Court. (Fed. Cir. Jan. 9, 2017). Specifically, while any party may challenge a patent via IPR regardless of Article III standing,…
Three years ago, the Supreme Court held in Federal Trade Comm’n v. Actavis, Inc. that pay-for-delay settlement agreements may constitute antitrust violations under the rule of reason if their anticompetitive effects are unreasonable when viewed in light of the agreements’ size, scale in relation to future litigation costs, independence from other services that might justify…
Last week, the FDA rejected Vanda Pharmaceutical’s Citizen Petition requesting that FDA withhold approval of ANDAs for its schizophrenia drug, Fanapt®, for three years. (Letter from Janet Woodcock, M.D., Director Center for Drug Evaluation and Research, to Richard L. Gulino, Senior Vice President, General Counsel and Secretary, Vanda Pharmaceuticals Inc., dated Nov. 28, 2016.) Specifically,…
Altaire Pharmaceuticals Inc. filed a Petition for a post-grant review of claims 1 to 13 of U.S. Patent No. 8,859,623 (“the 623 patent”) owned by Paragon Bioteck, Inc. The primary issue was whether Petitioner’s product—which qualified as 102(a) prior art—met the limitations of the ’623 patent claims and therefore rendered the claims obvious. The Board…
Earlier this month, the FDA published a final rule that updates the requirements for ANDA submissions under section 505(j) of the Food, Drug, and Cosmetic Act (“FDCA”) and NDA submissions under section 505(b)(2) of the FDCA. The new rule takes effect on December 5, 2016, and the following is an overview of the most important…
In Cox Communications, Inc. v. Sprint Communication Co., the Federal Circuit reversed a district court ruling holding six of Sprint’s patents invalid as indefinite. The definiteness dispute centered on the term “processing system,” which performed the function of transforming and routing telephone signals through a data network. Cox argued that “processing system” is a structural…