On June 11, a bipartisan group of Representatives including Hakeem Jeffries (D-N.Y.), Doug Collins (R-Ga.), Ben Cline (R-Va.), and Debbie Mucarsel-Powell (D-Fla.) introduced a new bill to address the rising cost of branded prescription drugs. The Terminating the Extension of Rights Misappropriated (TERM) Act of 2019, H.R. 3199, 116th Cong. (2019), aims to prevent pharmaceutical…
The District of Delaware recently weighed in on the scope of IPR estoppel in Novartis Pharmaceuticals Corp. v. Par Pharmaceutical, Inc., 14-cv-01289 (D. Del. Apr. 11, 2019). Describing the issue before it as a matter of first impression, the Court held that “IPR estoppel will still apply post-trial where the Court has not entered a…
The Federal Circuit upheld a PTAB decision in which meeting materials published on the FDA website and linked to in a notice in the Federal Register (“Notice”) were sufficiently accessible to constitute “printed publication” prior art in Jazz Pharm. Inc. v Amneal Pharm. LLC, No. 2017-1671, 2018 WL 3400764 (Fed. Cir. July 13, 2018). The…
Less than two months after Andrei Iancu was confirmed as the new Director of the USPTO, the Office issued a Notice of Proposed Rulemaking concerning the claim construction standards employed in contested USPTO proceedings, including IRPs, PGRs, and CBMs. The proposed change would abandon the broadest reasonable construction standard currently used for unexpired patents in…
Carlson Caspers successfully defended an indefiniteness verdict at the Federal Circuit in Forest Laboratories, Inc. v. Teva Pharmaceuticals USA, Inc. The asserted claims were directed to extended-release formulations of memantine, and were listed in the Orange Book for Forest’s Namenda XR® product. The applicants chose to define their formulation based on pharmacokinetic principles rather than…
In Mylan Institutional LLC v. Aurobindo Pharma Ltd., the Federal Circuit offered some clarity to the “sparse and confusing case law” concerning the doctrine of equivalents in the chemical context. In reviewing a preliminary injunction where the district court found a reasonable likelihood of infringement under the doctrine of equivalents, the Court suggested that the…