“Clever Labeling” of Prior Art Not Disclosed in Invalidity Contentions Insufficient to Satisfy District of New Jersey Local Patent Rules

A Special Discovery Master in Celgene Corp. v. Hetero Labs Ltd., No. 17-3387 (D.N.J. Mar. 29, 2021)1 recently issued a Report and Recommendation requiring defendants to move to amend their invalidity contentions to add dozens of prior art references that defendants’ experts relied on, but which defendants failed to disclose in their invalidity contentions. The court […]

Private Plaintiff Must Prove Antitrust Injury to Recover for Antitrust Violations Based on Reverse Payment Settlements of ANDA Litigation

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 […]

Submission of New Evidence After Institution of an IPR is “Perfectly Permissible”

Last week, in Genzyme v. Biomarin, the Court of Appeals for the Federal Circuit held petitioners may introduce new evidence after an institution decision in IPR proceedings as long as the opposing party received notice of the new evidence and an opportunity to respond. In its final written decision, the PTAB relied on references beyond […]

Federal Circuit Dramatically Expands ANDA Jurisdiction

Last week, the Federal Circuit issued its panel opinion in two cases: Accorda Therapeutics Inc. and Alkermes Pharma Ireland Ltd. v. Mylan Pharmacueticals, Inc. and Mylan Inc. and AstraZeneca AB v. Mylan Pharmacueticals, Inc.  The question before the Court in both cases was whether Mylan was properly subject to jurisdiction in the District of Delaware.  […]

District of Delaware Finds Terms of Namenda XR® Patents Indefinite During Claim Construction

On January 5, 2016, Chief Judge Leonard P. Stark of the District of Delaware found the claim language of several patents covering Namenda XR®—Forest Laboratories, Inc.’s extended-release drug for treating Alzheimer’s-type dementia—indefinite. Forest Labs., Inc. et. al v. Teva Pharm. USA, Inc. et al., Civ. No. 14-cv-00121-LPS (D. Del. Jan. 5, 2016). Notably, the court […]

Federal Circuit Clarifies Scope of § 271(e) Safe Harbor in Classen v. Elan

In Classen Immunotherapies, Inc. v. Elan Pharms., Inc., the Federal Circuit determined that an NDA-holder’s post-approval activities fall within the scope of the § 271(e) safe harbor.  2015 U.S. App. LEXIS 7854 (Fed. Circ. May 13, 2015).  Specifically, 35 U.S.C. § 271(e)(1) exempts activities reasonably relating to developing clinical data on an approved drug and submitting that […]

Federal Circuit Discounts Commercial Success Evidence Even Though Alleged Invention Helped Secure Regulatory Approval

Last Thursday, in its decision in AstraZeneca LP v Breath Ltd., the Federal Circuit affirmed Breath Ltd.’s Paragraph IV ANDA challenge of AstraZeneca’s Orange Book patent covering sterile budesonide compositions.  It was undisputed that those of ordinary skill in the art would have been motivated to pursue a sterile budesonide composition, limiting the obviousness dispute […]