Federal Circuit Upholds Decision to Delist System Patent from the Orange Book

Recently, the Federal Circuit affirmed the decision of the U.S. District Court for the District of Delaware granting a motion for an injunction to delist Jazz Pharmaceuticals, Inc.’s (“Jazz”) REMS patent from the Orange Book, as the patent covers neither the drug itself nor a method of using it. Jazz Pharms., Inc., v. Avadel CNS […]

IRS Treatment of Litigation Costs in ANDA Cases

The Third Circuit Court of Appeals will decide whether the IRS can force Mylan (and by extension other ANDA filers) to treat a) legal expenses to prepare notice letters and b) legal expenses to defend against infringement suits after paragraph IV certification both as capital expenditures that may not be deducted entirely in the year […]

“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 […]