The Third Circuit Court of Appeals affirmed on July 27, 2023, that infringement-suit defense costs for ANDA filers who file Paragraph IV certifications are deductible legal expenses, not capital expenditures to obtain FDA approval. The Court of Appeals noted that legal defense costs for ANDA filers do not “facilitate” obtaining an intangible asset because “ultimate…
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…
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…
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…
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…
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…
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…
The Patent Trial and Appeal Board (PTAB) recently denied motions by Teva to amend the filing dates of two petitions to institute IPRs related to patents covering Suboxone, a drug used to help patients suffering from opioid addiction. Teva’s deadline for filing these petitions was December 3, 2016, but due to technical difficulties in filing,…
Ever since the Supreme Court’s decision in Alice Corp. v. CLS Bank, 134 S.Ct. 2347 (2014), courts have churned out countless decisions holding patents invalid under 35 U.S.C. § 101 for claiming unpatentable subject matter. Most of these patents have involved the application of well-known business methods by means of a computer. In those cases,…
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. …