In a recent order, Judge John Bailey from the Western District of Virginia denied Defendant Mylan’s 12(b)(6) motion to dismiss § 271(e) infringement claims despite the USPTO issuing Plaintiff AstraZeneca’s patent after the FDA approved Mylan’s ANDA. AstraZeneca AB v. Mylan Pharmaceuticals Inc_, 2022 U.S. Dist. LEXIS 123111. Mylan’s ANDA application was approved on March…
Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited (“Amarin”) sued ANDA-holder Hikma Pharmaceuticals USA Inc., Hikma Pharmaceuticals PLC (“Hikma”) and health insurance provider Health Net, LLC (“Health Net”) for induced infringement of three patents covering methods of use for Amarin’s drug Vascepa®. Notably, the complaint asserts a novel theory of induced infringement against Health Net.…
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…
This month the Federal Circuit held that Breckenridge’s proposed labeling for a generic colonoscopy prep kit would induce infringement of Braintree’s patent covering SUPREP. Braintree Labs., Inc. v. Breckenridge Pharm., Inc., No. 16-1731 (Fed. Cir. May 5, 2017). In doing so, the Federal Circuit clarified when proposed labeling amounts to an affirmative intent to induce…
U.S. District Judge Renee Marie Bumb recently found two of three patents covering the epilepsy drug Oxtellar XR® to be valid and infringed. Supernus Pharms. Inc. v. Actavis Inc. et al., Civ. No. 13-cv-4740 (D. N.J. Feb. 5, 2016). As part of her opinion following a bench trial, Judge Bumb ruled that the term “homogeneous…
Shire has petitioned the Federal Circuit to rehear en banc its decision in Shire v. Amneal, where the Federal Circuit declined to hold an API manufacturer liable as an indirect infringer. Shire asked the court to address the question of whether a non-ANDA filer can be liable for future infringement under 35 U.S.C. § 271(e)(2)…
To prove infringement of a method of treatment claim under section 271(e), a patent owner must prove that the ANDA filer will induce infringement by another, typically a physician, who will directly infringe the asserted patent by carrying out the method according to instructions in the ANDA label. But what happens when the label instructs…
The Ruling. In a 6-2 decision issued Tuesday, the Supreme Court once again disagreed with the Federal Circuit and held that a defendant’s good-faith (but incorrect) belief that a patent is invalid is not a defense to an induced infringement claim. Commil USA, LLC v. Cisco Sys., Inc., No. 13-896. The Court also affirmed that induced…
In Takeda Pharmaceuticals USA, Inc. v. West-Ward Pharmaceutical Corp., Judge Sue L. Robinson of Delaware denied Takeda’s motion for a preliminary injunction, finding no likelihood of success on its claim that Hikma induces infringement of Takeda’s method patents under 35 U.S.C. § 271(b). The five patents-in-suit cover methods of treating acute gout flare with colchicine…
In a pair of opinions, both issued as Ferring B.V. v. Watson Laboratories, Inc., the Federal Circuit held that Watson’s and Apotex’s ANDA products will not infringe Ferring’s patents covering Lysteda, a tranexamic acid treatment for menorrhagia, or heavy menstrual bleeding in women. The cases had been consolidated at the district court level, where the…