EpiPen RICO Ruling Opens Door for Private AKS Enforcement
Originating tribunal: Patent Trial and Appeal Board - Date: March 12, 2021 - Panel: Judges Newman, Moore, and Stoll, with Judge Moore writing the precedential order - Result: Appeal dismissed, and mandamus...more
MYLAN LABS. LTD. v. JANSSEN PHARMACEUTICA, N.V. Before Newman, Moore, and Stoll. Appeal from the Patent Trial and Appeal Board. Summary: The Federal Circuit lacks jurisdiction over appeals from decisions denying...more
Case Name: Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., Civ. No. 15-cv-1455 (WCB), 2016 U.S. Dist. LEXIS 51851 (E.D. Tex. Apr. 19, 2016) (Bryson, J.) - Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
Case Name: Acorda Therapeutics, Inc. v. Mylan Pharms. Inc., Nos. 14-935-LPS, 2015 U.S. Dist. LEXIS 4056 (D. Del. Jan. 14, 2015) (Stark, C.J.). Drug Product and Patent(s)-in-Suit: Ampyra® (dalfampridine); U.S. Pats. Nos....more
Case Name: Forest Labs., Inc. v. Amneal Pharms. LLC, Civ. No. 14-508-LPS, 2015 U.S. Dist. LEXIS 23215 (D. Del. Feb. 26, 2015) (Burke, M.J.). Drug Product and Patent(s)-in-Suit: Namenda XR® (memantine hydrochloride); U.S....more
Case Name: Eli Lilly & Co. v. Mylan Pharms., Inc., Civ. No. 14-cv-00389-SEB-TAB, 2015 U.S. Dist. LEXIS 30175 (S.D. Ind. Mar. 12, 2015) (Barker, J.). Drug Product and Patents-in-Suit: Effient® (prasugrel hydrochloride);...more
Case Name: Novartis Pharms. Corp. v. Mylan Inc., Civ. No. 14-777-RGA, 2015 U.S. Dist. LEXIS 31812 (D. Del. March 16, 2015) (Andrews, J.). Drug Product and Patent(s)-in-Suit: Exelon Patch (rivastigmine); U.S. Patents...more
Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v....more
This is an ANDA case relating to generic dalfampridine extended-release tablets. The court finds, following that the Daimler decision, that neither the parent nor subsidiary defendant are “at home” in Delaware for purposes of...more