IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
Case Name: Mylan Pharms. Inc. v. Bayer Intellectual Property GmbH, C.A. No. 23-556-RGA, 2024 WL 359468 (D. Del. Jan. 31, 2024) (Hatcher, M.J.) - Drug Product and Patent(s)-in-Suit: Xarelto® (rivaroxaban); U.S. Patents Nos....more
In an opinion released July 27, 2023, the Third Circuit affirmed a 2021 Tax Court decision upholding a pharmaceutical company’s immediate deduction of patent defense litigation costs in suits brought under the Hatch-Waxman...more
The Hatch-Waxman Act provides a cause of action for infringement based on the submission of an abbreviated new drug application (ANDA) to FDA. 35 U.S.C. § 271(e)(2). Following the Supreme Court’s ruling in TC Heartland LLC v....more
In Mylan, Inc. & Subsidiaries v. Commissioner, 156 T.C. No. 10 (April 27, 2021), the Tax Court held that legal expenses incurred by a manufacturer of generic pharmaceutical drugs for the preparation, assembly and transmittal...more
Jublia® (efinaconazole) - Case Name: Valeant Pharm. N. Am. LLC v. Mylan Pharm. Inc.,978 F.3d 1374 (Fed. Cir. Nov. 5, 2020)(Circuit Judges Newman, O’Malley, and Taranto presiding; Opinion by O’Malley, J.) (Appeal from D.N.J.,...more
For the first time since the U.S. Supreme Court’s TC Heartland decision, the U.S. Court of Appeals for the Federal Circuit addressed the issue of venue specific to Hatch-Waxman litigation, pursuant to which branded...more
Colcrys®/colchicine - Case Name: Takeda Pharms. U.S.A., Inc. v. Mylan Pharms. Inc., No. 2020-1407, -1417 (Fed. Cir. July 31, 2020) (Circuit Judges Prost, Newman, and Hughes presiding; Opinion by Prost, C.J.; Dissent by...more
BECAUSE THE PRIOR ART TAUGHT OVERLAPPING PH RANGES AND STRUCTURALLY SIMILAR COMPOUNDS AS THOSE CLAIMED IN THE PATENT-IN-SUIT, THE FEDERAL CIRCUIT REVERSED SUMMARY JUDGMENT OF NON-OBVIOUSNESS. Case Name: Valeant Pharms...more
BECAUSE DELAWARE WAS AN IMPROPER VENUE FOR DEFENDANT MYLAN, AND DEFENDANT 3M DEMONSTRATED THAT VARIOUS FACTORS WEIGHED IN FAVOR OF A TRANSFER, THE CASE WAS TRANSFERRED TO THE NORTHERN DISTRICT OF WEST VIRGINIA. Case...more
BECAUSE PLAINTIFFS FAILED TO SHOW SPECIFICALLY HOW DEFENDANTS COMMITTED ANY ACT OF INFRINGEMENT IN NEW JERSEY—PARTICULARLY BY FILING AN ANDA IN WEST VIRGINIA WITH THE FDA IN MARYLAND—OR THAT ANY FUTURE, INTENDED ACTS WERE A...more
Case Name: Indivior Inc. v. Mylan Techs. Inc., 15-cv-1016-RGA, 15-cv-0477-RGA, 2018 U.S. Dist. LEXIS 47151 (D. Del. Mar. 22, 2018) (Andrews, J.)....more
Case Name: Pfizer Inc. v. Mylan Pharms. Inc., No. 15-79-GMS, 2017 U.S. Dist. LEXIS 125634 (D. Del. Aug. 9 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Toviaz® (fesoterodine fumarate extended-release tablets);...more
Addressing venue in the context of Hatch-Waxman litigation, the US District Court for the District of Delaware held that venue is proper in Delaware if a generic drug company has permanent and continuous presence in Delaware...more
Case Name: The Medicines Co. v. Mylan, Inc., No. 2015-1113, -1151, -1181 (Fed. Cir. Apr. 6, 2017) (Circuit Judges Dyk, Wallach, and Hughes presiding; Opinion by Dyk, J.) (appeal from N.D. Ill., St. Eve, J.)....more
Case Name: Cumberland Pharms. Inc. v. Mylan Institutional LLC, Nos. 2016-1155, -1259, 846 F.3d 1213 (Fed. Cir. Jan. 26, 2017) (Circuit Judges Moore, Taranto, and Reyna presiding; Opinion by Taranto, J.) (appeal from N.D....more
The Federal Circuit had the opportunity to provide guidance on a question now in its twilight: what is the standard for determining who is the true inventor under pre-AIA 35 U.S.C. § 102(f), in Cumberland Pharmaceuticals...more
Case Name: Mylan Institutional LLC v. Aurobindo Phama Ltd, 2:16-cv-00491-RWS-RSP, 2016 U.S. Dist. LEXIS 180551 (E.D. Tex. Nov. 21, 2016) (Payne, MJ). Drug Product and Patents-in-Suit: isosulfan blue; U.S. Patents Nos....more
In March 2016, a Federal Circuit panel issued a decision in Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc. in which it held that Mylan was subject to specific personal jurisdiction in the District of Delaware because...more
On November 3, 2016, the New York State Bar Association’s Sections, Food, Drug and Cosmetic Law and Antitrust Law, held a program in New York City: “REMS and Other Drug Distribution Restrictions: When Does a Brand Company...more
Generic and branded pharma companies alike are waiting with baited breath to see if the U.S. Supreme Court will take up the issue of personal jurisdiction in Hatch-Waxman patent cases this term. After a broad ruling from the...more
On March 18, 2016, the Federal Circuit affirmed the District of Delaware’s ruling in two companion cases that West Virginia-based defendant Mylan Pharmaceuticals is subject to specific personal jurisdiction in Delaware....more
In an opinion handed down Friday that will continue the trend of forum shopping, the Federal Circuit in Acorda Therapeutics Inc. v. Mylan Pharmaceuticals, Inc., 2015-1456, (Fed. Cir. 2016) held that the filing of an...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
Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more
Brand name pharmaceutical companies have long stood in the way of generic pharmaceuticals entering the market. To keep generics at bay, brands have used a variety tactics, including ultimately unlawful ones like fraudulently...more