EpiPen RICO Ruling Opens Door for Private AKS Enforcement
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
Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more
Ranges for Interdependent and Interactive Components Can Be Tricky to Derive - In Modernatx, Inc. v. Arbutus Biopharma Corporation, Appeal No. 20-2329, the Federal Circuit held that a presumption of obviousness based on...more
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more
Venue and Pleading Infringement in Hatch-Waxman Litigation Turn on Location and Identity of ANDA Filer - In Celgene Corp. v. Mylan Pharm. et al., Appeal No. 21-1154, the Federal Circuit held that in Hatch-Waxman...more
CELGENE CORP. v. MYLAN PHARM. et al. Before Prost, Chen, and Hughes. Appeal from the District of New Jersey. Summary: In Hatch-Waxman litigation: (1) infringement occurs where the ANDA is submitted and not where the...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
Symbicort® (budesonide and formoterol fumarate dihydrate) - Case Name: AstraZeneca AB v. Mylan Pharms. Inc., No. 1:18CV193, 2021 WL 798856 (N.D.W.V. Mar. 2, 2021) (Keeley, J.) - Drug Product and Patent(s)-in-Suit: Symbicort®...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
On November 5, 2020, in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where...more
Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc. Last Thursday, a Federal Circuit panel issued a decision applying a narrow reading of the patent venue statute, 28 U.S.C. § 1400(b), in a Hatch-Waxman...more
On November 5, 2020, the United States Court of Appeals for the Federal Circuit, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 19-2402, resolved a split among district courts over what constitutes...more
The US Court of Appeals for the Federal Circuit found that in cases brought under the Hatch-Waxman Act, for purposes of determining venue, infringement occurs only in districts where actions related to the submission of an...more
Somewhat remarkably, there is no settled Federal Circuit precedent regarding where a patentee can bring suit against a generic competitor in Hatch-Waxman litigation under 35 U.S.C. § 271(e)(2). While recognizing that this...more
This week, the Federal Circuit issued an order finding that in cases brought under 35 U.S.C. § 271(e)(2)(A), infringement occurs for venue purposes only in districts where actions related to the submission of an Abbreviated...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
On September 9, 2020, Judge Richard G. Andrews of the United States District Court for the District of Delaware ruled in favor of Takeda Pharmaceuticals U.S.A., Inc. in the case Takeda Pharmaceuticals U.S.A., Inc. v. Mylan...more
ANDA litigation, pursuant to the Hatch-Waxman Act, has become more complicated over the years since enactment of the statute in 1984, with more patents being asserted and more parties participating over the opportunity to...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
THE COURT GRANTED DEFENDANT’S MOTION TO ENFORCE ITS SETTLEMENT AGREEMENT, FINDING THAT THE AGREEMENT WAS NOT ANTICOMPETITIVE AND IN VIOLATION OF ANTITRUST LAW. Case Name: Somaxon Pharma, Inc. v. Actavis Elizabeth LLC, No....more
AMENDING CLAIMS AND ADDING INVENTOR TO CLAIM NEW ASPECT OF INVENTION, WITHOUT AMENDING SPECIFICATION, RESULTS IN JUDGMENT OF INVALIDITY FOR LACK OF WRITTEN DESCRIPTION. Case Name: Biogen Int’l GmbH v. Mylan Pharms. Inc.,...more
Case Name: Takeda Pharms. U.S.A., Inc. v. Mylan Pharms., Inc., No. 19-2216-RGA, 2020 U.S. Dist. LEXIS 12753 (D. Del. Jan. 27, 2020) (Andrews, J.)....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