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Life Sciences Mylan Pharmaceuticals Abbreviated New Drug Application (ANDA)

Robins Kaplan LLP

Mylan Pharms. Inc. v. Bayer Intellectual Property GmbH, C.A. - Xarelto® (Rivaroxaban)

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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

Knobbe Martens

Venue and Pleading Infringement in Hatch-Waxman Litigation Turn on Location and Identity of ANDA Filer

Knobbe Martens on

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

Robins Kaplan LLP

Valeant Pharm. N. Am. LLC v. Mylan Pharm. Inc.

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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

Patterson Belknap Webb & Tyler LLP

For the First Time Since TC Heartland, the Federal Circuit Addresses Venue in an ANDA Case – the Holding May Also Impact BPCIA...

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

Robins Kaplan LLP

Hatch-Waxman Venue Is Further Narrowed

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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

Robins Kaplan LLP

Takeda Pharms. U.S.A., Inc. v. Mylan Pharms. Inc.

Robins Kaplan LLP on

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

Robins Kaplan LLP

Valeant Pharms Int’l, Inc. v. Mylan Pharms Inc.

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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

Robins Kaplan LLP

Valeant Pharms. N. Am. LLC v. Zydus Pharms. (USA) Inc.

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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

Morgan Lewis

District Courts Split over Proper Patent Venue for Hatch-Waxman Act Litigation

Morgan Lewis on

There have been two interpretations of the “acts of infringement” language in the patent venue statute regarding ANDA submissions in Hatch-Waxman litigation....more

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