Intellectual Property Law Blog

JANUARY 18, 2024

2022-1194, 2022-1208, and 2022-1246 (December 7, 2023) , the Federal Circuit held that generic pharmaceutical companies may continue to use skinny labels to avoid infringement of method of treatment claims as long as they do not engage in advertising or promotional activities that encourage infringement of the patents. Lundbeck A/S, et al.

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Patently-O

DECEMBER 7, 2023

The Federal Circuit recently affirmed a district court judgment finding that Abbreviated New Drug Applications (“ANDAs”) submitted by generic drug manufacturers did not infringe patents rights held by H. Teva Pharmaceuticals USA, Inc. , 7, 2023) (Opinion by Judge Dyk, joined by Judges Prost and Hughes). 4th 1320, 1333 (Fed.

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LexBlog IP

JANUARY 18, 2024

2022-1194, 2022-1208, and 2022-1246 (December 7, 2023) , the Federal Circuit held that generic pharmaceutical companies may continue to use skinny labels to avoid infringement of method of treatment claims as long as they do not engage in advertising or promotional activities that encourage infringement of the patents. Lundbeck A/S, et al.

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IP Watchdog

AUGUST 18, 2022

Court of Appeals for the Federal Circuit (CAFC) today affirmed a district court’s finding that Eagle Pharmaceuticals, Inc.’s s abbreviated new drug application (ANDA) does not infringe two patents owned by Par Pharmaceutical, Inc., Par Sterile Products, LLC, and Endo Par Innovation Company, LLC (collectively, Par).

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Patently-O

NOVEMBER 8, 2021

Thus, a generic drug distributor infringes by simply submitting its ANDA application with a Paragraph IV certification. Mylan created and submitted an ANDA to the FDA, requesting permission to make a generic version of the drug and arguing that the Celgene’s patents were invalid. MPI), Mylan Inc., owns Mylan Inc.;

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Fish & Richardson Trademark & Copyright Thoughts

NOVEMBER 9, 2021

The Hatch-Waxman Act provides a cause of action for infringement based on the submission of an abbreviated new drug application (ANDA) to FDA. The key takeaways from Celgene are these: A Paragraph IV Letter is not considered “part of” an ANDA submission, so venue cannot be predicated upon where the letter is received. 35 U.S.C. §

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Fish & Richardson Trademark & Copyright Thoughts

NOVEMBER 13, 2020

Mylan Pharmaceuticals Inc. In Valeant , [1] the Court held that “acts of infringement” in Hatch-Waxman cases under § 1400(b) occur “where actions related to the ANDA submission occur,” not where “a generic product specified in an ANDA is likely to be distributed.” [2] Valeant Pharmaceuticals North America LLC v.

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