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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Manufacturing Statute Court Construction 125

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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Statute Manufacturing Court Decisions Court 94

Patently O

APRIL 16, 2024

The case garnered amicus curiae briefs filed by several innovative pharmaceutical companies in support of the patent owner, Salix Pharmaceuticals. Apotex Inc., By Chris Holman Salix Pharms., Norwich Pharms. 2024 WL 1561195 (Fed. Norwich Pharms. illustrates the concern. Teva Pharms. 2023 WL 3335538 (Fed. 3d 1375 (Fed. 3d 1051 (Fed.

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Court Court Decisions Laws Government 75

FDA Law Blog

OCTOBER 4, 2021

Catalyst Pharmaceuticals, Inc., Because it is undisputed that none of the statutory exceptions to Catalyst’s market exclusivity apply, the FDA was prohibited from approving for sale the same drug manufactured by Jacobus Pharmaceutical Company, Inc., With the Eleventh Circuit’s decision, companies (e.g.,

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Statute Court Manufacturing Court Rules 52

SCOTUSBlog

MAY 11, 2023

First up this week is Teva Pharmaceuticals USA, Inc. The generic drug maker’s abbreviated new drug application (ANDA) must address each patent that the branded manufacturer claims for a method of using the drug. Our third relist, Petrobras America Inc. Petrobras America Inc. New Relists Teva Pharmaceuticals USA, Inc.

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Manufacturing Contract Court Laws 96