Generically Speaking: A Hatch-Waxman Litigation Bulletin

By Oren Langer, Christopher Pinahs, and Bernard Pound

Second Quarter

The Summer 2022 issue of the GENERICally Speaking email campaign provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation.

In this issue we review Q2 cases and issue(s) presented:

Novartis Pharms. Corp. v. Accord Healthcare, Inc.
Gilenya® (fingolimod HCl)
The Federal Circuit granted Defendants’ petition for panel rehearing, vacated its prior decision, and reversed the district court’s judgment that the asserted claims were not invalid for inadequate written description.
Bausch Health Ireland, Ltd. v. Padagis Israel Pharms., Ltd.
Duobrii® (halobetasol propionate / tazarotene)
The court granted summary judgment of no inequitable conduct.
Astellas US LLC v. Hospira, Inc.
Lexiscan® (regadenoson)
After bench trial, the Court found that the patents-in-suit were not infringed by Hospira.

Relevant ANDA updates highlighted in this issue:

The articles on our website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice. The views and opinions expressed in this article are those of the author(s) and do not necessarily reflect the views or official position of Robins Kaplan LLP.

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Oren Langer, Christopher Pinahs, Emily Tremblay, and Bernard Pound