Webinar: Orange Book listing sheets under the microscope
Key Considerations for Reshoring U.S. Drug Manufacturing
Drug Pricing Initiatives During the Trump Presidency
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Patent law in Europe: What pharmaceutical companies need to know
EU excessive pricing laws
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
Actavis Labs. FL, Inc. v. United States, Appeal No. 2023-1320 (Fed. Cir. Mar. 21, 2025) Our Case of the Week, in the words of its author, Circuit Judge Stark, “is not actually a patent case. It is, instead, a tax case.” In...more
Mirror Worlds Technologies, LLC v. Meta Platforms, Inc., Appeal Nos. 2022-1600, -1709 (Fed. Cir. Dec. 4, 2024) In this appeal from the United States District Court for the Southern District of New York, the Federal...more
The Federal Circuit recently held a generic drug developer lacked Article III standing to appeal an adverse patentability determination by the Patent Trial and Appeal Board (PTAB) because it failed to prove that it suffered...more
In a precedential decision delivered this week, the Federal Circuit shot down arguments from Appellants BTG International Limited; Janssen Biotech, Inc.; Janssen Oncology, Inc.; and Janssen Research & Development, LLC (BTG),...more
PTAB May Invalidate Claims on Reconsideration Based on Grounds Raised in the Institution Decision that Were Not Originally Instituted - In AC Technologies S.A., V. Amazon.Com, Inc., Blizzard Entertainment, Inc., Appeal No....more
In Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH, generic drug manufacturer Amerigen appealed a decision of the Patent Trial & Appeal Board finding UCB’s patent to certain chemical derivatives of diphenylpropylamines...more
Federal Circuit Summary - Before Lourie, Chen, and Stoll. Appeal from the Patent Trial and Appeal Board. Summary: A generic pharmaceutical company had standing to appeal the Board’s decision in an IPR that claims of a...more
On July 20, 2018, the Federal Circuit affirmed in Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals, Inc. that tribal immunity cannot be asserted in IPRs. The appeal stemmed from a dispute between Allergan and various generic...more
On July 20, 2018, the Federal Circuit held that tribal sovereign immunity is not available as a defense in IPR. Allergan Pharmaceuticals owned patents that it had asserted in litigation against various generic...more
Federal Circuit Summary - Before Dyk, Moore, and Reyna. Appeal from the Patent Trial and Appeal Board. Summary: Tribal sovereign immunity does not shield Indian Tribe owned patents from IPR. ...more
St. Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc., Appeal No. 2018-1638, -1639, -1640, -1641, -1642, -1643 (Fed. Cir. July 20, 2018} - In a groundbreaking decision issued on Friday, the Federal Circuit held that tribal...more
Priority Claims Cannot Be Incorporated by Reference - In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited, Appeal Nos. 2016-2707 and 2016-2708, the Federal Circuit held that when a patent for a...more
Distribution Agreements Can Constitute Offers for Sale Under Section 102(b) - In The Medicines Company v. Hospira, Inc., Appeal Nos. 2014-1469, 2014-1504, the Federal Circuit held that a distribution agreement qualified as...more
The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more