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?
On August 22, 2024, Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals, PLC (collectively Hikma), filed a petition for rehearing en banc, asking the US Court of Appeals for the Federal Circuit to reconsider its recent...more
This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
The Hatch-Waxman Act regulates the relationship between branded and generic drugmakers and attempts to strike a balance between two competing policy interests — encouraging pioneering drug development and facilitating market...more
This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more
The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more
This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more
On August 13, the Federal Circuit issued a precedential ruling in Allergan v. MSN Laboratories (Case No. 24-1061). This decision reversed the District of Delaware's application of the Federal Circuit precedent in In re:...more
This issue of The PTAB Review begins by providing an analysis of how institution decisions consider declaration testimony submitted by a patent owner. Next, it summarizes proposed rulemaking from the United States Patent and...more
Case Name: Pharmacyclics LLC v. Alvogen Pine Brook LLC, Civ. No. 19-434-CFC, 2024 WL 1885677 (D. Del. Apr. 30, 2024) (Connolly, J.) - Drug Product and Patent(s)-in-Suit: Imbruvica® (ibrutinib); U.S. Patents Nos. 8,008,309...more
In a new precedential decision issued August 13, 2024, the Court of Appeals for the Federal Circuit in Allergan USA. v. MSN Labs, 24-1061, held that a first-filed, first-issued parent patent that receives a patent term...more
On August 1, 2024, following five years of litigation, Tevra’s antitrust suit against Bayer Healthcare LLC came to an end. Tevra, a manufacturer of generic version topical flea and tick medications, alleged that Bayer engaged...more
Case Name: Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC, Civ. No. 23-20964 (SRC), 2024 WL 2923018 (D.N.J. June 10, 2024) (Chesler, J.)....more
Case Name: Janssen Pharms., Inc. v. Tolmar, Inc., Civ. No. 21-1784-WCB, 2024 WL 2972832 (D. Del. June 13, 2024) (Bryson, J.) - Drug Product and Patent(s)-in-Suit: Invega Sustenna® (paliperidone palmitate); U.S. Patent No....more
Federal Circuit Allows Teva Patents to Remain in Orange Book. - The Federal Circuit recently granted Teva Pharmaceutical’s motion for a stay of removal of its patents from the Orange Book in its ongoing dispute with...more
Case Name: Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 2022-1258, 2022-1307, 2024 WL 1355733 (Fed. Cir. Apr. 1, 2024) (Circuit Judges Dyk, Prost, and Hughes presiding; Opinion by Prost, J.) (Appeal from D.N.J.,...more
Case Name: Salix Pharms., Ltd. v. Norwich Pharms. Inc., No. 2022-2153, 2023-1952, 2024 WL 1561195 (Fed. Cir. Apr. 11, 2024) (Circuit Judges Lourie, Chen, and Cunningham presiding; Opinion by Lourie, J.; Dissenting-in-part...more
Case Name: Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. 2023-1169, 2024 WL 3152087 (Fed. Cir. June 25, 2024) (Circuit Judges Moore, Lourie, and Albright presiding; Opinion by Lourie, J.) (Appeal from D. Del., Andrews,...more
The case of Amarin Pharma, Inc. and its affiliates versus Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC presents a fascinating intersection of patent law, FDA regulatory strategy, and pharmaceutical marketing....more
Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...more
The Situation: The Hatch-Waxman Act allows generic drug manufacturers to "carve out" a brand's patented indications from their proposed labeling. Generic manufacturers often rely on these so-called "skinny labels" to try to...more
Amarin Pharma, Inc., et al. v. Hikma Pharmaceuticals USA Inc., et al., No. 2023-1169 (Fed. Cir. (D. Del.) June 25, 2024). Opinion by Lourie, joined by Moore and Albright (sitting by designation). Amarin markets and sells...more
The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more
The English High Court has held that a patent relating to a once-daily dosing of an active ingredient was invalid for lack of inventive step over prior art posters presented to the public at conferences. The decision has been...more
In an effort to enhance collaboration, the Indian Pharmaceutical Alliance (IPA) recently proposed that a more formal preferred partnership between the U.S. and India can not only lower drug prices in the U.S. but can improve...more