Wolf Greenfield Attorneys Review 2024 and Look Ahead to 2025
Webinar: Orange Book listing sheets under the microscope
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
In recent years, the Federal Circuit has, with varying levels of agreement, considered what behavior by generic drugmakers constitutes inducement of infringement regarding so-called “off-label” prescribing for indications not...more
In the wake of the Federal Circuit’s 2024 Orange Book delisting decision in Teva v. Amneal, Hatch-Waxman practitioners have been left to grapple with several unanswered questions. Although the decision clarified what is...more
On January 16, 2026, the United States Supreme Court agreed to hear Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (No. 24-889), a case that will directly shape the future of generic drug competition and the scope of...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....more
Myrbetriq is indicated for the treatment of overactive bladder (OAB). The patents-in-suit claim compositions containing mirabegron and their use in treating OAB....more
In the United States, both patent law and U.S. Food and Drug Administration (FDA) regulations govern the commercial availability of drug products and any potential periods of market exclusivity....more
FDA has undergone fundamental changes under the Trump administration. The agency is smaller, but is it smarter? Commissioner Makary has embraced AI and appears to be looking for new ways to abbreviate clinical development for...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 Supreme Court on Jan. 16, 2026, agreed to decide a case about how generic companies can communicate to the market about their products, including whether their product promotion may infringe innovators’ use patents...more
In January 2020, Liquidia filed an NDA seeking approval to make and sell Yutrepia, a dry powder formulation of treprostinil used to treat certain pulmonary diseases. It referenced UTC’s Tyvaso product and filed Paragraph IV...more
On January 16, 2026, the U.S. Supreme Court announced its intent to hear the case of Hikma v. Amarin. This case follows the landmark GSK v. Teva case from 2021, in which the Federal Circuit held that a generic drug...more
Over several years and two administrations (see “FTC Announces Efforts to Police Pharmaceutical Companies’ Patent Behavior“; “FTC Warns Pharma Companies It Means Business with Its Orange Book Listing Policy“; “Federal Trade...more
The tension between regulatory compliance and antitrust exposure in Orange Book patent listings reached a dramatic inflection point this fall. In late October, Teva Pharmaceuticals agreed to pay $35 million to settle a...more
In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and in some cases...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
Attend ACI's 8th Annual Summit on Life Sciences IP Due Diligence, and join IP counsel from across the life sciences industry to benchmark your diligence strategies, strengthen portfolio valuation approaches, and stay ahead of...more
After more than six years of high-stakes litigation in multiple courts and regulatory fights at the Food and Drug Administration (FDA), generic versions of Novartis Pharmaceuticals Corp. (“Novartis”)’s Entresto® have entered...more
Nature of the Case and Issue(s) Presented: Novartis holds the NDA for Entresto, a drug used to treat heart failure, having the active ingredients sacubitril and valsartan. The ’918 patent is not an Orange Book-listed patent...more
Nature of the Case and Issue(s) Presented: Novo makes and sells Wegovy. Novo sued Mylan asserting patent infringement of five patents that are listed, or Novo intends to list, in FDA’s Orange Book. In its complaint, Novo...more
Nature of the Case and Issue(s) Presented: Mallinckrodt’s (“MNK”) patents cover INOmax and its delivery system, DSIR Plus, which comprise products that administer inhaled nitric oxide gas (“iNO”) in a hospital setting to...more
The Supreme Court may soon address a recent, pivotal case involving the use of “skinny labels” to avoid inducing infringement in pharmaceutical patent infringement cases. The outcome could clarify whether and how generic drug...more
Senate Bill S. 4878 seeks to force innovator pharmaceutical companies to select a single Orange Book listed patent for the 30-month stay. ...more
Attend ACI's inaugural Forum on Pharma & Biotech Patent Litigation USA and garner a winning edge in the high- stakes life sciences patent ligation arena. Get the in-depth and practical information that you need to develop...more
ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more