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What Were the Cooler Wars? (Part 1) — No Infringement Intended Podcast
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(Podcast) The Briefing: 2025 IP Resolutions Start With a Review of IP Assets
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Wolf Greenfield Attorneys Review 2024 and Look Ahead to 2025
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4 Tips for Protecting Your AI Products
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Navigating Intellectual Property Challenges in the Renewable Energy Sector - Energy Law Insights
Using Innovative Technology to Advance Trial Strategies | Episode 70
Patent Considerations in View of the Nearshoring Trends to the Americas
Hetlioz® (tasimelteon) - Case Name: Vanda Pharms., Inc. v. FDA, Civ. No. 23-280 (TSC), 2025 WL 485401 (D.D.C. Feb. 13, 2025) (Chutkan, J.) Drug Product and Patent(s)-in-Suit: Hetlioz® (tasimelteon); U.S. Patent No. , a...more
AZURITY PHARMACEUTICALS, INC. v. ALKEM LABORATORIES LTD. Before Murphy, Moore, and Chen. Appeal from the United States District Court for the District of Delaware. Arguments and amendments made during prosecution of a parent...more
Yutrepia® (treprostinil inhalation powder) - Case Name: Liquidia Techs., Inc. v. FDA, No. 24-2428 (D.D.C. Feb. 27, 2025) (Kelly, J.) Drug Product and Patent(s)-in-Suit: Yutrepia® (treprostinil inhalation powder) Nature of...more
Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
The US Court of Appeals for the Federal Circuit affirmed a district court’s noninfringement determination, finding that the presence of a disclaimed compound in the accused product precluded infringement. Azurity Pharm., Inc....more
Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
The US Senate Judiciary Committee advanced to the full Senate six bills intended to reduce pharmaceutical prices and enhance market competitiveness. The package collectively targets several aspects of the pharmaceutical...more
On October 31, 2024, the European Commission (the Commission) delivered its long-awaited decision in the Teva Copaxone case (which was published on April 8, 2025). Teva, a global pharmaceutical company, was fined EUR 462.6...more
Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., Appeal No. 2023-1977 (Fed. Cir. Apr. 8, 2025) In our Case of the Week, the Federal Circuit affirmed that defendant Alkem’s proposed generic antibiotic did not...more
In re Entresto, 125 F.4th 1090 (Fed. Cir. 2025) - After Novartis’ patent on the blockbuster blood pressure medication Entresto was found invalid at the district court for covering technology that was developed after the...more
Merck Sharp & Dohm B.V. v. Aurobindo Pharma USA, Inc. et al (Fed. Cir. March 13, 2025) - The Hatch-Waxman Act seeks to strike a balance in the pharmaceutical industry by incentivizing drugs makers to develop innovative...more
Tax developments - Actavis and deductible expenses - On March 21, 2025, the Court of Appeals for the Federal Circuit released a decision in Actavis Laboratories FL, Inc. v. United States, holding that taxpayers could...more
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
In Actavis v. U.S., a case at the intersection of tax law and patent law, the Federal Circuit held that generic drug companies’ Hatch-Waxman litigation expenses are “ordinary and necessary business expenses” and can be...more
Early last year, Aurobindo, one of the Defendants* in ANDA litigation against Merck, advanced the proposition that in cases where a patent had been reissued patent term extension ("PTE") under 35 U.S.C. § 156 should be...more
Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more
In a precedential opinion issued on March 6, the Federal Circuit affirmed the US District Court for the Eastern District of Virginia that the claims in ImmunoGen’s US patent application 14/509,809 (“the ’809 application,”...more
Novartis markets and sells a combination therapy of valsartan and sacubitril under the brand name Entresto® for the treatment of various forms of heart failure. MSN submitted an Abbreviated New Drug Application seeking...more
A bipartisan Senate bill dubbed the “Skinny Label, Big Savings Act” was introduced in January. The bill would expand the scope of protection afforded by section viii carve-outs, a mechanism that allows Abbreviated New Drug...more
In October 2023, Teva Pharmaceuticals filed a patent infringement lawsuit against Amneal Pharmaceuticals alleging that their generic version of Teva’s ProAir® HFA inhaler infringed upon the asserted claims of U.S. Patent Nos....more
The Federal Circuit recently reversed a district court decision that found a patent that did not describe after-arising technology failed to satisfy the written description requirement. In so doing, the Federal Circuit...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 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