What Were the Cooler Wars? (Part 2) — No Infringement Intended Podcast
What Were the Cooler Wars? (Part 1) — No Infringement Intended Podcast
PODCAST: Williams Mullen's Trending Now: An IP Podcast - IP and M&A Transactions
AGG Talks: Cross-Border Business Podcast - Episode 20: Mastering ITC Section 337 Investigations
3 Key Takeaways | What Corporate Counsel Need to Know About Patent Damages
Patent Litigation: How Low Can You Go?
(Podcast) The Briefing: Netflix to Pay $2.5M to GoTV for Patent Infringement
The Briefing: Netflix to Pay $2.5M to GoTV for Patent Infringement
The Art of Teaching Complex Technology in Patent Litigation - IMS Insights Podcast Episode 67
The Briefing: Failure to Disclose Relationship with Real Party in Interest Results in Serious Sanctions
Podcast: The Briefing - Failure to Disclose Relationship with Real Party in Interest Results in Serious Sanctions
5 Key Takeaways | How to Effectively Leverage the Chinese Patent System
Estoppel Doctrine in China's Patent System
Donation (Disclosure-Dedication) Doctrine in China’s Patent Litigation
6 Key Takeaways | Patent Opinions – New Developments and Pitfalls
Patent Right Evaluation Report in China’s Patent System
Kidon IP War Stories: David Cohen & Daryl Lim
Protecting the PB&J – Preserving IP Rights from Concept to Market
Patent Marking in China
Webinar: Orange Book listing sheets under the microscope
Under a new U.S. Patent and Trademark Office ("USPTO") policy issued in March 2025, pre-institution inter partes review ("IPR") proceedings are now bifurcated, consisting of a first phase in which the director considers...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
The Federal Circuit recently considered the scope of a permanent injunction that prohibited a drug manufacturer from conducting certain clinical and regulatory activities in Jazz Pharmaceuticals, Inc. v. Avadel CNS...more
The Federal Circuit affirmed a District Court decision that the label for a generic drug obtained from an ANDA would not induce infringement by reciting optional drug storage conditions the read on the NDA holder's Orange...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
Appellate courts issued a variety of notable intellectual property (IP) cases in 2024, including cases touching on Orange Book listings, extraterritoriality, willful infringement, design patent obviousness, and public...more
Precedential and Key Federal Circuit Opinions - TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. AMNEAL PHARMACEUTICALS OF NEW YORK, LLC [OPINION] (2024-1936, 12/20/2024) (Prost, Taranto, Hughes) - Prost, J. The...more
In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon of scrutinizing the types of patents that can be listed in the Food & Drug...more
The US Court of Appeals for the Federal Circuit affirmed a district court’s delisting of patents from the Orange Book because the patent claims did not “claim the drug that was approved” or the active ingredient of the drug...more
For branded drugmakers, the development of a pharmaceutical product approved by the Food and Drug Administration (FDA) all but assures generic competition. As discussed during the first installment of our Hatch-Waxman series,...more
Exeltis USA, Inc. and other parties (Exeltis) recently prevailed against Lupin Ltd. and Lupin Pharmaceuticals, Inc. (Lupin) in a patent infringement suit brought in the District of Delaware. After a three-day bench trial, the...more
Forty years ago, Congress passed the Hatch-Waxman Act, which streamlined the generic drug approval process and revamped how patent infringement claims would be litigated against those prospective generic drug applicants. At...more
The Federal Circuit heard oral argument on November 8, 2024, grappling with the issue of what patent claims may properly be listed in the Orange Book. In late 2023, Teva filed a complaint for patent infringement in response...more
In Teva Branded Pharm. Prods. R&D v. Amneal Pharms. of N.Y., LLC, the US District Court for the District of New Jersey ordered Teva to delist five patents from the Food and Drug Administration (FDA)’s Approved Drug Products...more
As we previously discussed, on November 7, 2023, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listings of device patents in the Food and Drug...more
On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more
In a precedential opinion issued on April 11, 2024 in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., Nos. 22-2153, 23-1952, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for...more
The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug...more
Illumina Agrees to Unwind Acquisition of Grail Following Fifth Circuit Decision. On December 15, 2023, the Fifth Circuit vacated the FTC’s order that Illumina unwind its acquisition of Grail—a developer of a multi-cancer...more
On November 7, 2023, the Federal Trade Commission (FTC) sent notice letters1 to 10 brand drug manufacturers of drug-device combination products, including drugs delivered by asthma inhalers, epinephrine autoinjectors, and...more
FTC’s Challenge of Improperly Listed Patents On November 7, 2023, the Federal Trade Commission (FTC) officially challenged more than 100 patents that brand name drug manufacturers have listed in the Food and Drug...more
As part of the Hatch-Waxman Act, given the lack of information on the allegedly infringing product, courts have found that patentees can satisfy the pleading requirements of Twombly/Iqbal without having access to the accused...more
The FTC recently issued a policy statement warning drug manufacturers that it “intends to scrutinize improper Orange Book listings” and “use its full legal authority” to “tak[e] actions against companies and individuals that...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
This week’s case of the (recent) week could serve as a crash course in several areas of patent law. It touches on Hatch-Waxman litigation and the Orange Book, claim construction, anticipation/obviousness, written description...more