PODCAST: Williams Mullen's Trending Now: An IP Podcast - Cease and Desist Letters: Protecting Your Intellectual Property the Right Way
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
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 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
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
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
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
High Stakes: Hatch-Waxman Litigation Comes for Cannabis - GW Pharma, now a subsidiary of Jazz Pharmaceuticals, is no stranger to patent litigation. It previously found itself on the receiving end of a patent infringement...more
Thank you for reading the January 2023 issue of Sterne Kessler's MarkIt to Market® newsletter. This month, we discuss an ongoing trademark dispute between the band OK Go and cereal company Post, how to stay vigilant about...more
The consequences of expressly recited claim limitations and how patentees can be held to these limitations was illustrated in the Federal Circuit's recent decision in Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc. ...more
Prescription drug prices have long been a source of frustration for the American public and the subject of intense political debates about the best way to lower them without stifling innovation. One of the most significant...more
Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its October 2020 decision that a labeling...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
Abbreviated new drug (ANDA) applicant Amneal petitioned for an inter partes review (IPR) of Almirall’s patent listed in the Food and Drug Administration’s (FDA) Orange Book for a prescription drug to treat acne. Almirall...more
Federal District Court Cases That Are Filed Pursuant To The Hatch-Waxman Act - This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to...more
ANDA litigation, pursuant to the Hatch-Waxman Act, has become more complicated over the years since enactment of the statute in 1984, with more patents being asserted and more parties participating over the opportunity to...more
On April 6, 2020, the U.S. District Court for the District of New Jersey, in Celgene Corp. v. Sun Pharma Global FZE, No. 19-cv-10099, denied Sun’s motion to dismiss Celgene’s claims that Sun’s generic Revlimid® (lenalidomide)...more
Please see full Chart below for more information....more
On April 17, 2019, Judge Gilstrap of the United States District Court for the Eastern District of Texas, in Apicore v. Beloteca, No. 19-cv-00077, held that while the court could exercise personal jurisdiction over a generic...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