Is My Guitar Pedal a Klone or a Counterfeit? — No Infringement Intended Podcast
(Podcast) The Briefing: The Wrong Argument – Why Authors Lost Against Meta and What Comes Next
The Briefing: The Wrong Argument – Why Authors Lost Against Meta and What Comes Next
PODCAST: Williams Mullen's Trending Now: An IP Podcast - Cease and Desist Letters: Protecting Your Intellectual Property the Right Way
PODCAST: PODCAST: Williams Mullen's Trending Now: An IP Podcast - Cease and Desist Letters: Protecting Your Intellectual Property the Right Way
The Briefing: Anthropic, Copyright, and the Fair Use Divide
Will I Get Sued if I Create Another Hospital Drama? — No Infringement Intended Podcast
The Briefing: The Supreme Court Dodges the Discovery Rule Question—What That Means for Copyright Enforcement
(Podcast) The Briefing: Who Owns WallStreetBets? Trademark Use in Commerce and the Reddit Battle
The Briefing: Who Owns WallStreetBets? Trademark Use in Commerce and the Reddit Battle
(Podcast) The Briefing: Sinking the Rogers Test? What Pepperdine’s Lawsuit Could Mean for Hollywood
The Briefing: Sinking the Rogers Test? What Pepperdine’s Lawsuit Could Mean for Hollywood
(Podcast) The Briefing: The Ninth Circuit Puts the Brakes on Eleanor’s Copyright Claim
The Briefing: The Ninth Circuit Puts the Brakes on Eleanor’s Copyright Claim
Unexpected Paths to IP Law with Dan Young and Colin White
Why Can't I Clean the Graffiti Off My Walls? — No Infringement Intended Podcast
(Podcast) The Briefing: Who Owns Jack Nicklaus? Lessons for The Creator Economy From a Brand Battle
The Briefing: Who Owns Jack Nicklaus? Lessons for The Creator Economy From a Brand Battle
(Podcast) The Briefing: Trademark Smoked: The Fall of General Cigar’s COHIBA Registration
The Briefing: Trademark Smoked: The Fall of General Cigar’s COHIBA Registration
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
JANSSEN PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC. - Before Prost, Reyna, and Taranto. Appeal from the United States District Court for the District of New Jersey. The Federal Circuit found that claims reciting a...more
On July 16, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen, Inc. (“Amgen”) and Accord BioPharma, Inc. (“Accord”)...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
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
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
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
Lonsurf® (tipiracil) - Case Name: Taiho Pharma Co. v. MSN Labs Private Ltd., No. 19-2342-JLH (D. Del. Jan. 23, 2025) (Hall, J.) Drug Product and Patent(s)-in-Suit: Lonsurf® (tipiracil); U.S. Patent No. 10,457,666 (“the ’666...more
INOMax® (nitric oxide) - Case Name: Mallinckrodt Pharms. Ireland Ltd. v. Airgas Therapeutics LLC, Civ. No. 22-1648-RGA, 2025 WL 472557 (D. Del. Feb. 12, 2025) (Andrews, J.) Drug Product and Patent(s)-in-Suit: INOMax® (nitric...more
Trastuzumab 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
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
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
On December 19, 2024, FDA formally announced the end of the tirzepatide shortage in a Declaratory Order issued to Eli Lilly & Co. (“Lilly”). Lilly is tirzepatide’s patentholder and the manufacturer of the two branded versions...more
Each fall, leading pharmaceutical patent litigators for brand name and generic drug companies gather at the Paragraph IV Disputes Master Symposium in Chicago to receive up-to-the-minute information on the latest developments...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
After a turbulent year that roiled the economy, and the health care sector more than most, the Democrats emerged with control of both the White House and Congress for the first time since 2014. Business leaders and in-house...more
For the past 13 years, leading pharmaceutical patent litigators for brand name and generic drug companies gather at the Paragraph IV Disputes conference to discuss, debate, and analyze the latest trends, judicial rulings and...more
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more
In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more
The recent jury verdict in a dispute over a generic version of the heartburn medication Pepcid® Complete® would be enough for anyone to reach for a few tablets of the accused product. After an eight day trial presided over by...more
In UCB, Inc. v. Yeda Research and Development Co., the Federal Circuit affirmed the determination by the District Court for the Eastern District of Virginia that UCB, Inc.’s Cimzia® (certolizumab pegol), a biologic medicine...more
Addressing the issue of subject matter jurisdiction in Hatch-Waxman litigation, the U.S. Court of Appeals for the Federal Circuit reversed a district court’s dismissal for lack of case or controversy of an action seeking...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Vaccines and Diagnostics, Inc. et al. v. Pfizer, Inc. 2:15-cv-01283; filed February 18, 2015 in the District...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis AG et al. v. Ezra Ventures LLC. 1:15-cv-00150; filed February 11, 2015 in the District Court of Delaware. •...more