Understanding the Impact of IPR Estoppel and PTAB Discretionary Denials — Patents: Post-Grant Podcast
What Were the Cooler Wars? (Part 2) — No Infringement Intended Podcast
A Guide to SEP: Standard Essential Patents for Tech Startups
Wolf Greenfield’s New Shareholders
5 Key Takeaways | Building a Winning Evidentiary Record at the PTAB (and Surviving Appeal)
Wolf Greenfield Attorneys Review 2024 and Look Ahead to 2025
5 Key Takeaways | Alice at 10: A Section 101 Update
Director Review Under the USPTO's Final Rule – Patents: Post-Grant Podcast
AGG Talks: Cross-Border Business Podcast - Episode 20: Mastering ITC Section 337 Investigations
Navigating Intellectual Property Challenges in the Renewable Energy Sector - Energy Law Insights
Patent Considerations in View of the Nearshoring Trends to the Americas
Tonia Sayour in the Spotlight
New Developments in Obviousness-Type Double Patenting and Original Patent Requirements — Patents: Post-Grant Podcast
3 Key Takeaways | What Corporate Counsel Need to Know About Patent Damages
5 Key Takeaways | Rolling with the Legal Punches: Resetting Patent Strategy to Address Changes in the Law
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
Legal Alert: USPTO Proposes Major Change to Terminal Disclaimer Practice
PODCAST: Williams Mullen's Trending Now: An IP Podcast - Artificial Intelligence Patents & Emerging Regulatory Laws
Are Your Granted Patents in Danger of a Post-Grant Double Patenting Challenge?
Patent Litigation: How Low Can You Go?
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
On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more
A Senate panel has advanced three sets of bipartisan bills purportedly aimed at reforming the intellectual property (IP) landscape and lowering the cost of prescription drugs. Together, these bills seek to address issues with...more
In the mid-2000s, the U.S. Patent Office (USPTO) determined that reexaminations would be more consistent and legally correct if performed by a centralized set of experienced and specially trained Examiners. As a result, the...more
In our previous articles, we reported that the Federal Circuit affirmed the district court’s decision on December 20, 2024 ordering Teva Pharmaceuticals (“Teva”) to delist certain patents related to Teva’s ProAir® HFA...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
Amarin sells the drug icosapent ethyl under the brand name Vascepa. Vascepa is approved by the FDA for two indications: (i) to treat severe hypertriglyceridemia, a condition characterized by blood triglyceride levels greater...more
Entresto® (sacubitril/valsartan) - Case Name: Novartis Pharms. Corp. v. Becerra, Civ. No. 24-cv-2234 (DLF), 2024 WL 4492072 (D.D.C. Oct. 15, 2024) (Friedrich, J.) Drug Product and Patent(s)-in-Suit: Entresto®...more
Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Appeal Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. Jan. 29, 2025) Our Case of the Week is a 31-page decision that touches on a variety of issues, including...more
ProAir® HFA (albuterol sulfate) - Case Name: Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC, No. 2024-1936, 2024 WL 5176737 (Fed. Cir. Dec. 20, 2024) (Circuit Judges Prost, Taranto, and Hughes...more
The Federal Circuit recently reversed a District of Delaware decision that invalidated claims of Novartis’s Orange Book listed patent, U.S. Patent No. 8,101,659 (the “’659 patent”), for its blockbuster drug Entresto®, a...more
In our previous article, we reported that the Federal Circuit affirmed the district court’s decision requiring Teva to delist certain patents related to its Teva’s ProAir® HFA metered-dose inhaler from the FDA’s Orange...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
The District of Delaware recently denied a motion to dismiss a patent infringement complaint involving gene editing technology that sought relief under the Safe Harbor Provision of the Hatch-Waxman Act. Specifically, the...more
Welcome to the Intellectual Property Litigation Newsletter, our review of decisions and trends in the intellectual property arena. In this edition, we learn that that changing a definition has consequences, an apex...more
In BlueAllele Corp. v. Intellia Therapeutics, Inc., 2024 U.S. Dist. Lexis 222094 (D. Del. Dec. 9, 2024)1, the District of Delaware addressed several issues relevant to the safe harbor defense in Hatch-Waxman litigation. ...more
The safe harbor exception in 35 U.S.C. § 271(e)(1) applies “solely for uses reasonably related to the development and submission of information” to the Food and Drug Administration (FDA). The Federal Circuit interpreted the...more
Returning to Washington in May, ACI’s 16th Annual Practitioners’ Think Tank on ITC Litigation & Enforcement is your opportunity to learn from and network with key members of the ITC Bench, senior ITC Attorneys and leading...more
Hosted by American Conference Institute, the 20th Annual Paragraph IV Disputes & the 40th Anniversary of the Hatch-Waxman Act returns for another exciting year with curated programming that will take a retrospective look at...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
The Supreme Court is expected to consider Teva’s pending petition for certiorari in the highly anticipated GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. on May 11, 2023, a case that could carry enormous implications for the...more
Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more