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?
On July 1, 2025, Fresenius Kabi announced the U.S. launch of Conexxence™ / Bomyntra™ (denosumab-bnht), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab), pursuant to a settlement agreement between the parties ending BPCIA...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
On June 2, 2025, Sandoz announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are now available to patients in the United States. ...more
On June 25, 2025, Amgen filed its sixth and seventh BPCIA lawsuits against proposed biosimilars of Prolia® / Xgeva® (denosumab), Case No. 1:25-cv-12152 (D.N.J.) against Hikma and Gedeon Richter’s RGB-14 and Case No....more
In the last week, Amgen, Inc and Amgen Manufacturing Ltd, LLC (“Amgen”) filed three more BPCIA complaints against companies seeking approval for a denosumab biosimilar. ...more
On June 2, 2025, the Patent Trial and Appeal Board (“Board”) issued decisions denying institution of Samsung Bioepis’s IPR2025-00176 and Formycon’s IPR2025-00233 against claims 1–12, 14–17, 19, 20, 22–36, 39–42, 44, 45, and...more
On June 17, 2025, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed another complaint against Amgen Inc. (“Amgen”) under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU®, infringes U.S. Patent No. 12,331,099...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
On May 14, 2025, HyClone Laboratories, LLC (“HyClone”) filed a Motion to Quash in the U.S. District Court for the District of Utah, seeking to quash Amgen Inc.’s (“Amgen”) subpoena to HyClone issued in Amgen’s denosumab BPCIA...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
On April 22, 2025, the U.S. District Court for the Northern District of West Virginia entered a Stipulation and Order Vacating Permanent Injunction and Dismissing All Claims and Counterclaims with Prejudice in In re:...more
On March 14, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s denial of a preliminary injunction against Amgen Inc. (“Amgen”) in the ongoing...more
On March 7, 2025, the District Court for the District of New Jersey entered a Stipulation and Order of Dismissal Without Prejudice in view of a settlement agreement between Amgen and Fresenius Kabi resolving the BPCIA...more
On March 5, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entry of a preliminary injunction preventing Celltrion, Inc. (“Celltrion”) from...more
Inventions made in a particular country are generally first-filed in that country before entering the United States via a direct Paris Convention filing or, more commonly, a PCT national stage entry. Convenience, national...more
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more
Last year marked an all-time record of 18 Food and Drug Administration (FDA) biosimilar approvals, bringing the total number of FDA-approved biosimilars to 63. Forty-one of those biosimilars have launched in the U.S. market....more
Note: This post addresses two Federal Circuit decisions issued on January 29, 2025. Both appeals involved Plaintiff-Appellee Regeneron Pharmaceuticals, Inc., with the first appeal involving Defendant-Appellant Formycon AG...more
On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction by the Northern District of West Virginia in favor of Regeneron Pharmaceuticals, Inc. against Samsung...more
With the recent convocation of the 119th Congress, a change in administration, and resignation of USPTO Director Vidal, pharmaceutical patent reform is likely on the minds of many in Washington. Prior to this political...more
Addressing a preliminary injunction in patent litigation related to the Biologics Price Competition and Innovation Act (BPCIA), the US Court of Appeals for the Federal Circuit upheld the district court’s grant of a...more
On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entries of preliminary injunction preventing Samsung Bioepis Co., Ltd....more