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?
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
Simbrinza® (brinzolamide / brimonidine) - Case Name: Alcon Inc. v. Padagis Israel Pharms. Ltd., Civ. No. 22-1422-WCB, 2025 WL 457119 (D. Del. Feb. 5, 2025) (Bryson, C.J.) Drug Product and Patent(s)-in-Suit: Simbrinza®...more
Rituximab 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 February 28, 2025, the FDA approved Celltrion’s Stoboclo® / Osenvelt® (denosumab-bmwo) as the third company to receive FDA approval of biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...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
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
On February 28, 2025, Amgen filed three IPRs against Bristol-Myers Squibb’s patents covering methods of treatment using a combination of Opdivo® (nivolumab), an anti-PD-1 antibody, and Yervoy® (ipilimumab), an anti-CTLA-4...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
The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated Biologics License Applications (aBLAs) are subject to jurisdiction in the United States....more
On January 24, 2025, the FDA approved Celltrion’s Avtozma® (tocilizumab-anoh), in intravenous and subcutaneous formulations, as the third biosimilar of Genentech’s Actemra® (tocilizumab)...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 Federal Circuit issued paired decisions addressing Samsung Bioepis’s (“SB”) and Formycon AG’s (“Formycon”) appeals of preliminary injunctions entered in ongoing aflibercept biosimilar litigations with...more
Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more
In 2024, the Rx IP Update team at Smart & Biggar reported on a number of developments in Canadian life sciences IP and regulatory law. Highlights from 2024 are below; see also our top ten Rx IP Update reads of 2024....more
In the ongoing case of Carefirst of Maryland Inc. v. Johnson & Johnson, the plaintiffs successfully overcame a motion to dismiss. At the heart of the case is J&J’s legal strategy against biosimilar competitors, including...more
On October 22, 2024, the Federal Circuit (CAFC Case No. 24-2351) denied Regeneron’s request for an injunction pending appeal for Amgen’s EYLEA® (aflibercept) biosimilar Pavblu™ (aflibercept-ayyh), concluding that “Regeneron...more
September 21, 2024, marked the seventh anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the seventh year...more
Antibody-drug conjugates (ADCs) are typically composed of a monoclonal antibody attached to a cytotoxic drug via a chemical linker. The antibody is able to identify biomarkers on and attach to cancer cells, allowing targeted...more
The Situation: Senate Bill 150 ("S.B. 150")—the Affordable Prescriptions for Patients Act of 2023—unanimously passed the Senate and would amend 35 U.S.C. § 272(e) to limit, under certain circumstances, the number of patents...more
Welcome to Venable’s BiologicsHQ Monthly Injection – July 2024...more
The Federal Circuit's recently issued decision in the Amarin/Hikma case continues the drama around skinny labeling for generic and biosimilar products, but the panel certainly went out of its way to couch its analysis as an...more
As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....more
Welcome to Venable’s BiologicsHQ Monthly Injection – April 2024...more
On April 10, 2024, the Court granted Plaintiffs Genentech, Hoffmann-La Roche, and Biogen and Defendants Dr. Reddy’s and Fresenius Kabi’s joint stipulation of dismissal due to settlement in Case No. 1:23-cv-22485 (D.N.J.)...more