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(Podcast) The Briefing: 2025 IP Resolutions Start With a Review of IP Assets
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Wolf Greenfield Attorneys Review 2024 and Look Ahead to 2025
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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 U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available treatment options and accounted...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
Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more
Patent term extension (PTE) under 35 U.S.C. § 156 is a statutory program that restores to a patent at least a portion of the term that was effectively lost while the covered product was undergoing regulatory review and could...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
Understanding what to patent versus what to keep as a trade secret is an increasingly important and challenging decision facing companies developing biologics products, such as cell and gene therapies, where technologies are...more
On August 20, 2024, the Federal Trade Commission (FTC) filed a comment letter in support of the Food and Drug Administration’s (FDA’s) June 2024 draft guidance on biosimilar interchangeability (the “Draft Guidance”). When...more
Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to...more
As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more
Welcome to Venable’s BiologicsHQ Monthly Injection – July 2024...more
As we previously reported, in May 2023, Amgen filed a BPCIA complaint in the District of New Jersey alleging infringement based on Sandoz’s denosumab biosimilars of Amgen’s PROLIA and XGEVA (“the Sandoz Denosumab...more
Welcome to Venable’s BiologicsHQ Monthly Injection – April 2024...more
Hosted by American Conference Institute, the Summit on Biosimilars & Innovator Biologics returns to New York City, on June 20 - 21, 2024. Now in its 15th year, the 2024 conference will dive deep into the latest legal,...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
On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo’s ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have...more
On January 28, 2024 Celltrion announced the submission to the FDA of an aBLA for CT-P47, a proposed biosimilar of Genentech’s Actemra® (tocilizumab). This is the third publicly announced aBLA filing for an...more
On November 30, 2023, Celltrion announced that it filed for an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P41 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab)...more
Celltrion Submits Denosumab BLA to FDA: On November 30, 2023, it was reported that Celltrion had completed submission of its application to the FDA for CT-P41, its denosumab biosimilar of Amgen’s PROLIA and XGEVA....more
On November 22, 2023, Biocon Biologics Inc. (“Biocon”) submitted a Petition for Inter Partes Review of claims 1-34 of U.S. Patent No. 10,961,307 (“the ’307 patent”), assigned to Janssen Biotech, Inc. (“Janssen”), requesting...more
We all know that policymakers are increasingly focused on lowering drug costs. From the Inflation Reductions Act's Medicare price negotiations (aka price controls) to the recent proposals directed at pharmacy benefit managers...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
Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The...more