On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), announced a new strategy aimed at…
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/ Administrative Law, Health, Intellectual Property
Artificial Intelligence (“AI”) has been utilized by innovative companies across the array of industry spaces, but its impact on biotech (and human health in general) could become the most significant among all sectors…
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/ Health, Intellectual Property, Science, Computers, & Technology
The TTAB recently hit a sour note for Shaklee Corporation, affirming on appeal a Section 2(d) refusal of its application to register IN HARMONY WITH NATURE for “online retail store services” because it found the mark too close…
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/ Intellectual Property
On July 15, 2025, U.S. Senators Peter Welch (D‑VT), Josh Hawley (R‑MO), and Amy Klobuchar (D‑MN) introduced the ETHIC Act—the Eliminating Thickets to Increase Competition Act (S. 2276)—in the U.S. Senate. The bill is designed to…
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/ Antitrust & Trade Regulation, Civil Procedure, Health, Intellectual Property
The first half of 2025 has brought many changes at the United States Patent and Trademark Office (“USPTO”), including policy changes at the Patent Trial and Appeal Board (“PTAB”). At the end of March 2025, the issuance of the…
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/ Administrative Law, Civil Procedure, Intellectual Property
Acting Director of the USPTO, Coke Morgan Stewart, issued a memorandum last week that will change the way petitioners levy challenges to patents via inter partes review (IPR). The change will apply to any petition for IPR filed…
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/ Administrative Law, Intellectual Property
The U.S. Court of Appeals for the Federal Circuit recently issued a non-precedential Rule 36 affirmance of the Patent Trial and Appeal Board (PTAB) in In re Adhami, No. 2024-1218, 2025 WL 1949797 (Fed. Cir. July 16, 2025). This…
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/ Intellectual Property
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This…
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/ Health, Intellectual Property, Science, Computers, & Technology
The District Court for the District of Delaware recently rejected Novartis’s effort to block MSN Pharmaceuticals from launching a generic version of Entresto® (sacubitril/valsartan), its top-selling heart failure medication. The…
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/ Civil Procedure, Intellectual Property, Science, Computers, & Technology
With healthcare costs rising and biologics driving a large portion of drug spend, the next wave of biosimilar launches promises to reshape the U.S. pharmaceutical market in profound ways, including reduced prices for close…
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/ Health, Science, Computers, & Technology
The USPTO’s recent guidance on discretionary denials has shifted patent practitioners back to the Fintiv and Sotera Wireless framework…
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/ Administrative Law, Civil Procedure, Intellectual Property
In a precedential ruling, the U.S. Court of Appeals for the Federal Circuit in Jazz Pharma. v. Avadel CNS Pharma., 2025 WL 1298920, — F.4th — (Fed. Cir. May 6, 2025), addressed the scope of the 35 U.S.C. § 271(e)(1) “safe…
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/ Administrative Law, Civil Procedure, Health, Intellectual Property, Science, Computers, & Technology
Partner Dan Shores will present a webinar titled "mRNA Patent Wars Update: Litigations Expand and Key Rulings Expected in 2025" for Medmarc, the leading expert in the products liability risks facing medical technology and life…
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/ Health, Intellectual Property, Products Liability, Science, Computers, & Technology
FDA approves Omylco® (omalizumab), first biosimilar of Xolair®.
After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025…
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/ Administrative Law, Health, Science, Computers, & Technology
The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure is an international agreement to establish a uniform system for depositing microorganisms and other…
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/ Intellectual Property, International Law & Trade, Science, Computers, & Technology
