The U.S. Court of Appeals for the Federal Circuit recently issued a non-precedential Rule 36 affirmance of the Patent Trial and Appeal Board (PTAB) in In re Adhami, No. 2024-1218, 2025 WL 1949797 (Fed.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
The Fedtrade® podcast recently interviewed Daniel Clark, Vice President and Director of Business Development at the New York City Economic Development Corporation (NYCEDC), as part of our SelectUSA Investment Summit Spotlight…
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/ Immigration Law, Intellectual Property, International Law & Trade
The Fedtrade® podcast recently interviewed Anders Victor, Director of Business Development for the Economic Development Partnership of North Carolina (EDPNC), as part of our SelectUSA Investment Summit Spotlight series. EDPNC…
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/ Business Organizations, International Law & Trade, Science, Computers, & Technology
Targeted protein degradation (TPD) is transforming drug discovery by leveraging the cell’s natural protein disposal systems to eliminate disease-causing proteins. Innovators are making rapid and successful advancements in the…
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/ Commercial Law & Contracts, Health, Intellectual Property, Science, Computers, & Technology
Hello, welcome to Fedtrade®. I’m James Hastings of Rothwell Figg. Joining us on the podcast today is Tony Davis, Executive General Manager, The Americas of the Australian Trade and Investment Commission (“Austrade”). Tony will…
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/ Agriculture, International Law & Trade, Science, Computers, & Technology
The Fedtrade® podcast recently interviewed Bill Noonan, Chief Business Development Officer of Choose New Jersey, as part of our SelectUSA Investment Summit Spotlight series. Choose New Jersey is the state’s leading non-profit…
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/ International Law & Trade, Nonprofit Law, Real Estate - Commercial
The Fedtrade® podcast recently interviewed Adam Boltik, Program Manager for the Office of International Commerce of the State of New Hampshire Department of Business and Economic Affairs, as part of our SelectUSA Investment…
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/ Intellectual Property, International Law & Trade, Taxation
