On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to…
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/ Administrative Law, Health, Science, Computers, & Technology
On January 27, 2025, the Federal Circuit held that the Patent Trial and Appeal Board (“PTAB”) “has jurisdiction over IPRs concerning expired patents.” See Apple Inc. v. Gesture Tech. Partners, LLC, 2025 WL 299939, *2 (Fed. Cir…
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/ Administrative Law, Civil Procedure, Intellectual Property
Modern gene-editing technology, such as CRISPR/Cas technology, represents a ground-breaking advancement that has transformed our genetic engineering capabilities and has enormous potential for revolutionising medicine, food…
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/ Agriculture, Intellectual Property, Science, Computers, & Technology
The Fedtrade® Podcast recently interviewed Tim Tierney, Director of Business Recruitment and International Trade at the Vermont Department of Economic Development. The mission of the Vermont Department of Economic Development is…
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/ Business Organizations, International Law & Trade, Mergers & Acquisitions
The Federal Circuit’s recent decision in Palo Alto Networks, Inc. v. Centripetal Networks, LLC, No. 2023-1636, 2024 WL 5114204 (Fed. Cir. Dec. 16, 2024) concerns an obviousness determination based on a motivation to combine…
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/ Administrative Law, Civil Procedure, Intellectual Property
We recently interviewed Mike Papineau, CEO of RideFlag Technologies in Ontario, Canada for our Fedtrade® podcast. RideFlag has successfully partnered with highway systems across the United States to validate passenger count for…
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/ Business Organizations, Intellectual Property, Transportation
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…
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/ Civil Procedure, Health, Intellectual Property, Science, Computers, & Technology
The Fedtrade® Podcast recently interviewed William (Bill) Hite, CEO and Founder of HSA Global, as part of our SelectUSA Investment Summit Spotlight series. With locations in Boston, Chicago, and Germany, HSA Global helps with…
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/ Intellectual Property, International Law & Trade, Mergers & Acquisitions
With U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal’s return to private practice in December 2024 and the future permanent Director yet to be tapped for nomination, it is a good time to reflect on one of the most…
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/ Administrative Law, Civil Procedure, Intellectual Property
The Federal Circuit recently reversed a District of Delaware decision that invalidated claims of Novartis’s Orange Book listed patent, U.S. Patent No. 8,101,659 (the “’659 patent”), for its blockbuster drug Entresto®, a…
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/ Civil Procedure, Intellectual Property, Science, Computers, & Technology
The Fedtrade® podcast recently interviewed William (Bill) Kitay, Secretary of the American Chamber of Commerce in Canada for our SelectUSA Investment Summit spotlight series. With seven chapters located throughout Canada, AmCham…
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/ Business Organizations, International Law & Trade
In our previous article, we reported that the Federal Circuit affirmed the district court’s decision requiring Teva to delist certain patents related to its Teva’s ProAir® HFA metered-dose inhaler from the FDA’s Orange Book..…
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/ Civil Procedure, Health, Intellectual Property, Science, Computers, & Technology
The recent decision by the Federal Circuit in Honeywell International Inc. v. 3G Licensing, S.A., issued on January 2, 2025, overturned the Patent Trial and Appeal Board’s (“the Board”) factual and legal holdings in the final…
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/ Administrative Law, Civil Procedure, Intellectual Property, Science, Computers, & Technology
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 affordable…
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/ Administrative Law, Health, Intellectual Property, Science, Computers, & Technology
Artificial intelligence dominated this year's emerging technology updates from the U.S. Patent and Trademark Office and the U.S. Copyright Office. These agencies, among many others, were kept quite busy under the directives set…
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/ Administrative Law, Intellectual Property, Science, Computers, & Technology