Patent Law Weblog
recent posts
- REGENEXBIO Inc. v. Sarepta Therapeutics, Inc. (Fed. Cir. 2026)
- Apple v. Squires: USPTO Director Has Unlimited Discretion on IPR Institution
- The Ghost in the Machine: Why GenAI Can Be Both a Brilliant Researcher and a Terrible Advocate
- Bayer Files Suit Against Trio of COVID-19 Vaccine Makers
- Allen v. Cooper (4th Cir. 2026)
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Category: Federal Circuit
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By Michael Borella — One of the more intellectually dishonest aspects of current patent eligibility law is that it allows one to ignore certain claim elements when evaluating claims under 35 U.S.C. § 101. In Mayo v. Prometheus, it was stated that once one has identified a judicial exception to patentability (e.g., a law of…
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By Kevin E. Noonan — Somewhat remarkably, there is no settled Federal Circuit precedent regarding where a patentee can bring suit against a generic competitor in Hatch-Waxman litigation under 35 U.S.C. § 271(e)(2). While recognizing that this situation has arisen in large part to the disruption created by the Supreme Court in TC Heartland LLC…
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By Michael Borella — One of the more frustrating aspects of current patent-eligibility law is that it lends itself all too easily to mischief. In particular, given that the eligibility test under 35 U.S.C. § 101 as interpreted by the courts is poorly-defined, conclusory reasoning frequently rears its ugly head. Such reasoning is sometimes found…
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Federal Circuit Refuses to Issue Stay in Mandate Pending Certiorari Decision By Kevin E. Noonan — One of the most interesting (albeit troubling) decisions by the Federal Circuit in the past year or so was its decisions, by a panel and then in denying review en banc, in American Axle & Manufacturing, Inc. v. Neapco…
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By Kevin E. Noonan — At least some of the judges on the Federal Circuit have been reported to have voiced some frustration regarding the number of appeals of decisions by the Patent Trial and Appeal Board that are on the Court's docket, particularly Board decisions in inter partes review. There being little evidence that…
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What Quantum of Culpable Conduct Is Required for an ANDA Applicant to Induce Infringement? By Kevin E. Noonan — The back-and-forth, (almost) cat-and-mouse-like competition between branded innovator and generic drug makers sanctioned under the Hatch-Waxman Act has been on-going for over thirty years. As part of this regime, Congress has provided a pathway for generic…
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By Kevin E. Noonan — Novelty is perhaps the principal, most fundamental requirement for patentability, and depriving the public of anything in the prior art must be avoided. The Federal Circuit recently reinforced the primacy of these rubrics in Biogen MA, Inc. v. EMD Serono, Inc. The issues arose in litigation over Biogen's Rebif* product…
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By Donald Zuhn — Last month, the Federal Circuit affirmed an Order by the U.S. District Court for the Northern District of California, finding that Appellant Walter A. Tormasi lacked the capacity to sue under Federal Rule of Civil Procedure 17(b). Mr. Tormasi had filed suit against Appellee Western Digital Corp., asserting that Western Digital…
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By Donald Zuhn — Earlier today, the Federal Circuit vacated the final written decision by the U.S. Patent and Trademark Office Patent Trial and Appeal Board in an inter partes review involving Appellant Snyders Heart Valve LLC and Appellee St. Jude Medical, LLC, and remanded for proceedings consistent with the Court's decision in Arthrex, Inc.…
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By Kevin E. Noonan — Today, the Federal Circuit affirmed under Rule 36 the decision by the District Court of Nevada (Du, J.) in March that the claims asserted by Amarin Pharma against West-Ward Pharmaceuticals International Ltd., Hikma Pharmaceuticals USA Inc., Dr. Reddy's Laboratories, Inc., and Dr. Reddy's Laboratories, Ltd. were invalid for obviousness, in…
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