Patent Law Weblog
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Category: Federal Circuit
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By Kevin E. Noonan — Early last year, Aurobindo, one of the Defendants* in ANDA litigation against Merck, advanced the proposition that in cases where a patent had been reissued patent term extension ("PTE") under 35 U.S.C. § 156 should be calculated based on the grant date of the reissue patent and not of the…
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Note: This post addresses a Federal Circuit decision that issued on March 14, 2025. This appeal involved Plaintiff-Appellant Regeneron Pharmaceuticals, Inc., Defendant-Appellee Amgen Inc. (Case 24-2351). At trial, this case also included Defendants Mylan Pharmaceuticals Inc.; Amgen USA, Inc.; Biocon Biologics Inc.; Celltrion, Inc.; Formycon AG; and Samsung Bioepsis Co.; as well as the Defendants-Appellee.…
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By Kevin E. Noonan — Sometimes important contributions to innovation can come from the mundane rather than the extraordinary. One (perhaps apocryphal) example comes from the story of the early development of television by Philo Farnsworth (the story, but not the apocrypha, is set forth in Evan Schwartz's book The Last Lone Inventor). In this aspect…
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By Kevin E. Noonan — Completing a recent jurisprudential "hat trick,"* the Federal Circuit affirmed a District Court grant of a preliminary injunction against a biosimilar applicant for Regeneron's EYLEA biologic drug in Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. As in the earlier appeals, the injunction was based on infringement by Celltrion's EYLEA biosimilar (designated…
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By Kevin E. Noonan — After creating something of a frisson due to the apprehension that the Federal Circuit might be convinced to re-evaluate whether it was a necessary element for establishing obviousness for the skilled artisan to have had a reasonable expectation of success (see "U.S. Patent Office Challenges the Reasonable Expectation of Success Prong…
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By Kevin E. Noonan — The Honorable Pauline Newman, Circuit Judge for the U.S. Court of Appeals for the Federal Circuit, has been battling her suspension from the Court imposed by the Judicial Council for two years (including proceedings leading up to the suspension; see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit";…
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Note: This post addresses two Federal Circuit decisions issued on January 29, 2025. Both appeals involved Plaintiff-Appellee Regeneron Pharmaceuticals, Inc., with the first appeal involving Defendant-Appellant Formycon AG (Case 24-2009) and the second appeal involving Defendant-Appellant Samsung Bioepsis Co. (Case 24-1965). At trial, each case also included Defendants Mylan Pharmaceuticals Inc., Amgen USA, Inc., Biocon…
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By Kevin E. Noonan — The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, in a case captioned In re Sugammadex (alternatively, Aurobindo v. Merck Sharp and Dohme). The issue before the Court is whether Patent Term Extension under 35 U.S.C. § 156 in a reissue…
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Published Patent Applications Are Prior Art as of the Filing Date, Not the Publication Date By Joshua Rich — Lynk Labs raises a simple question of statutory interpretation with surprisingly important ramifications: in inter partes review, is a published patent application considered prior art as of the date of filing or the date of publication? …
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Distinguished Judges File Amicus Brief in Newman v. Moore et al. By Kevin E. Noonan — It has been a remarkable feature of the Federal Circuit's suspension of the Honorable Judge Pauline Newman that few have taken a stand publicly on the propriety of the suspension (something the Judge herself recently mentioned; see "An American (and…
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