By Kevin E. Noonan -- The inter partes review provisions of the Leahy-Smith America Invents Act have been criticized for the propensity of the Patent Trial and Appeal Board (PTAB) to find invalid all or at least some of the challenged claims, frequently on obviousness grounds. Failure to so find, in addition to being less common has also often upheld on appeal, in view of the substantial evidence standard of review on factual questions involved in both novelty and obviousness questions before the Board. The Federal Circuit's recent decision in Recor Medical, Inc. v. Medtronic Ireland Mfg. illu ..read more

By Kevin E. Noonan -- The dispute between the Judicial Council of the Federal Circuit and The Honorable Pauline Newman, Circuit Judge for the U.S. Court of Appeals for the Federal Circuit has been waging for more than a year (see links below). The case has prompted amici to weigh in (see "Enough is (Apparently) Enough," Parts I, II, III, and IV) and last month a panel of physicians (neurologist James Noble, clinical neuropsychologist Jonathan DeRight, and diagnostic radiologist Jason Johnson) disputed the conclusions that Judge Newman's counsel asserted to refute allegations that the Judge was ..read more

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 "original" patent from which the reissue was obtained. The Federal Circuit weighed in on this argument and found it unavailing (at least under the circumstances of these patents) in its Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. decision handed down earlier this...   ..read more

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. By Kevin E. Noonan -- The Defendants in biosimilar litigation involving Regeneron's EYLEA biologic drug got off the schneid last week (see "Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceut ..read more

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 of the tale, Farnsworth's brother-in-law, wanting to help but knowing nothing about electronics, learned to blow glass television tubes which he realized were necessary components of Farnsworth's invention. This story comes to mind in a recent nonp ..read more

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 CT-P42) of U.S. Patent No. 11,084,865 and the appeal limited to the propriety of the District Court granting a preliminary injunction (PI) to Regeneron (as well as some jurisdictional issues). The opinion ..read more

By Donald Zuhn –- On March 11, 2020, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," and cautioned that the WHO has "rung the alarm bell loud and clear." At the time of the announcement, the WHO noted that there were 118,000 cases reported globally in 114 countries. As of February 13, 2025, when it issued its most recent report, WHO reported 777,291,317 cases globally, regrettably resulting in 7,083,769 deaths. When the Director-General declared that the COVID-19 outbreak had become a pandemic, he noted that ..read more

By Donald Zuhn –- On Monday, President Trump's nomination for Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office, John A. Squires, was submitted to the U.S. Senate for confirmation. Mr. Squires is currently a partner at Dilworth Paxson LLP in New York. His Dilworth Paxson biography indicates that Mr. Squires' practice area is litigation, that he is a graduate of the University of Pittsburgh School of Law, and that he has a B.S. in Chemistry from Bucknell University. Mr. Squires' firm biography also indicates that he is "globally recognize ..read more

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 of Obviousness Law Precedent in Immunogen v. Vidal")*, cooler (or perhaps more conventionally doctrinal) heads prevailed in the Court's recent decision in Immunogen, Inc. v. Stewart (albeit by ignoring the argument while nevertheless affirmi ..read more

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"; "Judge Newman Matter Continues"; "Federal Circuit Special Committee Responds to Judge Newman's Counsel's Request for Clarification Regarding Misconduct Hearing"; "Federal Circuit Special Committee Recommends One-Year Suspension of Judge Newman ..read more