Patent Law Weblog
recent posts
- Otsuka Pharmaceutical Co. v. Lupin Ltd. (Fed. Cir. 2026)
- Supreme Court Denies Certiorari in Newman v. Moore
- Judge Newman Responds to Federal Circuit Judicial Council’s Opposition to Petition for Certiorari
- Federal Circuit Judicial Council Opposes Judge Newman’s Certiorari Petition
- Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (2026)
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By Kevin E. Noonan – On April 27, the Supreme Court heard oral argument in Hikma v. Amarin, with Charles Klein, representing Hikma, Michael Huston representing Amarin, and Malcolm Stewart addressing the Court on behalf of the Government. First, some statistics. Charles Klein was questioned by the fewest Justices (Justices Thomas, Sotomayor, and Jackson), while…
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By Kevin E. Noonan – While the Supreme Court established a rather definitive standard (“reasonable certainty by a person having ordinary skill in the art”) for determining indefiniteness under 35 U.S.C. § 112(b) in Nautilus, Inc. v. Biosig Instruments, Inc., and indefiniteness is a question of law mandating less deference by the Federal Circuit, the…
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By Kevin E. Noonan – In addition to the briefs from the parties, seventeen amicus briefs were filed with the Supreme Court in Hikma v. Amarin: six in favor of Petitioner Hikma, seven in favor of Respondent Amarin, and the remaining five on behalf of neither party (although the latter category is in some instances…
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By Kevin E. Noonan – In addition to the briefs from the parties, seventeen amicus briefs were filed with the Supreme Court in Hikma v. Amarin: six in favor of Petitioner Hikma, seven in favor of Respondent Amarin, and the remaining five on behalf of neither party (although the latter category is in some instances…
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By Kevin E. Noonan – In addition to the briefs from the parties, seventeen amicus briefs were filed with the Supreme Court in Hikma v. Amarin: six in favor of Petitioner Hikma, seven in favor of Respondent Amarin, and the remaining five on behalf of neither party (although the latter category is in some instances…
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By Kevin E. Noonan – In recent years, the Federal Circuit has, with varying levels of agreement, considered what behavior by generic drugmakers constitutes inducement of infringement regarding so-called “off-label” prescribing for indications not covered in their approved label (known as a “skinny label; see “GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2020)“). In the latest instance…
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By Kevin E. Noonan – A distinguished groups of retired judges* filed an amicus brief supporting Judge Pauline Newman’s Petition for Certiorari over the unwillingness of the Court of Appeals for the D.C. Circuit to rule on her complaint regarding constitutional violations by the Federal Circuit Judicial Council (see “Judge Newman Seeks Recourse from Supreme Court“). …
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By Kevin E. Noonan – In recent years, the Federal Circuit has, with varying levels of agreement, considered what behavior by generic drugmakers constitutes inducement of infringement regarding so-called “off-label” prescribing for indications not covered in their approved label (known as a “skinny label; see “GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2020)“). In the latest instance…
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By Kevin E. Noonan – The Federal Circuit reversed a District Court grant of judgment as a matter of law (JMOL) that overturned a jury verdict that defendant Eli Lilly had not satisfied the clear-and-convincing-evidence standard in challenging on Section 112(a) grounds claims asserted by Teva Pharmaceuticals in Teva Pharmaceuticals International v. Eli Lilly &…
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By Michael Borella – The U.S. Patent and Trademark Office has extended its Artificial Intelligence Search Automated Pilot Program (ASAP!) until June 1, 2026. Originally slated to close to new petitions on April 20, 2026 (see “USPTO Announces That It Has Turned the Corner on Unexamined Application Backlog“), the Office has expanded both the duration and…
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