Category: Uncategorized

By Joshua Rich and Kevin E. Noonan – The Hatch-Waxman Act has always represented a delicate balance between the interests of innovator and generic drugmakers: innovators seek to maintain exclusivity as broadly and long as possible, generics seek to come to market as soon as possible and leverage previous marketing by the innovators as much…

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…

By Donald Zuhn – The China National Intellectual Property Administration (CNIPA) has instituted a change in its inventor information requirements.  For Chinese patent applications filed on or after January 1, 2026, Applicants must submit an inventor ID number for every inventor along with each inventor’s nationality.  The nationality of each Inventor mustbe submitted at the time an…

By Kevin E. Noonan – The preclusive scope of 35 U.S.C. § 314(d) regarding decisions on instituting post grant review proceedings (specifically, inter partes review or IPR) has been decided several times by the Supreme Court since enactment of the Leahy-Smith America Invents Act in 2013 to be very preclusive (see Cuozzo Speed Technologies, LLC…

By Kevin E. Noonan – The D.C. Circuit Court today denied Judge Pauline Newman’s request for rehearing en banc of the panel decision handed down by the Court on August 22, 2025 (see “Judge Newman’s Challenge Fails at D.C. Circuit“).  That decision affirmed the D.C. District Court’s dismissal of Judge Newman’s complaint against the Judicial…

By Donald Zuhn – In an email Patent Alert that was distributed this afternoon, the U.S. Patent and Trademark Office announced that it has issued the one millionth electronic patent grant (eGrant), which the Office stated “mark[ed] a major milestone in the agency’s modernization of the patent grant process.”  The Office highlighted the benefits of…

The authors and contributors of Patent Docs wish their readers and families a Happy Holidays!  It is also our hope that all of our readers, along with their families and friends, have a healthy and safe holiday.

By Donald Zuhn – In an email USPTO Alert that was distributed this afternoon, the U.S. Patent and Trademark Office announced that its offices will be closed on December 24 and December 26.  Because December 25 is listed as one of eleven federal holidays on the U.S. Office of Personal Management web site (as it…

By Mike Borella – One might be forgiven for assuming, based on a cursory reading of the Constitution or perhaps a fleeting bout of logic, that the U.S. patent system exists to promote the progress of science and useful arts. Historically, this meant incentivizing inventors to create tools that reduced human drudgery, increased accuracy, and…

By Kevin E. Noonan – Over several years and two administrations (see “FTC Announces Efforts to Police Pharmaceutical Companies’ Patent Behavior“; “FTC Warns Pharma Companies It Means Business with Its Orange Book Listing Policy“; “Federal Trade Commission Continues Efforts to Delist Drug Device Administration Patents in Orange Book“), the Federal Trade Commission has maintained a…