Written Description Requirement Challenges: Federal Circuit Decision Sheds Light On How Expert Testimony Can Help

• Published date: 25 January 2022
• Subject Matter: Intellectual Property, Patent
• Law Firm: Mintz
• Author: Mr Brad Scheller and Meena Seralathan

Earlier this month, in Novartis Pharms. Corp., Inc. v. Accord Healthcare, Inc., et al., No. 2021-1070, the Federal Circuit issued a helpful decision concerning the not-often-discussed written description requirement. The panel specifically addressed whether sufficient written description can exist for claim limitations that are not explicitly or directly disclosed in the specification (including negative claim limitations). This new ruling provides patent owners with a useful guide for successfully navigating similar written description challenges in patent infringement cases. For example, Patent Owners seeking to combat written description requirement challenges should proffer expert witnesses who can clearly articulate how they understand the patent description in relation to the claims and what portions of that description support the same.

Novartis Pharmaceuticals Corporation, Inc. ("Novartis") filed a patent infringement suit against several defendants, including HEC Pharm Co., Ltd. and HEC Pharm USA Inc. ("HEC"), alleging that the defendants infringed US Patent No. 9,187,405, directed to treating relapsing remitting multiple sclerosis with a 0.5mg daily dose of findolimod. At trial, HEC argued that several claim limitations, including the claim limitation requiring "a daily dosage of 0.5 mg" and the negative limitation of "absent an immediately preceding loading dose regiment," were invalid as lacking sufficient written description. The District Court rejected HEC's argument, holding that sufficient written description existed for both limitations. On appeal, HEC argued that the specification did not indicate that the inventors knew that the 0.5 mg dose would be effective and that the fact that the specification was silent as to a loading dose did not mean there was sufficient written description for the negative claim limitation. The Federal Circuit ultimately affirmed the decision of the District Court, holding that the claims were valid and did not run afoul of the written description requirement.

Judge O'Malley first noted that the specification contained sufficient supporting disclosures. For example, the patent described a Prophetic Trial where humans would be dosed at a daily dosage of 0.5, 1.25, or 2.5 mg and, according to the Court, the citation of...