Federal Circuit Holds Claimed Ranges Must be Expressly Disclosed to Satisfy Written Description Requirement

In Individor UK Limited v. Dr. Reddy’s Laboratories, Inc., the Federal Circuit affirmed an inter partes review decision finding that certain claims to a film with specific ranges of a polymer weight percentage were invalid as lacking written description support in a relied upon priority application. Dr. Reddy’s Laboratories (DRL) filed the IPR to challenge U.S. Patent No. 9,687,454 (“the ‘454 patent”), owned by Individor. While the PTAB invalidated claims of the ‘454 Patent that recited polymer weight percentage ranges, one claim that recited a specific polymer weight percentage was upheld. On appeal, the Federal Circuit considered the support in the priority application and reasoned that, with respect to a claimed range, “a skilled artisan must be able to reasonably discern a disclosure of that range.” On review of the record, the Court noted that the claimed ranges do not appear in the priority application, and, additionally, the priority application also provides “other indications of the polymeric content of the film . . . rendering it even less clear” that an invention incorporating the claimed range was contemplated by the priority application. Moreover, in response to Individor’s argument that tables in the application with exemplary formulations would have led to the claimed ranges, the Federal Circuit stated “[a] written description sufficient to satisfy the requirement of the law requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention.” As to the claim that recited a specific polymer weight percentage, the Federal Circuit found that such claim was supported by the priority application and reasoned that it could have been derived from the table of formulations. The Court recognized the potential tension between the two holdings but noted that a claim directed to a specific amount is different from a range, and in this case, there is substantial evidence to support the specific amount.

Click here for link to the case: https://cafc.uscourts.gov/opinions-orders/20-2073.OPINION.11-24-2021_1870396.pdf