Federal Circuit Affirms PTAB Decision Finding Claimed Amount Had Written Description Support and Claimed Ranges Did Not

Held: Written description cases are intensively fact-oriented and a disclosure with isolated examples does not support claimed ranges with lower and upper bounds

Indivior owns a patent that generally describes orally dissolvable films containing therapeutic agents. The patent claimed priority to an earlier-filed application, and the question presented by an inter partes review was whether a claim, on a claim-by-claim basis, could get the benefit of the earlier filing date. The Patent Trial and Appeal Board (PTAB) held that claims reciting a range of polymeric content did not have written description support and a claim that recited an amount of polymeric content did have written description support. The Federal Circuit affirmed.

An issue facing Indivior was that its application did not recite the claimed ranges. Instead, Indivior relied on tables in application, which it converted to the claimed polymeric content and ranges. The Federal Circuit, however, pointed out that the application stated “[t]he film may contain any desired level of . . . polymer,” which is found to be “contrary to Indivior’s assertion that the level of polymer should be closed and between ‘about 40 wt % to about 60 wt %.” It also felt that Indivior’s approach amounted to “cobbling together numbers after the fact.”

On the other hand, for the claim reciting a specific amount of polymeric content, the Federal Circuit held that substantial evidence supported the PTAB’s decision and deferred to the PTAB’s fact-finding.