IBSA Institut Biochimique, S.A. et al. v. Teva Pharmaceuticals USA, Inc.
Docket No. 2019-2400
PROST, REYNA, HUGHES
July 31, 2020
Brief Summary: DC finding of invalidity for indefiniteness of the term “half-liquid” affirmed.
Summary: IBSA appealed DC decision finding claims 1, 2, 4, and 7-9 of Orange Book patent US 7,723,390 relating to “[a] pharmaceutical composition comprising thyroid hormones” invalid for indefiniteness because “the meaning of ‘half-liquid’ was not otherwise reasonably ascertainable from the record” (the claim recites “a soft elastic capsule consisting of a shell of gelatin material containing a liquid or half-liquid”). IBSA filed suit against Teva regarding ANDA No. 211369 for a generic version of Tirosint®. In its decision, the DC acknowledged the parties agreement “that the intrinsic record does not define ‘half-liquid’” (including the claims). The ‘390 patent issued from the US ‘467 application and claimed priority to an Italian application that is written in Italian. IBSA argued “that the Italian application used the term ‘semiliquido’ in the same places where the ‘390 patent used ‘half-liquid,’ and where a certified translation of the Italian Application prepared for IBSA in 2019 used ‘semi-liquid’” and “that there is a link between these terms such that a person of ordinary skill in the art (‘POSA’) would understand ‘half-liquid’ and ‘semi-liquid’ to be synonyms”, but the DC gave the translation “no weight in its analysis”. Instead, the DC found “that the document that best reflected the applicant’s intent was the document submitted for examination-the ‘467 application.” The DC also concluded the prosecution history provided “evidence that the application did not mean ‘semi-liquid’ when he used the term ‘half-liquid’” and that the specification indicated in its references to “pharmaceutical references…did not show that ‘half-liquid’ meant ‘semi-liquid’” (i.e., “the applicant knew of the term ‘semi-liquid’ yet intentionally chose not to use it”). The DC also concluded that “it is ‘exceedingly unlikely that [‘half-liquid’] was a term of art at the relevant date” and “afforded” IBSA’s expert opinion “no weight” as it was “exclusively based on evidence that the court already found unpersuasive”. The FC panel explained that “[t]he definiteness requirement…’must take into account the inherent limitations of language’” but also that “a patent must be precise enough to afford clear notice of what is claimed” (Nautilus, US 2014). The FC panel agreed with the DC that the specification did not clarify the meaning of the term, “that a POSA would likely consider the discrepant usage of ‘half-liquid’ and ‘semiliquido’ between the ‘390 patent and the Italian Application to be intentional, implying that the different word choice has a different scope”, and that this “does not amount to a refusal to consider a foreign priority document” (Abbott, FC 2009 (“when discrepancies between a foreign priority document and the U.S. filing exist, it may be proper to view the discrepancies as intentional”)). The FC panel also noted that during prosecution “the applicant had a pending claim using ‘half-liquid’ and another claim, depending from that claim, using the term ‘semi-liquid’”, providing “additional evidence that the application knew the term ‘semi-liquid’ yet elected to use ‘half-liquid’ to mean something different.” The FC panel also agreed with the DC that the extrinsic evidence does not supply a definite meaning for “half-liquid”.