August 17, 2020
The Federal Circuit affirms the lower court ruling that “half-liquid” translated from the original Italian “semiliquido” is indefinite in IBSA Institut Biochimique, S.A., Altergon, S.A., IBSA Pharma Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. July 31, 2020). http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-2400.OPINION.7-31-2020_1628842.pdf
IBSA is the owner of U.S. patent no. 7,723,390 and Teva filed an Abbreviated New Drug Application that included a certification of invalidity of that patent. Claim 1 of that patent is
1. A pharmaceutical composition comprising thyroid hormones or their sodium salts in the form of either:
a) a soft elastic capsule consisting of a shell of gelatin material containing a liquid or half-liquid inner phase comprising said thyroid hormones or their salts in a range between 0.001 and 1% by weight of said inner phase, dissolved in gelatin and/or glycerol, and optionally ethanol, said liquid or half-liquid inner phase being in direct contact with said shell without any interposed layers, or
b) a swallowable uniform soft-gel matrix comprising glycerol and said thyroid hormones or their salts in a range between 0.001 and 1% by weight of said matrix.
At issue is the limitation “half-liquid inner phase” and more specifically the meaning of half-liquid as there was no intrinsic record that defined this term:
IBSA pointed out 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.” IBSA contended 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. The district court disagreed.
The district court also noted that, during prosecution, the applicant proposed a dependent claim using the term “semi-liquid.” This claim depended on an independent claim that used the term “half-liquid.” Although the dependent claim using the term “semi-liquid” was removed by the applicant, the district court reasoned this portion of the prosecution history was “evidence that the applicant did not mean ‘semi-liquid’ when he used the term ‘half-liquid.’”
Similarly, in reviewing the ’390 patent’s specification, the district court determined that citation to pharmaceutical references, including Remington’s Pharmaceutical Sciences, which used the term “semi-liquid,” did not show that “half-liquid” meant “semi-liquid.” Instead, the court reasoned that such citation showed that the applicant knew of the term “semi-liquid” yet intentionally chose not to use it.
These were all fatal flaws to the District Court and the CAFC:
The district court relied on a passage of the specification stating that “[i]n particular, said soft capsule contains an inner phase consisting of a liquid, a half-liquid, a paste, a gel, an emulsion or a suspension comprising the liquid (or half-liquid) vehicle and the thyroid hormones together with possible excipients in suspension or solution,” to determine that a “half-liquid is not, or at least is not necessarily, a gel or a paste.” Decision, 2019 WL 3936656, at *6 (quoting ’390 patent col. 7 l. 65–col. 8 l. 2). Not only do we agree with the district court’s interpretation of this passage, but a second passage reinforces this interpretation. See ’390 patent col. 10 ll. 38–39 (“Soft capsules (SEC) with liquid, half-liquid, paste-like or gel-like inner phase”). These disjunctive lists designate that a “half-liquid” is an alternative to the other members of the list, including pastes and gels.