Certified Translation of Italian Patent Loses Case for Pharma Company

Language service providers (LSPs) specializing in the life sciences (SlatorPro) are aware of how complex and rigorous — not to mention costly — pharmaceutical translations can be. This fact was highlighted in a recent ruling by the US Federal Circuit Court of Appeals, where the English translation of the Italian term “semiliquido” was at issue.

In its ruling dated July 31, 2020, the Court stated that “half-liquid” translated from the original Italian word in the patent filing by Swiss pharma company IBSA Institut Biochimique (which had already been granted a US patent for thyroid hormone formulations) was “indefinite.”

Indefinite simply means that half-liquid could be construed as several things. IBSA stated the term meant “semi-liquid, i.e., having a thick consistency between solid and liquid.” The opposing side, American Israeli company Teva Pharmaceuticals, argued that half-liquid should be understood to mean “non-solid, non-paste, non-gel, non-slurry, nongas” — therefore, indefinite.

IBSA further contended that the Italian patent application used the term “semiliquido” in the same places where their patent used “half-liquid” — as well as where a certified translation of the Italian patent application used “semi-liquid.” So, IBSA said, “half-liquid” and “semi-liquid” would be taken to be synonyms by a POSA or a person of ordinary skill in the art.

But the Court disagreed. Moreover, giving no weight to the Italian patent application and the certified translation submitted by IBSA, concluded, “We have considered IBSA’s remaining arguments and find them unpersuasive.”

In an August 17, 2020 article published by online legal journal Lexology, author Daniel J. Pereira commented on the Court’s decision: “It can be speculated if the correct translation of the original claim term ‘semiliquido’ had been used in the specification and claims, there would not have been the same problem.”

He added, however, that “based on the totality of the record […] it does seem likely that the claim term would have still been found to be indefinite.”

“Pay extra scrutiny to a patent application that has been translated, translators are human and errors occur”

Pereira, who holds a Genetics PhD and is a partner at IP law firm Oblon, McClelland, Maier & Neustadt, pointed out that there are important lessons to be learned from the IBSA v. Teva case: (1) “pay extra scrutiny to a patent application that has been translated, translators are human and errors occur”; (2) “if a central part of the invention involves a term or phrase that is not well-defined in the relevant art, particularly one that may have a subjective interpretation, consider defining it in the specification.”