Drug Patent Invalid Due to Poor Quality Translation

Bradley Arant Boult Cummings LLP

Bradley Arant Boult Cummings LLP

In IBSA Institut Biochimique v. Teva Pharmaceuticals USA, Inc. a valuable lesson was learned about relying on a translation of a non-English patent application. The IBSA Institut Biochimique (IBSAIB) hired an Italian patent agent to file a patent application in Italian for a thyroid drug formulation. The application was filed in Italy. Within 12 months of filing in Italy, IBSAIB filed a patent application in the United States, citing its Italian patent application under the Paris Convention for Intellectual Property. However, instead of filing the Italian application in the U.S., a poor-quality English translation was filed, and material was added. The translation contained the meaningless term “half-liquid.” Because this term has no established meaning in pharmacology, a district court found the resulting patent to be invalid as indefinite, a finding that was affirmed by the court of appeals.

The Law of Indefiniteness

Section 112 of the Patent Act (as amended by the America Invents Act) requires a minimum level of clarity in the claims of patents. Specifically:

The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.

The courts interpret this section of the act to prohibit claims that are “indefinite.” The Supreme Court further defined this standard in its landmark case of Nautilus v. Biosig: “…we hold that a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.

The IBSAIB Patent

The patent application at issue in this case claimed a drug formulation containing (among other things) “a soft elastic capsule consisting of a shell of gelatin material containing a liquid or half-liquid inner phase comprising said thyroid hormones.” Based on the contents of the patent itself, the testimony of experts, and the contents of scientific texts, the court found that “half-liquid” was not a term whose meaning was reasonably certain. IBSAIB argued that this term should be interpreted to mean “semi-liquid.” It was not disputed that the term “semi-liquid” is an understood term, but the court disagreed that a person skilled in the art would understand “half-liquid” to be synonymous with “semi-liquid.”

IBSAIB’s argument was based in part on the fact that the original Italian patent contained the term “semiliquido,” which properly translates to “semi-liquid” in English. IBSAIB argued that a person trying to interpret the term “half-liquid” would understand that it was meant to be the English translation of “semiliquido” based on the sworn statement by the inventor that the Italian application was cited under the Paris Convention for Intellectual Property. The Paris Convention requires that, when a person applies for a patent in a first country and then in a second country, the second country treat its patent application as having the filing date in the first country, so long as the patent application in the second country is filed within 12 months of that in the first country. An earlier filing date is advantageous for many reasons, so this treaty is widely used.

The Court’s Rebuke

The court was unpersuaded. It reasoned that the Italian and U.S. patents were separate and distinct; although the U.S. patent was largely a translation of the Italian one, it contained additional information as well. There was nothing in the U.S. patent saying that it should be interpreted to be identical as the Italian one, in whole or in part. As a result, the court based its interpretation only on sources that are usually used under U.S. law: the contents of the patent itself, the prosecution history before the USPTO, and the knowledge of persons skilled in the art at the time of filing.

The Lesson on Foreign Filings

While low-quality patent translations abound (and are difficult to detect), IBSAIB’s problems could have been easily avoided. Under U.S. law one may file a patent application in any language, so long as an English translation is filed within a certain time limit. In such a situation the foreign language application is considered the authoritative version, and the translation merely that. As a result, translation errors can be corrected so long as the original non-English documents shows that they are clearly errors. This differs from IBSAIB’s situation, in which the translation itself was filed as the application.

One may also make an explicit statement in the U.S. application that the foreign application is incorporated by reference into the U.S. application. The USPTO officially recognizes that such an explicit statement allows for the correction of translation errors in section 213.02 of the Manual of Patent Examination Procedure. Had IBSAIB included such a statement in its U.S. patent application, it would have had the opportunity to correct translation errors such as the one that sunk its patent.

When a patent application has been drafted in a language other than English, one should not rely on a third-party translator to draft the patent application in the United States. Instead the foreign language application should either be used as the U.S. patent application or explicitly incorporated by reference, in case corrections need to be made or the foreign language application is needed to understand the English claims. Another option is to ask a U.S. patent agent or attorney to draft an application in English from scratch, which may still cite the foreign application for priority if correctly drafted.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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Bradley Arant Boult Cummings LLP

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