Small patent filing mistakes can have a decisive impact on high-stakes disputes

At first glance, a translation error in a patent may seem to be of little consequence, but a small such mistake in a patent owned by IBSA Institute Biochimique (IBSA) cost the company a lot to litigate.

IBSA filed a petition for writ of certiorari in March 2021 to the US Supreme Court. The petition against Teva Pharmaceuticals seeks to overturn the Federal Circuit and district court decisions invalidating a pharmaceuticals patent for indefiniteness. A small error in translation from an original Italian patent application resulted in the direct loss of Abbreviated New Drug Application (ANDA) litigation for the patentee, IBSA.

Background of the Case

Petitioner IBSA owned a pharmaceutical patent for Tirosint®, a soft gel capsule that enables a safe and stable administration of a thyroid hormone called levothyroxine. Teva sought to market a generic version of Tirosint® by filing an ANDA. This application included an allegation that IBSA’s patent was invalid. As a response, IBSA filed a lawsuit for patent infringement against Teva in 2018.

The parties’ dispute revolved around the construction of the term “half-liquid,” referring to the composition of the drug in question. Its capsule consisted of an outer shell of gelatin material, while the active ingredient it contained was in the form of a “half-liquid.”

IBSA claimed that the term “half-liquid” should be construed to mean “semi-liquid,” as this would be how a person of ordinary skill in the art would interpret it. IBSA defined “semi-liquid” as a thick consistency somewhere between solid and liquid. In addition, a priority Italian Patent Application’s use of the word “semiliquido” is the same manner that “half-liquid” was used in the patent for Tirosint®. This supported IBSA’s position that the two terms were synonymous.

District Court Ruling

The district court ruled in favor of Teva, holding that the claims were indefinite. It examined the evidence presented to identify how a person of ordinary skill would interpret the term “half-liquid” and found that the meaning of the term “half-liquid” was not reasonably ascertainable from the record.

First, the district court examined the intrinsic evidence. This included the claims, specification, and prosecution history. The differences between the Tirosint® patent and the Italian Application’s use of the terms “half-liquid” and “semiliquido” showed that the word choice was intentional.

Furthermore, during prosecution, a proposed dependent claim used the term “semi-liquid” while the independent claim used the term “half-liquid.” The evidence presented showed that the applicant did not mean “semi-liquid” and “half-liquid” to be interchangeable. The two terms have a different scope.

Even the examination of the drug’s specification showed that a “half-liquid” was listed separately among other components of the capsule’s contents. The specifications showed that “paste” and “gel,” among others, were listed alongside “half-liquid.” This indicated that a “half-liquid” was neither a paste nor a gel. However, pastes and gels fall somewhere between a liquid and a solid. They would then qualify by definition as a “half-liquid” under IBSA’s proposed construction.

Court of Appeals Ruling

Upon IBSA’s appeal, the Court of Appeals for the Federal Circuit affirmed the decision. It agreed with the district court’s analysis of the intrinsic evidence presented. In so doing, it found that neither the claims nor the specification supported IBSA’s proposed construction of “half-liquid.”

The Court next examined the extrinsic record and found that IBSA failed to identify any scientific dictionary or journal which defined the term “half-liquid.” Furthermore, the four other patents IBSA cited, used the term “half-liquid” in contexts different from that of the asserted patent. Lastly, the expert testimony presented showed that “half-liquid” was not a well-known term in the art. A person of ordinary skill in the art would have difficulty ascertaining the definition of a “half-liquid.”

The Present Petition

IBSA argued in its latest petition that the Court’s decision is a contravention of U.S. obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). TRIPS is an international agreement that requires foreign and domestic inventors to be treated equally. IBSA contended that the translation of “semiliquido” retained the intended meaning of “half-liquid,” which was clearly shown based on the initial evidence presented.

In the petition, IBSA urged the U.S. Supreme Court to overturn the Federal Circuit ruling. It claimed that if the ruling is upheld, a precedent will be set to give foreign applications no weight in claim construction proceedings because of the commonality of these types of differences when it comes to translations. Thus, it would flatly contravene the requirement that a foreign application be treated equally as a domestic one.

However, the U.S. Supreme Court denied IBSA’s petition. While it did not give any reasoning behind its decision, it turned down the request to examine a court’s obligations under the TRIPS Agreement.

Key Takeaways for Patent Holders

It is clear from this dispute that obtaining high-quality patent translations is a must. A small error in translation caused not only the invalidation of IBSA’s patent but also cost them their battle in court against a would-be generic competitor. All because of a failure to distinguish between two very similar prefixes.

It must also be noted that the case might have turned out very differently for IBSA had it not filed an application translated into English directly. Rather, it could have filed its application at the United States Patent and Trademark Office (USPTO) in its original Italian, later followed by a translation. This would allow the easy correction of translation errors.

While mistakes such as this may seem minor, cases like this demonstrate how they can have devastating effects in pharma patent disputes. Patent holders must always study and review their intellectual property rights and the laws which protect their commercial products.

In bringing a lawsuit, potential litigants must always check that their patents are in order to ensure nothing is missing in the patent or its history that could be a cause for concern. This is essential in cases where a patent was originally filed in a language other than English. Such analyses are important even when the patent is newly issued or when the product is first approved for market. This case is a reminder that details matter when it comes to patents.

Categories: Patents