Be careful in translating foreign applications into English, particularly with respect to uncommon terms
| September 18, 2020
IBSA Institut Biochimique, S.A., Altergon, S.A., IBSA Pharma Inc. v. Teva Pharmaceuticals USA, Inc.
July 31, 2020
Prost (Chief Judge), Reyna, and Hughes. Opinion by Prost.
Summary
In a U.S. application claiming priority to an Italian application, the term “semiliquido” was translated as “half-liquid.” This term was found to be indefinite, in view of a lack of a clear meaning in the art, as well as the statements of the prosecution history and specification. Further, attempts to argue that the term “half-liquid” should be interpreted as “semi-liquid” failed due to inconsistencies with the specification.
Details
IBSA is the owner of U.S. Patent No. 7,723,390, which claims priority to an Italian application. Claim 1 of the ‘390 patent is as follows:
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.
Teva filed an ANDA with a Paragraph IV certification asserting that the patent is invalid. In particular, Teva asserted that claim 1 is invalid as being indefinite. Upon filing of the ANDA, IBSA filed suit against Teva.
The key issue in this case is the meaning of the term “half-liquid.” IBSA asserted that this term should mean “semi-liquid, i.e., having a thick consistency between solid and liquid.” Meanwhile, Teva argued that the term is either invalid, or should be interpreted as a “non-solid, non-paste, non-gel, non-slurry, non-gas substance.”
District Court
At the district court, all parties agreed that the intrinsic record does not define the term “half-liquid.” However, IBSA asserted that its construction is supported by intrinsic evidence, including the Italian priority application. The Italian priority application used the term “semiliquido” at all places where the ‘390 patent used the term “half-liquid.” In 2019, IBSA obtained a certified translation in which “semiliquido” was translated as “semi-liquid.” IBSA asserted that “semi-liquid” and “half-liquid” would be understood as synonyms.
However, the district court noted that there were other differences between the Italian priority application and the ‘390 patent specification, beyond the “semiliquido”/“half-liquid” difference. These differences included the “Field of Invention” and “Prior Art” sections. Because of these other differences, the district court concluded that the terminology in the U.S. specification reflected the Applicant’s intent, and that any difference was deliberate.
Furthermore, the district court noted that during prosecution, there was at one point a dependent claim using the term “semi-liquid” which was dependent on an independent claim using the term “half-liquid.” Even though the term “semi-liquid” was eventually deleted, this was interpreted as evidence that the terms are not synonymous.
Additionally, the specification cited to pharmaceutical references that used the term “semi-liquid.” According to the district court, this shows that the Applicant knew of the term “semi-liquid,” but chose to use the term “half-liquid” instead.
Finally, all extrinsic evidence was considered by the district court to be unpersuasive. The extrinsic evidence used the term “half-liquid” in a different context than the present application. As such, the district court concluded that the term “half-liquid” was “exceedingly unlikely” to be a term of art at the time of filing.
Next, the district court analyzed whether a skilled artisan would nevertheless be able to determine the meaning of the term “half-liquid.” First, the court noted that the claims do not clarify what qualifies as a half liquid, other than the fact that it is neither liquid nor solid. The district court concluded that one skilled in the art would only understand “half-liquid” to be something that is not a gel or paste. This conclusion was based on a passage in the specification that stated:
In particular, said soft capsule contains an inner phase consisting of a liquid, 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.
Additionally, during prosecution, the Applicant responded to an obviousness rejection by including the statement that the claimed invention “is not a macromolecular gel-lattice matrix” or a “high concentration slurry.” As such, the Applicant disclaimed these from the scope of “half-liquid.”
Finally, the district court commented on the expert testimony. IBSA’s expert had “difficulty articulating the boundaries of ‘half-liquid’” during his deposition. Meanwhile, Teva’s expert stated that “half-liquid is not a well-known term in the art.”
Based on the above, the district court concluded that one having ordinary skill in the art would find it impossible to know “whether they are dealing with a half-liquid within the meaning of the claim,” and concluded that the claims are invalid as being indefinite.
CAFC
The CAFC agreed with the district court on all points. First, the CAFC agreed that the claim language does not clarify the issue. Rather, the claim language only clarifies that “half-liquid” is not the same as liquid.
As to the specification, the CAFC agreed with the district court that the portion of the specification noted above clarifies that “half-liquid” cannot mean a gel or paste. Moreover, the CAFC cited another passage, which refers to “soft capsules (SEC) with liquid, half-liquid, paste-like or gel-like inner phase.” The CAFC concluded that the use of the word “or” in these passages shows that “half-liquid” is an alternative to the other members of the list, such as pastes and gels. Meanwhile, since gels and pastes have a thick consistency, IBSA’s proposed claim construction is in contradiction with these passages of the specification.
Additionally, the CAFC refuted IBSA’s argument that the specification includes passages that are at odds with the description of “half-liquid” as an alternative to pastes and gels. These passages include:
…an SEC capsule containing an inner phase consisting of a paste or gel comprising gelatin and thyroid hormones or pharmaceutically acceptable salts thereof…in a liquid or half liquid.
However, this argument conflates the inner phase and the vehicle within the inner phase, and does not explain why these are the same.
Additionally, the CAFC noted that the specification includes a list of examples of liquid or half-liquid vehicles, and a reference to a primer on making “semi-liquids.” However, even if some portions of the specification could support the position that “half-liquid” and “semi-liquid” are synonyms, the specification fails to describe the boundaries of “half-liquid.”
Next, the CAFC discussed the prosecution history. As in the district court, IBSA asserted that “half-liquid” means “semi-liquid.” This was because the term “half-liquid” was used in all places where “semiliquido” was used, and a certified translation showed that “semiliquido” is translated as “semi-liquid.”
The CAFC agreed the use of “half-liquid” was intentional, relying on not only the differences between the Italian application and the U.S. application noted by the district court, but others as well. In particular, claim 1 of the U.S. application differed from claim 1 of the Italian application, and incorporated an embodiment not found in the Italian application. Further, the Italian application does not use the term “gel” in the first passage noted above.
The CAFC also agreed with the district court that the temporary presence of a claim reciting “semi-liquid” dependent on a claim reciting “half-liquid” further demonstrates that these terms are not synonymous.
Finally, the CAFC reviewed the extrinsic evidence. The CAFC noted the IBSA’s expert’s inability to explain the boundaries of the term “half-liquid.” The CAFC also pointed out that only one dictionary of record had a definition including the term “half liquid,” and this was a non-scientific dictionary. This dictionary defined “semi-liquid” as “Half liquid; semifluid.” But, IBSA’s expert stated that “semifluid” and “half-liquid” are not necessarily the same.
Further, although other patents using the term “half-liquid” were cited, these patents used the term in a different context, and thus were not helpful to define the term in the context of the ‘390 patent. IBSA’s expert acknowledged the lack of any other literature such a textbook or a peer-reviewed journal using the term “half-liquid.” Additionally, IBSA’s expert stated that he was uncertain about whether his construction of “half-liquid” would exclude gels or slurries.
Based on the above, the CAFC concluded that the term “half-liquid” does not have a definite meaning. As such, the claim is invalid as failing to comply with §112.
Takeaways
-When translating a specification from a foreign language to English, it is preferable that the specifications are as close to identical as possible.
-If there are differences between a foreign language specification and the U.S. specification, these differences should ideally be limited to non-technical portions of the specification.
-If using a term that is not widely used, it is recommended to clearly define this term in the record. Failure to do so may result in the term being interpreted in an unintended manner, or worse, the term being considered indefinite.
-Where there are discrepancies between a foreign priority application and a US application, such differences may be interpreted as intentional.
