It does not happen too often that a patent is declared invalid by the CAFC due to a translation mistake, but this is what happened in IBSA Institut Biochemique, S.A. v. Teva Pharmaceuticals USA, Inc. Quite a bit has been written about this decision already (for example here and here and here), so I will concentrate on some translation-related aspects of this case.
IBSA’s patent (U.S. Pat. 7,723,390) concerned a pharmaceutical composition in form of a pill. The relevant portion of claim 1 reads as follows:
- 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 …, said liquid or half-liquid inner phase being in direct contact with said shell without any interposed layers, or …
The patentee, IBSA, argued that the term “half-liquid” is a synonym for “semi-liquid” and should be understood as such, whereas Teva argued that the term “half-liquid” is indefinite and the patent thus invalid. The District Court had held the term “half-liquid” to be unclear and this decision was upheld by the CAFC. This might be a bit surprising to some, because it seems to be quite obvious what using this term was supposed to accomplish: Capsule-type pills are often filled with liquids, but sometimes the pay-load of the pill is not entirely liquid, but has a thicker texture, like a slurry, paste or gel, and it is quite apparent that the term “half-liquid” is supposed to cover the ground that is not covered by “liquid” alone.
Well, it wasn’t apparent to the CAFC, which noted that the correct technical term for this concept is “semi-liquid”. Indeed, the patent claimed priority to an Italian application, which used the term “semiliquido” in those instances where the English translation said “half-liquid” and it appears that the patent might still be alive, had the translator opted for the (correct?) term “semi-liquid” instead of “half-liquid”. However, the CAFC decided to look a bit further than just the claims and first looked at the description, which contains the following passage: “In 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.” Another passage discloses: “Soft capsules (SEC) with liquid, half-liquid, paste-like or gel-like inner phase…” The CAFC regarded these as disjunctive lists specifying that a half-liquid is not a paste or a gel. Which raises the question whether it might have made difference if the translator had chosen “and/or” instead of “or”. This might have implications on how to best translate conjunctions like や in lists. The CAFC further found that this interpretation (i.e. half-liquid being different from paste- or gel-like) is at odds with the patentee’s assertion that half-liquids also encompass gels and pastes, thus making the claim unclear.
Furthermore, the CAFC noted that during prosecution the patentee had introduced a claim (later deleted) using the term “semi-liquid” that was dependent upon a claim using the term “half-liquid”. The CAFC took this as a further indication that the two terms refer to different concepts.
So what can patent translators learn from this case? Unfortunately not very much, I’m afraid, apart from better getting the terminology right, in particular in the claims. And yet this decision is frightening for translators; I’m sure that there are quite a few who have thought “That could have been me!” and checked whether they have used the term “half-liquid” in their past translations. Half-liquid, semi-liquid — it seems a bit ludicrous that one is supposed to be readily understood and the other one isn’t.
If there is one lesson for patent translators in this, it is that all terms exist in a context. Thus, case summaries that state that the CAFC or USC has decided that a term “means this”, are mostly rubbish. Courts decide on the meaning of terminology in a given context. Therefore, it cannot even be concluded from the present case that the term “half-liquid” is intrinsically unclear and should be avoided at all costs. Had it been properly defined in the description, it would have been just fine.
No, I think the true lesson in this case is for patent drafters: Define your terminology! Especially the terminology that is used in the claims. The case would likely have been decided differently if there had been a proper explanation of the term “semiliquido” in the original Italian priority application. Maybe the drafting patent attorney did not think of defining the term because it is a well-defined term in the art. But as we can see from this case, a well-defined term in one language can morph into something not well-defined and ambiguous when it is translated into another language. That is especially true for translations between languages of different language families like Japanese and English. Now, there is a school of patent drafting that argues against giving definitions, because such definitions can be held to be limiting in litigation, but I think that this argument is utter nonsense. It is up to the patent drafter to provide proper definitions. In the present case it would have been almost trivial to define the term in question as something encompassing gels, pastes and emulsions, giving the patentee exactly what he wanted. While it may be true that some patents wind up to be construed narrowly because of an unfortunate defintion, I believe that many more cases are not even granted and die at the hands of a confused examiner because of their lack of definitions. Of course, a lack of proper definitions is a problem that is not easily solved by the patent translator, and the best a patent translator can do (without editing and redrafting) is suggesting to the client that it might be better to include a definition for certain terms. In fact, that’s what a patent translator should do if they anticipate clarity problems with claim terminology.
One more comment: This case would have gone down entirely differently in Europe, where clarity or indefiniteness is no grounds for invalidation. If a claim contains unclear terminology, an infringement court (e.g. in Germany) would be forced to interpret the meaning. In the present case, I have no doubt that the court would have arrived at the conclusion that the term is synonymouns with “semi-liquid”. After all, what else could it possibly mean in the given context? No, here, a patent was declared invalid because the translator chose to translate the term “semiliquido” as “half-liquid” instead of “semi-liquid”. How is that an equitable decision?
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