From The Field

September 8, 2020

One of the fundamental requirements for a patent is that the claims must particularly point out and distinctly define the metes and bounds of the subject matter to be protected.  This is also known as the “definiteness” requirement of 35 U.S.C. §112.   If this requirement is not  met, the claim is considered indefinite and therefore invalid.  In IBSA Institut BioChimique, S.A., Altergon, S.A., IBSA Pharma Inc., v. Teva Pharmaceuticals USA, Inc., Slip Op. 2019-2400 (Fed. Cir. July 31, 2020), a certified translation of a foreign priority application could not save claims in a US counterpart patent from indefiniteness.   

The patent (7,723,390) in IBSA claims pharmaceutical formulations based on thyroid hormones for the treatment of thyroid disorders.  The ’390 patent claims priority to an Italian Patent Application, which is written in Italian.  The central issue in IBSA was the dispute over the claim construction of the term “half-liquid” from claim 1.  “Half liquid” appears twice in the following phrase from claim 1:  

a soft elastic capsule consisting of a shell of gelatin material containing a liquid or half-liquid inner phase comprising said thyroid hormones … said liquid or half-liquid inner phase being in direct contact with said shell without any interposed layers.

IBSA proposed that the term “half-liquid” be construed to mean “semi-liquid, i.e., having a thick consistency between solid and liquid.”  Among other things, IBSA relied on a pre-litigation certified translation of the Italian priority application and argued that a person of ordinary skill in the art (POSA) would equate the Italian word “semiliquido” with “half-liquid.”  Teva argued that the term “half-liquid” is indefinite or should be construed as “a non-solid, non-paste, non-gel, non-slurry, non-gas substance.”  The district court held claim 1 and several claims depending from claim 1 invalid as indefinite.  IBSA appealed.

In affirming the district court’s holding of invalidity, the Federal Circuit examined the claim language itself, the specification, the prosecution history, and the extrinsic evidence.  For the claim itself, the Federal Circuit found that the claim language clarifies only that a “half-liquid” differs from a liquid, because the term “half-liquid” is merely used alongside “liquid” to describe the inner phase of a soft elastic capsule.

Next, the Federal Circuit turned to the specification.  One relevant part of the specification states that “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 relevant passage of the specification refers to “[s]oft capsules (SEC) with liquid, half-liquid, paste-like or gel-like inner phase.”  

The Federal Circuit agreed with the district court that these parts of the specification provide disjunctive lists, which indicate that a “half-liquid” is an alternative to the other members of the lists.  In other words, a POSA reading the specification would understand that a “half-liquid” is not, or at least is not necessarily, a paste or a gel.  But a paste or a gel would be “a thick consistency between solid and liquid,” which is the construction proposed by IBSA.  Therefore, the specification is at odds with IBSA’s proposed construction and creates uncertainty as to the boundaries of a “half-liquid.”

The Federal Circuit then analyzed the prosecution history and IBSA’s certified translation of the Italian priority application.  IBSA relied on this translation to argue that “half-liquid” is a synonym of “semi-liquid.”  The Federal Circuit disagreed with IBSA’s argument, primarily because there were several differences between the U.S. ’390 patent and the Italian application. 

For example, unlike the ‘390 patent specification, the certified translation of the Italian application omitted the term “gel” from the list “of a liquid, a semi-liquid, a paste, an emulsion or a suspension.”  In addition, claim 1 of the ’390 patent was based on an embodiment that was not even found in the Italian application.  Moreover, during the prosecution of the application for the ’390 patent, the applicant had a pending claim using the term “half-liquid,” while another claim used the term “semi-liquid.”  Based on all these discrepancies, the Federal Circuit concluded that the use of “half-liquid” in the ’390 patent and “semiliquido” in the Italian application were intended to be different, and that the applicant elected to use “half-liquid” to mean something other than “semi-liquid.”   

After concluding that the intrinsic evidence failed to establish the boundaries of a “half-liquid,” the Federal Circuit turned to the extrinsic evidence and held that it too did not supply a definite meaning for the term.  Only one of the non-scientific dictionaries to which IBSA pointed included the term “half-liquid” in its definition of “semi-liquid.”  And even IBSA’s expert was uncertain about this definition when he stated that “semi-liquid” and “half-liquid” are not necessarily synonymous.  

In addition, the four patents cited by IBSA use the term “half-liquid” in a different context than that of the ’390 patent, and they therefore did not help define the term “half-liquid.”  Finally, even IBSA’s own expert could not answer the question how someone could determine whether he or she made a soft-capsule inner phase that was not a “half-liquid.”  This demonstrated the difficulty a POSA would face in ascertaining the boundaries of the claim term.  As such, the extrinsic evidence failed to save the claim term “half-liquid” from indefiniteness.

The IBSA decision reflects the importance of defining and using claim terms consistently throughout prosecution.  A patent practitioner should, with or without the inventor’s help, determine whether a claim term is well-known in the art.  If not, the term should be clearly defined to clarify the boundaries of the claim.  The IBSA decision further illustrates that while including a term in a list containing other terms could define what the term is not, it may not suffice to define what the term is.  

More importantly, if a term is not used consistently throughout the specification and prosecution history, even a certified translation of a foreign priority application may not save the claims from indefiniteness.  Depending on the overall circumstances, a court might find the inconsistency to have been intended.  As such, the court might give no weight to the translation.  

Finally, a small extra investment in having U.S. counsel review the translated specification before filing can go far to help ensure the patent has appropriate scope. 

Author: Ray Huang