Teva wins appeal over thyroid drug at Fed Circuit

In a victory for  Teva Pharmaceuticals, the  US Court of Appeals for the Federal Circuit dismissed  IBSA Institut Biochimique’s appeal against a ruling that held parts of its patent invalid.

The ruling, handed down on July 31, affirmed an earlier decision by the US district court for the state of Delaware. The dispute began when Teva sought to market a generic version of Tirosint, a thyroid medication in a gel cap, and filed an abbreviated new drug application. IBSA, which owns the patent for the drug, number 7,723,390, sued Teva for infringement in November 2019.

The district court ruled in Teva’s favour after finding parts of the patent used an indefinite term to express the meaning of “semi-liquid”.  IBSA had pointed out that its Italian patent application for the medicine has used the term semiliquido in the same places where the ’390 patent used “half-liquid,” and that a certified translation of the Italian application prepared for IBSA in 2019 used “semi-liquid.”

IBSA argued that there was a link between these terms and that a person of ordinary skill in the art would understand “half-liquid” and “semi-liquid” to be synonyms. But the district court found a number of differences between the certified translation and the ’390 patent’s specification, besides the use of “half-liquid.”  On appeal, IBSA argued that “half-liquid” should be perceived as  “semi-liquid, or as having a thick consistency between solid and 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 Federal Circuit found that language listing “half-liquid” separately from gels and pastes indicated that a “half-liquid” is not necessarily a gel or paste. It also held that the term ‘half-liquid’ would not be recognisable as a term of art, as IBSA was unable to source any scientific dictionaries containing the term.

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