This is part of a series of articles discussing recent orders of interest issued in patent cases by the United States District Court for the District of Massachusetts.
In Radius Health, Inc. v. Orbicular Pharmaceutical Technologies Private Limited, Cipla Limited, and Cipla USA Inc., No. 24-cv-11770, Judge Stearns issued a claim construction order construing two claim terms from a patent directed to beta-Asp10 isomers of abaloparatide and pharmaceutical compositions containing these isomers.
First, the parties disputed whether “an isomer of abaloparatide” encompassed only a single isomer (urged by Defendants), as opposed to one or more isomers (urged by Plaintiff). The Court applied the general rule that the term “an” in a patent claim carries the meaning of “one or more” and noted that there was no clear intent by the patent applicant to limit “an” to only a single instance. Accordingly, the Court construed “an isomer of abaloparatide” to mean “one or more isomers of abaloparatide.”
The second disputed term was “formulated drug product.” Plaintiff proposed “a formulation in which an active pharmaceutical ingredient has been formulated in an aqueous vehicle suitable for drug delivery,” while Defendants argued it means “a formulation that may comprise one or more additional components beyond an active pharmaceutical ingredient.” The Court observed that the specification defines “formulated abaloparatide drug product” as “an abaloparatide formulation in which the abaloparatide [active pharmaceutical ingredient] has been formulated in an aqueous vehicle suitable for drug delivery,” and that a “formulated drug product” without the abaloparatide requirement logically follows the same definition. The Court further observed that other definitions within the specification confirmed this construction. Accordingly, the Court construed “formulated drug product” as “a formulation in which an active pharmaceutical ingredient has been formulated in an aqueous vehicle suitable for drug delivery.”
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