Filing an ANDA is not Infringement, Unless the Specified Use is Claimed in the Patent

In H. Lundbeck A/S v. Lupin Ltd., [2022-1194, 2022-1208, 2022-1246] (December 7, 2023), the Federal Circuit affirmed the judgment of non-infringement of U.S. Patent Nos.

9,278,096 and 9,125,910, and the determination that Lupin infringed claim 12 of U.S. Patent No. 9,101,626.

The Federal Circuit agreed with the district court that filing an ANDA is not infringement, unless the specified use is claimed in the patent.  The defendants solely seek approval to market the drug for the treatment of MDD pursuant to the methods of expiring patents—that is the “purpose” of the ANDA submissions. Thus, the patented uses are not those for which ANDA approval is sought. The Federal Circuit found that Plaintiffs have failed to establish that section 271(e)(2)(A) provides an independent basis of infringement.

The Federal Circuit also rejected the argument that the ANDA induced infringement, noting that the label in question is not a label that induces infringement of the ’096 patent. It was the label FDA required for the sale of the drug to treat MDD—a label that the patentee itself proposed for that purpose in connection with its NDA for treating MDD and that preexisted the issuance of the ’096 patent.  It cannot be, as plaintiffs suggest, that a patentee can bar the sale of a drug for a use covered only by patents that will have expired simply by securing a new patent for an additional, narrower use.

On its cross appeal, argued that the district court erred in construing “reacting” in the ’626 patent to mean “the changing of a reactant(s) to product(s)” and in finding infringement under that construction. The Federal Circuit disagreed.  Lupin contended that “reacting” meant “the specified chemicals are added to the reaction vessel at the beginning of the process as starting material,” and Lupin’s process does not use one of the compounds as a starting material.  The Federal Circuit said that it was true that the specification only refers to using the compound as starting materials, but nothing in the claims, specification, or file history requires Lupin’s narrower reading.

The Federal Circuit noted that the district court’s definition was consistent with the dictionary definition, that the prosecution did not support Lupin’s definition, nor did Lupin’s arguments about claim differentiation.  Based upon what the Federal Circuit found was the correct definition of reacting, the Federal Circuit affirmed the finding of infringement.