Judge Andrews today granted a rare Rule 12(c) motion in an ANDA action, entering judgment against the plaintiffs on their inducement claim based on the pleadings alone.
The method claim at issue requires administering a drug "from about 3 hours to about 1 hour" before a colonoscopy.
The accused product's label includes instructions to administer the drug "start[ing] approximately 5 hours prior to [a] colonoscopy," and then to "drink at least three 8-ounce cups . . . of clear liquids . . . at least 2 hours before" the procedure.
Judge Andrews held that those allegations—even if true—cannot show inducement of infringement, even if in practice some amount of infringement would occur.
He rejected plaintiff's claim that discovery was necessary to determine how physicians and patients will interpret the instructions, because
There is no genuine dispute of material fact as to whether Defendants’ proposed ANDA product label recommends, encourages, or promotes an infringing use. It does not, and therefore Defendants’ label does not induce infringement of the ’110 patent.
Judge Andrews drew a clear line that the label controlled this ANDA inducement allegation, and refused to let a plaintiff escape the language of the label through fact discovery.
Ferring Pharmaceuticals Inc. et al v. Lupin Inc., No. 19-913-RGA (D. Del. June 22, 2020).
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