BECAUSE THE PROPOSED LABEL OF THE ANDA PRODUCT DID NOT CONTEMPLATE THE CLAIMED TIMEFRAME IN THE ASSERTED PATENT FOR ADMINISTERING THE DRUG, THE COURT GRANTED DEFENDANT’S MOTION FOR JUDGMENT OF NON-INFRINGEMENT ON THE PLEADINGS.
Case Name: Ferring Pharms. Inc. v. Lupin Inc., No. 19-913-RGA, 2020 WL 3414750 (D. Del. June 22, 2020) (Andrews, J.)
Drug Product and Patent(s)-in-Suit: Clenpiq® (sodium picosulfate / magnesium oxide / anhydrous citric acid oral solution); U.S. Patents Nos. 9,827,231 (“the ’231 patent”) and 9,669,110 (“the ’110 patent”)
Nature of the Case and Issue(s) Presented: The ’231 patent claimed a composition of sodium picosulfate, magnesium oxide, citric acid, and malic acid and methods for making and using the composition. The ’110 patent claimed a method of timing a colonoscopy procedure. Specifically, the ’110 patent claimed “administering a picosulfate bowel composition to the patient; and performing the colonoscopy procedure from about 3 hours to about 1 hour after the administration of the picosulfate bowel composition.” The patents-in-suit covered Ferring’s Clenpiq product, which is indicated for cleansing the colon as a preparation for colonoscopy in adults. The labeling instructed that a first dose be administered during the evening before the colonoscopy and a second dose be administered the next day, during the morning prior to the colonoscopy. Lupin’s proposed label mirrored that of Ferring’s, as is required by law.
Ferring sued Lupin for patent infringement, but only the ’110 patent was at issue in Lupin’s motion for judgment on the pleadings. Ferring alleged that physicians and patients who used Lupin’s ANDA product in accordance with its label would directly infringe the claims of the ’110 patent by “performing the colonoscopy from about 3 hours to about 1 hour after administration of the picosulfate bowel composition.” Lupin argued that Ferring’s complaint failed to state a claim for induced infringement because Lupin’s ANDA label did not encourage, recommend to, or promote to anyone performance of the claimed use of the ’110 patent. The court granted Lupin’s motion.
Why Lupin Prevailed: Lupin argued that nothing in its proposed label encouraged the administration of the picosulfate solution about 1 to 3 hours before the colonoscopy begins, as required by the ’110 patent. Moreover, the full prescribing instructions directed the second dose to be started “approximately 5 hours prior to colonoscopy.” Ferring principally relied on the legal posture of a Rule 12 motion because it alleged “facts in the Complaint that, when accepted as true and viewed in a light most favorable to [Plaintiffs], plausibly demonstrate that [Defendants] will induce infringement of the ’110 patent.” Specifically, Ferring relied on the part of Lupin’s label that instructed doctors and patients to take the second dose the “next day, during the morning prior to the colonoscopy.” Because Ferring and Lupin had different interpretations of the label’s instructions, Ferring argued that discovery was necessary to determine how a doctor would prescribe the ANDA product. The court disagreed: “I do not see why discovery is necessary to determine whether Defendants’ proposed ANDA label encourages, recommends, or promotes an infringing use. The label does not do so.”
On its face, the label did not instruct the second dose of drug to be administered less than 3 hours and more than 1 hour before the colonoscopy procedure. All that was said was that the second dose should be taken the “next day, during the morning of the colonoscopy.” This instruction did not contemplate the infringing timeframe. To the extent that a timeframe was referenced, the full prescribing instructions instructed that the second dose should be taken starting approximately five hours before the colonoscopy. “The mere fact that the label may permit an infringing use is insufficient to show inducement, regardless of whether that fact is alleged in the complaint or stated later by an expert.” Additionally, the court found that Ferring did not allege any facts to support the conclusion that the label encouraged, recommended, or promoted the infringement of the ’110 patent.