CLENPIQ® - USA

On Jun. 22, 2020 Delaware Court granted Defendants’ Motion for Judgment on the Pleadings & did not find induced infringement of method of administration claims.

Civil Action No.   : 19-913

Plaintiffs               : Ferring Pharmaceuticals Inc. et al

Defendants          : Lupin Inc. et al

Before the Court is Defendants’ Motion for Judgment on the Pleadings pursuant to Federal Rule of Civil Procedure 12(c) for failure to state a claim upon which relief may be granted.

Background:

Plaintiffs filed this action on May 16, 2019, alleging infringement of U.S. Patent Nos. 9,827,23 and 9,669,110. The instant action is in response to Defendants filing an ANDA seeking FDA approval for a generic of Plaintiffs’ product, CLENPIQ® (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution. The ’231 patent claims a composition of sodium picosulfate, magnesium oxide, citric acid, and malic acid and methods for making and using the composition. The ’110 patent claims a method of timing a colonoscopy procedure. Only the ’110 patent is at issue in Defendants’ motion for judgment on the pleadings.

Claim 1 of the ’110 patent recites:

1. A method of timing a colonoscopy procedure performed on a patient in need thereof, comprising: 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.

CLENPIQ® is indicated “for cleansing of the colon as a preparation for colonoscopy in adults.” The CLENPIQ® label describes a “Split-Dose Dosage Regimen,” which instructs:

First dose: administer during evening before the colonoscopy.

Second dose: administer the next day, during the morning prior to the colonoscopy.

The full prescribing information for the Split-Dose method for “second dose” reads:

Dose 2 – Next morning on the day of colonoscopy (start approximately 5 hours prior to colonoscopy):

• Continue to consume only clear liquids (no solid food or dairy).

• Take the second dose (the second bottle) of Sodium Picosulfate, Magnesium Oxide, and Anhydrous Citric Acid Oral Solution.

• Following the Sodium Picosulfate, Magnesium Oxide, and Anhydrous Citric Acid Oral Solution dose, drink at least three 8-ounce cups (cup provided) of clear liquids (24 ounces) at least 2 hours before the colonoscopy.

Court’ analysis:

Plaintiffs alleged that physicians and patients who use Defendants’ ANDA product in accordance with its label will 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.” Thus, Plaintiffs claim that Defendants will indirectly infringe the ’110 patent under 35 U.S.C. § 271(b) by inducing physicians who prescribe picosulfate solution, or patients who take it, to directly infringe. Defendants argued that Plaintiffs’ “complaint fails to state a claim [for induced infringement] because [Defendants’] ANDA label does not encourage, recommend, or promote anyone to perform the claimed use” of the ’110 patent. Regarding Dose 2, Defendants argued that because the label instructs physicians and patients to see the full prescribing instructions, and the full prescribing instructions direct that the 5.41-fluid ounce dose should be started “approximately 5 hours prior to colonoscopy,” the label therefore does not “encourage, recommend, or promote” that Dose 2 be taken less than 3 hours before the colonoscopy. Defendants continue that, even if “a patient could still be drinking the 5.41-fluid ounce dose within three hours of the colonoscopy” because the label is interpreted to “describe” or “permit” this use, the label does still not rise to the level of inducement because it is not encouraging, recommending, or promoting such use. Defendants claim that Plaintiffs cannot “create a material issue of fact” by asserting that it is possible for doctors and patients to infringe without showing that the label promotes or encourages that possible infringement.

Court agreed with Defendants & said that on its face, the label does not instruct that the Dose 2 picosulfate solution be administered less than 3 hours and more than 1 hour before the colonoscopy procedure. The label states that Dose 2 should be taken the “next day, during the morning of the colonoscopy.” It is a broad guideline for safe and effective timing of the second dose. The final step of the Split-Dose Regimen instructs that the patient should drink at least 24 ounces of clear liquid following the picosulfate solution but “at least 2 hours before the colonoscopy.” Logically, the instruction for the final step would require consumption of the picosulfate solution more than 2 hours before the colonoscopy. That instruction therefore cannot be interpreted as encouraging, recommending, or promoting consumption of the picosulfate solution less than 3 hours before the colonoscopy. The only reasonable reading of the full prescribing instructions is that they say to take the picosulfate solution no more than 5 hours before the colonoscopy and to finish it no later than 2 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. See HZNP Medicines, 940 F.3d at 702. Thus, Defendants’ label cannot be the basis for a finding of any affirmative action or intent to induce infringement. Therefore Defendants’ label does not induce infringement of the ’110 patent.