Colchicine - USA

On Dec 12, 2018, U.S. District Court of Delaware granted summary judgment of non-infringement & recovery of damages on bond to Hikma / West-Ward pharmaceuticals.

Background:

Plaintiff Takeda Pharmaceuticals manufactures and markets Colcrys®, a branded 0.6 mg colchicine tablet used for the treatment of gout prophylaxis and acute gout flares. Plaintiffs owned several patents directed to a method of treating acute gout flares with colchicine by administering 1.2 mg oral colchicine at the onset of an acute flare, followed by 0.6 mg oral colchicine one hour later  (U.S. Patent Nos. 7,964,647;  7,981,938; 8,415,39). Defendants Hikma / West-ward received FDA approval of a paper New Drug Application ("paper NDA") for Mitigare® on September 26, 2014. Mitigare is a 0.6 mg colchicihe capsule indicated solely for the prophylaxis of gout. Shortly thereafter, on October 3, 2014, Plaintiff filed suit against Defendants. After the Federal Circuit affirmed the denial of a preliminary injunction on January 9, 2015 Defendants launched Mitigare and its authorized generic (Mitigare AG). The Court then granted Plaintiffs Motion to Alter Judgment of Dismissal and for Leave to amend its Complaint on December 15, 2016. Plaintiffs Second Amended Complaint alleges Defendants induced infringement of the Acute Gout Flare Patents through post-launch marketing efforts for Mitigare. Defendants filed a motion for summary judgment on May 4, 2018.

Defendants asserted that summary judgment should be granted because (1) there is no support for Plaintiffs allegations that Defendants' marketing materials and insurance contracts induced infringement, and (2) there is no evidence of any identified direct infringement tied to the allegation that a Mitigare sales representative encouraged infringement. Plaintiff responded that evidence in the record gives rise to a genuine issue for trial on the following allegations: (1) Defendants' promotional materials, labeling of Mitigare, and sampling activities evidence Defendants' intent to induce infringement; (2) Defendants induced infringement by negotiating exclusive agreements with payers; and (3) Defendants induced infringement by engaging in off-label promotion.

A. Promotional Activities:

Plaintiff alleged that Mitigare's labeling, promotional materials, and samples show that Defendants intended to induce infringement. The Court disagreed & said that the Federal Circuit has already determined that the Mitigare and Mitigare AG label language directing patients to consult their doctor if they suffer an acute gout flare does not induce infringement. Takeda, 785 F.3d at 632-33. Second, Defendants' promotional materials do not create an inference that Defendants intended to induce infringement. Defendants' promotional materials generally reference the specific sections of the Guidelines related to Mitigare's indicated non-patented use-the treatment of gout prophylaxis. Finally, intent to induce cannot be inferred from Defendants' sampling activities. Plaintiff pointed to a few statements from physicians consulted in third-party market research as evidence of Defendants' intent to induce infringement through providing samples. Court said that however, these statements support only the inference that Defendants knew that some doctors would provide samples of Mitigare to their patients for an infringing use. Other quotations of physicians were provided in this research which indicated that samples would likely be used for gout prophylaxis. Defendants' distribution of samples of a product with a substantial non-infringing use is not any different from the lawful sale of that same product. The mere knowledge that the third-party recipient may engage in infringing use upon receipt of the product therefore cannot create an inference of intent to induce.

B. Exclusive Payer Contracts:

Plaintiff next asserted that Defendants induced infringement by (1) offering insurance payers substantial financial incentives in the forms of rebates to enter exclusive agreements for Mitigare/Mitigare AG with (2) the intention to drive a complete conversion from Colcrys/Colcrys AG to Mitigare/Mitigare AG (3) without regard to the indicated use of prescriptions. Plaintiff alleged that a complete conversion of the market from Colcrys/Colcyrs AG to Mitigare/Mitigare AG through the "blocks" and "step edits" included in these contracts would necessarily cause infringement of the Acute Gout Flare Patents. Court found that it is clear that negotiating an exclusive contract with an insurance payer is comparable to a lawful sale of the product. As with lawful sales of a product with substantial non-infringing use, the knowledge that an exclusive payer contract may result in infringing use cannot support an inference of intent to induce by itself. Second, Plaintiff has not provided sufficient evidence to create a reasonable inference that Defendants intended to induce infringement. Defendants' Mitigare has a substantial non-infringing use-gout prophylaxis. Therefore, efforts to encourage the sale of Mitigare cannot be converted into an attempt to induce infringing behavior without more evidence. Third, even if there was sufficient evidence to create a genuine issue of Defendants' intent to induce for trial, there is no evidence that the contracts have actually induced infringement.

C. Off-Label Promotion:

Plaintiff finally asserted that Defendants induced infringement by engaging in off-label promotion. Plaintiff identified a single doctor, Dr. Elmahdi Saeed, who it alleges was induced to write infringing prescriptions by a Mitigare sales representative. Dr. Saeed stated that he prescribed Mitigare off-label for acute gout flares about 4-6 times because of the sales representative's statements. However, the parties have not discovered any record of a Mitigare prescription written by Dr. Saeed for the treatment of acute gout flares. Court further said that proving of induced infringement would require that a patient (1) actually filled the prescription, (2) actually had a gout flare, and (3) actually took the prescribed Mitigare according to the very particular method of treatment. Given the lack of any evidence beyond Dr. Saeed's statements, there is insufficient evidence to infer that at least one of Dr. Saeed's patients used Mitigare/Mitigare AG in an infringing manner due to the statements of the sales representative.

Thus, court granted summary judgement of non-infringement to defendants.

Court also simultaneously granted defendants motion for recovery of damages on bond because of improper temporary restraining order (TRO) imposed on defendants. In conclusion court granted defendants' motion to recover damages for wrongful restraint in the amount of $31,407,800 in lost profits and $463,272.09 in prejudgment interest.