Takeda Pharms., U.S.A., Inc. v. West-Ward Pharm. Corp.

Case Name: Takeda Pharms., U.S.A., Inc. v. West-Ward Pharm. Corp., C.A. No. 14-1268-RGA-SRF, 2018 U.S. Dist. LEXIS 209127 (D. Del. Dec. 12, 2018) (Andrews, J.) 

Drug Product and Patent(s)-in-Suit: Colcrys® (colchicine tablets); U.S. Patents Nos. 7,694,647 (“the ’647 patent”), 7,981,938 (“the ’938 patent”), and 8,415,395 (“the ’395 patent”)

Nature of Case and Issue(s) Presented: Plaintiff Takeda manufactures and markets Colcrys, a colchicine tablet for the treatment of gout prophylaxis and acute gout flares. Defendant Hikma received FDA approval of its 505(b)(2) NDA for Mitigare® on September 26, 2014. Mitigare is a colchicine capsule indicated solely for prophylaxis of gout. Takeda sued Defendants and after defeating a motion for a preliminary injunction, Hikma launched Mitigare. Takeda amended its complaint to allege induced infringement of the asserted patents through post-launch marketing efforts for Mitigare.

The parties agreed on the following facts: that Defendants (i) negotiated both exclusive and non-exclusive contracts with insurance payers; (ii) hired a pharmaceutical marketing force to encourage prescribers to prescribe Mitigare; (iii) created promotional materials that directed readers to the American College of Rheumatology Guidelines (“the Guidelines”) for the treatment of gout; and (iv) provided samples of Mitigare directly to prescribers. Mitigare’s label also directed patients to consult their physician if they experienced an acute gout flare.

Defendants filed a motion for summary judgment in which they argued: (i) there was no support for Takeda’s allegation that Defendants’ marketing materials and insurance contracts induced infringement; and (ii) there was no evidence of any identified direct infringement tied to the allegation that a Mitigare sales representative encouraged infringement. Takeda argued that the evidence in the record was sufficient to raise a genuine issue for trial on the following allegations: (i) Defendants’ labeling, promotional materials, and sampling activities evidenced intent to induce infringement; (ii) Defendants induced infringement by negotiating exclusive agreements with payers; and (iii) Defendants induced infringement by engaging in off-label promotion. The court granted Defendants’ motion.

Why Defendants Prevailed: First, the court noted that the Federal Circuit had already held that the Mitigare label’s direction to consult a doctor if a patient experienced an acute gout flare did not induce infringement. Second, the court held that the reference to the Guidelines in Defendants’ promotional materials did not create an inference of intent to induce. The Guidelines contain directions for both the non-patented method of treating gout prophylaxis with colchicine and the patented method of treating acute gout flares. The promotional materials, however, referenced the sections of the Guidelines directed to the treatment of gout prophylaxis. The court held that “[i]ntent to induce cannot be inferred from a citation to instructions for the product’s legitimate use solely because the Guidelines also contain instructions for the patented method.” Finally, the court held that intent to induce could not be inferred from Defendants’ sampling activities. While Takeda offered some statements from doctors indicating that the samples might be used to treat acute gout flares, the court found that the statements only supported the inference that Defendants knew some doctors would provide samples for an infringing use. However, the court explained that “it is well established that mere knowledge of possible infringement by others does not amount to inducement.”

Next the court discussed Defendants’ exclusive-payer contracts. Plaintiff asserted that Defendants induced infringement by negotiating exclusive agreements for Mitigare with insurance payers with the intention to drive a complete conversion from Colcrys to Mitigare without regard to the indicated use. The court noted that the congressional intent behind authorizing ANDA and paper NDAs was to allow the possibility of marketing a generic drug for a non-patented use. Thus, the court concluded that mere sale of a drug with the knowledge that a third party may use it in an infringing manner cannot constitute inducement. The court then undertook an analysis to answer what it identified as the relevant questions: (i) whether negotiation of an exclusive contract with insurance providers were comparable to a lawful sale; (ii) whether there were sufficient evidence to support an inference that Defendants intended to induce infringement by negotiating the contracts; and (iii) whether there were sufficient evidence to support an inference that the insurance contracts actually induced doctors to prescribe Mitigare for the treatment of acute gout flares.

In answering those questions, the court found that negotiating an exclusive contract with a payer is comparable to a lawful sale of the product. The court noted that Takeda pointed to no evidence that in negotiating the contracts Defendants represented to payers that Mitigare should be used to treat acute gout flares. Second, the court held that because there was a substantial non-infringing use of Mitigare – gout prophylaxis – efforts to encourage sale of Mitigare through the negotiation of exclusive contracts with payers could not be converted to intent to induce. Finally, the court held that there was no evidence that the contracts actually induced infringement. The court found that Takeda presented no evidence that doctors consider insurance information in determining whether to prescribe a drug or a particular dosage form of a drug. Further, Takeda did not provide evidence that the incidence of infringing Mitigare prescriptions was higher under an exclusive plan versus a non-exclusive plan, nor did Takeda point to evidence that any doctor prescribed Mitigare instead of Colcrys because of an exclusive contract.

Finally, the court addressed Takeda’s allegations of off-label promotion. Takeda identified a single doctor who allegedly was induced to write an off-label prescription by a Mitigare sales representative. For the purposes of the motion, the court treated the doctor’s testimony as true. Defendants argued that there were no facts pointing to any direct infringement and that Takeda offered only a theoretical possibility that the doctor’s patients actually filled and administered the prescriptions. The court agreed with Defendants that such speculation did not create a genuine issue of material fact that direct infringement occurred.