United States District Court, D. Delaware
SUE L. ROBINSON, District Judge.
At Wilmington this 9th day of October, 2014, having conferred with counsel and having reviewed the papers filed in connection with plaintiff's motion for a temporary restraining order ("TRO");
IT IS ORDERED that said motion (D.I. 5) is granted, for the reasons that follow:
1. Background. Plaintiff Takeda Pharmaceuticals U.S.A., Inc. ("Takeda") has requested a TRO to preserve the status quo while the parties more fully brief (and the court considers) Takeda's motion for a preliminary injunction. Takeda is the owner of the asserted patents,  all of which cover methods of administering colchicine products for the treatment of acute gout flares, as well as for concomitant administration of colchicine with other drugs for prophylaxis (prevention) of gout flares. Defendants West-Ward Pharmaceutical Corporation, Hikma Americas Inc., and Hikma Pharmaceuticals PLC (collectively referred to as "Hikma") have launched a branded product, MitigareTM, an oral single-ingredient colchicine product, "indicated for prophylaxis of goutflares in adults" (D.I. 1, ex. H at 1). and intends to launch a generic version of such as early as Friday, October 10, 2014 at a price significantly below that of Takeda's pricing structure. Although MitigareTM has the same active ingredient, route of administration, and strength as Takeda's colchicine product (Colcrys®), Hikma did not file its application with the FDA as an ANDA. Moreover, in its proposed label, Hikma has omitted specific mention of uses for which Takeda has patent protection.
2. Standard of review. "The decision to grant or deny... injunctive relief is an act of equitable discretion by the district court." eBay, Inc. v. MercExchange, LLC, 547 U.S. 388, 391 (2006). The grant of such relief is considered an "extraordinary remedy" that should be granted only in "limited circumstances." See Kos Pharma, Inc. v. Andrx Corp., 369 F.3d 700, 708 (3d Cir. 2004) (citation omitted). A party seeking preliminary injunction relief must demonstrate: (1) a reasonable likelihood of success on the merits; (2) the prospect of irreparable harm in the absence of an injunction; (3) that this harm would exceed harm to the opposing party; and (4) the public interest favors such relief. See, e.g., Scie/e Pharma Inc. v. Lupin Ltd., 684 F.3d 1253, 1259 (Fed. Cir. 2011); Antares Pharma, Inc. v. Medac Pharma, Inc., Civ. No. 14-270, 2014 WL 3374614, at *2 (D. Del. July 10, 2014). A request for a TROis governed by the same general standards that govern the issuance of a preliminary injunction. In re Cyclobenzaprine, 2011 WL 1980610, at *1 (D. Del. May 20, 2011).
3. Analysis. I start with the recognition that this dispute did not proceed through the statutory regime established to vet patent infringement issues before drugs enter the stream of commerce. This is so because defendants did not note the asserted patents as having any relevance to their product MitigareTM. Because the infringement analysis need not reflect the artificial construct of ANDA litigation,  I in turn am not confined to the principle that "section 271(e)(2)(A) lies only against a patented use that has been approved by the FDA." Bayer Schering Parma AG v. Lupin, Ltd., 676 F.3d 1316, 1319 (Fed. Cir. 2012). To put the point differently, I can consider the record in light of the realities of the marketplace in which the parties compete.
4. In this regard, as I have noted before, "off-label prescribing -the prescription of a medication in a manner different from that approved by the FDA - is legal and common." Stafford, "Regulating Off-Label Drug Use- Rethinking the Role of the FDA, " The New England Journal of Medicine (April 3, 2008) ("Stafford") at 1427. See generally Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 350-351 and n.5 (2001). Indeed, it has been suggested that the FDA itself has a "permissive attitude toward the promotion of off-label uses of drugs." See Stafford at 1428. Therefore, the fact that the Mitigare TM label does not instruct users to perform the patented method is not dispositive. And, indeed, the label does contain relevant information regarding use of Mitigare TM with other drugs:
Co-administration of P-gp or CYP3A4 inhibitors or inhibitors of both P-gp and CYP3A4 (e.g., clarithromycin or cyclosporine) have been reported to lead to colchicine toxicity. The potential for drug-drug interactions must be considered prior to and during therapy.
Concomitant use of MITIGARE and inhibitors of CYP3A4 or P-gp should be avoided if possible. If co-administration of MITIGARE and an inhibitor of CYP3A4 or P-gp is necessary, the dose of MITIGARETM should be reduced and the patient should be monitored carefully for colchicine toxicity.
(D.I. 1, ex. H at 1)
5. To prove infringement, the patentee must show that the accused method meets every claim limitation either literally or under the doctrine of equivalents. Pfizer, Inc. v. Teva Pharms., USA, Inc., 429 F.3d 1364, 1376 (Fed. Cir. 2005). To establish inducement, the patentee must show "direct infringement, and that the alleged infringer 'knowingly induced infringement and possessed specific intent to encourage another's infringement."' i4i Ltd. P'ship v. Microsoft Corp., 598 F.3d 831, 851 (Fed. Cir. 2010).
6. Having reviewed the record, including the claim charts prepared by Takeda (D.I. 9, exs. M, 0, and P), I conclude that Takeda has carried its burden to prove a likelihood of success on the merits with respect to direct and induced infringement. More specifically, prescribing and filling prescriptions (by doctors and pharmacists) and use (by patients) of MitigareTM for prophylaxis of gout flares will directly infringe representative claims of the '655, '648, and '722 patents. Based on the listing of these patents in the FDA's Orange Book, the parties' previous litigation history related to other colchicine patents,  and Hikma's instructions in the product labeling for Mitigare TM, I conclude that Hikma knew about the patents and that the prescription or use of MitigareTM infringes those patents. See AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1060 (Fed. Cir. 2010) (a finding of specific intent is justified when the language of the accused infringer's product labeling "would inevitably lead some customers to practice the claimed method.").
7. With respect to the '938 and '647 patents, the pharmacological properties of Takeda's branded drug Colcrys® and Mitigare TM are identical. (D.I. 7, ¶12) Although MitigareTM is approved for a more limited use than is Colcrys® - the latter is approved for treatment and prophylaxis of gout flares, while the former is approved only for prophylaxis- the record indicates that it is likely that some patients may use the same medication they use for prophylaxis to treat an acute gout flare when it occurs, because the dosing is similar (administration of "0.6 mg (one capsule) once or twice daily"). (D.I. 1, ex. H at 1; see D.I. 7, ¶ ¶[10-14) Consistent with the claim chart provided by Takeda (D.I. 9, ex. S), I conclude that Takeda has carried its burden of proof to demonstrate direct infringement. Furthermore, by providing patients using colchicine for prophylaxis of gout flares with the same 0.6 mg colchicine that is used to treat acute gout flares, with knowledge of the patents and the dosing recommendations specified by the FDA in the Orange Book, there is sufficient evidence of a specific intent on Hikma's part to induce infringement. By selling Mitigare TM, Hikma is providing a 0.6 mg colchicine product to gout patients who will likely need to treat acute gout attacks and can readily do so by taking Mitigare rM consistent with the use of colchicine as recommended by the FDA and disclosed by the '983 and '647 patents. Indeed, the limited market for Mitigare TM's approved use - prophylaxis only -further demonstrates a specific intent to induce infringement, as the vast majority of gout patients using colchicine for prophylaxis also suffer acute gout flares. (D. I. 7, ¶ 13)
8. I also conclude that Takeda has carried its burden to demonstrate the remaining prerequisites for preliminary relief. There is sufficient record evidence to demonstrate that the generic launch will significantly impact Takeda's market share of colchicine products, as well as impair goodwill, pricing, and research and development efforts. (D.I. 8) Further, it is my impression that Hikma has effectively side-stepped the ANDA regime in an effort to get its generic product to market without appropriate legal ...