Did Hatch-Waxman Act Really Worked? Takeda Pharmaceuticals USA, Inc. v. West-Ward Pharmaceutical Corp (Hikma Americas Inc)

Before NEWMAN, DYK, and HUGHES, Circuit Judges; Takeda (Plaintiff-Appellant) vs West-Ward (Defendants-Cross-Appellants).

Now its Federal Circuit, which denied Takeda’s motion for preliminary injunction against Hikma pharmaceuticals for launching Mitigare, a colchicine product for prophylactic treatment of gout. Wherein Takeda sought to enjoin West–Ward Pharmaceutical Corporation, Hikma Americas Inc., and Hikma Pharmaceuticals PLC (collectively “Hikma”) from continuing its launch of Mitigare, a colchicine product for prophylactic treatment of gout, and from launching an authorized generic version of Mitigare. The appeal to Federal Circuit was actually raised from the order of United States District Court of Delaware No. 1:14-cv-01268-SLR.

Colchicine is a natural product which is extracted from plants of the genus Colchicum (autumn crocus, Colchicum autumnale). Use of Colchicine for the treatment of Gout is already known; due to its high toxicity the use of Colchicine in the therapeutic field was less known. The structure of Colchicine is given below:


The research was carried out by AR Holding CO INC (now its Takeda) to reduce the toxicity of Colchicine in the treatment of gout. Further, Takeda received FDA approval for Colchicine TABLET; ORAL: 0.6MG which is marketed under the brand name Colcrys.

Takeda owns several asserted patents that cover several methods of administering colchicine products to treat gout. Colchicine itself, which has been used for centuries, is not covered by Takeda’s patents. US 7,964,647 and US 7,981,938 directed to methods of treating acute gout flares. US 8,097,655, US 7,964,648 and US 8,440,722 patents (the “drug-drug-interaction (DDI) patents”) are directed to methods for administering colchicine for prophylaxis of gout in patients who are concomitantly taking certain drug inhibitors known as “CYP3A4” and “P-gp” inhibitors; wherein the above said patents are listed in Orange Book for Colcrys.

In 2010, Hikma sought FDA approval of a colchicine product for prophylaxis of gout flares. It submitted an NDA under § 505(b)(2) of the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch- Waxman Act”), codified at 21 U.S.C. § 355(b)(2). On September 26, 2014, the FDA granted Hikma approval to market its Mitigare colchicine capsule.

The FDA initially objected to this omission from the Hikma label, stating that “If Mitigare is being used for prophylaxis, it may be natural for the provider to use it for acute treatment as well.” Hikma then added to its label that Mitigare was not “studied” for “safety and effectiveness” of treatment of acute gout flares. On this statement, the FDA withdrew its objection.

On October 3, 2014, Hikma launched Mitigare, and Takeda filed suit against Hikma, asserting induced infringement under 35 U.S.C. § 271(b) based on Hikma’s labeling of the Mitigare product. Hikma planned on launching an authorized generic version of Mitigare as early as October 10, 2014. However, the district court granted Takeda’s request for a temporary restraining order (“TRO”) on October 9, 2014, restraining Hikma from selling Mitigare and from launching a generic colchicine product.

On November 4, 2014, the district court denied Takeda’s motion for preliminary injunction on the grounds that Takeda did not meet its burden of showing a likelihood of success on the merits for its induced infringement claims or irreparable injury. On the issue of the likelihood of success on the merits, the district court concluded that, although Hikma failed to raise a substantial question regarding the validity of the patents, Takeda had not met its burden of showing likelihood of proving induced infringement. On the issue of irreparable harm, the district court concluded that Takeda had not shown a causal nexus between Hikma’s infringement and Takeda’s alleged harm.

Takeda timely appealed the denial of preliminary injunction, and Hikma cross-appealed.

wherein Federal Circuit states that:
Hikma elected to file a paper NDA pursuant to 21 U.S.C. § 355(b)(2). Hikma did not, however, file a Paragraph IV certification with respect to Takeda’s patents because it relied on prior FDA findings of safety and efficacy concerning colchicine, and did not seek FDA approval for a use covered by Takeda’s patents. Further, it cited Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003), in which congress intended “that a single drug could have more than one indication and yet that ANDA applicant could seek approval for less than all of those indications. A patent certification such as a Paragraph IV certification need not be provided “for a patent claiming a use for which the ANDA applicant is not seeking approval. In such a situation, a generic manufacturer may avoid infringement by proposing a label that does not claim a patented method of use. Based on the above discussion the Federal Circuit address the question of whether Takeda showed a likelihood of success on the merits of the induced infringement claim.

However, Hikma did not seek FDA approval to market Mitigare for treatment of acute gout flares, Mitigare’s label stated that Mitigare is “indicated for prophylaxis” and that the “safety and effectiveness of for acute treatment of gout flares during prophylaxis has not been studied. Further, the label also said that if you have a gout flare while taking [Mitigare], tell your healthcare provider.

Takeda argued that this latter statement induced infringement because, in the case of the patient taking Mitigare for prophylaxis, the physician would likely tell the patient to use the Mitigare product to treat the acute flare. However, district court as well as Federal Circuit concluded that the latter instruction was not sufficient to establish induced infringement.

Finally Federal Court issued an Order which states that:

The district court’s order denying Takeda Pharmaceuticals U.S.A., Inc.’s motion for preliminary injunction is affirmed, and it further states that both parties are free to immediately offer colchicine products for prophylactic use, without regard to the 10-day provision of the district court’s order.


Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s