IP Law Daily Injunction request to block generic version of hyperparathyroidism drug SENSIPAR denied
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Monday, May 6, 2019

Injunction request to block generic version of hyperparathyroidism drug SENSIPAR denied

By Brian Craig, J.D.

The court denied Amgen, Inc’s preliminary injunction request to block the sale of a generic version of Amgen’s hyperparathyroidism drug SENSIPAR based on a previous settlement agreement.

Because Amgen, Inc. failed to show a likelihood of success on the merits of its breach of contract claim involving a settlement agreement in a previous patent infringement suit concerning Amgen’s hyperparathyroidism drug SENSIPAR with a generic drug maker, the federal district court in Wilmington, Delaware, has refused to grant Amgen a preliminary injunction to block the sale of a generic versions of the drug. While the court concluded that Amgen will likely suffer irreparable harm without an injunction and the balance of the harms somewhat favors Amgen, Amgen failed to show a likelihood of success in the underlying claim over the previous settlement agreement warranting denial of Amgen’s request for a preliminary injunction (Cipla Ltd. v. Amgen, Inc., May 3, 2019, Stark, L.).

Amgen owns United States Patent No. 9,375,405 (the ’405 patent) which claims pharmaceutical compositions of cinacalcet. Cinacalcet can be used to treat hyperparathyroidism, hyperphosphonia, hypercalcemia, and elevated calcium-phosphorus product. Amgen markets a branded drug, SENSIPAR, that practices the ’405 patent. In earlier litigation, Amgen alleged that Cipla’s generic version of SENSIPAR infringes Amgen's '405 patent. The parties settled the prior case by executing an agreement (the “Amgen-Cipla Agreement”). In the present case, Cipla filed a suit seeking a declaratory judgment that, under the terms of the Amgen-Cipla Agreement, and due to circumstances arising from the launch of a generic version by Teva Pharmaceuticals USA, Inc., Cipla now had the right to launch its own generic version. Amgen filed a motion for a preliminary injunction seeking to block the sale of the generic version of the drug sold by Cipla.

Likelihood of success on the merits. The court first analyzed whether Amgen is likely to succeed on the merits of its claim that Cipla is violating the Amgen-Cipla Agreement with the sale of a generic version of the drug. A plaintiff seeking a preliminary injunction must establish that he is likely to succeed on the merits. Winter v. Natural Res. Def Council, Inc., 555 U.S. 7, 20 (2008). In the Amgen-Cipla Agreement, Amgen agreed it would not seek a temporary restraining order or preliminary injunction with respect to Cipla’s launch. Based on the clear and unambiguous meaning of the terms of the settlement agreement, Amgen did not meet its burden to show a likelihood of success on its claim that Cipla breached the agreement.

Irreparable harm. Having found that Amgen failed to show a likelihood of success on the merits, the court said that it must deny the preliminary injunction motion. Nonetheless, the court addressed the other requisites to granting injunctive relief. Here, the court found Amgen will suffer irreparable harm in the absence of a preliminary injunction. While the market for cinacalcet will go completely generic by mid-2021, that is still two years away. Just because the market is essentially guaranteed to be fully genericized two years from now, Amgen showed it will be irreparably harmed by what occurs between now and that time absent a preliminary injunction.

Balance of hardships. The court also found that the balance of hardships favors Amgen. It appears that the magnitude of the harm to Amgen in having its market genericized by Cipla is greater than the harm to Cipla in missing out on pre-genericization sales. The court found that Amgen will experience irreparable harm as a result of price erosion, loss of market share, harm to its goodwill, and other non-quantifiable harm. Cipla would also face harm if it were enjoined from further sales of its generic product until after trial.

Public interest. Finally, the court found the public interest somewhat favors granting an injunction. The court agreed with Amgen that the public interest would favor granting its motion if Amgen had succeeded in showing a likelihood of success on the merits, albeit only slightly. The public has a strong interest in protecting valid patent rights, particularly as the patent system provides incentive to the innovative drug companies to continue costly development efforts. Yet the public also has a strong interest in enforcing contractual rights and encouraging the widespread distribution of life-saving pharmaceuticals to patients in need of them, an interest fostered by careful adherence to the laws permitting approval and marketing of less expensive generic versions of drugs. There is also a public interest in promoting settlement of litigation.

Because Amgen failed to show likelihood of success on its underlying breach of contract claim with respect to the previous settlement agreement, the court denied Amgen’s motion for a preliminary injunction.

This case is No. 19-44-LPS.

Attorneys: Sue L. Robinson (Farnan LLP) and James W. Dabney (Hughes Hubbard & Reed LLP) for Cipla Ltd. and Cipla USA, Inc. Jack B. Blumenfeld (Morris, Nichols, Arsht & Tunnell LLP) and M. Sean Royall (Gibson, Dunn & Crutcher LLP) for Amgen Inc. and Teva Pharmaceuticals USA, Inc.

Companies: Cipla Ltd.; Cipla USA, Inc.; Amgen Inc.; Teva Pharmaceuticals USA, Inc.

MainStory: TopStory Patent DelawareNews

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