Friday, January 06, 2017

D. Delaware grants permanent injunction against Praluent but delays imposition for 30 days so appeal to CAFC can be made

See the post Regeneron Cholesterol-Lowering Drug Banned From U.S. Market in Stunning Loss to Amgen in Patent Case , which includes the following, somewhat backwards text:

The judge went further, ruling Regeneron "demonstrated irreparable harm" to Amgen and that money damages were inadequate compensation. Regeneron and Sanofi must stop selling Praluent in the U.S., although the ban has been delayed 30 days to allow the companies to appeal.

It would be Amgen's burden to demonstrate irreparable harm to Amgen by the actions of Regeneron/Sanofi.

See Amgen v. Sanofi, 2017 U.S. Dist. LEXIS 1351, which includes the text

In eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006) (vacating and remanding MercExchange, L.L.C. v. eBay Inc., 401 F.3d 1323, 1339 (Fed. Cir. 2005)) (hereinafter "eBay"), the Supreme Court overruled the Federal Circuit's longstanding "general rule that courts will issue permanent injunctions against patent infringement absent exceptional circumstances." The Supreme Court held in eBay that permanent injunctions in patent cases must be based on a case-by-case assessment of the traditional equitable factors governing injunctions. Id. at 391-92. That is, to be awarded a permanent injunction, a plaintiff must demonstrate: "(1) that it has suffered an irreparable injury; (2) that remedies available at law, such as monetary damages, are inadequate to compensate for that injury; (3) that, considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the public interest would not be disserved by a permanent injunction." Id. at 391. "[T]he decision whether to grant or deny injunctive relief rests within the equitable discretion of the district courts, and that discretion [*5] must be exercised consistent with traditional principles of equity, in patent disputes no less than in other cases governed by such standards." Id. at 394.


Irreparable harm. Plaintiffs present traditional evidence of loss of market share and momentum. Specifically, plaintiffs allege that they have been forced to compete with defendants for contracts with insurers and exclusive formulary positions, particularly since defendants were first to market. Plaintiffs argue that defendants' market position is causing harm to their reputation as the innovator in the PCSK9 cholesterol-lowering medicine, and defendants' marketing of Praluent as "The First U.S. FDA-Approved PCSK9 Inhibitor" compounds such harm. Defendants respond that it is well known that plaintiffs were the first to file a biologics license application with the FDA and receive regulatory approval worldwide for Repatha. According to defendants, Repatha would have faced pricing pressures even without competition from Praluent. This factor weighs in favor of plaintiffs.

The "public interest" prong merits discussion:

10. Public interest. Plaintiffs rely on the traditional notions of being a patent holder and a verdict winner. Plaintiffs point to the FDA's approval of Repatha to treat all patients covered by the Praluent label to assuage the consequence of an injunction on patients. (JTX 392) Defendants rely heavily on the availability of (and physicians' alleged preference for) the low 75 mg dose of Praluent to argue that an injunction would harm the treatment of patients. Defendants also point to Praluent's label stating that "[t]he recommended starting does for Praluent is 75 mg." (PTX 5012)

11. The court will not substitute its judgment for that of the FDA, nor delve into weighing testimony on the propriety of treating patients with the 75 mg dose of Praluent (instead of the 150 mg dose or the 140 mg dose of Repatha). The public generally is better served by having a choice of available treatments. Therefore, the court finds itself between a rock and a hard place, i.e., being a patent holder and a verdict winner should be a meaningful factor in the balancing test, but taking an independently developed, helpful [*9] drug off the market does not benefit the public. "[T]he touchstone of the public interest factor is whether an injunction, both in scope and effect, strikes a workable balance between protecting the patentee's rights and protecting the public from the injunction's adverse effects." i4i Ltd. P'ship v. Microsoft Corp., 598 F.3d 831, 863 (Fed. Cir. 2010), aff'd, 564 U.S. 91 (2011). The court concludes that the public interest of having a choice of drugs should prevail. This factor weighs in favor of defendants.

The bottom line:

For the aforementioned reasons, plaintiffs have demonstrated irreparable harm, as well as the inadequacy of money damages. The public interest factor weighs in favor of defendants. Plaintiffs' motion for a permanent injunction (D.I. 336) is granted. Given the ramifications of an injunction, the court will delay its imposition for thirty (30) days to allow defendants the opportunity to appeal and request expedited review of this ruling by the Federal Circuit, and/or to encourage the parties to reach an appropriate business resolution.


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