Richards Layton & Finger
 

Chief Judge Stark Denies Motion for Preliminary Injunction to Prevent Launch of Generic Product

August 24, 2018

In Noven Pharmaceuticals, Inc. v. Mylan Technologies Inc., No. 17-1777-LPS (D. Del. Aug. 20, 2018), Chief Judge Stark declined to preliminarily enjoin the defendants from launching a generic version of the plaintiff’s pharmaceutical product but granted a temporary restraining order that would expire within two days unless additional relief was granted by the Court or the Federal Circuit. A trial in this case is scheduled to take place in December.

Chief Judge Stark found that the plaintiff failed to show a likelihood of success on its infringement claim. According to the Court, infringement hinged on the disputed construction of a claim term: the plaintiff argued that the term required in vitro testing adjusted with reference to a control to arrive at the relevant value, whereas the defendants proposed that the value be calculated by dividing the amount of the drug estradiol by the active surface area of the patch used to deliver the product. The defendants argued that their proposed construction found support in the intrinsic evidence, inventor testimony, and the testimony of the plaintiff’s expert. Noting that the plaintiff had the burden to prove its entitlement to extraordinary relief, the Court found that at this stage the defendants’ proposed construction was correct. Chief Judge Stark additionally found that the plaintiff failed to show that the defendants’ written description and indefiniteness defenses lacked substantial merit.

Although describing the plaintiff’s position as “far from overwhelming,” the Court found that the plaintiff showed that it would suffer irreparable harm in the absence of injunctive relief. But the Court found that the defendants would suffer greater harm if kept off the market for the four months until trial, let alone during post-trial briefing. Chief Judge Stark further found that the public interest favored the defendants, who at present had not been found to have infringed a valid claim, were not subject to the automatic 30-month stay, and would have no apparent difficulty making the plaintiff whole by way of damages, should that be the consequence of an at-risk launch.

Upon a separate application of the plaintiff, on August 22, 2018, the Court granted a limited injunction until the earlier of August 30th or until the Federal Circuit rules on the plaintiff’s appeal of the Court’s order and any related request for injunctive relief. The limited injunction depends on the plaintiff’s moving to expedite its appeal; posting a bond; not authorizing or allowing the marketing of a generic version of (or discontinuing) its brand product; and not taking action that would cause the FDA to revoke the defendants’ ANDA.

Key Point: The Court deemed the plaintiff’s motion for a temporary restraining order as seeking preliminary injunctive relief, as the issues on either motion would be the same, a preliminary injunction was effectively what the plaintiff was seeking, and the resulting order could be immediately appealed to the Federal Circuit.