Chief Judge Stark Denies Motion for Preliminary Injunction to Prevent Launch of Generic Product
August 24, 2018
Publication| Intellectual Property
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
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
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
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.