On April 22, 2019, Judge Colleen McMahon (S.D.N.Y.) denied plaintiffs Ferring’s (“Ferring”) motion for summary judgment on invalidity due to lack of written description and lack of enablement and motion for summary judgment on non-infringement in Ferring B.V. v. Serenity Pharm., LLC. Ferring filed a declaratory judgment suit against defendants Serenity and Reprise (“Defendants”) for patent invalidity, unenforceability and non-infringement with respect to the three patents in suit in the District of Delaware. The suit was subsequently transferred to the Southern District of New York, where the Defendants answered the Amended Complaint and asserted counterclaims, including patent infringement.

Ferring contends that the claims of the ‘203 and ‘321 Patents, as construed, are without a dosage limitation, making the invention indistinguishable from the prior art. Referencing the Patent Examiner’s conclusion that the shared specification of the two patents was sufficiently detailed in its description of the relationship among dose amount, plasma concentration and bioavailability profiles, the Court rejected Ferring’s argument for lack of written description.

Next, the Court denied Ferring’s motion for summary judgment on invalidity due to lack of enablement. Here, Judge McMahon again looked to the Patent Examiner, who opined in his Notice of Allowance that the claims “are supported by the disclosure sufficient to withdraw the rejections” and that “[i]t would not pose an undue burden to determine what dosage/ dosage form would be necessary.” Ferring contends that the Examiner’s conclusion on validity and enablement was undermined by the inventor’s later statements to the European Patent Office regarding whether the inventor’s European patent was enabled by the ‘203 Patent. The Court was unpersuaded, holding that Ferring did not present “clear and convincing evidence of invalidity” to undermine the Examiner’s conclusion. Instead, as referenced above regarding written description, the Court found that the shared specification sufficiently detailed how to determine dose amount.

Lastly, Ferring’s motion for summary judgment on non-infringement was denied because it was directed at Ferring’s proposed, but rejected, claim constructions and failed to show a lack of genuine, material fact with respect to non-infringement of the as-construed asserted claims.

The case is Ferring B.V. v. Serenity Pharm., LLC, No. 17-cv-9922(CM) (S.D.N.Y. Apr. 22, 2019).