Mylan and Partner Biocon Win on Insulin Ruling

We previously reported on Judge Chesler’s claim construction order in Sanofi-Aventis v. Mylan et al. concerning Mylan’s proposed insulin glargine pen device, Vystra. This week, following a 5-day bench trial held on December 2-6, 2019, the U.S. District Court of New Jersey found U.S. Patent No 9,526,844, a pen-type injector patent related to insulin glargine, not infringed and invalid for lack of written description. With respect to the infringement claims, Judge Chesler found that “claim [21] says, ‘releasably connected,’ and there is no evidence that the pen that will be delivered to customers will contain the required releasable connection,” and that because the Mylan pen device’s “tower core does not prevent the piston rod from rotating during dose setting. . .  [p]laintiffs have not proven that the Vystra infringes the piston rod holder limitation in claim 21.” Moreover, Judge Chesler concluded that the Mylan device does not infringe claims 25 and 30 because it “does not contain a clutch that provides audible clicks during dose canceling,” and because the “dose step” does not have an “internal thread,” respectively. Therefore, Judge Chesler concluded that Vystra does not infringe the ‘844 patent.

In terms of invalidity, the Court stated that “that Mylan has proven, by clear and convincing evidence, that the disclosure of the ’844 patent does not reasonably convey to a [person of ordinary skill in the art] that the inventor had possession of all of the subject matter [specifically, the internally threaded piston rod and an externally threaded driving member,] of claim 21 as of the Priority Date. [Therefore,] Claim 21 of the ’844 patent is invalid for failure to meet the written description requirement.”

As Mylan reported in a press release earlier this week, “Sanofi’s formulation patents (U.S. Patent No. 7,476,652 and U.S. Patent No. 7,713,930) were previously affirmed to be invalid by the Federal Circuit. The ‘844 and ‘652 patents were the only patents being asserted by Sanofi against Mylan’s insulin glargine product.”

Download PDF