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IPR Victories in Innovators’ Hatch-Waxman Battles

Industry: Life Sciences

Key Facts

  • 3 IPRs filed against claims in U.S. Patents 5,856,336 and 8,557,993
  • ‘336 patent covers the active pharmaceutical ingredient in Livalo®, pitavastatin calcium, and its use for treating elevated cholesterol
  • ‘993 patent covers the polymorph of pitavastatin calcium contained in Livalo®
  • PTAB Denied Institution to all challenges

The Situation

Eight generic drug manufacturers filed Abbreviated New Drug Applications (ANDA) with the US Food & Drug Administration (FDA) in 2014 and 2015, claiming that several of our clients’ patents are invalid and/or would not be infringed by the drugs they planned to manufacture.

To protect our clients’ interests, Mintz’s team sued each of the generic manufacturers in a series of cases filed in the SDNY beginning in late 2014. As part of their attack, defendants Mylan and Sawai petitioned for inter partes review of our clients’ main compound patent before the Patent Trial and Appeal Board.

The Approach

Mintz filed a Preliminary Response, pointing out that Mylan’s reasoning and the references on which it relied did not support invalidity of the patent.

In August, just a few days after the team completed their Preliminary Response on the Mylan Petition, our clients were hit with two more petitions for IPRs on the same patent, but by a different generic defendant, Sawai Pharmaceuticals. Each of these petitions asserted a different theory of invalidity, both vis-à-vis the Mylan Petition and each other. The team again filed a Preliminary Response to each petition.

The Outcome

On the strength of our response, the PTAB denied Mylan’s petition, and declined to institute an IPR. They also denied both of the Sawai petitions, and again declined to institute either IPR.

Supporting Professionals