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How They Won It: Kaye Scholer Saves Viagra Patent

As appeared in Law360

September 20, 2011

Law360’s editors describe the creative litigation strategies employed by the Kaye Scholer team in the recent Pfizer v. Teva Pharmaceuticals victory – among which was the decision to have a biologist and chemist translate the story of the drug’s genesis into lay terms.

According to Kaye Scholer partner Dan DiNapoli, one of the lead attorneys in the case, along with partner Aaron Stiefel, “Getting to see some of the witnesses testify in those other proceedings, and getting an idea of what they were capable of, helped us make some decisions about how we wanted to proceed with our case.”

On the stand, the biologist explained that Pfizer scientists first realized Viagra might be able to treat ED orally when the volunteers in a Phase 1 study began to experience spontaneous erections. This testimony aided in the defense of Pfizer’s method-of-use patent from Teva’s obviousness challenge.

“[I]t was an enormous change in direction, and we certainly told that story through the inventor,” Stiefel said, referring to this “serendipitous event in the clinical trial.”

The amount of information, in part from earlier disputes and related litigation, surrounding the drug posed particular challenges for the legal team.

Stiefel added, “When you come to a case and nobody’s done anything about it before, you … can develop the case as you see fit. Here it was anything but a blank slate. There had been so much said before and done before that we had to be very cognizant of that.”

 
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