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Judge Sleet finds patent is not obvious following ANDA trial

In the post-trial opinion in Genzyme Corporation, et al. v. Dr. Reddy’s Laboratories, et al., C.A. No. 13-1506-GMS (Cons.) (D. Del. May 11, 2016), Judge Gregory M. Sleet found that the single asserted claim of the patent-in-suit was not obvious. Plaintiffs’ brand drug “is an accepted standard of care for a patient who fails to mobilize the minimum number of stem and/or progenitor cells needed for transplant.” Id. at 10.

Included in the Court’s post-trial findings of fact was the conclusion that a reference relied on by Defendants (“Hendrix”) was not prior art. The reference focused on “evaluating the safety and pharmacology of . . . a drug for treating HIV,” and had been considered by the Examiner during prosecution of the patent-in-suit and rejected as not prior art. Id. at 15. The Court concluded that “[w]hile from today’s perspective the relationship between Hendrix [the asserted claim] may seem clear . . . Defendants’ relevance analysis is colored by hindsight.” Id. at 16. For example, Defendants’ expert “improperly based his opinion on his own experiments . . . not prior art.” Id. at 16. And the same expert was conducting research relevant to the subject matter of the prior art when Hendrix was published but did not remember reading it. Id. Further, “the USPTO Examiner thoroughly considered Hendrix and concluded that it was non-analogous art . . . . There is a presumption that decisions made by the PTO Examiner are valid. These decisions are particularly pertinent because they were made contemporaneously with full view of the art at the time and not tainted by hindsight.” Id. at 17.

Genzyme Corporation, et al. v. Dr. Reddy’s Laboratories, et al., C.A. No. 13-1506-GMS (Cons.) (D. Del. May 11, 2016)

 

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