Evercore ISI Raffat Highlights New Development on Teva Pharma (TEVA) from Copaxone Hearing

September 28, 2016 10:33 AM EDT
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Evercore ISI analyst Umer Raffat reports on Teva Pharma (NYSE: TEVA) from the 7-day district court hearing on Copaxone 2030 patents, noting while uneventful so far today there is a new tidbit that's worth highlighting"

New evidence emerged this morning which weakens Teva's case further: supposedly, Teva submitted a protocol to FDA for GALA trial (which is on label for Copaxone 40 mg). In this trial protocol, Teva referenced Flechter and Cohen prior arts as one of the reasons for pursuing 40 mg 3x/week dose in GALA trial.

He said the statement weakens Teva's case materially … but, there are 3 points to make:

  • Technically, this trial protocol was NOT public … meaning, a person skilled in the art technically didn't have access to it
  • Judge Sleet will decide later today whether this trial protocol is admissible for Mylan expert's testimony (Dr. Green)
  • However, even if this trial protocol is not admissible as prior art for obviousness, it may sway Judge Sleet's opinion on the overall case: perhaps it was obvious to try out 40 mg 3x/week etc.

"In summary, trial proceedings so far provide little reason to believe that district court may produce a different decision than the IPR on the first three Copaxone 2030 patents," Raffat said.

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