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  • khumbu61 khumbu61 May 8, 2012 11:11 AM Flag

    Otsuka v. Sandoz--Must Read

    Those who have an interest in the outcome of the appeal should peruse the above opinion of the Circuit Court issued yesterday. Maybe not on all fours with SNTS v. Par, but I think it is a harbinger of good news for all of us and that an opinion in our case is imminent. It is an obviousness case and the opinion very much follows the reasoning of the court in the two obviousness opinions issued by the court in the past 10 months since Morgan Chu's oral argument.

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    • Thanks Khumb (Kitty is on all fours, LOL, positive outcome for SNTS is within reach):

      A seemingly simple modification of formulation might not have been intuitively obvious to those skilled in the art to improve drug delivery/efficacy. Prior art for the SNTS case teaches away from the unexpected success of Zegrid formulation, as CHU alluded to in the appeals case.

      Here is brief summary from the Otsuka case (tiny structural modification led to UNEXPECTED (non-obvious) anti-psychotic activity:

      http://ipbiz.blogspot.com/2012/05/otsuka-prevails-over-sandoz-apotex-and.html

      "the evidence here not only demonstrates the unpredictability of minor struc- tural changes on a compound’s antipsychotic properties, but also indicates that the prior art would not have pro- vided the skilled artisan with a reason to make the neces- sary structural changes to the unsubstituted butoxy to yield aripiprazole. Otsuka, 2010 U.S. Dist. LEXIS 132595, at *61, *91. Zickendraht, therefore, is distin- guishable from the present case."

      • 1 Reply to siamesekitty711
      • Couldn't agree more. I bought more on the dip today just on the basis of the Otsuka decision. If I have concern, it is because Otsuka confirmed the trial court and we, of course, are hoping to reverse the trial court decision. However, in my mind, that may be offset by the presumption that the PO got it right in issuing the patent under the appropriate analysis of obviousness. We win, so I am on all fours with you; ready to rumble.