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Biotech / Medical : Momenta Pharmaceuticals Inc. -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (2833)	9/20/2011 7:25:12 PM
From: mopgcw	Respond to of 3027

Thanks for the pointer. here is day 8: Copaxone Trial Day 8: Teva's Rebuttal Begins ¦ Day 8 of the Copaxone trial saw the defense call their final witness and the start of Teva’s rebuttal case. Nearly every issue previously raised in the case was revisited and Teva introduced a new angle to the issue of enablement. The case remains on track to finish Wednesday with briefs to be submitted by both sides from October 10th to 31st. ¦ The defense revisits obviousness: The defendants’ final witness was Dr. Ari Green, a neurologist at UCSF, who was called upon to demonstrate that Copaxone was not much of a breakthrough in terms of treating MS. Dr. Green’s argument was based primarily on the existence of a pilot study conducted in 1987 which hinted that copolymer-1 (Copaxone) could be effective as a treatment for MS. Teva, however, during cross-examination dismantled the doctor’s testimony, arguing that conducting a small pilot study is a far cry from having and understanding the patented drug, and addressing the unmet need for a MS treatment at the time. Dr. Green stated that he personally does not think Copaxone has a materially different medical profile from prior MS treatments, but did concede that the Copaxone patents include substantial evidence of medical differences versus prior therapies as shown by various animal studies. Overall, our legal expert believes the doctor’s testimony was not helpful to the defense’s case. Teva’s rebuttal begins: Teva’s rebuttal began with Dr. Grant, one of its original expert witnesses in the trial, who responded to a wide range of the defense’s theories. In response to the defense’s enablement argument, he testified that the Copaxone patents do, in fact, disclose sufficient information to allow someone skilled in the art to produce the patented drug, and measure the necessary molecular weights in particular. Dr. Grant refuted the defense’s claim that prior art rendered Copaxone obvious, and argued that most of the patent claims at issue are infringed by the defendants. He explicitly chose not to address some of the infringement claims which will presumably be addressed by another witness. ¦ A slight variation on the enablement issue: Dr. Grant’s main contribution on Day 8 regarded enablement and whether the Copaxone patents adequately describe how to make the drug, pointing out that Teva itself was able to produce Copaxone. The defense painted a very different picture, that plausibly showed Teva struggling for years with the appropriate techniques to measure the various molecular weights specified in the patents. Ultimately, Dr. Grant argued that while Teva may have struggled with the ideal approach, it was able to accomplish the appropriate measurements at all times, even if imperfectly. ¦ Facts around the enablement issue seem murky but the defense’s burden of proof remains high. From our perspective, the facts on both sides of the enablement argument seem murky as each side has presented documents consistent with its proposed sequence of events, and Teva certainly did not have a perfectly clear understanding of the development process from the start. Dr. Grant made some good points about what was known in the literature at the time, but the defense had strong evidence showing that Teva struggled with their measurements for years. Moreover, this is an issue where the defendants bear a heavy burden of proof. ¦ What’s next: trial should finish Wed. with briefs due by end of Oct. Teva expects to finish its rebuttal case today (Tuesday), presumably focusing on 1) the remaining infringement allegations, and 2) the details about how Copaxone is made, including the still-open question of whether Sandoz/Momenta made a meaningful change when they replaced the “time and temperature” test reaction with viscometry. The defendants will then present their rebuttal which will likely last one day (Wednesday). There will be no closing arguments. The judge has asked all parties to submit briefs in October summarizing the trial from their own perspectives and arguing the key legal issues. The first briefs would be due October 10 with responses due October 24, and then further responses due October 31.