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

To: mopgcw who wrote (2844)	9/23/2011 11:11:25 AM
From: mopgcw	1 Recommendation Read Replies (1) \| Respond to of 3027

Copaxone Trial Day 9: Conclusion of Teva's Rebuttal Case ¦ Day 9 of the Copaxone Trial featured two of Teva’s expert witnesses and the conclusion of Teva’s rebuttal case. Drs. Goekel and Sampson testified on a range of infringement and validity issues. The questioning, at times, was disjointed as lawyers from both sides often chose to focus on small details rather than the key legal issues in play, details that will likely be used to “connect the dots” when the lawyers compose their briefs. The defendants are set to respond to Teva’s rebuttal today (Wednesday) in what could be the final day of testimony, unless the defense presents something new to which Teva would like to respond. ¦ Teva’s expert testimony was puzzling at times: Teva began the day by having one of its experts, Dr. Goekel, affirm in detail that Teva itself, in the manufacturing of Copaxone, practices the patents at issue in the case. When asked if Copaxone and Teva’s manufacturing process meet at least one of the asserted claims in each patent in dispute, Dr. Goekel answered in the affirmative. This focus on Teva’s adherence to the patents, however, seems strange as the case is about whether the defendants’ generic versions of Copaxone infringe upon the patents. Moreover, the expert never opined on an important argument by the defense – that they have changed the production process in order to avoid the patented claims. Most surprisingly, the expert did not address the one process change that the defense emphasized earlier in the trial – the abandonment of the “time and temperature” test reaction. Teva’s lawyers presumably have reasons for framing their questions in the manner they did, which will likely come out when their brief is written, but are not yet clear. Teva’s expert revisits the amino acid ratio, emphasizing “impurities”: Dr. Goekel went on to discuss how someone skilled in the art would measure the amino acids in both Copaxone and the accused generics. His new emphasis was to highlight several amino acids present in Copaxone (and the generics) aside from the 4 included in the 6:2:5:1 ratio; byproducts considered to be “impurities”. He went on to say that these impurities should not be included in the in the molecular weights used to calculate the amino acid ratio. This testimony was presumably entered to respond to the defendants’ argument that their amino acid ratio differs from the patented ratio. If some amino acids do not count, the difference between their amino acid ratio and the patented ratio is likely muted. ¦ Teva’s second expert witness, Dr. Sampson, revisited the obviousness argument, arguing that the patents in dispute include important distinguishing features relative to the prior art. Most of his points have been argued previously during the trial. Also, we note that the legal standard regarding obviousness heavily favors Teva, as the Patent Office issued the Copaxone patents while taking into account the very prior art referenced by the defense. ¦ Questioning from the defense did not seem to add much either: On crossexamination of Dr. Goekel the defendants focused, primarily, on the idea that even Teva’s manufacturing process of Copaxone uses additional steps beyond those disclosed in the patent. Although true, this logic seems irrelevant. Per our legal expert, a patent is infringed so long as all the patented steps are included in that process, even if the patented steps are supplemented by others. The additional step(s) would only matter if the process led to a product other than Copaxone, e.g. by causing the amino acid ratio to deviate from the patented ratio. The defendants have already argued that their amino acid ratio is different; highlighting the extra steps involved in getting there did not seem to add much ammunition to their defense. ¦ Barring any surprises, testimony could conclude today: With Teva’s rebuttal case now finished, Wednesday is open for the defendants’ response. There is a possibility that new information will come out in the response that will prompt to Teva to present further rebuttal. At the conclusion of testimony each side will 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.

To: mopgcw who wrote (2844)	9/24/2011 8:54:44 AM
From: IRWIN JAMES FRANKEL	Read Replies (1) \| Respond to of 3027

============= At one point the lawyers argued over whether certain evidence should be admitted at this late date in the trail. The evidence would have supported Dr. Wall’s point that different measurement techniques available at the time the patents were issued would actually yield entirely different estimates for molecular weight. The judge refused to allow Dr. Wall’s testimony regarding this evidence to be admitted, but the point was clear even without the formal admission of the evidence. In another instance the judge shut down a line of questioning that revolved around an unrelated patent and what it might teach about prior art knowledge, refocusing the lawyers on the core issues in the case. ================ That is pretty interesting. Could constitute a "tell". ================= Teva's patents on Copaxone should be found to NOT block mL. -- JMHO ij