Leerink Swann’s alert re today’s Copaxone ruling
(no link for this item; emphasis added by me):
›Bottom Line: Last Friday (8/26), the Southern District Court of New York published MNTA/Sandoz' statement of claims and defenses that they intend to present at the upcoming generic Copaxone litigation commencing on 9/7. Upon review of the document, we noted several items of interest. MNTA/Sandoz disclosed that they received the court's claim construction ruling last Friday, and filed the statement of claims and defenses in response. Reiterate Outperform rating and $26 fair value on MNTA.
• The actual claim construction ruling has not yet been made public on the Southern District Court of NY website; however, TEVA issued a press release today announcing that the ruling was favorable for them since it adopted all of their interpretations of relevant words used in the patent claims. While the court's interpretations of these claims' terms impact the assessment of infringement and validity, we continue to believe that MNTA could introduce some strong arguments in the court, at least relative to the very minimal credit that the market appears to ascribe MNTA shares for MNTA being able to overcome TEVA's patents.
• MNTA/Sandoz list a series of possible defenses to be used for a non-infringement strategy potentially used in the trial. According to the document, TEVA has the burden of proof on infringement and at the trial MNTA/Sandoz will present evidence showing that their proposed GA [glatiramer acetate, i.e. Copaxone] product does not meet the asserted claims since it does not meet the molar ratio limitations (6:2:5:1) claimed in the patents and also does not use a "test reaction" as claimed in a manufacturing step. Further, since TEVA's patents claim that it is not possible to determine the molecular weight of individual polypeptides or their GA product, MNTA argues it is not possible for TEVA to prove infringement. MNTA also states that their formulation does not exhibit lower toxicity than TEVA's formulation having an average molecular weigh about 8.6kDa.
• No surprises on MNTA/Sandoz' plans to present possible evidence for an invalidity strategy. MNTA/Sandoz/Mylan have the burden of proof regarding invalidity. They intend to present evidence that the claims are invalid based on obviousness, lack of enablement, indefiniteness, and lack of best mode. As expected, the obviousness strategy is based on a series of prior art. Lack of enablement will be based on whether one of ordinary skill in the art can make low-toxicity improved composition of COP-1 and determine the molecular weight of COP-1. Lack of definiteness focuses on determination of molecular weight as the claims construction ruling did not foreclose a finding that the claims are indefinite.
• MNTA/Sandoz will also present additional evidence on its inequitable conduct part of the trial, although the document did not elaborate further on this aspect of the defense.‹
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