Last month, Judge Stark issued an opinion following a July bench trial in The Research Foundation of State Univ. of New York v. Mylan Pharma., Inc., C.A. No. 09-184-LPS (D. Del. August 26, 2011). This is a long opinion with a number of interesting points and findings of fact, and which ultimately found that one of the five patents was both valid and infringed. One interesting portion of the opinion discusses a reversal by the Court from an initial position it took in granting a preliminary injunction:
The Court recognizes there is further tension between today’s ruling and the following statement in the preliminary injunction opinion: “It follows that Mylan’s argument is that Mr. Ashley, the inventor, expressly defined key claim terms in a manner that had the consequence of excluding from the scope of his patent the very embodiment ofhis invention that his employer intended to practice. There is no support in the record for this highly improbable contention.”
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As the instant case proves, “highly improbable” does not mean “impossible.” At trial, unlike at the preliminary injunction (or claim construction) stage, Mylan presented a significant amount of evidence that demonstrated that a 40 mg daily administration of doxycycline – either 40 mg once-daily or 20 mg twice daily – does not not significantly inhibit the growth of microorganisms. It follows, then, that Oracea® and Periostat®, despite being identified as preferred and “especially preferred” embodiments of the Ashley Patents, respectively, are not actually embodiments ofthe asserted claims. Although unusual, this is the conclusion compelled by the record developed at trial.