In a recent post-trial opinion, Chief Judge Gregory M. Sleet found that defendants had not met their burden of proof in showing that the asserted claims of the patent-in-suit were invalid, either as anticipated or obvious. In re Armodafinil Patent Litigation Inc. (‘722 Patent Litigation), MDL No. 10-md-2200-GMS (D. Del. Mar. 30, 2013). Because the defendants had stipulated that their ANDAs infringed the asserted claims, id. at 9, the Court’s ruling on invalidity also led it to award injunctive relief to plaintiff.
The patent-in-suit was related to plaintiff’s drug that “is indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy, and shift work sleep disorder.” Id. at 4. Plaintiff originally asserted all claims of this patent, but it had agreed that defendants’ “right to enter the market with respect to the [patent-in-suit] . . . will stand or fall based upon the outcome of this litigation with respect to” two of the claims. Id. at 9. Therefore, the bench trial had been limited to the presentation of evidence related to these claims. Id. The two claims “cover a pharmaceutical composition with an active component consisting essentially of Form I armodafinil.” Id. at 48.
As to anticipation, the Court concluded that the claims were not invalid as inherently anticipated. Defendants argued that a person of ordinary skill in the art “will necessarily and inevitably obtain Form I armodafinil from following the prior art Preparation I process” described in another patent (“the ‘855 Patent”) that “discloses how to synthesize armodafinil.” Id. at 10, 48. Generally, the Court found plaintiff’s experts’ testimony more credible than those of defendants with respect to anticipation issues. See, e.g., id. at 20, 29. Specifically, defendants had not met their burden because (i) “defendants have not demonstrated clearly and convincingly through their experts’ experiments and testing that the performance of Preparation I necessarily and inevitably results in Form I armodafinil, (ii) “defendants have failed to show by clear and convincing evidence that the result of performing Preparation I meets the requirements of the asserted claims of the patent-in-suit,” and (iii) “defendants have not demonstrated clearly and convincingly that their reproductions of the ‘855 Patent’s Preparation I were consistent with how a person of ordinary skill in the art would have performed the Preparation and, therefore, have not proven that their experts’ experiments accurately demonstrate that Form I armodafinil inevitably results from Preparation I.” Id. at 18.
At one point in its discussion, the Court noted that both sides referenced “the ‘court’s construction’” of certain terms in the patent-in-suit that the Court had not construed, but instead whose meaning the parties had agreed on before the Markman hearing. Id. at 24. Noting that “the parties’ arguments—and particularly those of defendants, who repeatedly reference how the court construed [these terms]—[therefore struck] the court as misleading,” the Court accepted plaintiff’s constructions. Id.
“Defendants focused their obviousness arguments on the assertion that” the ‘855 patent, combined with other references, invalidated the asserted claims of the patent-in-suit. Id. at 49. The Court, again accepting plaintiff’s experts’ testimony as more credible, concluded that defendants had not shown obviousness. First, “there was no more than a general motivation to find new crystal forms of armodafinil with nothing directed to the unknown Form I itself.” Id. at 68. Second, “the defendants [had] not produced sufficient evidence to demonstrate that skilled artisans would have had reason to select the route that produced the claimed invention or that the prior art provided indication of which parameters were critical or likely to prove successful amongst the numerous testing conditions and variables available.” Id. at 69. Finally, “the defendants’ contention based on allegedly ‘obvious to try’ experiments . . . [fell] short” because “‘[o]bvious to try’ is not equivalent to obviousness in every case, particularly where, as here, the prior art provided at most general motivation to conduct trial and error experimentation in a decidedly unpredictable field” and defendants’ arguments were “based on an impermissible hindsight analysis.” Id. at 70-71.
In light of these findings, the Court awarded plaintiff’s requested injunctive relief. Id. at 72-73.