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Judge Stark: non-infringement finding in favor of one ANDA defendant has collateral estoppel effect in a separate action against another defendant.

In a recent memorandum order, Judge Stark granted Amneal Pharmaceuticals’ motion for partial judgment on the pleadings of non-infringement, finding that a non-infringement ruling against Galderma Laboratories in a separate action had collateral estoppel effect. Galderma Laboratories Inc. v. Amneal Pharmaceuticals, LLC, C.A. No. 11-1106-LPS (D. Del. Sept. 7, 2012). In the separate action, the Court found that Mylan Pharmaceuticals’ proposed generic product “containing 40 mg doxycycline administered once daily does not infringe [Galderma’s] patents, because such products do not contain the required ‘sub-antibacterial amounts’ of doxycycline but, rather, significantly inhibit the growth of microorganisms.” Id. at 1-2. Amneal, whose proposed product also contained 40 mg of doxycycline, to be administered once daily, argued that the Court’s non-infringement ruling against Galderma in that separate action had collateral estoppel in the instant case. The Court agreed, explaining “in order to prevail against Amneal on its claim for infringement …, Galderma would have to prevail on the ‘identical’ issue it previously litigated – and lost – in the Mylan action.” Id. at 4. That issue was “whether a product containing 40 mg of doxycycline, administered once daily, infringes [Galderma’s] patents.” Id. In rejecting several arguments by Galderma why collateral estoppel was not appropriate in this case, the Court explained that “the Court’s finding of non-infringement of [Galderma’s] patents in the Mylan Action was in no meaningful sense tied to anything unique about Mylan’s proposed product.” Id. at 7.


Galderma Laboratories Inc. v. Amneal Pharmaceuticals, LLC, C.A. No. 11-1106-LPS (D. Del. Sept. 7, 2012).

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