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Judge Stark grants defendants’ Rule 12(b)(6) motions in related ANDA actions

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Judge Leonard P. Stark recently dismissed two complaints filed by a plaintiff alleging that defendants’ respectively filed ANDA’s infringe U.S. Patent No. 8,148,356. Cumberland Pharm. Inc. v. Innopharma, Inc., C.A. No. 12-618-LPS (D. Del. Nov. 1, 2013); Cumberland Pharm. Inc. v. Sagent Agila LLC, et al., C.A. No. 12-825-LPS (D. Del. Nov. 1, 2013). Judge Stark dismissed the complaints in each action for failure to state claim on the same grounds. That is, Judge Stark found that plaintiff’s asserted claims covered only compositions “free from a chelating agent,” despite the complaints’ allegations that defendants’ products contained EDTA, a chelating agent. Innopharma, C.A. No. 12-618-LPS, at 2-3; Sagent Agila LLC, C.A. No. 12-825-LPS, at 2-3. The “free from a chelating agent” limitation appeared explicitly in the asserted claims and was discussed in the complaints. See Innopharma, C.A. No. 12-618-LPS, at 3-4; Sagent Agila LLC, C.A. No. 12-825-LPS, at 3-4. While plaintiff argued, among other things, that dismissing the complaints would require a premature claim construction, Judge Stark found that no claim construction was necessary “to determine that ‘free from a chelating agent’ means that a claimed composition may not include a chelating agent.” Innopharma, C.A. No. 12-618-LPS, at 3-4; Sagent Agila LLC, C.A. No. 12-825-LPS, at 2-4. Judge Stark also noted that the doctrine of equivalents would be inapplicable in either case, as a “finding of infringement would vitiate the ‘free from a chelating agent’ claim limitation.” Innopharma, C.A. No. 12-618-LPS, at 3-4; Sagent Agila LLC, C.A. No. 12-825-LPS, at 2-4.

Cumberland Pharm. Inc. v. Innopharma, Inc., C.A. No. 12-618-LPS (D. Del. Nov. 1, 2013); Cumberland Pharm. I…

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