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Judge Leonard P. Stark: Motion to Dismiss Counterclaims Based on Covenant Not to Sue in ANDA Case DENIED

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In Bristol-Myers Squibb Co. v. Mylan Pharmaceuticals Inc., Mylan brought declaratory judgment counterclaims for invalidity and non-infringement against Bristol-Myers Squibb and Merck. C.A. No. 09-651-LPS, Memo. Op. (D. Del. July 11, 2011). In response, Bristol-Myers and Merck sent a proposed covenant not to sue to Mylan for infringement of two the patents asserted by Mylan in its counterlcaims (but not originally asserted by Bristol-Myers Squibb in its complaint). Id. at 6. Mylan did not respond to the proposed covenant and a motion to dismiss by Bristol-Myers Squibb and Merck followed based on lack of subject matter jurisdiction. Id. The Court denied the motion and found that a case or controversy exists because the covenant not to sue contained conditional language that would allow Bristol-Myers Squibb to bring suit if it determines that Myaln’s Notice Letter was inaccurate. Id. at 9, 11. The Court stated, “By conditioning the covenant on BMS’ own view of the accuracy of Mylan’s representations, and by reserving to itself the right to sue Mylan for infringement of the Unasserted Patents based on Mylan’s ANDA as it presently exists, BMS has failed to provide Mylan with the certainty to which it is entitled.” Id. at 11.


Bristol-Myers Squibb Co. v. Mylan Pharmaceuticals Inc., C.A. No. 09-651-LPS, Memo. Op. (D. Del. July 11, 2011).

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