Judge Sleet grants motion to dismiss generic’s declaratory judgment of non-infringement counterclaims relating to unasserted patents.

In a recent Order, Judge Gregory M. Sleet granted a plaintiff’s motion to dismiss counterclaims seeking a declaratory judgment of non-infringement of two patents related to the brand-name drug Aloxi® which the plaintiff did not assert against the defendant and which were the subject of a covenant not to sue.  Helsinn Healthcare S.A., et al. v. Cipla Ltd., et al., Consol. C.A. No. 13-688-GMS (D. Del. Jan. 6, 2015).  The plaintiff’s motion to dismiss was based on the argument that there did not yet exist a case or controversy warranting adjudication since the defendant’s Paragraph III certification relating to the asserted patent would prevent it from entering the market until at least October 2015 when the asserted patent expires.  The Court agreed with the plaintiff, and reasoned that “[i]n the ANDA-litigation context, there is cognizable injury to a generic drug manufacturer when it is ‘restrain[ed from] the free exploitation of non-infringing goods.’”  Id. at 3 n.1 (quoting Caraco Pharm. Labs., Ltd. v. Forest Labs., Inc., 527 F.3d 1278, 1292 (Fed. Cir. 2008) (alteration in original)).  And “[w]here a generic company accepts the ‘validity, infringement, and enforceability’ of a drug patent, there is no injury giving rise to a case or controversy.”  Id. (quoting Janssen Pharm., N.V. v. Apotex, Inc., 540 F.3d 1353, 1361 (Fed. Cir. 2008)).  Because filing a Paragraph III certification “serves as recognition of the fact, that the patent is valid and enforceable[,]” id. (quoting Janssen, 540 F.3d at 1358), the Court found that the defendant could not claim it was currently being restrained from exploiting non-infringing goods by the two unasserted patents, as opposed to by its filing of the Paragraph III certification and recognition of the asserted patent’s validity and infringement.  Id.  The Court left open the possibility that a case or controversy with respect to these unasserted patents could arise upon the expiration of the asserted patent, since at that point potential infringement of the unasserted patents could be the only thing standing in the way of the defendant bringing its generic to market.

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