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Idenix Pharmaceuticals, Inc. v. Gilead Sciences, Inc.

United States District Court, D. Delaware

August 25, 2014

IDENIX PHARMACEUTICALS, INC., UNIVERSITA DEGLI STUDI DI CAGLIARI, CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE, and L'UNIVERSITE MONTPELLIER II, Plaintiffs,
v.
GILEAD SCIENCES, INC. and GILEAD PHARMASSET LLC, Defendants.

REPORT AND RECOMMENDATION

CHRISTOPHER J. BURKE, Magistrate Judge.

Presently pending in this patent infringement action is a motion (the "Motion") filed by Plaintiffs Idenix Pharmaceuticals, Inc. ("Idenix"), Universita Degli Studi di Cagliari ("U Cagliari"), Centre National de la Recherche Scientifique ("CNRS"), and L' Universite Montpellier II ("UMII") (collectively, "Plaintiffs"), seeking dismissal of various counterclaims filed by Defendants Gilead Sciences, Inc. and Gilead Pharmasset LLC ("Defendants"). For the reasons set forth below, the Court recommends that Plaintiffs' Motion be GRANTED without prejudice.

I. BACKGROUND

On December 1, 2013, Plaintiffs filed the instant suit against Defendants. (D.I. 1) In that suit, Plaintiffs sought: (1) a declaratory judgment that Defendants' planned sale and distribution of the drug sofosbuvir (a drug intended to treat the hepatitis C virus, or "HCV") will infringe Plaintiffs' United States Patent No. 7, 608, 600 ("the 600 patent); and (2) a declaration of interference under 25 U.S.C. § 291 ("Section 291") declaring that one or more claims of Defendant Gilead Pharmasset LLC's United States Patent No. 8, 415, 322 ("the 322 patent") interfered with one or more claims of the 600 patent, that the claims of the 600 patent were invented first, and that the interfering claims of the 322 patent are invalid. (D.I. 1) Later on the same day, Plaintiffs Idenix and U Cagliari filed a second lawsuit against Defendant Gilead Sciences, Inc. in the District of Massachusetts. (D.I. 1, Civil Action No. 14-846-LPS-CJB) In that suit, these Plaintiffs sought a declaratory judgment that Gilead Sciences, Inc.'s planned sale and distribution of sofosbuvir (or drugs and compositions containing sofosbuvir) would infringe their United States Patent Nos. 6, 914, 054 ("the 054 patent") and 7, 608, 597 ("the 597 patent"). ( Id. )

Defendants thereafter answered the Complaint in the instant case and, inter alia, asserted 11 counterclaims. (D.I. 9) Plaintiffs, in turn, filed the instant Motion on April 2, 2014. (D.I. 13) The Motion was referred to the Court for resolution by Chief Judge Leonard P. Stark on May 20, 2014, (D.I. 22), and the Court held oral argument on the Motion on August 14, 2014.

Certain of Defendants' 11 counterclaims remain at issue with regard to the instant Motion. Those are: (1) Counts 5-6, which assert counterclaims for a declaratory judgment of non-infringement and invalidity, respectively, of Idenix and U Cagliari's United States Patent No. 8, 299, 038 ("the 038 patent"); (2) Counts 7-8, which assert counterclaims for a declaratory judgment of non-infringement and invalidity, respectively, of Plaintiffs' United States Patent No. 7, 662, 798 ("the 798 patent"); (3) Count 10, which asserts a counterclaim for a declaratory judgment of invalidity of the 600 patent; and (4) Count 11, which asserts a counterclaim seeking a declaratory judgment, pursuant to Section 291, declaring that one or more claims of the 600 patent interfere with one or more claims of Gilead Pharmasset LLC's 322 patent and that the interfering claims of the 600 patent are invalid. ( See D.I. 9, 14; D.I. 57 (hereinafter, "Tr.") at 7-9)

The United States District Court for the District of Massachusetts later transferred to this Court the case in which Plaintiffs alleged infringement of the 054 patent and the 597 patent; that matter became Civil Action No. 14-846-LPS-CJB in this District. (D.I. 39, Civil Action No. 14-846-LPS-CJB) It was consolidated for scheduling purposes with the instant case and a third case, Civil Action No. 14-109-LPS (a case in which Plaintiffs brought an action against Defendant Gilead Pharmasset LLC challenging a decision of the Patent Trial and Appeal Board of the United States Patent and Trademark Office ("PTO"), pursuant to 25 U.S.C. § 146, regarding a related interference action). (D.I. 42; D.I. 1, Civil Action No. 14-109-LPS) The transfer of now Civil Action No. 14-846-LPS-CJB has mooted some arguments previously pressed by Plaintiffs in the Motion, but the remaining issues are ripe for resolution.[1]

II. DISCUSSION

The parties have three separate remaining disputes that implicate the Counts referenced above, which the Court will address in turn.

A. Whether Counts 5-8 Should Be Dismissed For Lack of Subject Matter Jurisdiction

Plaintiffs assert that Counts 5-8 (involving counterclaims seeking a declaratory judgment of non-infringement and invalidity of the 038 patent and the 798 patent, respectively) should be dismissed for lack of subject matter jurisdiction, pursuant to Federal Rule of Civil Procedure 12(b)(1). (D.I. 14 at 13-16; D.I. 19 at 6-8)

In assessing a factual attack to subject matter jurisdiction, such as this one, the reviewing court is not confined to the allegations in the complaint, but instead can consider affidavits, depositions, testimony and other similar evidence in order to resolve factual issues bearing on jurisdiction. Gotha v. United States, 115 F.3d 176, 179 (3d Cir. 1997); Nexans Inc. v. Belden Inc., 966 F.Supp.2d 396, 401 (D. Del. 2013). In such a situation, no presumption of truthfulness attaches to the allegations, and the existence of disputed material facts will not preclude a trial court from evaluating for itself the merits of jurisdictional claims. Nexans Inc., 966 F.Supp.2d at 401.

The Declaratory Judgment Act requires that a "case of actual controversy" exist between the parties before a federal court may exercise jurisdiction. 28 U.S.C. § 2201(a). In determining whether there is subject matter jurisdiction over declaratory judgment claims, a court should ask "whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment." MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118, 127 (2007) (internal quotation marks and citation omitted) (noting that the Declaratory Judgment Act's requirement that a "case of actual controversy'" exist is a reference to the types of cases and controversies that are justiciable under Article III); see also Prasco, LLC v. Medicis Pharm. Corp., 537 F.3d 1329, 1334 (Fed. Cir. 2008). A case or controversy must be "based on a real and immediate injury or threat of future injury that is caused by the [counterclaim] defendants - an objective standard that cannot be met by a purely subjective or speculative fear of future harm." Prasco, LLC, 537 F.3d at 1339 (emphasis in original). Thus, in the patent context, "jurisdiction generally will not arise merely on the basis that a party learns of the existence of a patent owned by another or even perceives such a patent to pose a risk of infringement, without some affirmative act by the patentee." Id. (internal quotation marks and citation omitted).

A decision as to whether an actual controversy exists in the context of a patent declaratory judgment claim "will necessarily be fact specific and must be made in consideration of all the relevant circumstances." W.L. Gore & Assocs., Inc. v. AGA Med. Corp., Civil No. 11-539 (JBS-KMW), 2012 WL 924978, at *4 (D. Del. Mar. 19, 2012) (citing MedImmune, Inc., 549 U.S. at 127). The burden is on the party asserting declaratory judgment jurisdiction (here, Defendants) to establish the existence of an Article III case or controversy. Danisco U.S. Inc. v. Novozymes A/S, 744 ...


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