Case 1:14-cv-00984-RGA Document 10 Filed 09/24/14 Page 1 of 5 PageID #: 41
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`IMPAX LABORATORIES, INC. and
`ASTRAZENECA AB,
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`Plaintiffs,
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`v.
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`LANNETT HOLDINGS, INC., and
`LANNETT COMPANY, INC.,
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`Defendants.
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`C.A. No. 1:14-cv-984 (RGA)
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`OPENING MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF
`LANNETT HOLDINGS, INC. AND LANNETT COMPANY, INC.’S RULE 12(b)(1)
`MOTION TO DISMISS FOR LACK OF SUBJECT MATTER JURISDITION
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` FOX ROTHSCHILD LLP
`Seth A. Niederman, Esquire (#4588)
`Austen C. Endersby, Esquire (#5161)
`Citizens Bank Center
`919 North Market Street, Suite 300
`Wilmington, DE 19801
`(302) 654-7444
`sniederman@foxrothschild.com
`aendersby@foxrothschild.com
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`Attorneys for Defendants Lannett Holdings,
`Inc. and Lannett Company, Inc.
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`Of Counsel:
`Joseph F. Posillico, Esq.
`FOX ROTHSCHILD LLP
`2000 Market Street, 20th Floor
`Philadelphia, PA 19103-3222
`(215) 299-2000
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`Dated: September 24, 2014
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`ACTIVE 27525213v2 09/24/2014
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`Page 1 of 5
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`AstraZeneca Exhibit 2008
`Lannett v. AstraZeneca
`IPR2015-01629
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`Case 1:14-cv-00984-RGA Document 10 Filed 09/24/14 Page 2 of 5 PageID #: 42
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`Pursuant to Fed. R. Civ. P. 12(b)(1), Defendants Lannett Holdings, Inc. and Lannett
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`Company, Inc. (collectively “Lannett”), by counsel, hereby move to dismiss the above-captioned
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`action for lack of subject matter jurisdiction.
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`I.
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`Nature and Stage of the Proceedings
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`By virtue of the Complaint filed in the above-captioned case, Plaintiffs have brought an
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`action against Lannett for alleged infringement of U.S. Patent Nos. 6,750,237 (“the ’237
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`patent”) and 7,220,767 (“the ’767 patent”) (hereinafter “the First Action.”).
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`The allegations of infringement in the First Action are based upon the submission to the
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`U.S. Food and Drug Administration (“FDA”) by Lannett Holdings of Abbreviated New Drug
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`Application No. 206350 (the “Lannett ANDA”).
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`According to the Complaint in the First Action, “AstraZeneca AB is the owner by
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`assignment of the ’767 patent and has the right to sue for infringement thereof.” See D.I. 1
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`at ¶ 26.
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`According to the Complaint in the First Action, “AstraZeneca AB is the owner by
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`assignment of the ’237 patent and has the right to sue for infringement thereof.” See D.I. 1
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`at ¶ 27.
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`On July 30, 2014, a second Complaint for patent infringement was filed on behalf of the
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`same two Plaintiffs in the First Action and an additional plaintiff, namely, AstraZeneca UK
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`Limited and has been docketed as 1:14-cv-00999 (hereinafter the “Second Action”).
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`The allegations of infringement in the Second Action are based upon the same Lannett
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`ANDA and the same patents, namely the ‘237 patent and ‘767 patent, as in the First Action.
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`The Complaint in the Second Action differs from the First Action, inter alia, in the
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`identification of the ownership of the patents. Specifically, in the Second Action the Plaintiffs
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`state “AstraZeneca AB and AstraZeneca UK Limited own all rights, title, and interest in
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`Page 2 of 5
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`Case 1:14-cv-00984-RGA Document 10 Filed 09/24/14 Page 3 of 5 PageID #: 43
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`the ’237 patent and have the right to sue for infringement thereof.” See C.A. No. 14-999,
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`D.I. 1 at ¶ 25 (emphasis added). Similarly, in the Second Action, the Plaintiffs state
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`“AstraZeneca AB and AstraZeneca UK Limited own all rights, title, and interest in the
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`’767 patent and have the right to sue for infringement thereof.” See C.A. No. 14-999, D.I. 1
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`at ¶ 27 (emphasis added).
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`AstraZeneca UK Limited is not a party to the First Action.
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`II. Argument
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`A.
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`Legal Standards
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`Under Article III of the U.S. Constitution, a federal court does not have subject matter
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`jurisdiction to decide a claim unless there is an actual case or controversy between the parties,
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`and the court has either federal question jurisdiction or diversity jurisdiction over that case or
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`controversy. U.S. CONST. art. III, § 2, cl. 1; Warth v. Seldin, 422 U.S. 490, 498-502 (1975); 28
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`U.S.C. §§ 1331, 1332. Subject matter jurisdiction cannot be waived. Sosna v. Iowa, 419 U.S.
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`393, 398 (1975). Therefore, objections to subject matter jurisdiction may be raised at any time
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`during litigation and the Court is duty-bound to resolve the issue. Ins. Corp of Ireland v.
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`Compagnie des Bauxites de Guinee, 456 U.S. 694, 702 (1982).
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`Motions challenging subject matter jurisdiction under Fed. R. Civ. P. 12(b)(1) may
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`present either a facial or factual challenge. CNA v. U.S., 535 F.3d 132, 139 (3d Cir. 2008).
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`In reviewing a factual challenge to the Court’s subject matter jurisdiction, the Court is not
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`confined to the allegations of the Complaint, and no presumption of truthfulness attaches to
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`the plaintiff’s allegations. Id. at 145. Further, once the Court’s subject matter jurisdiction
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`over a Complaint is challenged, the plaintiff must bear the burden of persuasion and
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`establish that subject matter jurisdiction exists. Id.
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`3
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`Page 3 of 5
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`Case 1:14-cv-00984-RGA Document 10 Filed 09/24/14 Page 4 of 5 PageID #: 44
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`This Court has federal question jurisdiction over claims for patent infringement. 28
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`U.S.C. §1338(a) (“The district courts shall have original jurisdiction of any civil action arising
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`under any Act of Congress relating to patents.”).
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`There are two fundamental prerequisites to every patent infringement claim: (1) existence
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`of a valid and enforceable patent, and (2) a plaintiff who owns all substantial rights to that
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`patent. See 35 U.S.C. § 281 (“A patentee shall have remedy by civil action for infringement of
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`his patent.”) (emphasis added); Morrow v. Microsoft Corp., 499 F.3d 1332, 1339-40 (Fed. Cir.
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`2007) (discussing standing requirements in patent cases).
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`Standing is a constitutional requirement pursuant to Article III and it is a threshold
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`jurisdictional issue. Lujan v. Defenders of Wildlife, 504 U.S. 555, 560–61 (1992).
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`Relying on Supreme Court precedent, the Federal Circuit has held that “in a patent
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`infringement action, ‘the plaintiff must demonstrate that it held enforceable title to the patent at
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`the inception of the lawsuit’ to assert standing.” Abraxis Bioscience, Inc., v. Navinta, 625 F.3d
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`1359, 1364 (Fed. Cir. 2010) (citations omitted). Moreover, the Federal Circuit “has long
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`applied the rule that a patent co-owner seeking to maintain an infringement suit must join all
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`other co-owners.” STC.UNM v Intel Corp., 754 F.3d 940, 944 (Fed. Cir. 2014); see also
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`Ethicon, Inc. v. United States Surgical Corp., 135 F.3d 1456 (Fed. Cir. 1998) (holding that
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`when a patent is co-owned, a co-owner seeking to enforce the patent must join all other co-
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`owners as plaintiffs to establish standing and without this joinder, the plaintiff cannot pursue an
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`infringement suit).
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`B. By Judicial Admission in the Second Action, Plaintiffs have Conceded that Standing
`is Not Present in the First Action
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`Plaintiffs have admitted by virtue of judicial admission in the Second Action that not all
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`co-owners of the ‘237 patent and the ‘767 patent are named as plaintiffs in this case.
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`Page 4 of 5
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`Case 1:14-cv-00984-RGA Document 10 Filed 09/24/14 Page 5 of 5 PageID #: 45
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`Plaintiffs have stated in the Second Action that “AstraZeneca AB and AstraZeneca UK
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`Limited own all rights, title, and interest” in each of the patents-in-suit. See C.A. No. 14-
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`999, D.I. 1 at ¶¶ 25, 27. Although Lannett does not concede or in any sense admit that the
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`entire ownership is in fact present in the Second Suit, or that either of the Plaintiffs have an
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`ownership interest in the patents-in-suit, this statement by each of the plaintiffs in the
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`Second Action constitutes a judicial admission that at least one co-owner of each of the
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`patents is not a party to the First Action, namely, AstraZeneca UK Limited.
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`Since the Plaintiffs in this First Action have admitted that they do not constitute all of the
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`co-owners of the patents-in-suit, standing cannot be established, and therefore “… the plaintiff
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`cannot pursue [this] infringement suit.” STC.UNM, 754 F.3d at 944.
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`C. Conclusion
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`This Court lacks subject matter jurisdiction over the First Action and therefore the
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`Complaint in this case should be dismissed pursuant to Rule 12(b)(1).
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`Respectfully submitted,
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`FOX ROTHSCHILD LLP
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` /s/ Austen C. Endersby
`Seth A. Niederman, Esquire (#4588)
`Austen C. Endersby, Esquire (#5161)
`Citizens Bank Center
`919 North Market Street, Suite 300
`Wilmington, DE 19801
`(302) 654-7444
`sniederman@foxrothschild.com
`aendersby@foxrothschild.com
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`Attorneys for Defendants Lannett Holdings,
`Inc. and Lannett Company, Inc.
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`
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`Of Counsel:
`Joseph F. Posillico, Esq.
`FOX ROTHSCHILD LLP
`2000 Market Street, 20th Floor
`Philadelphia, PA 19103-3222
`(215) 299-2000
`
`
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`Dated: September 24, 2014
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`Page 5 of 5