Case 1:18-cv-00303-RGA Document 54-2 Filed 10/12/18 Page 1 of 61 PageID #: 1147
`Case 1:18—cv—00303-RGA Document 54-2 Filed 10/12/18 Page 1 of 61 PageID #: 1147
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`EXHIBIT 2
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`EXHIBIT 2
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`Case 1:18-cv-00303-RGA Document 54-2 Filed 10/12/18 Page 2 of 61 PageID #: 1148
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`BAXTER HEALTHCARE CORPORATION,
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` Plaintiff,
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`v.
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`HOSPIRA, INC. and ORION CORP.,
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` Defendants.
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`)
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`)
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`)
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`C.A. No. 18-303-RGA
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`(PROPOSED) FIRST AMENDED COMPLAINT
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`Plaintiff Baxter Healthcare Corporation (“Baxter”), through counsel, hereby brings files its
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`First Amended Complaint for Declaratory Judgment against Hospira, Inc. (“Hospira”) and Orion
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`Corp. (“Orion”) (collectively, “Defendants”), and alleges as follows:
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`I.
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`NATURE OF THE SUIT
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`1. This is a declaratory judgment action seeking a declaration of non-infringement of
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`United States Patent Nos. 6,716,867 (the “’867 Patent”), 8,242,158 (the “’158 Patent”), 8,338,470
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`(the “’470 Patent”), and 8,455,527 (the “’527 Patent”) (collectively, “the Patents-in-Suit”) to
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`enable Baxter to bring its generic dexmedetomidine hydrochloride in 0.9% sodium chloride
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`injection 200 mcg/50 mL and 400 mcg/100mL (the “Baxter ANDA Product”) to market at the
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`earliest possible date under the applicable statutory and Food and Drug Administration (“FDA”)
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`regulatory provisions, and to allow the public to enjoy the benefits of generic competition for these
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`products.
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`1.
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`This is a civil action brought by Baxter against Defendants seeking declaratory
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`judgment, treble damages, and other relief for harms arising out of Defendants’ unlawful misuse
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`of an invalid patent. United States Patent No. 6,716,867 (the “’867 Patent”) is invalid as obvious,
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`as originally determined by the United States District Court for the District of New Jersey in Civil
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`1
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`Action No. 3:09-cv-04591 (2012). Despite the invalidity of the ’867 Patent, Defendants have
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`misused the ’867 Patent to unlawfully exclude generic competition from the market for
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`dexmedetomidine hydrochloride injection, 200 mcg base/50mL and 400 mcg base/100mL, a drug
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`manufactured and marketed by Defendants under the brand name Precedex. As alleged below,
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`Defendants devised a scheme using a variety of illegal and deceptive acts to unlawfully preclude
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`or delay generic competition for Precedex. Through these acts, Defendants have unlawfully
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`monopolized and attempted to monopolize the dexmedetomidine hydrochloride market in
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`violation of numerous antitrust laws, including but not limited to the Sherman Act, 15 U.S.C. § 2,
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`and the Clayton Act, 15 U.S.C. §§ 15 and 26.
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`2.
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`Specifically, Defendants have engaged in a pattern and scheme to abuse the patent
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`system and have engaged in sham litigation to restrain competition from Baxter and other generic
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`manufacturers of premix dexmedetomidine hydrochloride. Defendants’ unlawful conduct
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`includes, inter alia:
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`(a)
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`Conspiring to monopolize and restrain trade by entering into a settlement
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`agreement with Sandoz in Case No. 3:09-cv-04591 (D.N.J.) to vacate the district court’s judgment
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`declaring the ’867 Patent invalid. Vacatur of this judgment through settlement enabled Defendants
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`to improperly manipulate the use codes for the ’867 Patent and to continue monopolizing the
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`dexmedetomidine hydrochloride market by asserting against Baxter and other generic
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`manufacturers a patent that they knew was invalid. The vacatur occurred after a full bench trial on
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`the merits and while the case was awaiting oral argument at the United States Court of Appeals
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`for the Federal Circuit;
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`(b)
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`Continuing to list the ’867 Patent in the Orange Book despite knowledge of
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`the patent’s fraudulent procurement and invalidity;
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`2
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`(c)
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`Misrepresenting and improperly altering the use code for the ’867 Patent to
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`preclude generic competition despite knowing that the claims in the ’867 Patent do not extend to
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`the new use code;
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`(d)
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`Asserting the ’867 Patent against Baxter despite knowing that this patent is
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`unenforceable and invalid as obvious, and that the patent was obtained through fraudulent
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`misrepresentations; and
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`(e)
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`Filing a sham counterclaim against Baxter for infringement of the ’867
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`Patent, despite knowing that such claim is objectively baseless, asserted in bad faith, and brought
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`for an anti-competitive purpose in violation of § 2 of the Sherman Act (as interpreted in Handgards
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`Inc. v. Ethicon Inc., 743 F.2d 1282 (9th Cir. 1984)) to unlawfully restrain competition in a relevant
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`market causing antitrust injury to Baxter and other generic premix dexmedetomidine
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`hydrochloride manufacturers.
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`3.
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`Baxter seeks judgment, damages, injunctive, and other relief for Defendants’
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`unlawful conduct with respect to the ’867 Patent and monopolization of the market for premix
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`dexmedetomidine hydrochloride injection.
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`II.
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`THE PARTIES
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`4.
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`2. Baxter Healthcare Corporation is a corporation incorporated in Delaware with
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`its principal place of business at One Baxter Parkway, Deerfield, IL 60015.
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`5.
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`3. Upon information and belief, Hospira, Inc. is a Delaware corporation with its
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`principal place of business at 275 North Field Drive, Lake Forest, Illinois 60045.
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`6.
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`4. Upon information and belief, Orion Corp. is a corporation organized under the
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`laws of Finland with its principal place of business at Orionintie 1, FIN-02200 Espoo, Finland.
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`3
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`III.
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`JURISDICTION, AND VENUE AND JOINDER
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`7.
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`5. This First Amended Complaint arises under the Patent Laws of the United States,
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`35 U.S.C. §§ 100 et seq.;, the antitrust laws of the United States, 15 U.S.C. § 2, the Declaratory
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`Judgment Act, 28 U.S.C. §§ 2201 and 2202;-02, and the Federal Food, Drug and Cosmetic Act,
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`21 U.S.C. §§ 301 et seq., as amended by the Drug Price Competition and Patent Term Restoration
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`Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984 (codified as amended at 21 U.S.C. § 355))
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`(the “Hatch-Waxman Amendments”), and the Medicare Prescription Drug, Improvement and
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`Modernization Act of 2003, Pub. L. No. 108-173, 17 Stat. 2066 (2003) (the “MMA”), based upon
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`an actual controversy between the parties to declare that Baxter is free, upon approval by the FDA,
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`to manufacture, use, market, sell, offer to sell, and/or import its proposed product as described in
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`Abbreviated New Drug Application (“ANDA”) No. 208532.
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`8.
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`6. This Court has original subject matter jurisdiction over Baxter’s claims under
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`28 U.S.C. §§ 1331 and 1338, 1337(a), and 1338, and 15 U.S.C. § 15.
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`9.
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`7. Venue is proper in this District pursuant to 28 U.S.C. § 1391 and 1400(b) and 15
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`U.S.C. § 22, at least because Hospira resides in this District within the meaning of 28 U.S.C. §
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`1400(b)and the Court may exercise personal jurisdiction over Hospira.
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`10.
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`8. This Court has personal jurisdiction over Hospira because, among other things,
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`Hospira is a Delaware corporation, that, having availed itself of Delaware’s corporate laws, is
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`subject to personal jurisdiction in Delaware.
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`11.
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`Hospira is also engaged in the sale of Precedex in interstate commerce and in this
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`judicial District.
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`12.
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`9. This Court has personal jurisdiction over Orion because, among other things, on
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`information and belief, Orion does business in this District by co-owning a patent covering
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`4
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`Precedex® (i.e., the ’867 Patent), exclusively licensing in the United States its ownership interest
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`in said that patent to Hospira—a Delaware corporation—and receiving royalty payments from
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`Hospira for the sale of Precedex®, which is sold in Delaware.
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`13.
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`10. This Court also has personal jurisdiction over Orion because Orion has regularly
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`and purposefully availed itself of the privileges and benefits of this forum, having brought multiple
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`suits in this District, including suits specifically alleging infringement of the ’867 Patent at issue
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`in this suit: Hospira, Inc. and& Orion Corp. v. Sandoz International Int’l GmbH, et al., Civ. No.
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`09-00665 (D. Del.); Hospira, Inc. and& Orion Corp. v. Aurobindo Pharma Ltd., atet al., Civ. No.
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`14-00486 (D. Del.); Hospira, Inc. and& Orion Corp. v. Ben Venue Labs, Inc., Civ. No. 14-00487
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`(D. Del.); Hospira, Inc. and& Orion Corp. v. Actavis LLC et. al., Civ. No. 14-00488 (D. Del.);
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`Hospira, Inc. and& Orion Corp. v. Ben Venue Labs., Inc., et al., Civ. No. 14-1008 (D. Del.).
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`14.
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`11. Upon information and belief, the license agreement between Orion and Hospira
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`imposes an obligation on obliges Orion to participate in the enforcement or defense of the ’867
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`paten tPatent with Hospira, which is engaged in exploiting the patent rights in Delaware through
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`its sale of Precedex®.
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`15.
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`12. By virtue of its repeated assertion of By repeatedly asserting infringement of
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`the ’867 Patent in this District, Orion has waived any argument that it is not subject to specific
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`personal jurisdiction in this District for actions relating to the infringement thereof’867 Patent.
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`16.
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`13. Venue is proper in this district for Orion pursuant to 28 U.S.C. §§ 1391(b) and
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`1400(b) and 15 U.S.C. § 22 because, inter alia, Orion is a corporation organized and existing under
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`the laws of Finland and is subject to personal jurisdiction in this judicial distric tDistrict.
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`THE PATENTS-IN-SUIT
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`IV.
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`FACTUAL BACKGROUND
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`A.
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`The ’867 Patent
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`5
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`17.
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`14. On its face, the ’867 Patent, entitled “Use of Dexmedetomidine for ICU
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`Sedation,” indicates it was issued by the U.S. Patent and Trademark Office (“PTO”) on April 6,
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`2004. A copy of the ’867 Patent is attached as Exhibit A.
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`18.
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`15. According to records at the U.S. Patent and Trademark Office PTO, Hospira
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`and Orion are co-assignees of the ’867 Patent.
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`19.
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`16. On information and belief, Hospira is the exclusive licensee in the United States
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`of Orion’s interest in the ’867 Patent.
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`20.
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`21.
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`22.
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`17. The ’867 Patent contains twelve claims.
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`18. The ’867 Patent contains two independent claims.
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`19. Each independent claim of the ’867 Patent recites “[a] method of sedating a
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`patient in an intensive care unit.”, which comprises administering to the patient an effective
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`amount of dexmedetomidine or a pharmaceutically acceptable salt therefor, wherein the patient
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`remains arousable and orientated.” (emphasis added).
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`23.
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`20. The ’867 Patent’s ten dependent claims incorporate the limitations of the claims
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`from which they depend. Thus, all claims of the ’867 Patent require “[a] method of sedating a
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`patient in an intensive care unit.”
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`24.
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`No portion of the ’867 Patent claims any method of use relating to administering
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`the drug to patients in surgical or other procedures.
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`B.
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`Statutory and Regulatory Background
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`25.
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`The Food and Drug Administration (“FDA”) regulates the approval, manufacture,
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`and commercial sale of pharmaceuticals in the United States pursuant to the Federal Food, Drug
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`and Cosmetic Act, 21 U.S.C. §§ 301 et seq. (the “Act”). Under the Act, a manufacturer who creates
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`a new, pioneer drug must obtain the approval of FDA to sell the new drug by filing a New Drug
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`6
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`Application (“NDA”). An NDA must include specific data concerning the safety and efficacy of
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`the drug, as well as any information on applicable patents. A manufacturer may only promote a
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`drug for uses that are approved by FDA.
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`26.
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`In 1984, Congress passed the Hatch-Waxman Amendments to the Act, which
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`permit a generic drug manufacturer to file an Abbreviated New Drug Application (“ANDA”) that
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`expedites the drug approval process. Rather than go through full clinical trials, as a branded drug
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`is required to undertake, an ANDA filer need only show that its drug is bioequivalent (as defined
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`by FDA) to a branded drug that FDA has already approved.
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`27.
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`Section 355(b)(1) of Title 21 of the United States Code mandates that the sponsor
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`of a branded drug submit in its NDA “the patent number and the expiration date of any patent
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`which claims the drug for which the [brand] submitted the [NDA] or which claims a method of
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`using such drug.” 21 U.S.C. § 355(b)(1). Once an NDA is approved, the brand company provides
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`the following information: (1) whether the patent claims one or more approved methods of using
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`the drug product for which use approval is being sought and a description of each pending method
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`of use or related indication and related patent claim of the patent being submitted; and (2)
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`identification of the specific section of the approved labeling for the drug product that corresponds
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`to the method of use claimed by the patent submitted. 21 C.F.R. § 314.53(c)(2)(ii)(P), (b)(1).
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`28.
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`This patent description submitted by the brand company is known as a “use code.”
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`See 21 C.F.R. § 314.53(c)(2)(ii)(P)(3), (e). The brand company must attest under penalty of perjury
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`that its submission of the patent information, including the use code, to FDA is “true and correct.”
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`Id. § 314.53(c)(2)(ii)(R). FDA does not attempt to verify the accuracy of the use codes that brand
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`companies supply, but relies on the certification of the brand company for its accuracy and
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`specificity, and simply publishes the codes, along with the corresponding patent numbers and
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`7
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`expiration dates, in a publication entitled “Approved Drug Products with Therapeutic Equivalence
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`Evaluations,” known as the “Orange Book.” 21 U.S.C. § 355(j)(7)(A)(iii).
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`29.
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`To obtain FDA approval of an ANDA (and thus the right to sell a generic version
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`of a brand-name drug), a generic manufacturer must certify that the generic drug addressed in its
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`ANDA does not violate any patent listed in the Orange Book as claiming the brand-name drug.
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`30.
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`If an ANDA applicant seeks approval to market a drug for which one or more
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`method-of-use patents are listed in the Orange Book but does not seek approval for uses claimed
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`by such patents, the ANDA may include a “section viii” statement to that effect. 21 U.S.C.
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`§ 355(j)(2)(A)(viii). With a section viii statement, the ANDA applicant must “carve out” all
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`references to the patented uses from its proposed label. FDA will not accept a section viii statement
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`if the ANDA applicant’s proposed label contains the use identified in the description in the use
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`code. The existence of method-of-use patents claiming uses omitted from the proposed label will
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`thus not act as a barrier to FDA’s approval of the ANDA. Alternatively, the ANDA applicant may
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`address the method-of-use patent with a certification of noninfringement or invalidity under 21
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`U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”), in which event the filing of an
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`infringement suit by the reference listed drug holder would delay FDA approval.
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`31.
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`ANDA applicants are not subject to any 30-month stay of approval, or any 180-day
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`exclusivity period, with respect to any patent(s) addressed via a section viii statement.
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`C.
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`Hospira’s NDA And The ’158867 Patent
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`32.
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`Hospira first began marketing Precedex in 1999, following FDA approval of its
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`New Drug Application No. 021038 for dexmedetomidine hydrochloride, a sedative delivered by
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`injection. When approved in 1999, the only available form of Precedex was a concentrate that
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`required dilution before administration.
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`8
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`33.
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` Two “ready to use” (“premix”) forms of Precedex were approved in supplements
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`to NDA No. 021038 in March 2013, and a third was approved in November 2014.
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`34.
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`As approved by FDA on December 17, 1999, NDA No. 021038 permitted Precedex
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`to be used for the sedation of initially intubated and mechanically ventilated patients in an intensive
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`care unit (“ICU”) setting (the “ICU Indication”). Hospira subsequently obtained FDA approval for
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`a second indication involving sedation of non-intubated patients prior to and/or during surgical
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`and other procedures (the “Procedural Indication”).
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`35.
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`In connection with NDA No. 021038, Hospira certified that the ’867 Patent, U.S.
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`Patent No. 5,344,840 (the “’840 Patent”), and U.S. Patent No. 4,910,214 (the “’214 Patent”) all
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`claimed either Precedex or a method of use for Precedex. As a result, FDA listed these patents in
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`the Orange Book.
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`36.
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`According to the Orange Book, the ’840 Patent expired on September 6, 2011, and
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`the ’214 Patent expired on July 15, 2013, with an associated pediatric exclusivity period expiring
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`on January 15, 2014.
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`37.
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`The ’867 Patent is the only unexpired patent listed in the Orange Book for the
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`concentrate form of Precedex and is among the patents listed for the premix forms of Precedex.
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`21. On its face the ’158 Patent, entitled “Dexmedetomidine Premix Formulation,” indicates
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`it was issued by the U.S. Patent and Trademark Office on August 14, 2012. A copy of the ’158
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`Patent is attached as Exhibit B.
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`22. The ’158 Patent issued from application number 13/343,672 (the “’672 Application”).
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`23. According to records at the U.S. Patent and Trademark Office, Hospira is the assignee
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`of the ’158 Patent.
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`24. The ’158 Patent contains four claims.
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`9
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`25. The ’158 Patent contains one independent claim.
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`26. The independent claim of the ’158 Patent recites “[a] ready to use liquid pharmaceutical
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`composition . . . disposed within a sealed glass container.”
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`27. The ’158 Patent’s three dependent claims incorporate the limitations of the claims from
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`which they depend. Thus, all claims of the ’158 Patent require “[a] ready to use liquid
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`pharmaceutical composition . . . disposed within a sealed glass container.”
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`28. When the ’672 Application was initially filed, its claims did not require that the sealed
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`container be made of glass.
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`29. On March 13, 2012, in response to an office action rejecting the originally-filed claims
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`of the ’672 Application, Hospira amended the sole pending independent claim to include the
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`present requirement that the sealed container be “a sealed glass container.”
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`30. In its March 13, 2012 filing with the U.S. Patent and Trademark Office, Hospira argued
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`that it discovered that using glass containers resulted in unexpectedly superior stability compared
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`to using plastic containers. Response to Office Action, at 7-8 (Mar. 13, 2012) (arguing it was
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`surprising that “a 4µg/mL premixture formulation stored in glass vials and ampoules maintained
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`a higher level of potency after a 5 month storage period compared to storage in plastic, CR3, or
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`PVC containers”).
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`31. On April 18, 2012, the U.S. Patent and Trademark Office issued a notice of allowance
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`for the ’672 Application. In this notice, the examiner stated that “requiring the composition to be
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`disposed within a sealed glass container[] was effective to overcome the previous rejection under
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`35 U.S.C[. §] 102(b).” Notice of Allowance, ¶ 3 (Apr. 18, 2012)
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`32. The specification of the ’158 Patent discloses plastic as an alternative material for the
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`container:
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`10
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`In certain non-limiting embodiments, the container or vessel includes, but
`is not limited to glass vials (for example, but not limited to, flint glass vials),
`ampoules, plastic flexible containers, for example, but not limited to, PVC
`(polyvinyl chloride) containers, VisIV™ plastic containers (Hospira, Inc.,
`Lake Forest, Ill.) and CR3 elastomer copolyester ether containers (Hospira,
`Inc., Lake Forest, Ill.), CZ resin containers, poly propylene containers and
`syringes.
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`’158 Patent at 9:17-24.
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`33. No claims of the ’158 Patent cover a ready to use liquid pharmaceutical composition
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`for parenteral administration to a subject, comprising dexmedetomidine or a pharmaceutically
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`acceptable salt thereof at a concentration of about 4 μg/mL disposed within a sealed plastic
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`container.
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`34. On February 6, 2018, the Honorable Richard G. Andrews of the United States District
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`Court for the District of Delaware entered a final judgment in the action Hospira, Inc. v. Amneal
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`Pharmaceuticals LLC, Civ. No. 1:15-cv-00697-RGA (the “Amneal Judgment”), invalidating
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`claims 3 and 4 of the ’158 Patent for obviousness. Because claims 3 and 4 depend from claims 1
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`and/or 2, a Court would likewise properly find claims 1 and 2 also invalid.
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`The ’470 Patent
`35. On its face the ’470 Patent, entitled “Dexmedetomidine Premix Formulation,” indicates
`
`it was issued by the U.S. Patent and Trademark Office on December 25, 2012. A copy of the ’470
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`Patent is attached as Exhibit C.
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`36. The ’470 Patent issued from application number 13/541,524 (the “’524 Application”).
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`37. According to records at the U.S. Patent and Trademark Office, Hospira is the assignee
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`of the ’470 Patent.
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`38.
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`The ’470 Patent contains seven claims867 Patent expires on March 31, 2019, and
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`an associated pediatric exclusivity period will expire on October 1, 2019.
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`11
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`D.
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`39. The ’470867 Patent contains one independent claim. Has Been Adjudicated to Be
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`Invalid
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`39.
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`Based upon information from prior proceedings, Sandoz Inc. submitted the first
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`ANDA for generic dexmedetomidine injection, 100 mcg base/mL (ANDA No. 091465) on April
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`7, 2009. ANDA No. 091465 was for a generic version of Precedex concentrate, not Precedex
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`premix.
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`40.
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`Defendants asserted the ’214 Patent and ’867 Patent against Sandoz International
`
`GmbH and Sandoz Inc. in response to Sandoz’s filing of ANDA No. 091465. See Hospira, Inc. &
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`Orion Corp. v. Sandoz Int’l GmbH et al., No. 3:09-cv-04591 (D.N.J.).
`
`41.
`
`On April 30, 2012, Judge Cooper, following a full bench trial, held the ’867 Patent
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`obvious under 35 U.S.C. § 103 and therefore invalid. Upon consideration of the Graham factors,
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`the court concluded that all claims of the ’867 Patent “would have been obvious to a person of
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`ordinary skill in the art by 1998.” ECF No. 380, at 61-62, Case No. 3:09-cv-04591 (May 4, 2012).
`
`42.
`
`Specifically,
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`the district court found
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`that “[t]he prior art
`
`taught
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`that
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`dexmedetomidine sedated patients in a dose-dependent manner but that those patients were easily
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`awakened and could participate in study assessments (i.e., they were orientated). Moreover, this
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`effect was seen not only in healthy patients but in sick patients awaiting major vascular surgery.
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`Therefore, a person of ordinary skill in the art would have had a reasonable expectation of success
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`in achieving and maintaining arousable sedation in intensive care patients.” Id. at 73. In summary,
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`the court noted that it “finds clear and convincing evidence that a person of ordinary skill in 1998
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`would have thought the ’867 Patent subject matter as a whole obvious in light of the prior art.” Id.
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`at 75. The court issued this ruling even after expressly considering the high burden of proof Sandoz
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`12
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`had to meet. Id. Indeed, the court stated that to find the ’867 Patent nonobvious would necessitate
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`deviating from Supreme Court precedent. Id.
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`43.
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`After the district court’s judgment of invalidity, Hospira negotiated with Sandoz
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`and induced Sandoz to drop its suit in exchange for Hospira permitting Sandoz to enter the market
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`with is generic dexmedetomidine product on December 26, 2014. (Hospira, Inc. 2013 10-K at 15.)
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`In exchange for this early entry, Hospira requested Sandoz to join it in moving the district court to
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`vacate the invalidity judgment in December 2013. This allowed Sandoz to share in the exclusivity
`
`of the ’867 Patent and enjoy a period as the sole generic dexmedetomidine product. The district
`
`court granted the parties’ motion.
`
`44.
`
`Hospira sought to vacate the district court’s invalidity judgment to maintain an
`
`illegal and anticompetitive monopoly on dexmedetomidine hydrochloride.
`
`45.
`
`Even though the ’867 Patent had been adjudicated to be invalid, and even though
`
`Hospira never obtained a reversal of that adjudication on the merits, Hospira continued to maintain
`
`the patent listed in the Orange Book to preclude generic competition.
`
`46.
`
`Hospira further has continued to assert the ’867 Patent against Baxter and other
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`generic dexmedetomidine hydrochloride manufacturers to prevent these manufacturers from
`
`entering the market.
`
`40. The independent claim of the ’470 patent recites “[a] ready to use liquid pharmaceutical
`
`composition . . . disposed within a sealed glass container.”
`
`41. The ’470 Patent’s six dependent claims incorporate the limitations of the claims from
`
`which they depend. See 35 U.S.C. § 112(d). Thus, all claims of the ’470 Patent require “[a] ready
`
`to use liquid pharmaceutical composition . . . disposed within a sealed glass container.”
`
`13
`
`

`

`Case 1:18-cv-00303-RGA Document 54-2 Filed 10/12/18 Page 15 of 61 PageID #: 1161
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`42. On August 17, 2012, the U.S. Patent and Trademark Office issued an office action
`
`rejecting all pending claims of the ’524 Application as obvious.
`
`43. On September 17, 2012, Hospira responded to the rejection, arguing that using glass
`
`containers resulted in unexpectedly superior stability compared to using plastic containers.
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`Response to Office Action, at 6 (Sept. 17, 2012) (arguing it was surprising that “a 4µg/mL
`
`premixture formulation stored in glass vials and ampoules maintained a higher level of potency
`
`after a 5 month storage period compared to storage in plastic, CR3, or PVC containers”); Decl. of
`
`Huailiang Wu, Ph.D., ¶ 13 (Sept. 17, 2012) (“[S]toring a ready to use formulation of
`
`dexmedetomidine at concentrations recited by the claims of the ’524 application in glass containers
`
`resulted in an unexpected reduction in potency loss of the composition compared to storage in
`
`plastic PVC containers.”).
`
`44. On October 22, 2012, the U.S. Patent and Trademark Office issued a notice of
`
`allowance for the ’524 Application. In this notice, the examiner credits Hospira’s arguments that
`
`dexmedetomidine formulations stored in glass containers exhibit unexpectedly better stability than
`
`those stored in plastic. Notice of Allowance, ¶ 3 (Oct. 22, 2012) (crediting Hospira’s argument
`
`that “the Specification demonstrates that a dexmedetomidine 4µg/mL formulation ‘stored in glass
`
`vials and ampoules maintained a higher level of potency after a 5 month storage period compared
`
`to storage in plastic, CR3 or PVC containers,’” as well as “the Declaration of Huailang Wu
`
`provided by Applicants [which] provides further evidence of the surprising increase in stability of
`
`dexmedetomidine compositions (1, 10, 15 and 50 µg/ml) stored in sealed glass containers
`
`compared to storage in PVC bags.”).
`
`45. The specification of the ’470 Patent discloses plastic as an alternative material for the
`
`container:
`
`14
`
`

`

`Case 1:18-cv-00303-RGA Document 54-2 Filed 10/12/18 Page 16 of 61 PageID #: 1162
`
`In certain non-limiting embodiments, the container or vessel includes, but
`is not limited to glass vials (for example, but not limited to, flint glass vials),
`ampoules, plastic flexible containers, for example, but not limited to, PVC
`(polyvinyl chloride) containers, VisIV™ plastic containers (Hospira, Inc.,
`Lake Forest, Ill.) and CR3 elastomer copolyester ether containers (Hospira,
`Inc., Lake Forest, Ill.), CZ resin containers, poly propylene containers and
`syringes.
`
`’470 Patent at 9:22-29.
`
`46. No claims of the ’470 Patent cover a ready to use liquid pharmaceutical composition
`
`for parenteral administration to a subject, comprising dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof at a concentration of about 4 μg/mL disposed within a sealed plastic
`
`container.
`
`47. On February 6, 2018, the Honorable Richard G. Andrews of the United States District
`
`Court for the District of Delaware entered the Amneal Judgment, invalidating claim 4 of the ’470
`
`Patent for obviousness. Because claim 4 depends from claim 1, a Court would likewise properly
`
`find at least claim 1 also invalid.
`
`E.
`
`The ’527867 Patent Use Code Amendment
`
`48. On its face the ’527 Patent, entitled “Methods of Treatment Using a Dexmedetomidine
`
`Premix Formulation,” indicates it was issued by the U.S. Patent and Trademark Office on June 4,
`
`2013. A copy of the ’527 Patent is attached as Exhibit D.
`
`49. The ’527 Patent issued from application number 13/678,148 (the “’148 Application”).
`
`50. According to records at the U.S. Patent and Trademark Office, Hospira is the assignee
`
`of the ’527 Patent.
`
`51. The ’527 Patent contains fifteen claims.
`
`52. The ’527 Patent contains one independent claim.
`
`53. The independent claim of the ’527 Patent recites a method of using “a ready to use
`
`liquid pharmaceutical composition . . . disposed within a sealed glass container.”
`
`15
`
`

`

`Case 1:18-cv-00303-RGA Document 54-2 Filed 10/12/18 Page 17 of 61 PageID #: 1163
`
`54. The ’527 Patent’s fourteen dependent claims incorporate the limitations of the claims
`
`from which they depend. Thus, all claims of the ’527 Patent require “a ready to use liquid
`
`pharmaceutical composition . . . disposed within a sealed glass container.”
`
`55. In the November 15, 2012 Accelerated Examination Support Document, filed
`
`concomitantly with the ’148 Application, Hospira argues that using glass containers resulted in
`
`unexpectedly superior stability compared to using plastic containers. Accelerated Examination
`
`Support Document, at 46 (Nov. 15, 2012) (arguing that it was unexpected that “when stored in
`
`glass vials or ampoules, the ready to use liquid pharmaceutical composition maintained over 98%
`
`potency after 5 months,” but “when stored in plastic or PVC containers, which include plastic
`
`syringes and plastic bags, the potency was reduced by as much as 20% after only a two-week
`
`storage period.”).
`
`56. On January 11, 2013, the U.S. Patent and Trademark Office issued a notice of
`
`allowance for the ’148 Application. In this notice, the examiner “concur[red] with [Hospira’s]
`
`detailed explanation of patentability as set forth at pages 44-73 of the Examination Support
`
`Document filed by [Hospira] on 11/15/2008 [sic, 2012].” Notice of Allowance, supra, ¶ 3.
`
`57. The specification of the ’527 Patent discloses plastic as an alternative material for the
`
`container:
`
`In certain non-limiting embodiments, the container or vessel includes, but
`is not limited to glass vials (for example, but not limited to, flint glass vials),
`ampoules, plastic flexible containers, for example, but not limited to, PVC
`(polyvinyl chloride) containers, VisIV™ plastic containers (Hospira, Inc.,
`Lake Forest, Ill.) and CR3 elastomer copolyester ether containers (Hospira,
`Inc., Lake Forest, Ill.), CZ resin containers, poly propylene containers and
`syringes.
`
`’527 Patent at 9:22-29.
`
`58. No claims of the ’527 Patent cover methods of using a ready to use liquid
`
`pharmaceutical composition
`
`for parenteral administration
`
`to a
`
`subject, comprising
`
`16
`
`

`

`Case 1:18-cv-00303-RGA Document 54-2 Filed 10/12/18 Page 18 of 61 PageID #: 1164
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 4
`
`μg/mL disposed within a sealed plastic container.
`
`59. On February 6, 2018, the Honorable Richard G. Andrews of the United States District
`
`Court for the District of Delaware entered the Amneal Judgment, invalidating claim 5 of the ’527
`
`Patent. Because claim 5 depends from claims 1, a Court would likewise properly find at least
`
`claim 1 also invalid.
`
`BACKGROUND
`
`60. In December 2003, Congress passed the Medicare Modernization Act of 2003 (the
`
`“MMA”). Title XI of that Act, entitled “Access to Affordable Pharmaceuticals,” included a
`
`provision allowing an ANDA app