Case 1:14-cv-00696-GMS Document 1 Filed 06/02/14 Page 1 of 13 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`Civil Action No. _____
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`ASTRAZENECA AB,
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`Plaintiff,
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`v.
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`MYLAN PHARMACEUTICALS, INC.,
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`
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`Defendants.
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`COMPLAINT
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`Plaintiff AstraZeneca AB (“AstraZeneca”), by its attorneys, hereby alleges as
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`follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement arising under the patent laws of the
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`United States, Title 35, United States Code, against Defendant Mylan Pharmaceuticals, Inc.
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`(“Mylan”). This action relates to Abbreviated New Drug Application (“ANDA”) Nos. 205980
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`and 205981 filed by Mylan with the U.S. Food and Drug Administration (“FDA”).
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`2.
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`In ANDA No. 205980, Mylan seeks approval to market 2.5 mg and 5 mg
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`saxagliptin hydrochloride tablets, generic versions of AstraZeneca’s ONGLYZA® drug product,
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`prior to expiration of RE44,186 (“the RE’186 patent”) and U.S. Patent No. 7,951,400 (“the ’400
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`patent”).
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`3.
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`In ANDA No. 205981, Mylan seeks approval to market 5 mg/500mg, 2.5
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`mg/1000 mg and 5 mg/1000 mg saxagliptin hydrochloride and metformin hydrochloride
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`ME1 17982829v.1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`Civil Action No. _____
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`
`
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`)
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`))
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`))))))))
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`ASTRAZENECA AB,
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`
`
`
`
`Plaintiff,
`
`v.
`
`
`MYLAN PHARMACEUTICALS, INC.,
`
`
`
`Defendants.
`
`COMPLAINT
`
`Plaintiff AstraZeneca AB (“AstraZeneca”), by its attorneys, hereby alleges as
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`follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement arising under the patent laws of the
`
`United States, Title 35, United States Code, against Defendant Mylan Pharmaceuticals, Inc.
`
`(“Mylan”). This action relates to Abbreviated New Drug Application (“ANDA”) Nos. 205980
`
`and 205981 filed by Mylan with the U.S. Food and Drug Administration (“FDA”).
`
`2.
`
`In ANDA No. 205980, Mylan seeks approval to market 2.5 mg and 5 mg
`
`saxagliptin hydrochloride tablets, generic versions of AstraZeneca’s ONGLYZA® drug product,
`
`prior to expiration of RE44,186 (“the RE’186 patent”) and U.S. Patent No. 7,951,400 (“the ’400
`
`patent”).
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`3.
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`In ANDA No. 205981, Mylan seeks approval to market 5 mg/500mg, 2.5
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`mg/1000 mg and 5 mg/1000 mg saxagliptin hydrochloride and metformin hydrochloride
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`extended-release tablets, generic versions of AstraZeneca’s KOMBIGLYZE™ XR drug product,
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`prior to expiration of the RE’186 patent and U.S. Patent No. 8,628,799 (“the ’799 patent”).
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`PARTIES
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`4.
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`Plaintiff AstraZeneca is a company operating and existing under the laws of
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`Sweden, with its principal place of business at S-151 85 Södertälje, Sweden.
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`5.
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`Plaintiff’s subsidiary, AstraZeneca Pharmaceuticals LP, is a limited partnership
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`operating and existing under the laws of Delaware, with its principal place of business at 1800
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`Concord Pike, Wilmington, Delaware 19803.
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`6.
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`AstraZeneca is engaged in the business of creating, developing, and bringing to
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`market revolutionary biopharmaceutical products to help patients prevail against serious
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`diseases, including treatments for Type II diabetes. Through its subsidiary, AstraZeneca
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`Pharmaceuticals LP, AstraZeneca markets and sells ONGLYZA® and KOMBIGLYZE™ XR in
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`this judicial district and throughout the United States.
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`7.
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`Upon information and belief, Mylan is a company organized and existing under
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`the laws of West Virginia, having a principal place of business at 781 Chestnut Ridge Road,
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`Morgantown, West Virginia 26505.
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`JURISDICTION AND VENUE
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`8.
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`This action arises under the patent laws of the United States, 35 U.S.C. §§ 100, et
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`seq., and this Court has jurisdiction over the subject matter of this action under 28 U.S.C.
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`§§ 1331, 1338(a), 2201 and 2202.
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`9.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b).
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`10.
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`This Court has jurisdiction over Mylan because, inter alia, this action arises from
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`actions of Mylan directed toward Delaware and because Mylan has purposefully availed itself of
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`the rights and benefits of Delaware law by engaging in systematic and continuous contacts with
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`Delaware. Mylan regularly and continuously transacts business within the State of Delaware,
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`including by selling pharmaceutical products in Delaware, either on its own or through its
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`affiliates. Upon information and belief, Mylan derives substantial revenue from the sale of those
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`products in Delaware and has availed itself of the privilege of conducting business within the
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`State of Delaware.
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`11. Mylan has previously been sued in this judicial district without objecting on the
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`basis of lack of personal jurisdiction and has availed itself of Delaware courts through the
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`assertion of counterclaims and by filing suits in Delaware.
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`12.
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`For these reasons, and for other reasons that will be presented to the Court if
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`jurisdiction is challenged, the Court has personal jurisdiction over Mylan.
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`PATENTS-IN-SUIT
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`13.
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`On April 30, 2013, the U.S. Patent and Trademark Office duly and legally
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`reissued the RE’186 patent, titled “Cyclopropyl-Fused Pyrrolidine-Based Inhibitors of
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`Dipeptidyl Peptidase IV and Method.” The RE’186 patent is a reissue of U.S. Patent No.
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`6,395,767 (“the ’767 patent”), which issued on May 28, 2002. A true and correct copy of the
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`RE’186 patent is attached hereto as Exhibit A. The claims of the RE’186 patent are valid and
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`enforceable. AstraZeneca is the owner of the RE’186 patent by assignment and has the right to
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`enforce it.
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`14.
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`On May 31, 2011, the U.S. Patent and Trademark Office duly and legally issued
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`the ’400 patent, entitled “Coated Tablet Formulation and Method.” A true and correct copy of
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`the ’400 patent is attached hereto as Exhibit B. The claims of the ’400 patent are valid and
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`enforceable. AstraZeneca is the owner of the ’400 patent by assignment and has the right to
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`enforce it.
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`15.
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`On January 14, 2014, the U.S. Patent and Trademark Office duly and legally
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`issued the ’799 patent, entitled “Coated Tablet Formulation and Method.” A true and correct
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`copy of the ’799 patent is attached hereto as Exhibit C. The claims of the ’799 patent are valid
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`and enforceable. AstraZeneca is the owner of the ’799 patent by assignment and has the right to
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`enforce it.
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`16.
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`AstraZeneca is the holder of New Drug Application (“NDA”) No. 022350, by
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`which the FDA granted approval for the marketing and sale of 2.5 mg and 5 mg strength
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`saxagliptin hydrochloride tablets as an adjunct to diet and exercise to improve glycemic control
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`in adults with type 2 diabetes mellitus in multiple clinical settings. AstraZeneca markets
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`saxagliptin hydrochloride tablets in the United States, through its Delaware subsidiary
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`AstraZeneca Pharmaceuticals LP, under the trade name “ONGLYZA®.” The FDA’s official
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`publication of approved drugs (the “Orange Book”) includes ONGLYZA® together with the
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`RE’186 and ’400 patents.
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`17.
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`AstraZeneca is the holder of New Drug Application (“NDA”) No. 200678 by
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`which the FDA granted approval for the marketing and sale of 5 mg/500 mg, 5 mg/1000 mg and
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`2.5 mg/1000 mg strength saxagliptin hydrochloride and metformin hydrochloride extended
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`release tablets as an adjunct to diet and exercise to improve glycemic control in adults with type
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`2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate.
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`AstraZeneca markets saxagliptin hydrochloride and metformin hydrochloride tablets in the
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`United States, through its Delaware subsidiary AstraZeneca Pharmaceuticals LP, under the trade
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`name “KOMBIGLYZE™ XR.”
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` The Orange Book
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`includes 5 mg/500 mg strength
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`KOMBIGLYZE™ XR together with the RE’186 and ’799 patents. The Orange Book includes 5
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`mg/1000 mg and 2.5 mg/1000 mg strength KOMBIGLYZE™ XR together with the RE’186
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`patent.
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`INFRINGEMENT BY MYLAN
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`A.
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`Submission of ANDA No. 205980
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`18.
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`By letter dated April 28, 2014, Mylan notified AstraZeneca that Mylan had
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`submitted ANDA No. 205980 to the FDA under Section 505(j) of the Federal Food, Drug, and
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`Cosmetic Act (21 U.S.C. § 355(j)) (“the Onglyza Notice Letter”). AstraZeneca received the
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`Onglyza Notice Letter on or about April 30, 2014.
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`19.
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`The Onglyza Notice Letter states that Mylan seeks approval from the FDA to
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`engage in the commercial manufacture, use, and sale of generic saxagliptin hydrochloride tablets
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`before the expiration of the RE’186 and ’400 patents. Upon information and belief, Mylan
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`intends to engage in the commercial manufacture, use, and sale of its generic saxagliptin
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`hydrochloride tablets promptly upon receiving FDA approval to do so.
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`20.
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`By filing ANDA No. 205980, Mylan has necessarily represented to the FDA that
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`its generic saxagliptin hydrochloride tablets have the same active ingredient as ONGLYZA®,
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`have the same method of administration, dosage form, and strengths as ONGLYZA®, and are
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`bioequivalent to ONGLYZA®.
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`21.
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`In the Onglyza Notice Letter, Mylan states that its ANDA contains a “Paragraph
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`IV certification” asserting that the RE’186 and ’400 patents are invalid, unenforceable and/or
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`will not be infringed by the commercial manufacture, use, and sale of Mylan’s generic
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`saxagliptin hydrochloride tablets.
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`22.
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`This Complaint is being filed before the expiration of the forty-five days from the
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`date AstraZeneca received the Onglyza Notice Letter.
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`B.
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`Submission of ANDA No. 205981
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`23.
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`By letter dated April 28, 2014, Mylan notified AstraZeneca that Mylan had
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`submitted ANDA No. 205981 to the FDA under Section 505(j) of the Federal Food, Drug, and
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`Cosmetic Act (21 U.S.C. § 355(j)) (“the Kombiglyze Notice Letter”). AstraZeneca received the
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`Kombiglyze Notice Letter on or about April 30, 2014.
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`24.
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`The Kombiglyze Notice Letter states that Mylan seeks approval from the FDA to
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`engage in the commercial manufacture, use, and sale of generic saxagliptin hydrochloride and
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`metformin hydrochloride extended-release tablets before the expiration of the RE’186 and ’799
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`patents. Upon information and belief, Mylan intends to engage in the commercial manufacture,
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`use, and sale of its generic saxagliptin hydrochloride and metformin hydrochloride extended-
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`release tablets promptly upon receiving FDA approval to do so.
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`25.
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`By filing ANDA No. 205981, Mylan has necessarily represented to the FDA that
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`its generic saxagliptin hydrochloride and metformin hydrochloride extended-release tablets have
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`the same active ingredient as KOMBIGLYZE™ XR, have the same method of administration,
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`dosage form, and strengths as KOMBIGLYZE™ XR, and are bioequivalent to KOMBIGLYZE™
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`XR.
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`26.
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`In the Kombiglyze Notice Letter, Mylan states that its ANDA contains a
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`“Paragraph IV certification” asserting that the RE’186 and ’799 patents are invalid,
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`unenforceable and/or will not be infringed by the commercial manufacture, use, and sale of
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`Mylan’s generic saxagliptin hydrochloride and metformin hydrochloride extended-release
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`tablets.
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`27.
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`This Complaint is being filed before the expiration of the forty-five days from the
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`date AstraZeneca received the Kombiglyze Notice Letter.
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`COUNT I (INFRINGEMENT OF THE RE’186 PATENT) (ANDA NO. 205980)
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`28.
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`Each of the preceding paragraphs 1 to 27 is incorporated as if fully set forth
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`herein.
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`29. Mylan’s submission of ANDA No. 205980 to obtain approval to engage in the
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`commercial manufacture, use, offer to sell, or sale of generic saxagliptin hydrochloride tablets
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`prior to the expiration of the RE’186 patent constituted a technical act of infringement. Upon
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`information and belief, the product described in ANDA No. 205980 would infringe one or more
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`of the claims of the RE’186 patent under 35 U.S.C. § 271(e)(2)(A).
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`30.
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`Upon information and belief, upon FDA approval of Mylan’s ANDA No. 205980,
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`Mylan will further infringe at least one claim of the RE’186 patent by making, using, offering to
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`sell, and selling its generic saxagliptin hydrochloride tablets in the United States and/or
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`importing such tablets into the United States, and by actively inducing and contributing to
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`infringement by others, in violation of 35 U.S.C. § 271(a)-(c) unless enjoined by the Court.
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`31.
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`If Mylan’s marketing and sale of generic saxagliptin hydrochloride tablets prior to
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`expiration of the RE’186 patent and all other relevant exclusivities is not enjoined, AstraZeneca
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`will suffer substantial and irreparable harm for which there is no remedy at law.
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`COUNT II (INFRINGEMENT OF THE ’400 PATENT) (ANDA NO. 205980)
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`32.
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`Each of the preceding paragraphs 1 to 31 is incorporated as if fully set forth
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`herein.
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`33. Mylan’s submission of ANDA No. 205980 to obtain approval to engage in the
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`commercial manufacture, use, offer to sell, or sale of generic saxagliptin hydrochloride tablets
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`prior to the expiration of the ’400 patent constituted a technical act of infringement. Upon
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`information and belief, the product described in ANDA No. 205980 would infringe one or more
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`of the claims of the ’400 patent under 35 U.S.C. § 271(e)(2)(A).
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`34.
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`Upon information and belief, upon FDA approval of Mylan’s ANDA No. 205980,
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`Mylan will further infringe at least one claim of the ’400 patent by making, using, offering to
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`sell, and selling its generic saxagliptin hydrochloride tablets in the United States and/or
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`importing such tablets into the United States, and by actively inducing and contributing to
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`infringement by others, in violation of 35 U.S.C. § 271(a)-(c) unless enjoined by the Court.
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`35.
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`If Mylan’s marketing and sale of generic saxagliptin hydrochloride tablets prior to
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`expiration of the ’400 patent and all other relevant exclusivities is not enjoined, AstraZeneca will
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`suffer substantial and irreparable harm for which there is no remedy at law.
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`COUNT III (INFRINGEMENT OF THE RE’186 PATENT) (ANDA NO. 205981)
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`36.
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`Each of the preceding paragraphs 1 to 35 is incorporated as if fully set forth
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`herein.
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`37. Mylan’s submission of ANDA No. 205981 to obtain approval to engage in the
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`commercial manufacture, use, offer to sell, or sale of generic saxagliptin hydrochloride and
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`metformin hydrochloride extended-release tablets prior to the expiration of the RE’186 patent
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`constituted a technical act of infringement. Upon information and belief, the product described
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`in ANDA No. 205981 would infringe one or more of the claims of the RE’186 patent under 35
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`U.S.C. § 271(e)(2)(A).
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`38.
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`Upon information and belief, upon FDA approval of Mylan’s ANDA No. 205981,
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`Mylan will further infringe at least one claim of the RE’186 patent by making, using, offering to
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`sell, and selling its generic saxagliptin hydrochloride and metformin hydrochloride extended-
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`release tablets in the United States and/or importing such tablets into the United States, and by
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`actively inducing and contributing to infringement by others, in violation of 35 U.S.C. § 271(a)-
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`(c) unless enjoined by the Court.
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`39.
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`If Mylan’s marketing and sale of generic saxagliptin hydrochloride and metformin
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`hydrochloride extended-release tablets prior to expiration of the RE’186 patent and all other
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`relevant exclusivities is not enjoined, AstraZeneca will suffer substantial and irreparable harm
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`for which there is no remedy at law.
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`COUNT IV (INFRINGEMENT OF THE ’799 PATENT) (ANDA NO. 205981)
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`40.
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`Each of the preceding paragraphs 1 to 39 is incorporated as if fully set forth
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`herein.
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`41. Mylan’s submission of ANDA No. 205981 to obtain approval to engage in the
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`commercial manufacture, use, offer to sell, or sale of generic saxagliptin hydrochloride and
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`metformin hydrochloride extended-release tablets prior to the expiration of the ’799 patent
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`constituted a technical act of infringement. Upon information and belief, at least one dosage
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`strength of the product described in ANDA No. 205981 would infringe one or more of the claims
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`of the ’799 patent under 35 U.S.C. § 271(e)(2)(A).
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`42.
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`Upon information and belief, upon FDA approval of Mylan’s ANDA No. 205981,
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`Mylan will further infringe at least one claim of the ’799 patent by making, using, offering to
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`sell, and selling at least one dosage strength of its generic saxagliptin hydrochloride and
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`metformin hydrochloride extended-release tablets in the United States and/or importing such
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`tablets into the United States, and by actively inducing and contributing to infringement by
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`others, in violation of 35 U.S.C. § 271(a)-(c) unless enjoined by the Court.
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`43.
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`If Mylan’s marketing and sale of at least one infringing dosage strength of its
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`generic saxagliptin hydrochloride and metformin hydrochloride extended-release tablets prior to
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`expiration of the ’799 patent and all other relevant exclusivities is not enjoined, AstraZeneca will
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`suffer substantial and irreparable harm for which there is no remedy at law.
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`PRAYER FOR RELIEF
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`WHEREFORE, AstraZeneca prays that this Court grant the following relief:
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`1.
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`A judgment that the claims of the RE’186 and ’400 patents are not invalid,
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`not unenforceable, and are infringed by Mylan’s submission of ANDA No. 205980, and that
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`Mylan’s making, using, offering to sell, or selling in the United States, or importing into the
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`United States Mylan’s generic saxagliptin hydrochloride tablets will infringe the RE’186 and
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`’400 patents.
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`2.
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`An order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective
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`date of any approval of ANDA No. 205980 shall be a date which is not earlier than the latest
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`expiration date of the RE’186 and ’400 patents, including any extensions and/or additional
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`periods of exclusivity to which AstraZeneca is or becomes entitled.
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`3.
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`An order permanently enjoining Mylan, its affiliates, subsidiaries, and
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`each of its officers, agents, servants and employees and those acting in privity or concert with
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`them, from making, using, offering to sell, or selling in the United States, or importing into the
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`United States Mylan’s generic saxagliptin hydrochloride tablets until after the latest expiration
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`date of the RE’186 and ’400 patents, including any extensions and/or additional periods of
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`exclusivity to which AstraZeneca is or becomes entitled.
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`4.
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`Damages or other monetary relief to AstraZeneca if Mylan engages in
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`commercial manufacture, use, offers to sell, sale, or importation in or into the United States of
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`Mylan’s generic saxagliptin hydrochloride tablets prior to the latest expiration date of the
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`RE’186 and ’400 patents, including any extensions and/or additional periods of exclusivity to
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`which AstraZeneca is or becomes entitled.
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`5.
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`A judgment that the claims of the RE’186 and ’799 patents are not invalid,
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`not unenforceable, and are infringed by Mylan’s submission of ANDA No. 205981, and that
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`Mylan’s making, using, offering to sell, or selling in the United States, or importing into the
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`United States Mylan’s generic saxagliptin hydrochloride and metformin hydrochloride extended-
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`release tablets will infringe the RE’186 patent and with regard to at least one dosage strength of
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`Mylan’s generic saxagliptin hydrochloride and metformin hydrochloride extended-release
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`tablets, the ’799 patent.
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`6.
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`An order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective
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`date of any approval of ANDA No. 205981 shall be a date which is not earlier than the latest
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`expiration date of the RE’186 and ’799 patents, including any extensions and/or additional
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`periods of exclusivity to which AstraZeneca is or becomes entitled.
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`7.
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`An order permanently enjoining Mylan, its affiliates, subsidiaries, and
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`each of its officers, agents, servants and employees and those acting in privity or concert with
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`them, from making, using, offering to sell, or selling in the United States, or importing into the
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`United States Mylan’s generic saxagliptin hydrochloride and metformin hydrochloride extended-
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`release tablets until after the latest expiration date of the RE’186 and ’799 patents, including any
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`extensions and/or additional periods of exclusivity to which AstraZeneca is or becomes entitled.
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`8.
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`Damages or other monetary relief to AstraZeneca if Mylan engages in
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`commercial manufacture, use, offers to sell, sale, or importation in or into the United States of
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`Mylan’s generic saxagliptin hydrochloride and metformin hydrochloride extended-release tablets
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`prior to the latest expiration date of the RE’186 and ’799 patents, including any extensions
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`and/or additional periods of exclusivity to which AstraZeneca is or becomes entitled.
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`9.
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`Such further and other relief as this Court deems proper and just, including
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`any appropriate relief under 35 U.S.C. § 285.
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`DATED: June 2, 2014
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`MCCARTER & ENGLISH, LLP
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`/s/ Michael P. Kelly
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4758)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, Delaware 19801
`(302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
`
`Attorneys for Plaintiff
`AstraZeneca AB
`
`
`
`
`ME1 17982829v.1
`
`- 13 -
`
`
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