Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page 1 of 18 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`SANOFI-AVENTIS U.S. LLC, SANOFI-
`AVENTIS DEUTSCHLAND GMBH, and
`SANOFI WINTHROP INDUSTRIE,
`
`
`Plaintiffs,
`
`C.A. No.
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`
`
`Defendant.
`
`
`
`
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs, Sanofi-Aventis U.S. LLC (“Sanofi U.S.”), Sanofi-Aventis Deutschland GmbH
`
`(“Sanofi GmbH”), and Sanofi Winthrop Industrie (“SWIND”) (collectively, “Plaintiffs” or
`
`“Sanofi”), by and through their attorneys, for their Complaint against Merck Sharp & Dohme
`
`Corp. (“Merck”), hereby allege as follows:
`
`THE PARTIES
`Plaintiff Sanofi U.S. is a Delaware limited liability corporation with its principal
`
`1.
`
`place of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807.
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`2.
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`Plaintiff Sanofi GmbH is a German corporation with its principal place of
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`business located at Industriepark Hoechst, Frankfurt Am Main, Germany D-65926.
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`3.
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`Plaintiff SWIND is a French corporation with its principal place of business
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`located at 20 avenue Raymond Aron, 92160 Antony, France.
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`4.
`
`On information and belief, Defendant Merck is a New Jersey corporation with its
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`principal place of business located at 2000 Galloping Hill Rd, Kenilworth, NJ 07033.
`
`Sanofi Exhibit 2005.001
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page 2 of 18 PageID #: 2
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`5.
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`On information and belief, Merck conducts business operations throughout the
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`United States, including in the State of Delaware.
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`JURISDICTION AND VENUE
`This is an action for patent infringement and arises under the Patent Laws of the
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`5.
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`United States, Title 35, United States Code. This Court has jurisdiction over the subject matter
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`of this action under 28 U.S.C. §§ 1331, and 1338(a).
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`6.
`
`This Court has personal jurisdiction over Merck because, inter alia, Merck
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`maintains continuous and systematic contacts with this judicial district. Either directly, or
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`through its subsidiaries, agents, and/or affiliates, Merck has conducted and continues to conduct
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`business in this judicial district, including, upon information and belief, by manufacturing,
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`marketing, and selling drug products throughout the United States and in the District of
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`Delaware. In addition, Merck, on information and belief, intends to market the infringing insulin
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`glargine product in this judicial district upon approval of such product by the Federal Food and
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`Drug Administration (“FDA”). This Court also has personal jurisdiction over Merck for the
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`additional reasons set forth below.
`
`7.
`
`8.
`
`Merck is registered to do business in the State of Delaware.
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`The Corporation Trust Company, 1209 Orange Street, Corporation Trust Center,
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`New Castle County, Wilmington, Delaware 19801, serves as Merck’s Registered Agent in the
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`State of Delaware.
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`9.
`
`Merck has previously elected to avail itself of the benefits of litigating its patent
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`disputes in the District of Delaware. See, e.g., Merck Sharp & Dohme Corp. v. Royalty Pharma
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`Collection Trust, C.A. No. 15-00757-GMS; Merck Sharp & Dohme Corp. v. Amneal Pharms.
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`L.L.C., C.A. No. 15-00250-SLR-SRF; Merck Sharp & Dohme Corp. v. Fresenius Kabi USA,
`
`
`
`2
`
`Sanofi Exhibit 2005.002
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page 3 of 18 PageID #: 3
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`L.L.C., C.A. No. 14-01018-UNA; Merck Sharp Dohme Corp. v. Sandoz Inc., C.A. No. 14-
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`00916-RGA.
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`10.
`
`Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391(b), (c), and
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`1400(b).
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`PATENTS-IN-SUIT
`On April 5, 2011, United States Patent No. 7,918,833 (“the ’833 Patent”), entitled
`
`11.
`
`“Pen-Type Injector,” was duly and legally issued by the United States Patent and Trademark
`
`Office (“PTO”). A true and correct copy of the ’833 Patent is attached as Exhibit A to this
`
`Complaint.
`
`12.
`
`On August 20, 2013, United States Patent No. 8,512,297 (“the ’297 Patent”),
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`entitled “Pen-Type Injector,” was duly and legally issued by the PTO. A true and correct copy
`
`of the ’297 Patent is attached as Exhibit B to this Complaint.
`
`13.
`
`On October 15, 2013, United States Patent No. 8,556,864 (“the ’864 Patent”),
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`entitled “Drive Mechanisms Suitable for Use in Drug Delivery Devices,” was duly and legally
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`issued by the PTO. A true and correct copy of the ’864 Patent is attached as Exhibit C to this
`
`Complaint.
`
`14.
`
`On December 10, 2013, United States Patent No. 8,603,044 (“the ’044 Patent”),
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`entitled “Pen-Type Injector,” was duly and legally issued by the PTO. A true and correct copy
`
`of the ’044 Patent is attached as Exhibit D to this Complaint.
`
`15.
`
`On March 31, 2015, United States Patent No. 8,992,486 (“the ’486 Patent”),
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`entitled “Pen-Type Injector,” was duly and legally issued by the PTO. A true and correct copy
`
`of the ’486 Patent is attached as Exhibit E to this Complaint.
`
`
`
`3
`
`Sanofi Exhibit 2005.003
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page 4 of 18 PageID #: 4
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`16.
`
`On March 25, 2014, United States Patent No. 8,679,069 (“the ’069 Patent”),
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`entitled “Pen-Type Injector,” was duly and legally issued by the PTO. A true and correct copy
`
`of the ’069 Patent is attached as Exhibit F to this Complaint.
`
`17.
`
`On April 21, 2015, United States Patent No. 9,011,391 (“the ’391 Patent”),
`
`entitled “Pen-Type Injector,” was duly and legally issued by the PTO. A true and correct copy
`
`of the ’391 Patent is attached as Exhibit G to this Complaint.
`
`18.
`
`On January 12, 2016, United States Patent No. 9,233,211 (“the ’211 Patent”),
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`entitled “Relating to a Pen-Type Injector,” was duly and legally issued by the PTO. A true and
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`correct copy of the ’211 Patent is attached as Exhibit H to this Complaint.
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`19.
`
`On January 13, 2009, United States Patent No. 7,476,652 (“the ’652 Patent”),
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`entitled “Acidic Insulin Preparations Having Improved Stability,” was duly and legally issued by
`
`the PTO. A true and correct copy of the ’652 Patent is attached as Exhibit I to this Complaint.
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`20.
`
`On May 11, 2010, United States Patent No. 7,713,930 (“the ’930 Patent”), entitled
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`“Acidic Insulin Preparations Having Improved Stability,” was duly and legally issued by the
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`PTO. A true and correct copy of the ’930 Patent is attached as Exhibit J to this Complaint.
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`21.
`
`The ’833, ’297, ’864, ’044, ’486, ’069, ’391, ’211, ’652 and ’930 Patents are
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`collectively referred to herein as the “Patents-in-Suit.” By assignment, Sanofi GmbH owns all
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`right, title, and interest in and to the Patents-in-Suit. Sanofi U.S. and SWIND are the exclusive
`
`licensees of certain rights in or to the Patents-in-Suit. Plaintiffs have the right to sue and recover
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`damages for the infringement of the Patents-in-Suit.
`
`BACKGROUND
`Sanofi U.S. is the holder of approved New Drug Application (“NDA”) No. 21-
`
`22.
`
`081 for insulin glargine [rDNA origin] for injection, which is prescribed and sold in the United
`
`
`
`4
`
`Sanofi Exhibit 2005.004
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page 5 of 18 PageID #: 5
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`States under the trademarks Lantus® and Lantus® SoloSTAR®. Currently, there are no generic
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`or follow-on versions of Lantus® or Lantus® SoloSTAR® on the market in the United States.
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`23.
`
`The publication Approved Drug Products with Therapeutic Equivalence
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`Evaluations (the “Orange Book”) identifies drug products approved on the basis of safety and
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`effectiveness by FDA under the Federal Food, Drug, and Cosmetic Act (“FFDCA”). Sanofi U.S.
`
`has listed each of the Patents-In-Suit in the Orange Book as covering its Lantus® and/or
`
`Lantus® SoloSTAR® products.
`
`24.
`
`On information and belief, Merck submitted NDA No. 208-722 to the FDA under
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`21 U.S.C. § 355(b)(2) (§ 505(b)(2) of the FFDCA) seeking FDA’s approval to manufacture
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`commercially and sell its proposed product—an insulin glargine [rDNA origin] for subcutaneous
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`injection in a prefilled insulin delivery device, 100 units/mL (“Proposed Product”)—that
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`contains data from bioavailability or bioequivalence studies conducted in connection with Sanofi
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`U.S.’s NDA No. 21-081.
`
`25.
`
`On information and belief, on August 4, 2016, Merck sent a “Notice of
`
`Certification” pursuant to § 505(b)(2)(A)(iv) of the FFDCA to Sanofi U.S. and Sanofi GmbH,
`
`which discloses that Merck’s NDA No. 208-722 contained Paragraph IV certifications for the
`
`Patents-in-Suit. In its Notice, Merck stated that its certifications to the FDA allege that each of
`
`the Patents-In-Suit is invalid, unenforceable, and/or will not be infringed by the commercial
`
`manufacture, use, or sale of Merck’s Proposed Product before their respective expirations.
`
`
`
`26.
`
`27.
`
`Sanofi U.S. received Merck’s Notice of Certification on August 9, 2016.
`
`Sanofi GmbH received Merck’s Notice of Certification on August 8, 2016.
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`28. Merck’s Notice of Certification was accompanied by an Offer of Confidential
`
`Access (“OCA”).
`
`
`
`5
`
`Sanofi Exhibit 2005.005
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page 6 of 18 PageID #: 6
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`29.
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`Since receiving the Merck Notice of Certification and the accompanying OCA,
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`Sanofi has negotiated in good faith with Merck to procure a copy of NDA No. 208-722 and
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`related product information under restrictions as would apply had a protective order been issued.
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`Sanofi timely responded to all correspondence with Merck and sought to reach reasonable
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`compromise with Merck regarding its OCA. These negotiations have been unsuccessful.
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`30.
`
`Because of the onerous and unreasonable restrictions on disclosure and use of the
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`information in the OCA insisted upon by Merck, which Sanofi could not reasonably accept, no
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`information in the OCA has been supplied by Merck to Sanofi.
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`31.
`
`In the absence of such information, Plaintiffs resort to the judicial process and the
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`aid of discovery to obtain, under appropriate judicial safeguards, such information as is required
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`to confirm its allegations of infringement and to present to the Court evidence that the Proposed
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`Product falls within the scope of one or more claims of the Patents-in-Suit.
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`32.
`
`Each of the Patents-in-Suit was submitted for listing and listed in the Orange
`
`Book for Sanofi’s NDA No. 21-081 prior to Merck’s submission of NDA No. 208-722.
`
`33.
`
`Plaintiffs commenced this action within 45 days after receiving Merck’s Notice of
`
`Certification.
`
`34.
`
`FDA’s approval of Merck’s NDA 208-722 may only be made effective upon a
`
`date consistent with 21 U.S.C. § 355(c)(3)(C).
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`35.
`
`On information and belief, Merck’s manufacture, use, sale and/or offer to sell in
`
`the United States, and/or importation into the United States, of its Proposed Product would
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`infringe one or more claims of each of the Patents-in-Suit, directly or indirectly.
`
`
`
`6
`
`Sanofi Exhibit 2005.006
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page 7 of 18 PageID #: 7
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`COUNT I
`(Infringement of U.S. Patent No. 7,918,833)
`Plaintiffs repeat and re-allege paragraphs 1-35 above as if fully set forth herein.
`
`On information and belief, Merck submitted NDA No. 208-722 to obtain approval
`
`36.
`
`37.
`
`under the FFDCA to engage in the commercial manufacture, use, and/or sale of its Proposed
`
`Product, which is claimed in the ’833 Patent, before the expiration of the ’833 Patent. On
`
`information and belief, Merck filed NDA No. 208-722 pursuant to § 505(b)(2) of the FFDCA
`
`seeking approval to engage in the commercial manufacture, use, and/or sale of the Proposed
`
`Product using data from bioavailability or bioequivalence studies conducted in connection with
`
`Sanofi’s NDA No. 21-081 before the expiration of the ’833 Patent. Merck’s submission of NDA
`
`No. 208-722 is an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`38.
`
` On information and belief, Merck was aware of the ’833 Patent prior to filing
`
`NDA No. 208-722. If Merck’s NDA No. 208-722 is approved, Merck’s manufacture, use, sale
`
`and/or offer to sell in the United States, and/or importation into the United States of its Proposed
`
`Product would infringe the ’833 Patent under 35 U.S.C. §§ 271(a), (b), and/or (c), literally and/or
`
`under the doctrine of equivalents.
`
`39.
`
`The acts of infringement set forth above will cause Plaintiffs irreparable harm for
`
`which they have no adequate remedy at law. Such infringement and resulting irreparable harm
`
`will continue unless FDA’s approval of NDA No. 208-722 is stayed, and Merck is enjoined by
`
`the Court from engaging in further infringing acts, pending a date that is not earlier than the
`
`expiration of the ’833 Patent, or any later date of exclusivity to which Plaintiffs and/or the ’833
`
`Patent are, or become, entitled.
`
`
`
`7
`
`Sanofi Exhibit 2005.007
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page 8 of 18 PageID #: 8
`
`COUNT II
`(Infringement of U.S. Patent No. 8,512,297)
`Plaintiffs repeat and re-allege paragraphs 1-39 above as if fully set forth herein.
`
`On information and belief, Merck submitted NDA No. 208-722 to obtain approval
`
`40.
`
`41.
`
`under the FFDCA to engage in the commercial manufacture, use, and/or sale of its Proposed
`
`Product, which is claimed in the ’297 Patent, before the expiration of the ’297 Patent. On
`
`information and belief, Merck filed NDA No. 208-722 pursuant to § 505(b)(2) of the FFDCA
`
`seeking approval to engage in the commercial manufacture, use, and/or sale of the Proposed
`
`Product using data from bioavailability or bioequivalence studies conducted in connection with
`
`Sanofi’s NDA No. 21-081 before the expiration of the ’297 Patent. Merck’s submission of NDA
`
`No. 208-722 is an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`42.
`
`On information and belief, Merck was aware of the ’297 Patent prior to filing
`
`NDA No. 208-722. If Merck’s NDA No. 208-722 is approved, Merck’s manufacture, use, sale
`
`and/or offer to sell in the United States, and/or importation into the United States of its Proposed
`
`Product would infringe the ’297 Patent under 35 U.S.C. §§ 271(a), (b), and/or (c), literally and/or
`
`under the doctrine of equivalents.
`
`43.
`
`The acts of infringement set forth above will cause Plaintiffs irreparable harm for
`
`which they have no adequate remedy at law. Such infringement and resulting irreparable harm
`
`will continue unless FDA’s approval of NDA No. 208-722 is stayed, and Merck is enjoined by
`
`the Court from engaging in further infringing acts, pending a date that is not earlier than the
`
`expiration of the ’297 Patent, or any later date of exclusivity to which Plaintiffs and/or the ’297
`
`Patent are, or become, entitled.
`
`
`
`8
`
`Sanofi Exhibit 2005.008
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page 9 of 18 PageID #: 9
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`COUNT III
`(Infringement of U.S. Patent No. 8,556,864)
`Plaintiffs repeat and re-allege paragraphs 1-43 above as if fully set forth herein.
`
`On information and belief, Merck submitted NDA No. 208-722 to obtain approval
`
`44.
`
`45.
`
`under the FFDCA to engage in the commercial manufacture, use, and/or sale of its Proposed
`
`Product, which is claimed in the ’864 Patent, before the expiration of the ’864 Patent. On
`
`information and belief, Merck filed NDA No. 208-722 pursuant to § 505(b)(2) of the FFDCA
`
`seeking approval to engage in the commercial manufacture, use, and/or sale of the Proposed
`
`Product using data from bioavailability or bioequivalence studies conducted in connection with
`
`Sanofi’s NDA No. 21-081 before the expiration of the ’864 Patent. Merck’s submission of NDA
`
`No. 208-722 is an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`46.
`
`On information and belief, Merck was aware of the ’864 Patent prior to filing
`
`NDA No. 208-722. If Merck’s NDA No. 208-722 is approved, Merck’s manufacture, use, sale
`
`and/or offer to sell in the United States, and/or importation into the United States of its Proposed
`
`Product would infringe the ’864 Patent under 35 U.S.C. §§ 271(a), (b), and/or (c), literally and/or
`
`under the doctrine of equivalents.
`
`47.
`
`The acts of infringement set forth above will cause Plaintiffs irreparable harm for
`
`which they have no adequate remedy at law. Such infringement and resulting irreparable harm
`
`will continue unless FDA’s approval of NDA No. 208-722 is stayed, and Merck is enjoined by
`
`the Court from engaging in further infringing acts, pending a date that is not earlier than the
`
`expiration of the ’864 Patent, or any later date of exclusivity to which Plaintiffs and/or the ’864
`
`Patent are, or become, entitled.
`
`
`
`9
`
`Sanofi Exhibit 2005.009
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page 10 of 18 PageID #: 10
`
`COUNT IV
`(Infringement of U.S. Patent No. 8,992,486)
`Plaintiffs repeat and re-allege paragraphs 1-47 above as if fully set forth herein.
`
`On information and belief, Merck submitted NDA No. 208-722 to obtain approval
`
`48.
`
`49.
`
`under the FFDCA to engage in the commercial manufacture, use, and/or sale of its Proposed
`
`Product, which is claimed in the ’486 Patent, before the expiration of the ’486 Patent. On
`
`information and belief, Merck filed NDA No. 208-722 pursuant to § 505(b)(2) of the FFDCA
`
`seeking approval to engage in the commercial manufacture, use, and/or sale of the Proposed
`
`Product using data from bioavailability or bioequivalence studies conducted in connection with
`
`Sanofi’s NDA No. 21-081 before the expiration of the ’486 Patent. Merck’s submission of NDA
`
`No. 208-722 is an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`50.
`
`On information and belief, Merck was aware of the ’486 Patent prior to filing
`
`NDA No. 208-722. If Merck’s NDA No. 208-722 is approved, Merck’s manufacture, use, sale
`
`and/or offer to sell in the United States, and/or importation into the United States of its Proposed
`
`Product would infringe the ’486 Patent under 35 U.S.C. §§ 271(a), (b), and/or (c), literally and/or
`
`under the doctrine of equivalents.
`
`51.
`
`The acts of infringement set forth above will cause Plaintiffs irreparable harm for
`
`which they have no adequate remedy at law. Such infringement and resulting irreparable harm
`
`will continue unless FDA’s approval of NDA No. 208-722 is stayed, and Merck is enjoined by
`
`the Court from engaging in further infringing acts, pending a date that is not earlier than the
`
`expiration of the ’486 Patent, or any later date of exclusivity to which Plaintiffs and/or the ’486
`
`Patent are, or become, entitled.
`
`
`
`10
`
`Sanofi Exhibit 2005.010
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page 11 of 18 PageID #: 11
`
`COUNT V
`
`(Infringement of U.S. Patent No. 8,603,044)
`
`52.
`
`53.
`
`Plaintiffs repeat and re-allege paragraphs 1-51 above as if fully set forth herein.
`
`On information and belief, Merck submitted NDA No. 208-722 to obtain approval
`
`under the FFDCA to engage in the commercial manufacture, use, and/or sale of its Proposed
`
`Product, which is claimed in the ’044 Patent, before the expiration of the ’044 Patent. On
`
`information and belief, Merck filed NDA No. 208-722 pursuant to § 505(b)(2) of the FFDCA
`
`seeking approval to engage in the commercial manufacture, use, and/or sale of the Proposed
`
`Product using data from bioavailability or bioequivalence studies conducted in connection with
`
`Sanofi’s NDA No. 21-081 before the expiration of the ’044 Patent. Merck’s submission of NDA
`
`No. 208-722 is an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`54.
`
`On information and belief, Merck was aware of the ’044 Patent prior to filing NDA
`
`No. 208-722. If Merck’s NDA No. 208-722 is approved, Merck’s manufacture, use, sale and/or
`
`offer to sell in the United States, and/or importation into the United States of its Proposed Product
`
`would infringe the ’044 Patent under 35 U.S.C. §§ 271(a), (b), and/or (c), literally and/or under the
`
`doctrine of equivalents.
`
`55.
`
`The acts of infringement set forth above will cause Plaintiffs irreparable harm for
`
`which they have no adequate remedy at law. Such infringement and resulting irreparable harm
`
`will continue unless FDA’s approval of NDA No. 208-722 is stayed, and Merck is enjoined by
`
`the Court from engaging in further infringing acts, pending a date that is not earlier than the
`
`expiration of the ’044 Patent, or any later date of exclusivity to which Plaintiffs and/or the ’044
`
`Patent are, or become, entitled.
`
`
`
`11
`
`Sanofi Exhibit 2005.011
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page 12 of 18 PageID #: 12
`
`COUNT VI
`
`(Infringement of U.S. Patent No. 8,679,069)
`
`56.
`
`57.
`
`Plaintiffs repeat and re-allege paragraphs 1-55 above as if fully set forth herein.
`
`On information and belief, Merck submitted NDA No. 208-722 to obtain approval
`
`under the FFDCA to engage in the commercial manufacture, use, and/or sale of its Proposed
`
`Product, which is claimed in the ’069 Patent, before the expiration of the ’069 Patent. On
`
`information and belief, Merck filed NDA No. 208-722 pursuant to § 505(b)(2) of the FFDCA
`
`seeking approval to engage in the commercial manufacture, use, and/or sale of the Proposed
`
`Product using data from bioavailability or bioequivalence studies conducted in connection with
`
`Sanofi’s NDA No. 21-081 before the expiration of the ’069 Patent. Merck’s submission of NDA
`
`No. 208-722 is an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`58.
`
`On information and belief, Merck was aware of the ’069 Patent prior to filing
`
`NDA No. 208-722. If Merck’s NDA No. 208-722 is approved, Merck’s manufacture, use, sale
`
`and/or offer to sell in the United States, and/or importation into the United States of its Proposed
`
`Product would infringe the ’069 Patent under 35 U.S.C. §§ 271(a), (b), and/or (c), literally and/or
`
`under the doctrine of equivalents.
`
`59.
`
`The acts of infringement set forth above will cause Plaintiffs irreparable harm for
`
`which they have no adequate remedy at law. Such infringement and resulting irreparable harm
`
`will continue unless FDA’s approval of NDA No. 208-722 is stayed, and Merck is enjoined by
`
`the Court from engaging in further infringing acts, pending a date that is not earlier than the
`
`expiration of the ’069 Patent, or any later date of exclusivity to which Plaintiffs and/or the ’069
`
`Patent are, or become, entitled.
`
`
`
`12
`
`Sanofi Exhibit 2005.012
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page 13 of 18 PageID #: 13
`
`COUNT VII
`
`(Infringement of U.S. Patent No. 9,011,391)
`
`60.
`
`61.
`
`Plaintiffs repeat and re-allege paragraphs 1-59 above as if fully set forth herein.
`
`On information and belief, Merck submitted NDA No. 208-722 to obtain approval
`
`under the FFDCA to engage in the commercial manufacture, use, and/or sale of its Proposed
`
`Product, which is claimed in the ’391 Patent, before the expiration of the ’391 Patent. On
`
`information and belief, Merck filed NDA No. 208-722 pursuant to § 505(b)(2) of the FFDCA
`
`seeking approval to engage in the commercial manufacture, use, and/or sale of the Proposed
`
`Product using data from bioavailability or bioequivalence studies conducted in connection with
`
`Sanofi’s NDA No. 21-081 before the expiration of the ’391 Patent. Merck’s submission of NDA
`
`No. 208-722 is an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`62.
`
`On information and belief, Merck was aware of the ’391 Patent prior to filing
`
`NDA No. 208-722. If Merck’s NDA No. 208-722 is approved, Merck’s manufacture, use, sale
`
`and/or offer to sell in the United States, and/or importation into the United States of its Proposed
`
`Product would infringe the ’391 Patent under 35 U.S.C. §§ 271(a), (b), and/or (c), literally and/or
`
`under the doctrine of equivalents.
`
`63.
`
`The acts of infringement set forth above will cause Plaintiffs irreparable harm for
`
`which they have no adequate remedy at law. Such infringement and resulting irreparable harm
`
`will continue unless FDA’s approval of NDA No. 208-722 is stayed, and Merck is enjoined by
`
`the Court from engaging in further infringing acts, pending a date that is not earlier than the
`
`expiration of the ’391 Patent, or any later date of exclusivity to which Plaintiffs and/or the ’391
`
`Patent are, or become, entitled.
`
`
`
`13
`
`Sanofi Exhibit 2005.013
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page 14 of 18 PageID #: 14
`
`COUNT VIII
`
`(Infringement of U.S. Patent No. 9,233,211)
`
`64.
`
`65.
`
`Plaintiffs repeat and re-allege paragraphs 1-63 above as if fully set forth herein.
`
`On information and belief, Merck submitted NDA No. 208-722 to obtain approval
`
`under the FFDCA to engage in the commercial manufacture, use, and/or sale of its Proposed
`
`Product, which is claimed in the ’211 Patent, before the expiration of the ’211 Patent. On
`
`information and belief, Merck filed NDA No. 208-722 pursuant to § 505(b)(2) of the FFDCA
`
`seeking approval to engage in the commercial manufacture, use, and/or sale of the Proposed
`
`Product using data from bioavailability or bioequivalence studies conducted in connection with
`
`Sanofi’s NDA No. 21-081 before the expiration of the ’211 Patent. Merck’s submission of NDA
`
`No. 208-722 is an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`66.
`
`On information and belief, Merck was aware of the ’211 Patent prior to filing
`
`NDA No. 208-722. If Merck’s NDA No. 208-722 is approved, Merck’s manufacture, use, sale
`
`and/or offer to sell in the United States, and/or importation into the United States of its Proposed
`
`Product would infringe the ’211 Patent under 35 U.S.C. §§ 271(a), (b), and/or (c), literally and/or
`
`under the doctrine of equivalents.
`
`67.
`
`The acts of infringement set forth above will cause Plaintiffs irreparable harm for
`
`which they have no adequate remedy at law. Such infringement and resulting irreparable harm
`
`will continue unless FDA’s approval of NDA No. 208-722 is stayed, and Merck is enjoined by
`
`the Court from engaging in further infringing acts, pending a date that is not earlier than the
`
`expiration of the ’211 Patent, or any later date of exclusivity to which Plaintiffs and/or the ’211
`
`Patent are, or become, entitled.
`
`
`
`14
`
`Sanofi Exhibit 2005.014
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page 15 of 18 PageID #: 15
`
`COUNT IX
`
`(Infringement of U.S. Patent No. 7,476,652)
`
`68.
`
`69.
`
`Plaintiffs repeat and re-allege paragraphs 1-67 above as if fully set forth herein.
`
`On information and belief, Merck submitted NDA No. 208-722 to obtain approval
`
`under the FFDCA to engage in the commercial manufacture, use, and/or sale of its Proposed
`
`Product, which is claimed in the ’652 Patent, before the expiration of the ’652 Patent. On
`
`information and belief, Merck filed NDA No. 208-722 pursuant to § 505(b)(2) of the FFDCA
`
`seeking approval to engage in the commercial manufacture, use, and/or sale of the Proposed
`
`Product using data from bioavailability or bioequivalence studies conducted in connection with
`
`Sanofi’s NDA No. 21-081 before the expiration of the ’652 Patent. Merck’s submission of NDA
`
`No. 208-722 is an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`70.
`
`On information and belief, Merck was aware of the ’652 Patent prior to filing
`
`NDA No. 208-722. If Merck’s NDA No. 208-722 is approved, Merck’s manufacture, use, sale
`
`and/or offer to sell in the United States, and/or importation into the United States of its Proposed
`
`Product would infringe the ’652 Patent under 35 U.S.C. §§ 271(a), (b), and/or (c), literally and/or
`
`under the doctrine of equivalents.
`
`71.
`
`The acts of infringement set forth above will cause Plaintiffs irreparable harm for
`
`which they have no adequate remedy at law. Such infringement and resulting irreparable harm
`
`will continue unless FDA’s approval of NDA No. 208-722 is stayed, and Merck is enjoined by
`
`the Court from engaging in further infringing acts, pending a date that is not earlier than the
`
`expiration of the ’652 Patent, or any later date of exclusivity to which Plaintiffs and/or the ’652
`
`Patent are, or become, entitled.
`
`
`
`15
`
`Sanofi Exhibit 2005.015
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page 16 of 18 PageID #: 16
`
`COUNT X
`
`(Infringement of U.S. Patent No. 7,713,930)
`
`72.
`
`73.
`
`Plaintiffs repeat and re-allege paragraphs 1-71 above as if fully set forth herein.
`
`On information and belief, Merck submitted NDA No. 208-722 to obtain approval
`
`under the FFDCA to engage in the commercial manufacture, use, and/or sale of its Proposed
`
`Product, which is claimed in the ’930 Patent, before the expiration of the ’930 Patent. On
`
`information and belief, Merck filed NDA No. 208-722 pursuant to § 505(b)(2) of the FFDCA
`
`seeking approval to engage in the commercial manufacture, use, and/or sale of the Proposed
`
`Product using data from bioavailability or bioequivalence studies conducted in connection with
`
`Sanofi’s NDA No. 21-081 before the expiration of the ’930 Patent. Merck’s submission of NDA
`
`No. 208-722 is an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`74.
`
`On information and belief, Merck was aware of the ’930 Patent prior to filing
`
`NDA No. 208-722. If Merck’s NDA No. 208-722 is approved, Merck’s manufacture, use, sale
`
`and/or offer to sell in the United States, and/or importation into the United States of its Proposed
`
`Product would infringe the ’930 Patent under 35 U.S.C. §§ 271(a), (b), and/or (c), literally and/or
`
`under the doctrine of equivalents.
`
`75.
`
`The acts of infringement set forth above will cause Plaintiffs irreparable harm for
`
`which they have no adequate remedy at law. Such infringement and resulting irreparable harm
`
`continue unless FDA’s approval of NDA No. 208-722 is stayed, and Merck is enjoined by the
`
`Court from engaging in further infringing acts, pending a date that is not earlier than the
`
`expiration of the ’930 Patent, or any later date of exclusivity to which Plaintiffs and/or the ’930
`
`Patent are, or become, entitled.
`
`
`
`16
`
`Sanofi Exhibit 2005.016
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page 17 of 18 PageID #: 17
`
`REQUESTED RELIEF
`Plaintiffs respectfully seek the following relief:
`
`a)
`
`The entry of judgment holding that Merck has infringed each of the ’833, ’297,
`
`’864, ’044, ’486, ’069, ’391, ’211, ’652 and ’930 Patents;
`
`b)
`
`The entry of an order pursuant to 35 U.S.C. § 271(e)(4)(A), declaring that the
`
`effective date of any approval of Merck’s NDA No. 208-722 shall be a date that is not earlier
`
`than the last date of expiration of any of the ’833, ’297, ’864, ’044, ’486, ’069, ’391, ’211, ’652
`
`and ’930 Patents or any additional period of exclusivity to which Plaintiffs and/or said Patents
`
`are, or become, entitled;
`
`c)
`
`The entry of a preliminary injunction, enjoining Merck, its officers, agents,
`
`attorneys, and employees, and those acting in concert with them, from infringing any of the
`
`Patents-in-Suit, from engaging in any commercial manufacture, use, offer to sell, or sale within
`
`the United States, or importation into the United States, of insulin glargine [rDNA origin]
`
`injection in 3 mL cartridges, 100 units/mL as claimed by the Patents-in-Suit for the full terms
`
`thereof (and any additional period of exclusivity to which Sanofi and/or the Patents-in-Suit are,
`
`or become, entitled), and from inducing or contributing to such activities.
`
`d)
`
`The entry of a permanent injunction pursuant to 35 U.S.C. § 271(e)(4)(B)
`
`enjoining Merck, its officers, agents, attorneys, and employees, and those acting or attempting to
`
`act in active concert with them or acting on their behalf, from infringing any of the ’833, ’297,
`
`’864, ’044, ’486, ’069, ’391, ’211, ’652 and ’930 Patents by engaging in any commercial
`
`manufacture, use, offer to sell, or sale within the United States, or importation into the United
`
`States, of any product covered by the ’833, ’297, ’864, ’044, ’486, ’069, ’391, ’211, ’652 and
`
`
`
`17
`
`Sanofi Exhibit 2005.017
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:16-cv-00812-RGA Document 1 Filed 09/16/16 Page