`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`--------------------------------------------------------------X
`:
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`MERCK SHARP & DOHME LLC,
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`:
`
`Plaintiff,
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`v.
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`:
`:
`:
`:
`:
`:
`:
`:
`Defendant.
`---------------------------------------------------------------X
`
`C.A. No. 1:19-cv-00101-IMK
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`MYLAN PHARMACEUTICALS INC.,
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`STIPULATED MODIFIED AMENDED FINAL JUDGMENT
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`THIS MATTER having come before the Court upon the Complaint of Plaintiff
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`Merck Sharp & Dohme LLC (“Merck”) alleging that Defendant Mylan Pharmaceuticals Inc.
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`(“Mylan”) infringed United States Patent No. 7,326,708 (“the ’708 Patent”) and United States
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`Patent No. 8,414,921 (“the ’921 Patent”), and with Counterclaims filed by Mylan seeking a
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`judgment of invalidity and noninfringement;
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`WHEREAS following a bench trial before this Court, the Court, on September
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`21, 2022, entered a Final Judgment (ECF No. 194) and amended on September 29, 2022 (ECF
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`No. 197), in favor of Merck;
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`WHEREAS subsequent to the entry of the Final Judgment, the parties have
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`entered into a settlement agreement dated March 14, 2023 (the “Settlement Agreement”);
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`WHEREAS the parties have jointly moved the Court to amend its Final
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`Judgment pursuant to Federal Rule Civil Procedure 60(b), and for good cause shown by the
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`parties, the Order is amended as follows:
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`IT IS ORDERED that the Amended Final Judgment (ECF No. 197) is vacated;
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`
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`Case 1:19-cv-00101-TSK Document 209 Filed 05/02/23 Page 2 of 3 PageID #: 11993
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`ORDERED AND ADJUDGED that Final Judgment shall be entered in favor of
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`Plaintiff and against Defendant; and it is further
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`ORDERED AND ADJUDGED that, pursuant to the provisions of 35 U.S.C. §
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`271(e)(4)(B), Mylan, its officers, agents, servants, employees and attorneys, and those persons
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`acting in privity or in active concert with Mylan, are enjoined, unless otherwise permitted
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`pursuant to the terms of the Settlement Agreement, from engaging in the commercial
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`manufacture, use, offer to sell, or sale within the United States, or importation into the United
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`States (to the extent such activities are not protected by 35 U.S.C. § 271(e)(1)), of the drug
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`products that are the subject of Mylan’s ANDA No. 202473 until the expiration of the ’708
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`Patent; and it is further
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`ORDERED AND ADJUDGED that, pursuant to the provisions of 35 U.S.C. §
`
`271(e)(4)(B), Mylan, its officers, agents, servants, employees and attorneys, and those persons
`
`acting in privity or in active concert with Mylan, are enjoined, unless otherwise permitted
`
`pursuant to the terms of the Settlement Agreement, from engaging in the commercial
`
`manufacture, use, offer to sell, or sale within the United States, or importation into the United
`
`States (to the extent such activities are not protected by 35 U.S.C. § 271(e)(1)), of the drug
`
`products that are the subject of Mylan’s ANDA No. 202478 until the expiration of the ’708
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`Patent and the ’921 Patent; and it is further
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`ORDERED that the stay of approval under 21 U.S.C. § 355(j)(5)(B)(iii) is
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`terminated. Nothing herein prevents the U.S. Food and Drug Administration from granting final
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`approval to ANDA Nos. 202473 and 202478 at any time.
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`ORDERED AND ADJUDGED that the Clerk be and is hereby directed to enter
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`forthwith this Amendment to the Order upon the Civil Docket.
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`
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`Case 1:19-cv-00101-TSK Document 209 Filed 05/02/23 Page 3 of 3 PageID #: 11994
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`Dated: May 2, 2023
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`UNITED STATES DISTRICT COURT JUDGE
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`We hereby consent to the form and entry of this Order:
`
` /s/ Michael W. Carey
`Attorneys for Plaintiff
`Merck Sharp & Dohme LLC
`
` /s/ Gordon H. Copland
`Attorneys for Defendant
`Mylan Pharmaceuticals Inc.
`
`
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