`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`NOVO NORDISK INC. and NOVO NORDISK A/S
`Plaintiffs,
`
`v.
`MYLAN PHARMACEUTICALS INC.
`Defendant.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`Civil Action No. 1:22-cv-00023
`
`SUPPLEMENTAL INFORMATION FOR PATENT CASES
`INVOLVING AN ABBREVIATED NEW DRUG APPLICATION (ANDA)
`
`Plaintiffs hereby provide the information below with respect to the deadlines set forth in
`
`21 U.S.C. 355(j):
`
`Date Patentee(s) Received Notice: February 7, 2022
`
`Date of Expiration of Patent: See Below*
`
`Thirty Month Stay Deadline: June 5, 2025**
`
`* U.S. Patent No. 8,114,833 expires on 8/13/2025; U.S. Patent No. 8,684,969 expires on
`10/20/2025; U.S. Patent Nos. 9,108,002, 9,616,180, 9,861,757, 10,357,616 and 10,376,652 expire
`on 1/20/2026; U.S. Patent No. 8,536,122 expires on 3/20/2026; Patent No. RE46,363 expires on
`8/3/2026; U.S. Patent No. 9,687,611 expires on 2/27/2027; U.S. Patent Nos. 8,920,383, 9,775,953,
`10,220,155, and 11,097,063 expire on 7/17/2026; U.S. Patent No. 9,457,154 expires on 9/27/2027;
`U.S. Patent No. 9,132,239 expires on 2/1/2032; U.S. Patent No. 8,129,343 expires on 12/5/2031;
`U.S. Patent No. 10,335,462 expires on 6/21/2033.
`
`** Under 21 C.F.R. Section 314.107(b)(3)(i)(B), the regulatory stay extends until the expiration
`of 7.5 years from the date of approval of the NDA, rather than 30 months.
`
`
`
`Case 1:22-cv-00023-JPB Document 6 Filed 03/18/22 Page 2 of 2 PageID #: 460
`
`DATED: March 18, 2022
`
`Respectfully submitted,
`
`SCHRADER COMPANION DUFF & LAW, PLLC
`
`OF COUNSEL:
`
`Jeffrey J. Oelke
`Ryan P. Johnson
`Robert E. Counihan
`Laura T. Moran
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010-6035
`(212) 430-2600
`
`/s/ James F. Companion
`James F. Companion (#790)
`Sandra K. Law, Esq. (#6071)
`401 Main Street
`Wheeling, WV 26003
`(304) 233-3390
`jfc@schraderlaw.com
`skl@schraderlaw.com
`Counsel for Plaintiffs
`
`