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MS Hatch-Waxman PTE REQUEST for EXTENSION of PATENT

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MS Hatch-Waxman PTE REQUEST for EXTENSION of PATENT Docket No.: 029420.0155-US02 (PATENT) IN THE UNITED STATES PATENT AND TRADEMARK OFFICE In re United States Patent of: Alan J. Korman, et aL. Patent No.: 7,605,238 Issued: October 20, 2009 For: HUMAN CTLA-4 ANTIBODIES MS Hatch-Waxman PTE Commissioner for Patents Offce of Patent Legal Administration Room MDW 7D55 600 Dulany Street (Madison Building) Alexandria, VA 223 14 REQUEST FOR EXTENSION OF PATENT TERM UNDER 35 U.S.C. §156 Sir: Pursuant to 35 U.S.C. §156 and 37 C.F.R. §§1.710-1.791, Medarex, Inc., the current address of which is Route 206 and Province Line Road, Princeton, New Jersey 08540 ("Applicant" or "Medarex"), hereby requests an extension of U.S. Patent No. 7,605,238 (the "'238 patent"). As permitted by 37 C.F.R. §1.785(b) and MPEP §2761, Applicant is concurrently fiing a request for patent term extension of U.S. Patent No. 6,984,720 based upon the same regulatory review period. Medarex represents that it is the owner and assignee of the entire interest in and to Letters Patent of the United States No. 7,605,238 (Exhibit 1) granted to Alan J. Korman, Edward L. Halk, Nils Lonberg, Yashwant M. Deo and Tibor P. Keler (the "inventors") on October 20, 2009, for "Human CTLA-4 Antibodies and Their Uses" by virtue of an assignment from the DC; 3983891.1 Patent No.: 7,605,238 - 2- Docket No.: 029420.0155-US02 Alan J. Korman, Edward L. Halk and Nils Lonberg to Medarex, recorded in the United States Patent and Trademark Offce ("PTO") on March 6, 2003 at Reel 013817, Frame 0628 and an assignment from Yashwant M. Deo and Tibor P. Keler to Medarex, recorded on May 23, 2007 at Reel 019334, Frame 0783 (Exhibit 2). The '238 patent matured from U.S. Patent Application No. 09/948,939, fied on September 7, 2001, which is a continuation-in-par of U.S. Patent Application No. 09/644,668, filed on August 24,2000, now U.S. Patent No. 6,984,720, which claims the benefit of U.S. Provisional Patent Application No. 60/150,452, fied on August 24, 1999, now expired. The approved product that is relevant to this Request is YERVOYTM (ipilmumab) Injection, for intravenous infusion, referred to herein as "YERVOY" or "Approved Product." The Marketing Applicant for YERVOY is Bristol-Myers Squibb Company ("BMS'). Medarex is a wholly-owned subsidiary ofBMS and is authorized to rely upon the activities ofBMS, its predecessors, and affiiates for purposes of this patent term extension application. The following information is submitted in accordance with 35 U.S.C. § 1 56(d) and the rules for extension of patent term issued by the PTO at 37 C.F.R. Subpart F, §§1.710 to 1.791 and follows the numerical format set forth in 37 C.F.R. § 1.740: Patent No.: 7,605,238 - 3 - Docket No.: 029420.0155-US02 (1) A COMPLETE IDENTIFICATION OF THE APPROVED PRODUCT AS BY APPROPRIATE CHEMICAL AND GENERIC NAME, PHYSICAL STRUCTURE OR CHARACTERISTICS: The approved product is YERVOY, an injection for intravenous infusion of the active ingredient ipilimumab, available in two dosage forms namely, 50 mg/1 0 ml (5 mg/mL) and 200 mg/40 mL (5 mg/mL). YERVOY has been approved for the treatment ofunresectable or metastatic melanoma (approved labeling attached as Exhibit 3). YERVOY is a human cytotoxic T-Iymphocyte antigen 4 (CTLA-4)-blocking antibody that is comprised of 1,326 amino acids. The amino acid sequence for YERVOY is as follows: Patent No.: 7,605,238 - 4 - Docket No.: 029420.0155-US02 Antibody Amino Acid Sequence"''' Segment Heavy Chain FR1 QVQLVESGGGVVQPGRSLRLSCAASGFTFS CDR1 SYTMH FRZ WVRQAPGKGLEWVT CDRZ FISYDGNNKYY ADSVKG FR3 RFTISRDNSKNTL YLQMNSLRAEDTAIYYCAR CDR3 TGWLGPFDY FR4 WGQGTL VTVSS Heavy ASTKGPSVFPLAPSSKSTSGGTAALGCL VKDYFPEPVTVSW Chain NSGAL TSGVHTFPA VLQSSGL YSLSSVVTVPSSSLGTQTYIC Constant NVNHKPSNTKVDKRV Region EPKSCDKTHTCPPCP APELLG GPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNW YVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNG KEYKCKVSNKALPAPIEKTISKAK GQPREPQVYTLPPSRDELTKNQVSL TCL VKGFYPSDIA YEW ESNGQPENNYKTTPPVLDSDGSFFL YSKL TVDKSRWQQGN VFSCSVMHEALHNHYTQKSLSLSPGK Light Chain FR1 EIVL TQSPGTLSLSPGERA TLSC CDR1 RASQSVGSSYLA FRZ WYQQKPGQAPRLLIY CDRZ GAFSRAT FR3 GIPDRFSGSGSGTDFTL TISRLEPEDF A VYYC CDR3 QQYGSSPWT FR4 FGQGTKVEIK Light RTV AAPSVFIFPPSDEQLKSGT ASVVCLLNNFYPREAKVQW Chain KVDNALQSGNSQESVTEQDSKDSTYSLSSTL TLSKADYEKH Constant KVY ACEVTHQGLSSPVTKSFNRGEC Region '" '" The one-letter amino acid code used in the table follows the nomenclature developed by the International Union of Pure and Applied Chemistry (IUP AC) and the International Union of Biochmistry and Molecular Biology (IUB) in the IUPAC-IUB Joint Commission on Biochemical Nomenclature (JCBN), "Nomenclature and Symbolism for Amino Acids and Peptides," 1983. See http://ww.chem.qmul.ac.ukiupac/AminoAcid/AA1n2.html#AA 1, visited May 13,2011. Patent No.: 7,605,238 - 5 - Docket No.: 029420.01 55-US02 (2) A COMPLETE IDENTIFICATION OF THE FEDERAL STATUTE INCLUDING THE APPLICABLE PROVISION OF LAW UNDER WHICH THE REGULA TORY REVIEW OCCURRD: The Approved Product is a drug product that was approved under section 35i 0.. :: "\ t~ublic Health~Ser.Yice.ActieHS,*) (42 U.S,C. §262). (3) AN IDENTIFICATION OF THE DATE ON WHICH THE PRODUCT RECEIVED PERMISSION FOR COMMERCIAL MARKETING OR USE UNDER THE PROVISION OF LAW UNDER WHICH THE APPLICABLE REGULATORY REVIEW PERIOD OCCURRED: The Approved Product received permission for commercial marketing or use by the United States Food and Drug Administration (FDA) pursuant to section 351 (a) of the PHSA (42 U.S.C. § 262(a)) in a letter dated,~.ch.25,20.l.i ~A copy of the approval letter is attached as Exhibit 4. (4) IN THE CASE OF A DRUG PRODUCT, AN IDENTIFICATION OF EACH ACTIVE INGREDIENT IN THE PRODUCT AND AS TO EACH ACTIVE INGREDIENT, A STATEMENT THAT IT HAS NOT BEEN PREVIOUSLY APPROVED FOR COMMERCIAL MARKETING OR USE UNDER THE FEDERAL FOOD, DRUG AND COSMETIC ACT, THE PUBLIC HEALTH SERVICE ACT, OR THE VIRUS-SERUM-TOXIN ACT OR A STATEMENT OF WHEN THE ACTIVE INGREDIENT WAS APPROVED FOR COMMERCIAL MARKETING OR USE (EITHER ALONE OR IN COMBINATION WITH Patent No.: 7,605,238 - 6 - Docket No.: 029420.0155-US02 OTHER ACTIVE INGREDIENTS), THE USE FOR WHICH IT WAS APPROVED, AND THE PROVISION OF LAW UNDER WHICH IT WAS APPROVED: (37 C.F.R. § 1.740(a)(4)) The active ingredient in YERVOY is ipilmumab. Ipilimumab is comprised of 1,326 amino acids and has an amino acid sequence as noted earlier in section (1) of this Request. YERVOY is a human cytotoxic T-Iymphocyte antigen 4 (CTLA-4)-blocking antibody that has been approved under section 351(a) of the PHS A for the treatment ofunresectable or metastatic melanoma. Ipilimumab has not been previously approved for commercial marketing or use under the Federal Food, Drug, and Cosmetic Act, the PHSA, or the Virus-Serum-Toxin Act. (5) A STATEMENT THAT THE APPLICATION IS BEING SUBMITTED WITHIN THE SIXTY DAY PERIOD PERMITTED FOR SUBMISSION PURSUANT TO SECTION 1. nO(f) AND AN IDENTIFICATION OF THE DATE OF THE LAST DAY ON WHICH THE APPLICATION COULD BE SUBMITTED: This Request is timely fied, pursuant to 35 U.S.C. § 156(d)(1), within the permitted sixty-day (60-day) period that began on March 25, 2011, when the product received permission for commercial marketing or use under section 351(a) of the PHSA and that wil expire on May 24,2011. Applicant understands that, pursuant to 37 C.F.R. § 1 .nO(f), the PTO may deem this period to expire one day earlier, on May 23, 2011. (6) A COMPLETE IDENTIFICATION OF THE PATENT FOR WHICH AN EXTENSION IS BEING SOUGHT BY THE NAME OF THE INVENTOR, THE PATENT NUMBER, THE DATE OF ISSUE, AND THE DATE OF EXPIRATION: Patent No.: 7,605,238 - 7 - Docket No.: 029420.0155-US02 UNITED STATES PATENT NO.: 7,605,238 INVENTORS: ALAN 1. KORMAN EDWARD L. HALK NILS LONBERG Y ASHW ANT M. DEO TIBOR P. KELER DA TE OF ISSUE: OCTOBER 20, 2009 EXPIRATION DATE: AUGUST 24,2020' The expiration date of U.S. Patent No. 7,605,238 ("the '238 patent") is August 24, 2020, based on the following information. The patent application that issued as the '238 patent, U.S. Patent Application No. 09/948,939 ("the '939 application"), was filed on September 7, 2001 as a continuation-in-part or U.S. Patent Application No. 09/644,668 fied on August 24,2000, now U.S. Patent No. 6,984,720 (the '''720 patent"), and claims the benefit of U.S. Provisional Patent Application No. 60/150,452, fied on August 24, 1999, now expired. The expiration of the '238 patent pursuant to 35 U.S.C. § 154 is August 24,2020. However, the '238 patent is subject to a terminal disclaimer fied to the '720 patent. The expiration date of the '720 patent is August 2, 2022, which includes a patent term adjustment pursuant to 35 U.S.C. § 154 of 708 days. Therefore, the expiration date of the '238 patent need not be shortened in view of the patent term of the '720 patent. i The expiration date identified for U.S. Patent No. 7,605,238 in this Request is based on the assumption that the '238 patent is not entitled to rely on the patent term adjustment that was granted to U.S. Patent No. 6,984,720, despite the language of the terminal disclaimer. However, if the PTO or the courts take the position that, in the circumstance such as the '238 patent, the '238 patent is entitled to rely on the patent term adjustment granted to the '238 patent, then Applicant reserves the right to amend this Request to seek a patent term extension application based on an expiration date of August 2, 2022 for the '238 patent.
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