IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`Patent No.
`Issue date
`Inventors
`For
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`5,532,372
`July 2, 1996
`Ikutaro Saji et al.
`IMIDE DERIVATIVES, AND THEIR PRODUCTION AND USE
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`Mail Stop Hatch-Waxman PTE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Sir:
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`RECEIVED
`DEC 0 9 2010
`PATENTdrJ[~ENSION
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`APPLICATION FOR EXTENSION OF PATENT TERM UNDER 35 U.S.C. § 156
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`Applicant, Dainippon Sumitomo Pharma Co., Ltd., a Japanese Corporation, represents
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`that it is the assignee of the entire interest in and to Letters Patent of the United States No.
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`5,532,372 granted to Ikutaro Saji, Masayuki Muto, Norihiko Tanno, and Mayumi Yoshigi on
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`July 2, 1996. The assignment (for parent application US Application No. 07/726,172 to which
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`U.S. Patent No. 5,532,372 claims priority), from the inventors to Sumitomo Pharmaceuticals
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`Company, Ltd. was recorded on July 17, 1991 at Reel 5773, Frame 0144 and the conveyance
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`from Sumitomo Pharmaceuticals Company, Ltd. to Dainippon Sumitomo Pharma Co., Ltd. was
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`recorded on December 16, 2005 at Reel 017089, Frame 0420.
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`01/21/2011 RLOGAN
`IU FC:1457
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`00008002 88113328
`1128.88 OP
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`U.S. Patent No. 5,532,372
`Attorney Docket No. 05273.0130-00000
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`Information Required Under 37 C.F.R. § 1.740
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`Applicant hereby submits this application for an extension of patent term under 35 U.S.C.
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`§ 156 by providing the following information as required by§ 1.740 ofTitle 37 of the Code of
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`Federal Regulations (37 C.F.R. § 1.740).
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`1. The approved product is Latuda®, generic name being lurasidone hydrochloride,
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`chemical name being (3aR,4S, 7R, 7aS)-2-{ (1 R,2R)-2-[4-(l ,2-benzisothiazol-3-yl)piperazin-1-
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`ylmethyl]cyclohexylmethyl} hexahydro-4, 7 -methano-2H-isoindole-1 ,3-dione hydrochloride, and
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`having the following formula:
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`2. The approved product was subject to regulatory review under Section 505 of the
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`Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355.
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`3. The approved product Latuda® (lurasidone hydrochloride) received permission for
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`commercial marketing or use under§ 505 of the Federal Food, Drug and Cosmetic Act, 21
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`U.S.C. § 355, on October 28, 2010. A copy of the approval letter from the Food and Drug
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`Administration is attached as Attachment "A".
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`4. The active ingredient in the approved product Latuda® is lurasidone hydrochloride,
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`which has not been previously approved for commercial marketing or use under the Federal
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`Food, Drug and Cosmetic Act, the Public Health Service Act, or the Virus-Serum-Toxin Act.
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`U.S. Patent No. 5,532,372
`Attorney Docket No. 05273.0130-00000
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`No other active ingredients are contained in this product. A copy of the U.S. package insert for
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`Latuda® (lurasidone hydrochloride) is attached as Attachment "B".
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`5. This application for extension of patent term under 35 U.S.C. § 156 is being submitted
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`within the sixty (60) day period permitted for submission pursuant to§ 1.720(±). The last day for
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`submitting an application for extension is December 26, 201 0 (a Sunday, so submission on
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`Monday December 27, 2010, would be timely. 35 U.S.C. § 2l(b)).
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`6. The complete identification of the patent for which an extension is being sought is as
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`follows:
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`Inventors
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`Patent No.
`Issue date
`Expiration date
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`Ikutaro Saji, Masayuki Muto, Norihiko Tanno, and Mayumi
`Yoshigi
`5,532,372
`July 2, 1996
`July 2, 2013
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`7. A copy of the patent for which an extension is being sought is attached hereto as
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`Attachment "C".
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`8. Receipts for maintenance fee payments for this patent are attached hereto as
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`Attachment "D". A certificate of correction issued November 24, 2009, is attached hereto as
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`Attachment "E". No terminal disclaimer or reexamination certificate has been issued with
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`respect to U.S. Patent No. 5,532,372.
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`9. The patent claims the active ingredient in the approved product Latuda® (lurasidone
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`hydrochloride) in at least claims 1, 2, 5, 6, 8(6), 9(6), 10, 11, 12, 13, and 14.
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`In particular, Claim 14 reads on the approved product as follows:
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`14. The imide compound of the formula:
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`U.S. Patent No. 5,532,372
`Attorney Docket No. 05273.0130-00000
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`or an acid addition salt thereof.
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`U.S. Patent No. 5,532,372
`Attorney Docket No. 05273.0130-00000
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`10. The relevant dates and information pursuant to 35 U.S.C. § 156(g) to enable the
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`Secretary of Health and Human Services to determine the applicable regulatory review period
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`are as follows:
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`(i)
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`the effective date of the investigational new drug (IND) application was
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`December 17, 2000;
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`(ii)
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`the IND number was 61,292;
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`(iii)
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`the date on which a new drug application (NDA) was initially submitted was
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`December 30, 2009;
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`(iv)
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`the NDA number was 200603; and
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`(v)
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`the date on which the NDA was approved was October 28,2010.
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`U.S. Patent No. 5,532,372
`Attorney Docket No. 05273.0130-00000
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`11. The following is a brief'description of the significant activities undertaken by the
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`marketing applicant during the applicable regulatory review period with respect to Latuda®
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`(lurasidone hydrochloride) and the significant dates applicable to such activities:
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`(i)
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`(ii)
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`the effective date of the IND filing was December 17, 2000;
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`the NDA was submitted on December 30, 2009; and
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`(iii)
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`the NDA was approved on October 28,2010.
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`A chronology of the activities undertaken with respect to the IND for Latuda®
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`(lurasidone hydrochloride; SM-13496) from the effective date of the IND to the filing ofthe
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`NDA is set forth in Attachment "F". A chronology of the activities undertaken with respect to
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`the NDA for Latuda® (lurasidone hydrochloride) from the filing date of the NDA to the approval
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`of the NDA is set forth in Attachment "G".
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`U.S. Patent No. 5,532,372
`Attorney Docket No. 05273.0130-00000
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`12(A). It is the opinion of the Applicant that U.S. Patent No. 5,532,372 claims the
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`approved product that has undergone a regulatory review which would be considered in
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`determining any extension for patent term under 35 U.S.C. § 156 for the following reasons:
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`(i)
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`(ii)
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`U.S. Patent No. 5,532,372 claims the approved product (35 U.S.C. § 156(a));
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`The term of U.S. Patent No. 5,532,372 has not expired before submission of this
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`application for an extension (35 U.S.C. § 156(a)(l));
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`(iii) The term of U.S. Patent No. 5,532,372 has never been previously extended
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`(35 U.S.C. § 156(a)(2));
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`(iv)
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`The application for extension is submitted by Dainippon Sumitomo Pharma Co.,
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`Ltd., the owner of record of U.S. Patent No. 5,532,372 in accordance with the
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`requirements of35 U.S.C. § I 56( d), 37 C.F.R. § 1.730, and 37 C.F.R. § 1.740 (35
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`U.S.C. § 156(a)(3));
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`(v)
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`The product Latuda® (lurasidone hydrochloride) has been subject to a regulatory
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`review period before its commercial marketing or use (35 U.S.C. § 156(a)( 4));
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`(vi)
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`The product Latuda® (lurasidone hydrochloride) has received permission for
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`commercial marketing or use, and the permission for the commercial marketing or
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`use of the product after the regulatory review period is the first permitted
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`commercial marketing or use of the product under the provision of the Federal
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`Food, Drug and Cosmetic Act, under which the regulatory review period occurred
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`(35 U.S.C. § 156(a)(5)(A));
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`(vii) No other patent has been extended for the same regulatory review period for the
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`product Latuda® (lurasidone hydrochloride) (35 U.S.C. § 156(c)(4)); and
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`(viii) Dainippon Sumitomo Pharma Co., Ltd., the owner of record of U.S. Patent No.
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`5,532,372 has hereby submitted an application to the Commissioner to obtain an
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`extension of the term of the patent within the sixty (60) day period beginning on
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`the date the product received permission for commercial marketing or use (35
`u.s.c. § 156(d)(l)).
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`12(B). The length of extension of the patent term of U.S. Patent No. 5,532,372 claimed
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`by Applicants is 1826 days (5 years). The length of extension was determined by the following:
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`U.S. Patent No. 5,532,372
`Attorney Docket No. 05273.0130-00000
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`(i)
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`The U.S. Patent No. 5,532,372 issued July 2, 1996, which was after the date of
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`enactment of35 U.S.C. § 156. The commercial marketing or use of the product,
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`Latuda®, (lurasidone hydrochloride), was approved after the date of enactment of
`35 u.s.c. § 156.
`The regulatory review period under 35 U.S.C. § 156(g)(l)(B) was from December
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`(ii)
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`17, 2000, until October 28,2010, which was 3603 days.
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`(iii)
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`The period of review under 35 U.S.C. § 156(g)(l)(B)(i) began on the date an
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`exemption under§ 505(i) became effective on December 17, 2000, and ended on
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`the date an application was initially submitted for Latuda® (lurasidone
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`hydrochloride) under§ 505 which was December 30,2009, a total of3301 days.
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`(iv)
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`The regulatory review period under 35 U.S.C. § 156(g)(l )(B)(ii) began on the
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`date the application was initially submitted for Latuda®, (lurasidone
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`hydrochloride), under§ 505(b), which was December 30, 2009, and ended on the
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`date such application was approved under such section, which was October 28,
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`2010, a total of 303 days.
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`(v)
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`The issuance of U.S. Patent No. 5,532,372 occurred on July 2, 1996, which was
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`before the effective date of the IND application (December 17, 2000).
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`(vi) Accordingly, the regulatory period under 35 U.S.C. § 156(g)(l)(B)(i) is 3301
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`days.
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`(vii) Under 35 U.S.C. § 156(c)(2), the period of extension includes only one-halfofthe
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`period determined under 35 U.S.C. § 156(g)(1)(B)(i), which is set forth in item
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`(vi) ofthis paragraph 12(B), i.e., 3301 days, which is 1651 days, together with the
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`number of days required for approval set forth in item (iv) of this paragraph
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`12(B), i.e., 303 days, for an extension of 1954 days, or a date of November 7,
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`2018.
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`(viii)
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`In compliance with 35 U.S.C. § 156(c)(3), the period remaining in the term of
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`U.S. Patent No. 5,532,372 after NDA approval ofLatuda® (lurasidone
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`hydrochloride) is from October 28,2010 to July 2, 2013, or 979 days, which when
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`added to the period of extension under item (vii) of this paragraph 12(B), i.e.,
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`U.S. Patent No. 5,532,372
`Attorney Docket No. 05273.0130~00000
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`1954 days, is a total of 2933 days, or 8 years and 13 days, which is not in excess
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`of fourteen (14) years provided in 35 U.S.C. § 156(c)(3).
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`(ix)
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`Since U.S. Patent No. 5,532,372 issued after September 24, 1984, a period of
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`extension may not exceed five (5) years from the original expiration date of July
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`2, 2013. Five years, when added to the original expiration date of the patent,
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`would result in the date of July 2, 2018.
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`(x)
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`The earlier date as determined in paragraph 12(B)(vii) and paragraph 12 (B)(ix) is
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`July 2, 20 18, or 1826 days ( 5 years) of term extension.
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`U.S. Patent No. 5,532,372
`Attorney Docket No. 05273.0130-00000
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`13. Applicant acknowledges a duty to disclose to the Director of the Patent and
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`Trademark Office and the Secretary of Health and Human Services any information which is
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`material to the determination of entitlement to the extension sought in this application.
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`14. The prescribed fee for receiving and acting upon the application for extension of
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`$1,120.00 is enclosed with this application. Should additional fees be necessary in connection
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`with the filing of this paper, or if a petition for extension of time is required for timely
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`acceptance of same, the Commissioner is hereby authorized to charge Deposit Account
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`No. 06-0916 for any such fees. Should a refund of fee paid be necessary, the Commissioner is
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`hereby authorized to credit any such amount to Deposit Account No. 06-0916.
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`15. Inquiries and correspondence relating to this application for patent term extension are
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`to be directed to the correspondence address associated with Customer No. 22852:
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`Charles E. Van Horn
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`901 New York Avenue, N.W.
`Washington, D.C. 20001
`Telephone No. 202-408-4072
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`A power of attorney to the registered practitioners associated with Customer Number
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`22852 is attached as Exhibit "H".
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`16. Two additional copies of the application papers for extension of the patent term of
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`U.S. Patent No. 5,532,372 are enclosed with the application.
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`17. The undersigned is a registered practitioner of the United States Patent and
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`Trademark Office and is authorized by the Applicant to act on behalf of the Applicant.
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`U.S. Patent No. 5,532,372
`Attorney Docket No. 05273.0130-00000
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`Date:
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`Respectfully submitted,
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`Charles E. Van Hom
`Reg. No. 40,266
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`Attachment A: Copy of FDA approval letter
`Attachment B: Package Insert for Latuda® (lurasidone hydrochloride)
`Attachment C: Copy ofUSP 5,532,372
`Attachment D: Maintenance Fee Statement for USP 5,532,372
`Attachment E: Certificate of Correction for USP 5,532,372
`Attachment F: Brief Description of Regulatory Activities for IND
`Attachment G: Brief Description of Regulatory Activities for NDA
`Attachment H: Power of attorney
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`U.S. Patent No. 5,532,372
`Attorney Docket No. 05273.0130-00000
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`CERTIFICATION
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`The undersigned hereby certifies that this application for extension of patent term under
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`35 U.S.C. § 156, including its attachments and supporting papers, is being submitted with two
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`additional copies of originals.
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`Date December 9, 2010
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`~E.V~tfvvh_
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`Charles E. Van Hom
`Reg. No. 40,266
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