UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`Commissioner for Patents
`United States Patent and Trademark Office
`PO. Box 1450
`Alexandria, VA 22313-1450
`www.uspto.gov
`
`Danielle L. Herritt
`
`In Re: Patent Term Extension
`
`McCarter & English LLP
`265 Franklin Street
`
`Boston, MA 02110
`
`Dear Ms. Herritt:
`
`Application for
`US. Patent No. 5,532,241
`
`u
`1
`,
`ELL 3 O 2014.
`
`A certificate under 35 U.S.C. § 156 is enclosed extending the term of US. Patent
`No. 5,532,241 for a period of 5 years. While a courtesy copy of this letter is being forwarded to
`the Food and Drug Administration (FDA), you should directly correspond with the FDA
`regarding any required changes to the patent expiration dates set forth in the Patent and
`Exclusivity Data Appendix of the Orange Book (Approved Drug Products with Therapeutic
`Equivalence Evaluations) of in the Patent Information set forth in the Green Book (FDA
`‘
`Approved Animal Drug Products). Effective August 18, 2003, patent submissions for
`publication in the Orange Book and Docket *958-0117 need to be submitted on form FDA-3542
`which may be downloaded from FDA's Electronic Forms Download Website:
`http://www. fda. gov/opacom/morechoices/fdaforms/default.html
`' (http://wwwfda.gov/opacom/morecholees/fdaforms/FDA3542.pdt).
`
`Inquiries regarding this communication should be directed to the undersigned by telephone at
`(571) 272-7755, or by e--mail at mary.till@uspto. gov.
`r
`
`ary C. Till
`Senior Legal Advisor
`Office of Patent Legal Administration
`Office of the Associate Commissioner
`
`for Patent Examination Policy
`
`cc:
`
`Office of Regulatory Policy
`Food and Drug Administration
`10903 New Hampshire Ave, Bldg. 51, Rm. 6284
`Silver Spring, MD 20993-0002
`
`RE: VIIBRYD® (vilozodone
`hydrochloride)
`Docket No.: FDA—2011-E-
`‘
`
`Attention: Beverly Friedman
`
`Argentum EX1022
`Argentum EX1022'
`Page 1
`
`Page 1
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`(12)
`
`CERTIFICATE EXTENDING PATENT TERM
`UNDER 35 U.S.C. § 156
`
`(68) ' PATENT NO.
`
`A
`
`‘ (45)
`
`ISSUED
`
`(75) TNVENTOR
`
`(73) PATENT OWNER
`_
`,
`
`(95)
`
`PRODUCT
`
`_
`
`:
`
`:
`
`:
`
`:
`
`:
`
`5,532,241
`
`July 2, 1996
`
`Henning Bottcher et al.
`
`Merck Patent Gesellschaft Mit Beschrankter
`Haftung
`
`VIIBRYD® (vilozodone hydrochloride)
`
`This is to certify that an application under 35 U.S.C. § 156 has been filed in the United
`
`States Patent and Trademark Office, requesting extension of the term of US. Patent No.
`
`5,532,241 based upon the regulatory review of the product VIIBRYD® (vilozodone
`
`hydrochloride) by the Food and Drug Administration. Since it appears that the
`
`requirements'of the law have been met, this certificate extends the term of the patent for
`
`the period of
`
`(94)
`
`A
`
`5 years
`
`from September 29, 2014, the original expiration date of the patent, subject to the payment
`of maintenance fees as provided by law, with all rights pertaining thereto as provided by
`
`35 U.S.C. § 156.
`
`
`
`I have caused the seal of the United States Patent and
`
`Trademark Office to be affixed this 24th day of July 2014.
`
`Michelle K. Lee
`.
`Deputy Under Secretary of Commerce for Intellectual Property and
`Deputy Director of the United States Patent and Trademark Office
`
`Page 2
`
`Page 2
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`Danielle-L. Herri-tt
`McCarter & English LLP
`265 Franklin Street
`Boston, MA 02110
`
`Commissioner for Patents
`.
`United States Patent and Trademark Office
`PO. Box 1450
`Alexandria, VA 22313-1450
`www.uspto.gov
`
`In Re: Patent Term Extension
`Application for
`US Patent No. 5,532,241
`
`EVER 29 2014
`
`NOTICE OF FINAL DETERMINATION
`
`A determination has been made that US. Patent No. 5,532,241 , which claims the human drug
`product VIIBRYD® (vilozodone hydrochloride), is eligible for patent term extension under 35
`U.S.C. § 156. The period of extension has been determined to be 5 years.
`
`A single request for reconsideration of this final determination as to the length of extension of the
`term of the patent may be made if filed within one month of the date of this notice. Extensions
`of time under 37 CFR § 1.136(a) are not applicable to this time period. In the absence of such
`request for reconsideration, the Director/will issue a certificate of extension, under seal, for a
`period of 5 years.
`
`The period of extension, if calculated using the Food and Drug Administration determination of
`the length of the regulatory review period published in the Federal Register of April 6, 2012, (77
`Fed. Reg. 20830), would be 2,542 days. Under 35 U.S.C. § 156(c):
`
`Period of Extension =
`=
`=
`
`RRP - PGRRP — DD - V2 (TP - PGTP)l
`4,778-0-0-‘/2(4472-0)
`2,542 (7.0 years)
`
`Since the regulatory review period began December 24, 1997, after the patent issued (July 2,
`1996), the entire regulatory review period has been considered in the above determination of the
`length of the extension period 35 U.S.C. § 156(c). No determination of a lack of due diligence
`under 35 U.S.C. § 156(c)(1) was made.
`
`The five year limitation of 35 U.S.C. § 156(g)(6)(A) applies in the present situation because the.
`patent was issued after the date of enactment of 35 U.S.C. § 156. Since the period of extension
`calculated under 35 U.S.C. § 156(c) for the patent cannot exceed five years under 35 U.S.C. § ‘
`156(g)(6)(A), the period of extension will be for five years.
`
`' Consistent with 35 U.S.C. § 156(c), “RRP” is the total number of days in the regulatory
`review period, “PGRRP” is the number of days of the RP which were on and before the date on
`which the patent issued, “DD” is the number of days of the RRP that the applicant did not act
`with due diligenCe, “TP” is the testing phase period described1n paragraphs (1)(B)(i), (2)(B)(i),
`(3)(B)(i), (4)(B)(i), and (5)(B)(i) of subsection (g) of 35 U. S. C. § 156, and “PGTP” is the number
`of days of the TP which were on and before the date on which the patent issued, wherein half
`days are ignored for purposes of the subtraction of '/2 (TP - PGTP).
`
`Page 3
`
`Page 3
`
`

`

`US. Patent No. 5,532,241
`
`Page 2
`
`The 14 year limitation of 35 U.S.C. § 156(c)(3) does not operate to further reduce the period of
`extension determined above.
`'
`
`Upon issuance of the certificate of extension, the following information will be published in the
`Official Gazette:
`
`US. Patent No.:
`
`5,532,241
`
`Granted:
`
`July 2, 1996
`
`Original Expiration Datez:
`
`September 29, 2014
`
`Applicant:
`
`‘
`
`Henning Bottcher et a1.
`
`Owner of Record:
`
`'
`
`Merck Patentgesellschaft Mit Beschrankter Haftung
`
`Title:
`
`7
`
`’ Piperidines and Piperazines
`
`Product Trade Name:
`
`V
`
`VIIBRYD® (Vilozodone hydrochloride)
`
`Term Extended:
`
`5 years
`
`Expiration Date of Extension:
`
`September 29, 2019
`
`2Subject to the provisions of 35 U.S.C. § 41(b).
`
`Page 4
`
`Page 4
`
`

`

`US. Patent No. 5,532,241
`
`'
`
`Page 3
`
`Any correspondence from applicant with respect to this matter should be submitted via the
`USPTO’s EFS Web system and should. be addressed as follows:
`
`By mail:
`
`Mail Stop Hatch-Waxman PTE
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 22313—1450.
`
`Telephone inquiries related to this determination should be directed to the undersigned at (571)
`272—7755.
`<
`'
`
`Mary C. Till
`Senior Legal Advisor
`Office of Patent Legal Administration
`Office of the Deputy Commissioner
`for Patent Examination Policy
`
`cc:
`
`Office of Regulatory Policy
`Food and Drug Administration
`10903 New Hampshire Ave., Bldg. 51, Rm. 6284
`Silver Spring, MD 20993-0002
`
`.
`
`RE: VIIBRYD® (vilozodone
`hydrochloride)
`Docket No.: FDA-201 1-E-03 80
`
`Attention: Beverly Friedman
`
`Page 5
`
`Page 5
`
`

`

`.29» “who” Department of Health and Human Services
`
`Public Health Service
`
`If
`
`5.6 C
`9%...”
`
`DEC 1 8 2012
`
`.
`
`Food and Drug Administration
`Rockville, MD 20857
`
`Re: VIIBRYD
`US. Patent Nos. 5,532,241 and 7,834,020
`Docket Nos. FDA-201 l -E-O3 80
`
`FDA-201 1-E—O389
`
`The Honorable David J. Kappos
`Under Secretary of Commerce for Intellectual Property
`Director of the United States Patent and Trademark Office
`
`Mail Stop Hatch-Waxman PTE
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`Dear Director Kappos:
`
`This is in regard to the patent term extension applications for US. Patent Nos. 5,532,241 and
`7,834,020 filed by Merck Patent GmbH under 35 U.S.C. § 156. The patents claim VIIBRYD,
`which was assigned new drug application 22-567.
`
`In the April 6, 2012, issue of the Federal Register (77 Fed. Reg. 20830), the Food and Drug
`Administration published its determination of this product's regulatory review period, as required
`under 35 U.S.C. § 156(d)(2)(A). The notice provided that on or before October 3, 2012, 180
`days after the publication of the determination, any interested person could file a petition with
`FDA under 35 U.S.C. § 156(d)(2)(B)(i) for a determination of whether the patent term extension
`applicant acted with due diligence during the regulatory review period.
`
`The ISO-day period for filing a due diligence petition pursuant to this notice has expired and
`FDA has received no such petition. Therefore, FDA considers the regulatory review period
`determination to be final.
`
`Please let me know if we can provide fiirther assistance.
`
`Sincerely yours,
`
`2,004,422.]
`
`Jane A. Axelrad
`
`Associate Director for Policy
`Center for Drug Evaluation and Research
`
`cc:
`
`Danielle L. Herritt
`
`McCarter & English LLP
`265 Franklin Street
`
`Boston, MA 02110
`
`Page 6
`
`Page 6
`
`

`

`mm»
`tn mumm
`OH)
`
`20830
`Federal Register/Vol. 77, No. 67/ Friday, April 6, 2012/ Notices
`
`DATSCAN and is publishing this notice
`of that determination as required by
`law. FDA has made the determination
`because of the submission of an
`application to the Director of Patents
`and Trademarks, Department of
`Commerce, for the extension of a patent
`which claims that human drug product.
`ADDRESSES: Submit electronic
`comments to http://
`www.regulations.gov. Submit written
`petitions along with three copies and
`written comments to the Division of
`Dockets Management (HFA—305), Food
`and Drug Administration, 5630 Fishers
`Lane, rm. 1061, Rockville, MD 20852.
`FOR FURTHER INFORMATION CONTACT:
`
`Beverly Friedman, Office of Regulatory
`Policy, Food and Drug Administration,
`10903 New Hampshire Ave. Bldg. 51,
`rm. 6222, Silver Spring, MD 20993—
`0002, (301) 796—3602.
`SUPPLEMENTARY INFORMATION: The Drug
`Price Competition and Patent Term
`Restoration Act of 1984 (Pub. L. 98—417)
`and the Generic Animal Drug and Patent
`Term Restoration Act (Pub. L. 100-670)
`generally provide that a patent may be
`extended for a period of up to 5 years
`so long as the patented item (human
`drug product, animal drug product,
`medical device, food additive, or color
`additive) was subject to regulatory
`review by FDA before the item was
`marketed. Under these acts, a product’s
`regulatory review period forms the basis
`for determining the amount of extension
`an applicant may receive.
`A regulatory review period consists of
`two periods of time: A testing phase and
`an approval phase. For human drug
`products, the testing phase begins when
`the exemption to permit the clinical
`investigations of the drug becomes
`effective and runs until the approval
`phase begins. The approval phase starts
`with the initial submission of an
`application to market the human drug
`product and continues until FDA grants
`permission to market the drug product.
`Although only a portion of a regulatory
`review period may count toward the
`actual amount of extension that the
`Director of Patents and Trademarks may
`award (for example, half the testing
`phase must be subtracted as well as any
`time that may have occurred before the
`patent was issued), FDA's determination
`of the length of a regulatory review
`period for a human drug product will
`include all of the testing phase and
`approval phase as specified in 35 U.S.C.
`156(g)(1)(B).
`FDA recently approved for marketing
`the human drug product DATSCAN
`(Ioflupane I—123 injection). DATSCAN
`is indicated for striatal dopamine
`transporter visualization using single
`
`photon emission computed tomography
`brain imaging to assist in the evaluation
`of adult patients with suspected
`Parkinsonian syndromes. Subsequent to
`this approval, the Patent and Trademark
`Office received a patent term restoration
`application for DATSCAN (US. Patent
`No. 5,310,912) from GE Healthcare
`Limited, and the Patent and Trademark
`Office requested FDA's assistance in
`determining this patent’s eligibility for
`patent term restoration. In a letter dated
`June 22, 2011, FDA advised the Patent
`and Trademark Office that this human
`drug product had undergone a
`regulatory review period and that the
`approval of DATSCAN represented the
`first permitted commercial marketing or
`use of the product. Thereafter, the
`Patent and Trademark Office requested
`that FDA determine the product’s
`regulatory review period.
`FDA has determined that the
`
`applicable regulatory review period for
`DATSCAN is 677 days. Of this time, 0
`days occurred during the testing phase
`of the regulatory review period, while
`677 days occurred during the approval
`phase. These periods of time were
`derived from the following dates:
`1. The date an exemption under
`section 505(i) of the Federal Food, Drug,
`and Cosmetic Act (the FFDFrC Act) {21
`U.S.C. 355(i)) became effective: not
`applicable. The applicant claims June
`19, 1997, as the date the investigational
`new drug application (H\ID) became
`effective. However, FDA records
`indicate that no IND was submitted
`under subsection 5050) of the FFD&C
`Act for this human drug product.
`2. The date the application was
`initially submitted with respect to the
`human drug product under section
`505(b) Of the FFD8C Act: March 9, 2009.
`The applicant claims March 6, 2009, as
`the date the new drug application
`(NDA) for DATSCAN (NDA 22—454) was
`initially submitted. However, FDA
`records indicate that NDA 22—454 was
`submitted on March 9, 2009.
`3. The date the application was
`approved: January 14, 2011. FDA has
`verified the applicant’s claim that NDA
`22454 was approved on January 14,
`2011.
`
`This determination of the regulatory
`review period establishes the maximum
`potential length of a patent extension.
`However, the US. Patent and
`Trademark Office applies several
`statutory limitations in its calculations
`of the actual period for patent extension.
`In its application for patent extension,
`this applicant seeks 5 years of patent
`term extension.
`Anyone with knowledge that any of
`the dates as published are incorrect may
`submit to the Division of Dockets
`
`. Management (see ADDRESSES) either
`electronic or written comments and ask
`for a redetermination by June 5, 2012.
`Furthermore, any interested person may
`petition FDA for a determination
`regarding whether the applicant for
`extension acted with due diligence
`during the regulatory review period by
`October 3, 2012. To meet its burden, the
`petition must contain sufficient facts to
`merit an FDA investigation. (See H.
`Rept. 857, part 1, 98th Cong, 2d sess.,
`pp. 41-42, 1984.) Petitions should be in
`the format specified in 21 CFR 10.30.
`Interested persons may submit to the
`Division of Dockets Management (see
`ADDRESSES) electronic or written
`comments and written petitions. It is
`only necessary to send one set of
`comments. However, if you submit a
`written petition, you must submit three
`copies of the petition. Identify
`comments with the docket number
`found in brackets in the heading of this
`document.
`Comments and petitions that have not
`been made publicly available on
`regulationsgov may be viewed in the
`Division of Dockets Management
`between 9 a.m. and 4 p.m., Monday
`through Friday.
`Dated: March 19, 2012.
`lane A. Axelrad,
`Associate Directorfor Policy, Centerfor Drug
`Evaluation and Research.
`[FR Doc. 2012—8340 Filed 4—5—12;8:45 am]
`BILLING CODE 4160-014
`
`DEPARTMENTQF HEALTH AND
`HUMAN SERVICES
`
`Food and Drug Administration
`
`[Docket Nos. FDA-2011-E—0380 and FDA-
`201 1—E—O389]
`
`Determination of Regulatory Review
`Period for Purposes of Patent
`Extension; VIIBRYD
`
`AGENCY: Food and Drug Administration,
`HHS.
`ACTION: Notice.
`
`SUMMARY: The Food and Drug
`Administration (FDA) has determined
`the regulatory review period for
`VIIBRYD and is publishing this notice
`of that determination as required by
`law. FDA has made the determination
`because of the submission of
`applications to the Director of Patents
`and Trademarks, Department of
`Commerce, for the extension of patents
`which claim that human drug product.
`Aooaesses: Submit electronic
`comments to http://
`www.mgulationsgov. Submit written
`
`Page 7
`
`Page 7
`
`

`

`20831
`#
`Federal Register/Vol. 77, No. 67/Friday, April 6, 2012/Notices
`
`petitions along with three copies and
`written comments to the Division of
`Dockets Management (HFA—305), Food
`and Drug Administration, 5630 Fishers
`Lane, rm. 1061, Rockville, MD 20852.
`FOR FURTHER INFORMATION CONTACT:
`
`Beverly Friedman, Office of Regulatory
`Policy, Food and Drug Administration,
`10903 New Hampshire Ave. Bldg. 51,
`rm. 6222, Silver Spring, MD 20993-
`0002, 301—795—3602.
`
`SUPPLEMENTARY INFORMATION: The Drug
`Price Competition and Patent Term
`Restoration Act of 1984 (Pub. L. 98—417)
`and the Generic Animal Drug and Patent
`Term Restoration Act (Pub. L. 100—670)
`generally provide that a patent may be
`extended for a period of up to 5 years
`so long as the patented item (human
`drug product, animal drug product,
`medical device, food additive, or color
`additive) was subject to regulatory
`review by FDA before the item was
`marketed. Under these acts, a product’s
`regulatory review period forms the basis
`for determining the amount of extension
`an applicant may receive.
`A regulatory review period consists of
`two periods of time: A testing phase and
`an approval phase. For human drug
`products, the testing phase begins when
`the exemption to permit the clinical
`investigations of the drug becomes
`effective and runs until the approval
`phase begins. The approval phase starts
`with the initial submission of an
`
`application to market the human drug
`product and continues until FDA grants
`permission to market the drug product.
`Although only a portion of a regulatory
`review period may count toward the
`actual amount of extension that the
`Director of Patents and Trademarks may
`award (for example, half the testing
`phase must be subtracted as well as any
`time that may have occurred before the
`patent was issued), FDA’s determination
`of the length of a regulatory review
`period for a human drug product will
`include all of the testing phase and
`approval phase as specified in 35 U.S.C.
`156(g)(1)(B)-
`FDA recently approved for marketing
`the human drug product VIIBRYD
`(vilazodone hydrochloride). VIIBRYD is
`indicated for the treatment of major
`depressive disorder. Subsequent to this
`approval, the Patent and Trademark
`Office received a patent term restoration
`application for VIIBRYD (US. Patent
`Nos. 5,532,241 and 7,834,020) from
`Merck Patent GmbH, and the Patent and
`Trademark Office requested FDA’s
`assistance in determining this patent’s
`eligibility for patent term restoratidn. In
`a letter dated June 22, 2011, FDA
`advised the Patent and Trademark
`Office that this human drug product had
`
`undergone a regulatory review period
`and that the approval of VIIBRYD
`represented the first permitted
`commercial marketing or use of the
`product. Thereafter, the Patent and
`Trademark Office requested that FDA
`determine the product's regulatory
`review eriod.
`FDA as determined that the
`
`applicable regulatory review period for
`VIIBRYD is 4,778 days. Of this time,
`4,472 days occurred during the testing
`phase of the regulatory review period,
`while 306 days occurred during the
`approval phase. These periods of time
`were derived from the followin dates:
`1. The date an exemption un er
`section 505(i) of the Federal Food, Drug,
`and Cosmetic Act (the FD&C Act) (21
`U.S.C. 355(0) became effective:
`December 24, 1997. FDA has verified
`the applicant’s claim that the date the
`investigational new drug application
`became effective was on December 24,
`1997.
`
`2. The date the application was
`initially submitted with respect to the
`human drug product under section
`505(b) of the FD&C Act: March 22, 2010.
`FDA has verified the applicant's claim
`that the new drug application (NDA) for
`VIIBRYD (NDA 22—567) was submitted
`on March 22,2010.
`3. The date the application was
`approved: January 21, 2011. FDA has
`verified the applicant’s claim that NDA
`22—567 was approved on January 21,
`2011.
`This determination of the regulatory
`review period establishes the maximum
`potential length of a patent extension.
`However, the US. Patent and
`Trademark Office applies several
`statutory limitations in its calculations
`of the actual period for patent extension.
`In its applications for patent extension,
`this applicant seeks either 67 days or 5
`years of patent term extension.
`Anyone with knowledge that any of
`the dates as published are incorrect may
`submit to the Division of Dockets
`
`Management (see ADDRESSES) either
`electronic or written comments and ask
`for a redetermination by June 5, 2012.
`Furthermore, any interested person may
`petition FDA for a determination
`regarding whether the applicant for
`extension acted with due diligence
`during the regulatory review period by
`October 3, 2012. To meet its burden, the
`petition must contain sufficient facts to
`merit an FDA investigation. (See H.
`Rept. 857, part 1, 98th Cong., 2d sess.,
`pp. 41—42, 1984.) Petitions should be in
`the format specified in 21 CFR 10.30.
`Interested persons may submit to the
`Division of Dockets Management [see
`ADDRESSES) electronic or written
`comments and written petitions. It is
`
`only necessary to send one set of
`comments. However, if you submit a
`written petition, you must submit three
`copies of the petition. Identify
`comments with the docket number
`found in brackets in the heading of this
`document.
`Comments and petitions that have not
`been made publicly available on
`regulationsgov may be viewed in the
`Division of Dockets Management
`between 9 a.m. and 4 p.m., Monday
`through Friday.
`Dated: March 19, 2012.
`Jane A. Axelrad,
`Associate Directorfor Policy, Cen terfor Drug
`Evaluation and Research.
`[FR Doc. 2012—8341 Filed 4—5—12: 8:45 am]
`BILLING CODE 4160-01-9
`
`DEPARTMENT OF HEALTH AND
`HUMAN SERVICES
`
`National Institutes of Health
`
`National Cancer Institute; Notice of
`Closed Meeting
`
`Pursuant to section 10(d) of the
`Federal Advisory Committee Act, as
`amended (5 U.S.C. App), notice is
`hereby given of the followin meeting.
`The meeting will be close to the
`public in accordance with the
`provisions set forth in sections
`552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
`as amended. The grant applications and
`the discussions could disclose
`confidential trade secrets or commercial
`property such as patentable material,
`and personal information concerning
`individuals associated with the grant
`applications, the disclosure of which
`would constitute a clearly unwarranted
`invasion of personal privacy.
`Name of Committee: National Cancer
`Institute Initial Review Group; Subcommittee
`A—Cancer Centers.
`Date: May 3, 2012
`Time: 8 a.m. to 5:20 p.m.
`Agenda: To review and evaluate grant
`applications.
`Place: Courtyard by Marriott, 5520
`Wisconsin Avenue, Chevy Chase, MD 20815.
`Contact Person: Gail 1 Bryant, MD, Medical
`Officer. Resources and Training Review
`Branch, Division of Extramural Activities,
`National Cancer Institute, 6116 Executive
`Blvd., Room 8107, MSC 8328, Bethesda. MD
`20892—8328, (301) 402—0801, gb30t@nih.gov.
`Information is also available on the
`Institute’s/Center's home page: http://
`deainfo.nci.nih.gov/advisory/irg/irghtm,
`where an agenda and any additional
`information for the meeting will be posted
`when available.
`
`(Catalogue of Federal Domestic Assistance
`Program Nos. 93.392, Cancer Construction;
`93.393, Cancer Cause and Prevention
`Research; 93.394, Cancer Detection and
`
`Page 8
`
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`

`DEPARTMENT OF HEALTH 81 HUMAN SERVICES
`
`
`
`APR
`
`3 2012
`
`Food and Drug Administration
`Rockville MD 20857
`
`Re: VIIBRYD
`
`Patent Nos. 5,532,241 and 7,834,020
`Docket Nos. FDA-201 1—E-03 80 and
`
`FDA-201 1-E-0389
`
`The Honorable David J. Kappos
`Undersecretary of Commerce for Intellectual Property
`Director of the United States Patent and Trademark Office
`
`Mail Stop Hatch-Waxman PTE
`PO. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Director Kappos:
`
`This is in regard to the applications for patent term extension for US. Patent Nos. 5,532,241 and
`7,834,020, filed by Merck Patent GmbH, under 35 U.S.C. section 156 e_t Q. We have reviewed
`the dates contained in the applications and have determined the regulatory review period for
`VIIBRYD (vilazodone hydrochloride), the human drug product claimed by the patents.
`
`5
`"nth of the mm” "W" review period for VHBR V. L' (vilazodone hydrochloride) is
`Th
`‘8 total leusu; \JL Lllv A» 3413““)
`4,778 days. Of this time, 4,47 days occurred during the testing phase and 306 days occurred
`during the approval phase. These periods of time were derived from the following dates:
`
`1.
`
`2.
`
`The date an exemption under subsection 505m of the Federal Food, Drug, and Cosmetic
`Act involving this drug product became effective: December 24, 1997.
`
`FDA has verified the applicant's claim that the date the investigational new drug
`application became effective was on December 24, 1997
`
`The date the application was initially submitted with respect to the human drug product
`under section 505 of the Federal Food, Drug, and Cosmetic Act: March 22, 2010.
`
`FDA has verified the applicant's claim that the new drug application (NDA) for
`VIIBRYD (NDA 22-567) was submitted on March 22, 2010.
`
`3.
`
`The date the application was approved: January 21, 2011.
`
`FDA has verified the applicant's claim that NDA 22-567 was approved on January 21,
`201 1 .
`
`This determination of the regulatory review period by FDA does not take into account the
`effective date of the patent, nor does it exclude one-half of the testing phase as required by 35
`U.S.C. section 156(c)(2).
`
`Page 9
`
`Page 9
`
`

`

`Kappos - VIIBRYD
`Patent No. 5,532,241 and 7,834,020
`Page 2
`
`Please let me know if we can be of further assistance.
`
`Sincerely yours,
`
` WW
`
`Jane A. Axelrad
`
`Associate Director for Policy
`Center for Drug Evaluation and Research
`
`cc:
`
`Danielle L. Herritt
`
`McCarter & English LLP
`265 Franklin Street
`
`Boston, MA 02110
`
`Page 10
`
`Page 10
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`NOV 2 9
`
`{vi
`2Uli
`
`Commissioner for Patents
`.
`United States Patent and Trademark Office
`'
`P.O. BOX 1450
`Alexandrla, VA 22313-1450
`www.uspto.gov
`
`Office of Regulatory Policy
`_
`Food and Drug Administration
`10903 New Hampshire Ave., Bldg. 51, Rm. 6222
`Silver Spring, MD 20993-0002
`
`Attention: Beverly Friedman
`
`Dear Ms. Axelrad:
`
`Transmitted herewith is a copy of the application for patent term extension of US. Patent No.
`5,532,241. The application was filed on March 17, 2011, under 35 U.S.C. § 156. Pleasenote
`that a patent term extension application for U.S. Patent No. 7,834,020 for NDA 22—567 for the
`human drug product VIIBRYD® (vilozodone hydrochloride) was filed concurrently, pursuant to
`the provisions of 37 C.F.R. § 1.785.
`
`The patent claims a product that was subject to regulatory review under the Federal Food, Drug
`and Cosmetic Act. Subject to final review, the subject patent is considered to be eligible for
`patent term extension. Thus, a determination by your office of the applicable regulatory review
`period is necessary. Accordingly, notice and a copy of the .application are provided pursuant to
`35 U.S.C. § 156(d)(2)(A).
`
`Inquiries regarding this communication should be directed to the undersigned at (571) 272-775 5
`(telephone) or (571) 273-775 5 (facsimile).
`-
`
`Mary C. Till
`Senior Legal Advisor
`Office of Patent Legal Administration
`Office of the Associate Commissioner
`
`for Patent Examination Policy
`
`cc:
`
`Danielle L. Herritt
`
`McCarter & English LLP
`265 Franklin Street
`
`Boston, MA 02110
`
`RE: VIIBRYD® (vilozodone hydrochloride)
`Docket No. FDA-201 1-E-389
`
`Page 1 1
`
`Page 11
`
`

`

`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`
`
`JUN 2 2 2011
`
`Food and Drug Administration
`Rockville MD 20857
`
`Re: VIIBRYD
`
`Patent Nos. 5,532,241 and 7,834,020
`Docket Nos. FDA—201 1-E-0389
`
`FDA-201 1-E-O3 80
`
`The Honorable David J. Kappos
`Under Secretary of Commerce for Intellectual Property
`Director of the United States Patent and Trademark Office
`
`Mail Stop Hatch-Waxman PTE
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`Dear Director Kappos:
`
`This is in regard-to the applications for patent term extension for US. Patent Nos.
`5,532,241 and 7,834,020 filed by Merck Patent GmbH, under 35 U.S.C. § 156. The
`human drug product claimed by the patents is VIIBRYD (vilazodone hydrochloride),
`which was assigned new drug application (NDA) No. 22-567.
`
`A review of the Food and Drug Administration‘s official records indicates that this
`product was subject to a regulatory review period before its commercial marketing or use,
`as required under 35 U .S.C. § 156(a)(4). Our records also indicate that it represents the
`first permitted commercial marketing or use of the product, as defined under 35 U.S.C. §
`156(t)(1).
`
`The NDA was approved on January 21, 201 l, which makes the submission of the patent
`term extension applications on March 17, 2011, timely within the meaning of 35 U.S.C. §
`156(d)(1).
`'
`
`Should you conclude that the subject patent is eligible for patent term extension, please
`advise us accordingly. As required by 35 U.S.C. § 156(d)(2)(A) we will then determine
`the applicable regulatory review period, publish the determination in the Federal
`Register, and notify you of our determination.
`
`Please let me know if we can be of further assistance. I
`
`Sincerely yours,
`
`JaneA.Axelrad W
`
`Associate Director for Policy
`Center for Drug Evaluation and Research
`
`Page 12
`
`Page 12
`
`

`

`Kappos - Viibryd
`Patent Nos. 5,532,241 and 7,834,020
`Page 2
`
`\
`cc:
`
`.
`.
`Danlelle L. Herntt
`
`McCarter & English LLP
`265 Franklin Street
`
`Boston, MA 02110
`
`Page 13
`
`Page 13
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`AddIESS. COMMISSIONER FOR PATENTS
`PO Box 1450
`Alexandria, ViJgLnia 22313-1450
`wwwusptogov
`
`
`
`
`F ING OR 371 (C) DATE
`
`
`
`'LIF
`
`>
`
`APPLICATION NUMBER
`
`FIRST NAMED APPLICANT
`
`ATTY. DOCKET NO./TITLE
`
`08/314,734
`
`09/29/1994
`
`HENNING BOTTCHER
`
`MERCK1617
`CONFIRMATION NO. 3429
`
`MILLEN WHITE ZELANO AND BRANIGAN
`ARLINGTON COURTHOUSE PLAZA | SUITE 1400
`2200 CLARENDON BOULEVARD
`ARLINGTON, VA 22201
`
`POWER OF ATTORNEY NOTICE
`
`llllllllllIIlllllIllllIlllllllllllIllllllllllllllIlllllllllllllllllllIllllllllllllllllllllll
`000000046925667
`
`Date Mailed: 04/27/2011
`
`NOTICE REGARDING CHANGE OF POWER OF ATTORNEY
`
`This is in response to the Power of Attorney filed 04/03/2011.
`
`. The Power of Attorney to you in this application has been revoked by the assignee who has intervened as
`provided by 37 CFR 3.71. Future correspondence will be mailed to the new address of record(37 CFR 1.33).
`
`/dolipscomb/
`
`
`
`Office of Data Management, Application Assistance Unit (571) 272-4000, or (571) 272-4200, or 1-888-786-0101
`
`page 1 of 1
`
`Page 14
`
`Page 14
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`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`AddIESS. COMMISSIONER FOR PATENTS
`PO Box 1450
`Alexandria, ViJgLnia 22313-1450
`wwwusptogov
`
`
`
`
`F ING OR 371 (C) DATE
`
`
`
`APPLICATION NUMBER
`
`FIRST NAMED APPLICANT
`
`ATTY. DOCKET NO./TITLE
`
`08/314,734
`
`09/29/1994
`
`HENNING BOTTCHER
`
`120140-00201
`CONFIRMATION NO. 3429
`
`86736
`
`VideoMining Corporation
`403 South Allen Street, Suite 101
`State College, PA 16801
`
`POA ACCEPTANCE LETTER
`
`llllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllll
`00000004739 030
`
`Date Mailed: 04/27/2011
`
`NOTICE OF ACCEPTANCE OF POWER OF ATTORNEY
`
`This is in response to the Power of Attorney filed 03/21/2011.
`
`The Power of Attorney in this application is accepted. Correspondence in this application will be mailed to the
`above address as provided by 37 CFR 1.33.
`
`/dtvern0n/
`
`
`
`Office of Data Management, Application Assistance Unit (571) 272-4000, or (571) 272-4200, or 1-888-786-0101
`
`page 1 of 1
`
`Page 15
`
`Page 15
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`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Addl'fiss. COMMISSIONER FOR PATENTS
`PO Box 1450
`Alexandria, Viigmia 22313-1450
`wwwuspto.gov
`
`
`
`
`F ING OR 371 (C) DATE
`
`
`
`APPLICATION NUMBER
`
`FIRST NAMED APPLICANT
`
`ATTY. DOCKET NO./TITLE
`
`08/314,734
`
`09/29/1994
`
`HENNING BOTTCHER
`
`120140-00201
`CONFIRMATION NO. 3429
`
`86738
`
`MCCARTER & ENGLISH, LLP BOSTON
`265 Franklin Street
`Boston, MA 02110
`
`POA ACCEPTANCE LETTER
`
`llIIlIlIlllllllllIllllIlllIIIIIlllIllllIllllIllllllllllIIIllllllIlIllllllllllllllllllllllll
`00000004739
`25
`
`Date Mailed: 04/27/2011
`
`NOTICE OF ACCEPTANCE OF POWER OF ATTORNEY
`
`This is in response to the Power of Attorney filed 03/21/2011.
`
`The Power of Attorney in this application is accepted. Correspondence in this application will be mailed to the
`above address as provided by 37 CFR 1.33.
`
`/dtvern0n/
`
`
`
`Office of Data Management, Application Assistance Unit (571) 272-4000, or (571) 272-4200, or 1-888-786-0101
`
`page 1 of 1
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