UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Commissioner for Patents
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`www.uspto.gov
`
`In Re: Patent Term Extension
`_Application for
`U.S. Patent No. 6,599,498
`
`Theresa C. Kavanaugh
`Goodwin Proctor
`Patent Administrator
`53 State Street Exchange Place ·
`Boston, MA 02109-2881
`
`Dear Ms. Kavanaugh:
`
`A certificate under 35 U.S.C. § 156 is enclosed extending the term of U.S. Patent
`No. 6,599,498 for a period of 1,209 days. 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) or 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 *95S-0117 need to be submitted on form FDA-3542
`which may be downloaded from FDA's Electronic forms Download Website:
`· http://www.fda.gov I opacom/morechoices/f daforms/ default.html
`(http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3542.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.
`~
`
`Mary C. Till
`Senior Lega 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: FERAHEME®
`(ferumoxytol)
`Docket No.: FDA-2010-E-0049
`
`Attention: Beverly Friedman
`
`Pharmacosmos, Exh. 1017, p. 1
`
`

`

`. I
`i
`
`UNITED ST A TES PA TENT AND TRADEMARK OFFICE
`
`(12)
`
`CERTIFICATE EXTENDING PATENT TERM
`UNDER 35 U.S.C. § 156
`
`(68) PATENT NO.
`
`(45)
`
`ISSUED
`
`(75)
`
`INVENTOR
`
`6,599,498
`
`July 29, 2003
`
`Ernest B.V. Groman et al.
`
`(73) PATENT OWNER
`
`AMAG Pharmaceuticals, Inc.
`
`(95) PRODUCT
`
`FERAHEME® (ferumoxytol)
`
`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 U.S. Patent No.
`6,599,498 based upon the regulatory review of the product FERAHEME® (ferumoxytol)
`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)
`
`1,209 days
`
`from March 8, 2020, 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 19th day of March 2014.
`
`Michelle K. Lee
`Deputy Under Secretary of Commerce for Intellectual Property and
`Deputy Director of the United States Patent and Trademark Office
`
`Pharmacosmos, Exh. 1017, p. 2
`
`

`

`'
`
`I
`
`Theresa C. Kavanaugh
`Goodwin Proctor
`Patent Administrator
`53 State Street Exchange Place
`Boston, MA 02109-2881
`
`Commissioner for Patents
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`www.uspto.gov
`
`In Re: Patent Term Extension
`Application for
`U.S. Patent No. 6,599,498
`
`lCl .- 9 2013
`
`NOTICE OF FINAL DETERMINATION
`
`A determination has been made that U.S. Patent No. 6,599,498, claims of which cover the human
`drug product FERAHEME® (ferumoxytol), is eligible for patent term extension under 35 U.S.C.
`§ 156. The period of extension has been determined to be 1,209 days.
`
`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 § l .136(a) are not applicable to this time period. In the absence of a
`request for reconsideration, the Director will issue a certificate of extension, under seal, for a
`period of 1,209 days.
`
`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 May 4, 2012 (77
`. Fed. Reg. 26557), would be 1,362 days. Under 35 U.S.C. § 156(c):
`
`Period of Extension
`
`=
`
`RRP - PGRRP - DD - 'Ii (TP - PGTP) 1
`3,680 - 1,516 - 0 - Yi (3,120 - 1,516)
`1,362 (years)
`
`Since the regulatory review period began June 5, 1999, before the patent issued (July 29, 2003),
`only that portion of the regulatory review period occurring after the date the patent issued has been
`considered in the above determination of the length of the extension period 3 5 U .S.C. § 156( c ).
`(From June 5, 1999, to and including July 29, 2003, is 1,516 days; this period is subtracted from
`the number of days occurring in the testing phase according to the FDA determination of the
`length of the regulatory review period.) No determination of a lack of due diligence under 35
`U.S.C. § 156(c)(l) was made.
`
`However, the 14 year exception of 35 U.S.C. § 156(c)(3) operates to limit the term of the
`
`1 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 RRP 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 described in paragraphs (l)(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 Yi (TP - PGTP).
`
`Pharmacosmos, Exh. 1017, p. 3
`
`

`

`'
`
`'
`
`U.S. Patent No. 6,599,498
`
`Page 2
`
`extension in the present situation, because it provides that the period remaining in the term of the
`patent measured from the date of approval of the approved product plus any patent term
`extension cannot exceed fourteen years. The period of extension calculated above, 1,362, would
`extend the patent from March 8, 2020, to November 30, 2023, which is beyond the 14-year limit
`(the approval date is June 30, 2009, thus, the 14 year limit is June 30, 2023). The period of
`extension is thus limited to June 30, 2023, by operation of 35 U.S.C. § 156(c)(3). Accordingly,
`the period of extension is the number of days to extend the term of the patent from its original
`expiration date, March 8, 2020, to and including June 30, 2023, or 1,209 days.
`
`The limitations of 35 U.S.C. 156(g)(6) do 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:
`
`U.S. Patent No.:
`
`Granted:
`
`Original Expiration Date2
`
`:
`
`6,599,498
`
`July 29, 2003
`
`March 8, 2020
`
`Applicant:
`
`Ernest B.V. Groman et al.
`
`Owner of Record:
`
`AMAG Pharmaceuticals, Inc.
`
`Title:
`
`Heat Stable Colloidal Iron Oxides Coated with
`Reduced Carbohydrates and Carbohydrate
`Derivatives
`
`Product Trade Name:
`
`FERAHEME® (ferumoxytol)
`
`Term Extended:
`
`1,209 days
`
`Expiration Date of Extension:
`
`June 30, 2023
`
`2Subject to the provisions of 35 U.S.C. § 41(b).
`
`Pharmacosmos, Exh. 1017, p. 4
`
`

`

`U.S. Patent No. 6,599,498
`
`Page 3
`
`Any correspondence 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
`P.O. Box 1450
`Alexandria, VA 22313-1450.
`
`Telephone inquiries related to this determination should be directed to the undersigned at (571)
`272-7755.
`
`~ ~ 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. 6222
`Silver Spring, MD 20993-0002
`
`RE: FERAHEME®
`(ferumoxytol)
`Docket No.: FDA-2010-E-0049
`
`Attention: Beverly Friedman
`
`Pharmacosmos, Exh. 1017, p. 5
`
`

`

`APPLICATION NUMBER
`09/521,264
`
`FILING OR 3 71 (C) DATE
`03/08/2000
`
`2101
`Sunstein Kann Murphy & Timbers LLP
`125 SUMMER STREET
`BOSTON, MA 02110-1618
`
`Ul\TfED STATES DEPA RTME'IT OF COMMERCE
`United States Patent and Trademark Office
`Adm"'· COMMISSIO'JER FOR PATENTS
`PO Box 1450
`Alexandria, Virgmia 22313-1450
`\VVi\V.USpto.gov
`
`FIRST NAMED APPLICANT
`Ernest V. Groman
`
`ATTY. DOCKET NO./TITLE
`1275/190 and 1275/700
`CONFIRMATION N0.1949
`POWER OF ATTORNEY NOTICE
`
`111111111111111111111111]~!l]~~1~~1~~HI ~II ~I~ ~1111111111111111111111111
`
`Date Mailed: 01/24/2013
`
`NOTICE REGARDING CHANGE OF POWER OF ATTORNEY
`
`This is in response to the Power of Attorney filed 01/14/2013.
`
`•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).
`
`/sharris/
`
`Office of Data Management, Application Assistance Unit (571) 272-4000, or (571) 272-4200, or 1-888-786-0101
`
`page 1of1
`
`Pharmacosmos, Exh. 1017, p. 6
`
`

`

`APPLICATION NUMBER
`09/521,264
`
`FILING OR 3 71 (C) DATE
`03/08/2000
`
`51414
`GOODWIN PROCTER LLP
`PATENT ADMINISTRATOR
`53 STATE STREET
`EXCHANGE PLACE
`BOSTON, MA 02109-2881
`
`Ul\TfED STATES DEPA RTME'IT OF COMMERCE
`United States Patent and Trademark Office
`Adm"'· COMMISSIO'JER FOR PATENTS
`PO Box 1450
`Alexandria, Virgmia 22313-1450
`\VVi\V.USpto.gov
`
`FIRST NAMED APPLICANT
`Ernest V. Groman
`
`ATTY. DOCKET NO./TITLE
`1275/190 and 1275/700
`CONFIRMATION N0.1949
`POA ACCEPTANCE LETTER
`
`111111111111111111111111]~!l]~~1~~1~~HI ~Hiii ~1111111111111111111111111
`
`Date Mailed: 01/24/2013
`
`NOTICE OF ACCEPTANCE OF POWER OF ATTORNEY
`
`This is in response to the Power of Attorney filed 01/14/2013.
`
`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.
`
`/sharris/
`
`Office of Data Management, Application Assistance Unit (571) 272-4000, or (571) 272-4200, or 1-888-786-0101
`
`page 1of1
`
`Pharmacosmos, Exh. 1017, p. 7
`
`

`

`POWER OF ATTORNEY BY APPLICANT
`
`in the application identified in the attached transmittal letter
`
`Customer Number as my/our attomey(s) or ao1entisl
`Pra1cti!ioner(:s) associated with the
`bu:s1m~ss 1n the
`States Patent and Trademark
`1n the attached transmittal letter (form PTO/AIAJ82A or equivalent)
`
`appoint Pract1tioner(s) named below as my/our att1:>rn•ey(s)
`Patent and Trademark Office connected therewith
`United
`transmittal letter (form PTO/AIN82A or equivalent):
`
`Name
`
`Registration
`Number
`
`Name
`
`-
`Nun1ber
`
`rec:oc1rn2:e or
`to
`
`co1rre::;oc1nderH:e address for the apJ)l1cat1<m identified
`
`the attached
`
`The address associated with the above-mentioned Customer Number·
`
`The address associated with Customer Number:
`
`OR
`
`Address
`
`State
`
`Email
`
`Inventor or Joint Inventor
`
`Representative of a Deceased or
`
`lnc:aoac11tated Inventor
`
`SIGNATURE of Applicant for Patent
`
`under
`
`CFR
`
`.4e>(bJ>(2) was
`
`forms are submitted
`
`Pharmacosmos, Exh. 1017, p. 8
`
`

`

`Under the Pa
`
`PTOiSB/96 (07-09)
`Approved for use through 07/3112012 OMB 0651-0031
`U.S Patent and Trademar1< Office; U S DEPARTMENT OF COMMERCE
`rwor1< Reducoon Act of 1995. no
`to a co!lectJon of infonnation unle$$ rt dis
`a valid OMB control oomber
`STATEMENT UNDER 37 CFR 3.73(b)
`
`ApplicanUPatent Owner:
`
`_ Groman et al. , AMAG Phannaceuticals
`
`12/963.308
`Application No./Patent No.
`ACTIVE ANKLE FOOT ORTHOSIS
`
`Titled
`
`Filed/Issue Date:
`
`Decembe~ 8. _20_1_0 __ _
`
`__ A_M_}\G ~h_a_rrnaceuticals, Inc
`(Name ct Assignee)
`
`corp_()~Cl_tiori ___________ _
`, a ___ _ _ _ _
`(Type of Assignee. e g rorporatlOO. partnership, Ufllverslfy. government agency. etc./
`
`states that 1t is
`.
`.
`'
`'
`'
`:--:-:i
`~ the assignee of the entire nght. htle, and interest in;
`
`2
`
`3
`
`an assignee of less than the entire right, title, and interest in
`(The extent (by percentage) of its ownership interest is
`
`%): or
`
`an assignee of an undivided interest in the entirety of (a complete assignment from one of the jmnt inventors was made)
`
`the patent application/patent identified abOve by virtue of either
`
`A
`
`OR
`
`B
`
`An assignment from the inventor(s) of the patent application/patent identified above The assignment was
`recorded 1n the United States Patent and Trademark Office at Reel
`.or for which a copy thereof is attached
`Frame
`
`;__j
`
`Ix! A chain of title from the inventor(s), of the patent application/patent identified above. to the current assignee as follows
`From:
`To:
`Gorman,.Paul. Frigo. Bengele, Lewis
`Advanced Magnetics
`The document was recorded in the United States Patent and Trademark Office at
`025549
`, Frame
`0~93 _
`, or for which a copy thereof is attached.
`Reel
`
`2. From
`AMAG Pharmaceuticals, Inc
`To
`Advanced Magnetics
`The document was recorded in the United States Patent and Trademark Office at
`025565
`, Frame
`0665
`, or for which a copy thereof is attached
`Reel
`
`3. From
`To
`The document was recorded in the United States Patent and Trademark Office at
`Reel
`, Frame -------~-~ . or for which a copy thereof is attached
`
`Additional documents in the chain of title are listed on a supplemental sheet(s}
`
`As required by 37 CFR 3 73(b)(1 )(i), the documentary evidence of the chain of title from the original owner to the
`assignee was. or concurrently is being, submitted for recordation pursuant to 37 CFR 3. 11
`
`[NOTE A separate copy (i.e .. a true copy of the original assignment document(s)) must be submitted to Assignment
`Division in accordance with 37 CFR Part 3. to record the assignment in the records of the USPTO. ~ MPEP 302 08]
`
`-::?=::::~~~~if£------
`
`.:::~_..,..,..,
`Scott B. Townsend
`
`uthorized to act on behalf of the assignee. .
`
`I
`, .
`,~i lb:-o#~,\ 2PfZ .
`
`Date
`Senior VP of Legal Affairs, AMAG
`
`-Pnnte«forTyped Name
`
`Title
`
`Pharmacosmos, Exh. 1017, p. 9
`
`

`

`Doc Code: PA ..
`Document Description: Power of Attorney
`
`PTO/AIA/82A (07-12)
`Approved for use through 11130/2014. OMB 0651-0035
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`
`TRANSMITTAL FOR POWER OF ATTORNEY TO ONE OR MORE
`REGISTERED PRACTITIONERS
`
`NOTE: This form is to be submitted with the Power of Attorney by Applicant form (PTO/AIA/828 or equivalent) to identify the
`application to which the Power of Attorney is directed, in accordance with 37 CFR 1.5. If the Power of Attorney by Applicant form
`is not accompanied by this transmittal form or an equivalent, the Power of Attorney will not be recognized in the application.
`
`Application Number
`
`Filing Date
`
`First Named Inventor
`
`Title
`
`09/521,264
`March 8, 2000
`Ernest V. Groman, et al.
`
`Heat Stable Colloidal Iron Oxides Coated with Reduced Carbohydrates and Carbohydrate Derivatives
`
`Art Unit
`
`Examiner Name
`
`1617
`Wells, Lauren Q.
`Attorney Docket Number AMG-001
`
`Signature
`
`SIGNATURE of Applicant or Patent Practitioner
`/Theresa C. Kavanaugh/
`Theresa C. Kavanaugh
`Registration Number 50,356
`
`Name
`
`Date Jam ary 14, 2013
`Telephone 617-570-1000
`
`NOTE: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4(d) for signature requirements and certifications.
`
`D *Total of
`
`forms are submitted.
`
`This collection of information is required by 37 CFR 1.31, 1.32 and 1.33. The information is required to obtain or retain a benefit by the public which is to file (and
`by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection is estimated to take 3 minutes
`to complete, including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any
`comments on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer,
`U.S. Patent and Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED
`FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`If you need assistance in completing the form, ca/11-800-PT0-9199 and select option 2.
`
`Pharmacosmos, Exh. 1017, p. 10
`
`

`

`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`14688924
`
`09521264
`
`International Application Number:
`
`Confirmation Number:
`
`1949
`
`Title of Invention:
`
`HEAT STABLE COLLOIDAL IRON OXIDES COATED WITH REDUCED
`CARBOHYDRATES AND CARBOHYDRATE DERIVATIVES
`
`First Named Inventor/Applicant Name:
`
`Ernest V. Groman
`
`Customer Number:
`
`2101
`
`Filer:
`
`Theresa Colleen Kavanaugh/Teresa McDonough
`
`Filer Authorized By:
`
`Theresa Colleen Kavanaugh
`
`Attorney Docket Number:
`
`1275/190 and 1275/700
`
`Receipt Date:
`
`Filing Date:
`
`Time Stamp:
`
`14-JAN-2013
`
`08-MAR-2000
`
`15:31:05
`
`Application Type:
`
`Utility under 35 USC 111 (a)
`
`Payment information:
`
`Submitted with Payment
`
`I no
`
`File Listing:
`
`Document
`Number
`
`Document Description
`
`File Name
`
`1
`
`Power of Attorney
`
`Warnings:
`
`Information:
`
`AMG-001 CPDl Cl poastatement
`.pdf
`
`File Size( Bytes)/
`Message Digest
`
`Multi
`Part /.zip
`
`Pages
`(if appl.)
`
`138113
`
`no
`
`2
`
`acc96f845607682c46f0dd68e243759bed3(
`115f
`
`Pharmacosmos, Exh. 1017, p. 11
`
`

`

`2
`
`Power of Attorney
`
`PagAMG-OOlTransmittalforPOA
`.pdf
`
`126732
`
`dc571b4b4804af350d747a9f8683616a940
`Ofed6
`
`no
`
`1
`
`Warnings:
`
`Information:
`
`Total Files Size (in bytes)
`
`264845
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New A~~lications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International A~~lication under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International A~~lication Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 181 O), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/R0/1 OS) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`Pharmacosmos, Exh. 1017, p. 12
`
`

`

`(/""~ Department of Health and Human Senices
`
`Public Health Service
`
`Food and Drug Administration
`Rockville, MD 20857
`
`Re: FERAHEME
`Docket No. FDA-2010-E-0049
`
`.... ,.~5,...
`
`DEC 1 8 2012
`
`The Honorable David J. Kappas
`Under Secretary of Commerce for Intellectual Property
`Director of the United States Patent and Trademark Office
`Mail Stop Hatch-Waxman PTE
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Director Kappas:
`
`This is in regard to the patent term extension application for U.S. Patent No. 6,599,498 filed by
`AMAG Pharmaceuticals, Inc., under 35 U.S.C. § 156. The patent claims FERAHEME, which
`was assigned new drug application 22-180.
`
`In the May 4, 2012, issue of the Federal Register (77 Fed. Reg. 26557), 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 31, 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 180-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 further assistance.
`
`Sincerely yours,
`
`ra.~
`
`Jane A. Axelrad
`Associate Director for Policy
`Center for Drug Evaluation and Research
`
`cc:
`
`Bruce D. Sunstein
`Sunstein, Kann, Murphy & Timbers LLP
`Customer No. 002101
`125 Summer Street
`Boston, MA 02110-1618
`
`Pharmacosmos, Exh. 1017, p. 13
`
`

`

`~·-· .. =9
`
`CPO
`
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`Federal Register/Vol. 77, No. 87/Friday, May 4, 2012/Notices
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`26557
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`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 animal drug
`products, the testing phase begins on
`the earlier date when either a major
`environmental effects test was initiated
`for the drug or when an exemption
`under section 512(j) of the Federal Food,
`Drug, and Cosmetic Act (21 U.S.C.
`360b(j)) became effective and runs until
`the approval phase begins. The approval
`phase starts with the initial submission
`of an application to market the animal
`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 ofthe
`length of a regulatory review period for
`an animal drug product will include all
`of the testing phase and approval phase
`as specified in 35 U.S.C. 156(g)(4)[B).
`FDA approved for marketing the
`animal drug product EQUIDONE GEL
`(domperidone). EQUIDONE GEL is
`indicated for prevention of fescue
`toxicosis in periparturient mares.
`Subsequent to this approval, the Patent
`and Trademark Office received a patent
`term restoration application for
`EQUIDONE GEL (U.S. Patent No.
`5,372,818) from Dechra, Ltd., and the
`Patent and Trademark Office requested
`FDA's assistance in determining this
`patent's eligibility for patent term
`restoration. In a letter dated April 26,
`2011, FDA advised the Patent and
`Trademark Office that this animal drug
`product had undergone a regulatory
`review period and that the approval of
`EQUIDONE GEL 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
`EQUIDONE GEL is 6,378 days. Of this
`time, 6,336 days occurred during the
`testing phase of the regulatory review
`period, while 42 days occurred during
`the approval phase. These periods of
`time were derived from the following
`dates:
`1. The date an exemption under
`section 512(j) of the Federal Food, Drug,
`and Cosmetic Act (21 U.S.C. 36Db(j))
`became effective: March 26, 1993.'The
`
`applicant claims February 24, 1992, as
`the date the investigational new animal
`drug application (IND) became effective.
`However, the date that a major health or
`environmental effects test is begun or
`the date on which the Agency
`acknowledges the filing of a notice of
`claimed investigational exemption
`(NCIE) for a new animal drug,
`whichever is earlier, is the effective date
`for the IND. According to FDA records,
`the applicant's first submission of an
`NCIE was March 26, 1993, which is the
`effective date for the IND.
`2. The date the application was
`initially submitted with respect to the
`animal drug product under section 512
`of the Federal Food, Drug, and Cosmetic
`Act: July 30, 2010. The applicant claims
`July 27, 2010, as the date the new
`animal drug application (NADA) for
`EQUIDONE GEL (NADA 141-314) was
`initially submitted. However, a review
`of FDA records reveals that the date of
`FDA's official acknowledgement letter
`assigning a number to NADA 141-314
`was July 30, 2010, which is considered
`to be the initially submitted date for
`NADA 141-314.
`3. The date the application was
`approved: September 9, 2010. FDA has
`verified the applicant's claim that
`NADA 141-314 was approved on
`September 9, 2010.
`This determination of the regulatory
`review period establishes the maximum
`potential length of a patent extension.
`However, the U.S. 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
`written or electronic comments and ask
`for a redetermination by July 3, 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 31, 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
`http://www.regulations.gov may be
`viewed in the Division of Dockets
`Management between 9 a.m. and 4 p.m.,
`Monday through Friday.
`Dated: April 16, 2012.
`Jane A. Axelrad,
`Associate Director for Policy, Center for Drug
`Evaluation and Research.
`[FR Doc. 2012-10853 Filed 5-3-12; 8:45 am]
`BILLING CODE 4160-0.1-P
`
`DEPARTMENT OF HEAL TH AND
`HUMAN SERVICES
`
`Food and Drug Administration
`[Docket No. FDA-2010-E-0049]
`
`Determination of Regulatory Review
`Period for Purposes of Patent
`Extension; FERAHEME
`AGENCY: Food and Drug Administration,
`HHS.
`ACTION: Notice.
`
`SUMMARY: The Food and Drug
`Administration (FDA) has determined
`the regulatory review period for
`FERAHEME 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. 6284, 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
`
`Pharmacosmos, Exh. 1017, p. 14
`
`

`

`' .
`26558
`
`Federal Register/Vol. 77, No. 87/Friday, May 4, 2012/Notices
`
`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 FERAHEME
`(ferumoxytol). FERAHEME is indicated
`for the treatment of iron deficiency
`anemia in adult patients with chronic
`kidney disease. Subsequent to this
`approval, the Patent and Trademark
`Office received a patent term restoration
`application for FERAHEME (U.S. Patent
`No. 6,599,498) from AMAG
`Pharmaceuticals, Inc., and the Patent
`and Trademark Office requested FDA's
`assistance in determining this patent's
`eligibility for patent term restoration. In
`a letter dated May 2, 2011, FDA advised
`the Patent and Trademark Office that
`this human drug product had undergone
`a regulatory review period and that the
`approval of FERAHEME 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
`FERAHEME is 3,680 days. Of this time,
`3,120 days occurred during the testing
`phase of the regulatory review period,
`while 560 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 FD&C Act) (21
`U.S.C. 355(i)) became effective: June 5,
`1999. The applicant claims June 4, 1999,
`as the date the investigational new drug
`application (IND) became effective.
`
`However, FDA records indicate that the
`IND effective date was June 5, 1999,
`which was 30 days after FDA receipt of
`the IND.
`2. The date the application was
`initially submitted with respect to the
`human drug product under section
`505(b) of the FD&C Act: December 19,
`2007. The applicant claims December
`18, 2007, as the date the new drug
`application (NDA) for FERAHEME
`(NDA 22-180) was initially submitted.
`However, FDA records indicate that
`NDA 22-180 was submitted on
`. December 19, 2007.
`3. The date the application was
`approved: June 30, 2009. FDA has
`verified the applicant's claim that NDA
`22-180 was approved on June 30, 2009.
`This determination of the regulatory
`review period establishes the maximum
`potential length of a patent extension.
`However, the U.S. 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 1,209 days 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 July 3, 2012.
`Furthermore, any interested person may
`petition FDA for a determination
`regarding whether the applicant f