UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Office of Regulatory Policy
`Food and Drug Administration
`10903 New Hampshire Ave., Bldg. 51, Rm. 6284
`Silver Spring, MD 20993-0002
`
`Attention: Beverly Friedman
`
`Commissioner for Patents
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`www.uspto.gov
`
`The attached application for patent term extei:ision of U.S. Patent No. 7,612,109 was filed on.
`September 19, 2013, under 35 U.S.C. § 156.
`
`The assistance of your Office is requested in confirming that the product identified in the
`application, INJECTAFER® (ferric carboxymaltose), has been subject to a regulatory review
`period within the meaning of 35 U.S.C. § 156(g) before its first commercial marketing or use and
`that the application for patent term extension was filed within the sixty-day period beginning on
`the date the product was approved. Since a determination has not been made whether the patent
`in question claims a product which has been subject to the Federal Food, Drug and Cosmetic Act,
`or a method of manufacturing or use of such a product, this communicatfon is NOT to be
`considered as notice which may be made in the future pursuant to 35 U.S.C. § 156(d)(2)(A).
`
`Our review of the application to date indicates that the subject patent would be eligible for
`extension.of the patent term under 35 U.S.C. § 156.
`
`Inquiries regarding this communication should be directed to the undersigned at (571) 272-7755
`(telephone) or (571) 273-7755 (facsimile).
`
`Senior Legal Advisor
`Office of Patent Legal Administration
`Office of the Associate Commissioner
`for Patent Examination Policy
`
`cc:
`
`Burton A. Amernick
`c/o Novak Druce Connolly Bove+ Quigg LLP
`1007 N. Orange St.
`Wilmingtori, DE 19801
`
`Pharmacosmos, Exh. 1022, p. 1
`
`

`

`Document code: WFEE
`
`United States Patent and Trademark Office
`Sales Receipt for Accounting Date: 10/22/2014
`
`CKHLOK
`
`032775 10531895
`SALE #00000008 Mailroom Dt: 09/19/2013
`01
`FC:1457
`1,120.00 DA
`
`Pharmacosmos, Exh. 1022, p. 2
`
`

`

`PTO/SB/17 (03-13)
`Approved for use through 01/31/2014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paoerwork Reduciion Aci of 1995, no oerson are reauired to resoond to a collection of information unless it disolavs a valid OMB control number
`Complete if known
`Patent #: 7,612, 109
`Issued: November 3, 2009
`Peter Geisser
`
`Application Number
`
`Filing Date
`
`First Named Inventor
`
`FEE TRANSMITTAL
`
`0 Applicant asserts small entity status. See 37 CFR 1.27
`D Applicant certifies micro entity status. See 37 CFR 1.29.
`
`Form PTO/SB/15A or B or equivalent must either be enclosed
`or have been submitted previously
`TOTAL AMOUNT OF PAYMENT
`
`($)
`
`1,120.00
`
`Examiner Name
`
`Art Unit
`
`N/A
`N/A
`
`Practitioner Docket No.
`
`METHOD OF PAYMENT (check all that apply)
`
`Deposit Account Number:
`
`.
`1-=:n
`-
`11211-00001<H:sp 1 9 20,3
`PATENT EXfENSlOl'
`Ocheck 0 Credit Card D Money Order ONone D Other (please identify):
`G~LA
`D Deposit Account
`Deposit Account Name: Novak Druce Connoll~ Bove + Quigg
`03-2775
`For the above-identified deposit account, the Director is hereby authorized to: (check all that apply)
`D Charge fee(s) indicated below
`O Charge any additional fee(s) or underpayment of
`
`D Charge fee(s) indicated below, except for the filing fee
`0 Credit any overpayment of fee(s)
`
`fee(s) under 37 CFR 1.16 and 1.17
`WARNING: Information on this form may become public. Credit card information should not be included on this form. Provide credit card
`information and authorization on PT0-2038.
`FEE CALCULATION
`1. BASIC FILING, SEARCH, AND EXAMINATION FEES (U = undiscounted fee; S =small entity fee; M =micro entity fee)
`EXAMINATl()N FEES
`FILING FEES
`SEARCH FEES
`F~es Paid m
`!.ill1
`!.ill1
`!.ill1
`M.J1l
`filtl.
`filtl.
`filtl.
`.M.J!l.
`.M.J!l.
`Aeelicatlon Tir:ee
`140*
`600
`. 720
`180
`Utility
`70
`300
`150
`360
`280
`90
`120
`180
`Design
`460
`230
`115
`45
`60
`30
`580
`290
`145
`190
`180
`Plant
`95
`45
`90
`380
`140
`280
`Reissue
`150
`2,160
`1,080
`540
`70
`600
`300
`130
`0
`0
`0
`260
`Provisional
`65
`0
`0
`0
`•The $140 small entity status filing fee for, a utility application is further reduced to $70 for a small entity status applicant who files the application via EFS-Web.
`2. EXCESS CLAIM FEES
`Fee Descrietion
`Each claim over 20 (including Reissues)
`Each independent claim over 3 (including Reissues)
`Multiple dependent claims
`Total Claims
`
`Undlscounted Fee m Small Entitir: Fee m Micro Entitir: Fee m
`40
`80
`20
`420
`210
`105
`390
`780
`195
`Myltigle Deeendent Claims
`Fee Paid !I}
`Fie Paid Iii
`.Ett.ill
`
`=
`
`Extra Claims
`
`.Ett.ill
`
`-20 or HP=
`x
`HP = highest number of total claims paid for, if greater than
`Efilll1l
`lndee. Claims
`Extra Claims
`
`Fee Paid m
`
`=
`x
`- 3 or HP"'
`HP = highest number of independent claims paid for, if greater than 3.
`3. APPLICATION SIZE FEE
`If the specification and drawings exceed 100 sheets of paper (excluding electronically filed sequence or computer listings under 37 CFR 1.52(e)), the application size
`fee due is $400 ($200 for small entity) ($100 for micro entity) for each additional 50 sheets or fraciion thereof. See 35 U.S.C. 41(a)(1)(G) and 37 CFR 1.16(s).
`Fee Paid m
`Total Sheets
`Extra Sheets
`Number of each additional 50 or fraction thereof
`illffi
`(round up to a whole number) x
`Eees Paid m
`
`/50 =
`
`=
`
`-100 =
`4. OTHER FEE(S)
`Non-English specification, $130 fee (no small or micro entity discount)
`Non-electronic filing fee under 37 CFR 1.16(t) for a utility application, $400 fee ($200.small or micro entity)
`1457 Extension of term of E?atent
`Other (e.g., late filing sureharge):
`I
`A
`
`SUBMITTED BY
`'
`~ '
`f; AkA r.---7 If f /\ A
`Signature
`Name (PrinVType) · Burton 'A. IXme'rfikkv -
`
`/
`
`~istration No.
`(Attomey/Agent)
`
`------
`
`24,852
`
`Telephone
`
`Date
`
`(302) 658-9141
`September 19, 2013
`
`11120.00
`
`Pharmacosmos, Exh. 1022, p. 3
`
`

`

`PT0-2038 (01-2010)
`Approved for use through 11/3012014. OMB 0651-0043
`.
`United States 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.
`
`Credit Card Payment Form
`(Do not submit this form e/ectronica.l/y via EFS-Web)
`Please Read Instructions before Completing this Form
`
`-,,
`·
`·
`Credit Card Information
`\Credit Card Type: D Visa D Mastercard 0 American Express
`
`D Discover
`
`:credit Card Account#:
`
`378597641961007
`
`!Credit Card Expiration Date (mm/yyyy):
`
`12/2016
`
`as it Appears on Credit Card:
`
`Donna Frunzi
`
`Payment Amount (US Dollars): $ 1120.00
`
`Cardholder Signature:
`
`/
`
`Date (mm/dd/yyyy): 09/19/2013
`
`Refund Policy: The USPTO may refund a fee paid by mistake or excess of that required. A change of purpose after the payment of a
`ee will not entitle a party to a refund of such fee. The US PTO will not refund amounts of $25.00 or less unless a refund is specifically
`tequested and will not notify the payer of such amounts (37 CFR 1.26). Refund of a fee paid by credit card will be issued as a credit to the
`:credit card account to which the fee was charged.
`;service Charge: There is a $50.00 service charge for processing each payment refused {including a check returned "unpaid") or charged
`,back by a financial institution (37 CFR 1.21 (m)).
`i
`
`·
`
`. Credit Card Billing Address
`
`.
`
`. .
`
`,
`
`·:
`
`.
`
`·
`
`·
`
`I
`JStreet Address 1 : Novak Druce
`
`jstreet Address 2: 1007 North Orange Street
`
`!city: Wilmington
`
`!state/Province: · DE
`i
`.
`i
`1Country: US
`
`Zip/Postal Code: . 19801
`
`pplication No.
`
`Drrademark Fee
`pplication No.
`
`D Other Fee
`
`IDON Customer No.
`
`!Description of Request and Payment Information:
`I
`.
`l 0 Patent Fee
`D Patent Maintenance Fee
`1Application No.
`I
`101531,895
`Patent No.
`7,612,109
`rney Docket No.
`17271-00007-US
`If the cardholder includes a credit card number on any form or document other than tile Credit Card Payment Form or
`submits this form electronically via EFS-Web, tile United States Patent and Trademark Office will 11ot be liable i11 the
`event that tlle creclit card 11umber becomes public k11owledge.
`
`Patent No.
`
`Registration No.
`
`Identify or Describe Mark
`
`Pharmacosmos, Exh. 1022, p. 4
`
`

`

`.,J'''\
`Patent Number: 7,612,109
`
`Attorney Docket Number: 17271-00007-US
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`IN RE U.S. PATENT NO. 7,612,109
`
`ISSUED: November 3, 2009
`
`INVENTORS: Peter Geisser, et al.
`
`FOR: Aqueous Iron Carbohydrate Complexes, Their Production and Medicaments Containing
`Them
`
`Office of Patent Legal Administration
`Mail Stop Hatch-Waxman PTE
`Room MDW 7D55
`600 Dulany Street (Madison Building)
`Alexandria, VA 22314
`
`RECEIVED
`SEP 1 9 2013
`PATENT EXTENSION
`~· OPLA
`PATENT TERM EXTENSION APPLICATION UNDER 35 U.S.C. §156
`
`Sir:
`
`Pursuant to 35 U.S.C. §156 and 37 C.F.R. §1.710 et seq., Vifor (International) AG, a
`
`corporation organized under the laws of Switzerland, hereby requests an extension of the patent
`
`term due to regulatory review of U.S. Patent No. 7,612,109, which was granted on November 3,
`
`2009.
`
`Applicant asserts that it is the owner of the entire right, title and interest in U.S. Patent No.
`
`7,612,109 by virtue of the following chain of title. The invention was assigned by the inventors,
`
`Geisser, Philipp and Riehle to Vifor (International) AG. This assignment was recorded in the U.S.
`
`Patent and Trademark Office (USPTO) at Reel 023066, Frame 0144 on August 7, 2009. A copy of
`
`the assignment is attached hereto as Appendix A.
`
`A copy of the Power of Attorney evidencing that Vifor (International) AG, being the owner
`
`of the entire right, title and interest in and to U.S. Patent No. 7,612,109, appoints Novak Druce
`
`Connolly Bove + Quigg LLP as its agent to act in its interest in this matter is attached hereto as
`
`Appendix B.
`
`00000008 032775
`!0/22/2014 Ci\HLOK
`01 FC:1457
`1120.00 DA
`
`10531895
`
`The marketing applicant for the approved product upon which this application for extension
`
`is based is Luitpold Pharmaceuticals, Inc. Luitpold Pharmaceuticals, Inc. is a corporation organized
`
`under the laws of New York and is the licensee of U.S. Patent No. 7,612,109. Luitpold
`
`Page 1 of 13
`
`Pharmacosmos, Exh. 1022, p. 5
`
`

`

`Patent Number.: 7 ,612,109
`
`Attorney Docket Number:l 7271-00007-US
`
`Pharmaceuticals, Inc. is authorized under that license to register, import, manufacture, market,
`
`distribute; use and sell the approved product. Attached as Appendix C is a permission letter from
`
`Luitpold·Pharmaceuticals, Inc. permitting use by Vifor (International) AG of the information
`generated and the activities undertaken during the IND and NDA period that is o~ed by them for
`
`the response required for this application, such as the information required under37 C.F.R. § 1.740
`
`(a) (10) and (11) ..
`
`In accordance with 35 U.S.C. §156 and 37 C.F.R. §1.740, Applicant provides the following
`information in support of its request for a patent term extension. The following sections are
`
`numbered analogously to 37 C.F.R. §1.740.
`
`(1)
`
`Identification of the Approved Product
`
`The approved product is Injectafer®, which contains the active ingredient ferric
`.
`.
`carboxyma1tose and having the chemical name polynuclear iron (III)-hydroxide 4(R)~CPoly-(1-+4)-
`0-a-D•gluc6pyi-an()syl)-oxy-2(R), 3(S), 5(R), 6-tetrahydroxy-hexanoate (USAN). A schematic
`
`represenU).tiOn.of the chemical structure is presented below:
`
`OH
`
`HO
`
`( ) Fe3•
`Q OH"
`() 02-
`
`• H20
`
`glc glucose
`
`hydrogen bond
`
`OH
`
`...
`HO~·· HO,,,,
`0
`
`OH.
`
`(glc)0
`
`0
`
`OH
`
`OH
`
`Page 2of13
`
`Pharmacosmos, Exh. 1022, p. 6
`
`

`

`i·
`Patent Number: 7,612,109
`
`Attorney Docket Number: 17271-00007-US
`
`Injectafer® is approved for sale as an intravenous push injection or infusion containing 750
`mg iron as ferric carboxymaltose in 15 mL single-use vials for the treatment of iron deficiency
`
`anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response in
`
`oral iron; or who have non-dialysis dependent chronic kidney disease. Attached as Appendix D is
`
`the approved prescribing information for lnjectafer®.
`
`(2)
`
`Identification of the Federal Statute under which Regulatory Review Occurred
`
`The approved product was subject to regulatory review under the Federal Food, Drug and
`
`Cosmetic Act, Section 505(b) (21 U.S.C. §355(b)).
`
`(3)
`
`The Date of Permission for Commercial Marketing
`
`The approved product received permission for commercial marketing under Section 505(b)
`
`of the Federal Food, Drug and Cosmetic Act (21 U.S.C. §355(b)) on July 25, 2013. A copy of the
`approval letter is attached hereto as Appendix E:
`
`( 4)
`
`Active Ingredient Statement
`
`The sole active ingredient in Injectafer® is ferric carboxymaltose, which has not been
`
`previously approved for commercial marketing or use under the Federal Food, Drug and Cosmetic
`
`Act, the Public Health Service A.ct, or the Virus-Serum Toxin Act prior to the approval ofNDA
`
`203565 by the United States Food and Drug Administration on July 25, 2013.
`
`(5)
`
`Statement of Timely Filing
`
`In accordance with USPTO practice on calculating the due date, the last day on which this
`
`application could be submitted is September 22, 2013, which is 60 days after the approval ofNDA
`
`203565 on July 25, 2013, with day one being the date of approval. Applicant respectfully submits
`
`that the due date may be calculated properly as September 23, 2013, with day one being the day
`
`after the approval date or because September 22, 2013 is a Sunday. This application is timely filed
`
`on or prior to September 20, 2013.
`
`Page 3of13
`
`Pharmacosmos, Exh. 1022, p. 7
`
`

`

`,,
`
`Patent Number: 7,612,109
`
`Attorney Docket Number: 17271-00007-US
`
`(6)
`
`Identification of Patent for which Extension is Sought
`
`This application seeks to extend the term of U.S. Patent No. 7,612,109, which issued
`
`November 3, 2009 with inventors Peter Geisser, Erik Philipp and Walter Riehle, the term of which
`
`would otherwise expire on February 5, 2024.
`
`(7)
`
`Patent Copy
`
`A complete copy of U.S. Patent No. 7,612,109, identified in paragraph 6 above, is attached
`
`as Appendix F.
`
`(8)
`
`Post-Issuance Activity Statement
`
`No Reexamination certificate has been issued or requested with respect to U.S. Patent No.
`
`7,612,109. No disclaimer has been issued or requested with respect to U.S. Patent No. 7,612,109.
`
`No certificate of correction has been issued or requested with respect to U.S. Patent No. 7,612,109.
`
`A maintenance fee was paid on April 26, 2013. A copy of the Maintenance Fee Statement
`
`showing that the fee was paid is attached as Appendix G.
`
`Statement Showing How the Claims of the Patent for which Extension is Sought Cover
`(9)
`the Approved Product
`
`Patent claims 1-16, and 19-27 either claim the approved product, Injectafer®, or a method of
`
`manufacturing the approved product.
`
`Product Claims
`
`The following product claims either claim the approved product itself or claim a
`
`combination of the approved product with other ingredients that reads on a composition that
`
`received permission for commercial marketing or use, as defined in 37 CFR l.710(a): Claims 1-5.
`
`Pursuant to MPEP 2753, one claim, claim 1, is provided below with a showing of how this
`
`product claim reads on the approved product.
`
`Page 4of13
`
`Pharmacosmos, Exh. 1022, p. 8
`
`

`

`_.,
`
`Patent Number: 7,612,109
`
`Attorney Docket Number: 17271-00007-US
`
`Claim 1
`
`1.
`
`A water soluble iron carbohydrate complex having a weight average molecular weight (Mw)
`
`of 80,000 to 400,000, comprising the reaction product of:
`
`(a)
`
`an aqueous solution of an iron (Ill) salt and
`
`(b)
`
`an aqueous solution of the oxidation product of
`
`(i)
`
`at least one maltodextrin and
`
`(ii)
`
`an aqueous hypochlorite solution in an alkaline pH, wherein,
`
`when one maltodextrin is present, the maltodextrin has a dextrose equivalent of
`between 5 and 20, and wherein,
`
`when a mixture of more than one maltodextrin is present, the dextrose equivalent of
`each individual maltodextrine is between 2 and 40, and the dextrose equivalent of
`the mixture is between 5 and 20.
`
`Analysis of Claim 1 ·
`
`Ferric carboxymaltose meets all of the limitations identified in claim l. The ferric
`carboxymaltose in Inj~ctafer® is a water soluble iron carbohydrate complex and has a weight
`average molecular weight (Mw) of approximately 120,000 to 200,000 Da. The approved process
`
`for manufacturing ferric carboxymaltose includes each process step identified in claim 1. The
`I
`complex is obtained from an aqueous solution of iron (III) chloride and an aqueous solution of the
`
`oxidation product of one or more maltodextrins. The oxidation product is made by dissolving a
`
`maltodextrin with a dextrose equivalents between 5 and 20 in water. The resulting aqueous solution
`
`is oxidized by adding a sodium hypochlorite solution at an alkaline pH. The oxidized maltodextrin
`
`solution is then mixed With an iron (III) chloride solution. The resultii:ig solution is filtered,
`
`precipitated, and dried in a vacuum. The dry product is then reconstituted with water and sealed in
`
`glass vials for injection. Therefore, claim 1 reads on the approved product.
`
`Page 5of13
`
`Pharmacosmos, Exh. 1022, p. 9
`
`

`

`.f\
`
`Patent Number: 7,612,109
`
`Attorney Docket Number: 17271-00007-US
`
`Method of Manufacturing Claims
`
`The following claims to methods of manufacturing read on the currently approved method
`
`of manufacturing the approved product: Claims 6-16, and 19-27.
`
`Pursuant to MPEP 2753, one claim, claim 6, is provided below with a showing of how this
`
`claim reads on the currently approved method used to manufacture the approved product.
`
`Claim 6
`
`A pro~ess for producing a water soluble iron carbohydrate complex having a weight average
`
`molecular (Mw) of 80,000 to 400,000, comprising the steps of:
`
`(a) oxidizing at least one maltodextrin in an aqueous solution at an alkaline pH with an
`aqueous hypochlorite solution to form an oxidized maltodextrin solution, and
`
`(b) contacting the oxidized maltodextrin solution with an aqueous solution of an iron (III)
`salt, wherein,
`
`when one maltodextrin is present, the maltodextrin has a dextrose equivalent of between
`5 and 20, and wherein,
`
`when a mixture of more than one maltodextrin is present, the dextrose equivalent of each
`individual maltodextrin is between 2 and 40, and the dextrose equivalent of the mixture
`is between 5 and 20.
`
`Analysis of Claim 6
`
`Ferric carboxymaltose with the characteristics of claim I is prepared by an approved
`
`manufacturing process that uses each step set forth in claim 6. That process is described above with
`
`respect to claim 1 which applies equally to claim 6 and is incorporated herein by reference.
`
`Therefore, claim 6 reads on the approved method of manufacturing the approved product.
`
`[required page break]
`
`Page 6of13
`
`Pharmacosmos, Exh. 1022, p. 10
`
`

`

`Patent Number: 7,612,109
`
`Attorney Docket Number: 17271-00007-US
`
`~\
`
`·(10)
`
`Statement of the Relevant Dates to Determine the Regulatory Review Period
`
`The relevant dates and information pursuant to 35 U.S.C. §156(g) to enable the Secretary of
`
`Health and Human Services to determine the application regulatory review period are as follows:
`
`(i)
`
`The patent for which extension of the term thereof is sought claims a human drug
`
`product. The human drug product is a composition containing ferric carboxymaltose.
`
`(A)
`
`An Investigational New Drug Application for ferric carboxymaltose was submitted
`
`on January 15, 2004, was received by the Department of Health and Human Services on January 22,
`
`2004, was assigned IND No. 063243, and became effective on February 21, 2004. A copy of the
`
`IND letter from the FDA is attached as Appendix H.
`
`(B)
`
`A New Drug Application for Injectafer® was submitted and received by the
`
`Department of Health and Human Services on June 15, 2006 and granted NDA No. 022054. A first
`
`refusal letter was issued by the FDA on July 9, 2007 and a second refusal letter was issued on
`
`March 11, 2008.
`
`(C)
`
`A second New Drug Application for Injectafer® was submitted and received by the
`
`Department of Health and Human Services on October 3, 2011 and granted NDA No. 203565. This
`
`second Application included data from NDA No. 022054 which was incorporated by reference.
`
`(D)
`
`NDA No. 203565 was approved on July 25, 2013.
`
`[required page break)
`
`Page 7of13
`
`Pharmacosmos, Exh. 1022, p. 11
`
`

`

`-f·
`
`Patent Number: 7,612,109
`
`Attorney Docket Number: 17271-00007-US
`
`(11) Brief Description of Activities Undertaken During the Regulatory Review Period
`
`As a brief description of the activities undertaken during the applicable regulatory review
`
`period, attached hereto as Appendix I is a chronology of the major correspondence and submissions
`
`between the U.S. Food and Drug Administration and Applicant or its agents.
`
`[required page break]
`
`Page 8of13
`
`Pharmacosmos, Exh. 1022, p. 12
`
`

`

`Patent Number: 7,612,109
`
`Attorney Docket Number: 17271-00007-US
`
`(12) Opinion of Eligibility for Extension and Length of Extension Claimed
`
`Applicant is of the opinion that U.S. Patent No. 7,612,109 is eligible for extension under 35
`
`U.S.C. §156 and 37 C.F.R. §1.720 because it satisfies all of the requirements for such extension as
`
`follows:
`
`(a)
`
`35 U.S.C. §156Ca) and 37 C.F.R. §l.720Ca)
`
`U.S. Patent No. 7,612,109 claims ferric carboxymaltose, the active ingredient of a human
`
`drug product and pharmaceutical compositions containing the active ingredient. MPEP 2751
`
`states:
`
`A patent is considered to claim the product at least in those situations
`where the patent claims the active ingredient per se, or claims a
`composition or formulation which contains the active ingredient(s)
`and reads on the composition or formulation approved for commercial
`marketing or use.
`
`(b)
`
`35 U.S.C. § 156(a)(l) and 37 C.F.R. §l.720(g)
`
`The term of U.S. Patent No. 7,612,109 (without the present extension, scheduled to expire
`
`on February 5, 2024) has not expired before the submission of this application.
`
`(c)
`
`35 U.S.C. §156(a)(2) and 37 C.F.R. §1.720(b)
`
`The term of U.S. Patent No. 7,612,109 has never been extended under 35 U.S.C. §156(e)(l).
`
`(d)
`
`35 U.S.C. §156(a)(3) and 37 C.F.R. §l.720(c)
`
`The application for extension of the term of U.S. Patent No. 7,612,109 is submitted by the
`
`authorized attorney of the owner of record thereof in accordance with the requirements of 35
`
`U.S.C. §156(d) and 37 C.F.R. §1.740.
`
`Page 9of13
`
`Pharmacosmos, Exh. 1022, p. 13
`
`

`

`Patent Number: 7,612,109
`
`Attorney Docket Number: 17271-00007-US
`
`(e)
`
`35 U.S.C. §156(a)(4) and 37 C.F.R. §l.720(d)
`
`The approved product, lnjectafer®, has been subjected to a regulatory review period before
`
`its commercial marketing or use.
`
`(f)
`
`35 u.s.c. §156(d)(l)
`
`This application for patent term extension is submitted within the 60-day period beginning
`
`on the date the approved product, lnjectafer®, received permission under the provision of
`
`law under which the applicable regulatory review period occurred for commercial marketing
`
`or use.
`
`(g)
`
`37 C.F.R. § l.720(h)
`
`No other patent has been extended for the same regulatory review period for the approved
`
`product, Injectafer®.
`
`(h)
`
`35 U.S.C. §156(a)(5)(A) and 37 C.F.R. §l.720(e)(l)
`
`The permission for the commercial marketing or use of the approved product, Injectafer®, is
`
`the first received permission for commercial marketing or use oflnjectafer® under the
`
`provision of law under which the applicable regulatory review occurred.
`
`Length of Extension Claimed
`
`The length of extension of the patent term of U.S. Patent No. 7,612,109 requested by
`Applicant.is 12~7 days, which length was calculated in accordance with 37 C.F.R. §1.775 as
`', , ....
`
`'
`
`'
`
`follows:
`
`(a)
`
`The regulatory review period under 35 U.S.C §156(g)(l)(B) began on January 15,
`
`2004 and ended on July 25, 2013 amounting to a total of 3481 days which is the sum of (i)
`
`and (ii) below:
`
`(i)
`
`The period ofreview under 35 U.S.C. §156(g)(l)(B)(i), the "Testing Period",
`
`began on January 15, 2004 and ended on June 15, 2006, which is 883 days;
`
`Page 10of13
`
`Pharmacosmos, Exh. 1022, p. 14
`
`

`

`Patent Number: 7,612,109
`
`Attorney Docket Number: 17271-00007-US
`
`(ii)
`
`The period for review under 35 U.S.C. §156(g)(l)(B)(ii), the "Approval
`
`Period," began on June 15, 2006 and ended on July 25, 2013, which is 2598 days;
`
`(b)
`
`The regulatory review period upon which the period for extension is calculated is the
`
`entire regulatory review period as determined in subparagraph (13)(a) above (3481 days)
`
`less:
`
`(i)
`The number of days in the regulatory review period which were on or before
`the date on which the patent issued (November 3, 2009) i.e., 2120 days and
`
`(ii)
`
`The number of days during which the Applicant did not act with due
`
`diligence, i.e., zero days, and
`
`(iii) One-half of the number of days remaining in the period in subparagraph
`
`(13)(a)(i) after subtracting the number of days in subparagraphs (13)(b)(i) and
`
`(13)(b)(ii), which is one-half of (0) or 0 days;
`
`which results in a period of 3481 - [2120 + 0 + 0 days]= 1361 days.
`
`( c)
`
`The number of days as determined in subparagraph ( 13 )(b ), when added to the
`
`original term. (February 5, 2024), would result in the date of October 28, 2027.
`
`(d)
`
`Fourteen (14) years when added to the date of the NDA Approval Letter (July 25,
`
`2013) would result in the date of July 25, 2027.
`
`(e)
`
`The earlier date as determined by subparagraphs (13)(c) and (13)(d) is July 25, 2027.
`
`(f)
`
`Since the original patent was issued after September 24, 1984, the extension
`
`otherwise obtainable is limited to not more than five (5) years. Five years, when added to
`
`the original expiration of U.S. Patent No. 7,612,109 (February 5, 2024) results in the date
`
`February 5, 2029.
`
`(g)
`
`The earlier date as determined in subparagraphs (13)(e) and (13)(£) is July 25, 2027.
`
`Page 11 of 13
`
`Pharmacosmos, Exh. 1022, p. 15
`
`

`

`Patent Number: 7,612,109
`
`Attorney Docket Number: 17271-00007-US
`
`(h)
`
`Therefore, Applicant believes that the expiry date of U.S. Patent No. 7,612,109
`
`should.be extended 1267 days, which, when added to the original term (February 5, 2024),
`
`results in an expiry date of July 25, 2027.
`(13) Duty of Disclosure Acknowledgment Under 37 C.F.R. §1.740(a)(13)
`Applicant acknowledges a duty to disclose to the Director of The United States Patent and
`
`Trademark Office and the Secretary of Health and Human Services any information which is
`
`material to the determination of entitlement to the extension sought.
`
`(14) Fee Charge
`
`The prescribed fee for receiving and acting upon this application is to be charged to the
`
`undersigned's credit card as authorized in the attached transmittal letter. Any deficiency in the fee
`
`paid or further fee required for this application for patent term extension is authorized to be charged
`
`to Deposit Account No. 03-2775 under order number 17271-00007-US, from which the
`
`undersigned is authorized to draw.
`
`(15) Correspondence Address Required by 37 C.F.R. §1.740(a)(15)
`
`All correspondence relating to this application for patent term extension should be addressed
`
`to:
`
`Burton A. Amernick
`c/o Novak Druce Connolly Bove + Quigg LLP
`The Nemours Building, 8th Floor
`1007 N. Orange Street
`Wilmington, DE 19801
`Telephone: (202) 331-7111 (general)
`(202) 572-0330 (direct)
`
`The undersigned hereby certifies that the instant application, including its attachments and
`
`supporting papers, is being submitted as one original and two copies thereof for a total of three
`
`copies in accordance with 37 C.F.R. §l.740(b).
`
`Page 12of13
`
`Pharmacosmos, Exh. 1022, p. 16
`
`

`

`•'
`
`Patent Number: 7,612,109
`
`. Dated: September Ll 2013
`
`Attorney Docket Number: 17271-00007-US
`
`·c
`onA.Am
`Registration No. 24852
`Novak Druce Connolly Bove + Quigg LLP
`The Nemours Building, 8th Floor
`1007 N. Orange Street
`Wilmington, DE 19801
`Telephone: (202) 331-7111 (general)
`(202) 572-0330 (direct)
`Attorney for Applicant
`
`5283372_1.doc
`
`Page 13 of 13
`
`Pharmacosmos, Exh. 1022, p. 17
`
`

`

`EXHIBIT A
`EXHIBIT A
`
`Pharmacosmos, Exh. 1022, p. 18
`
`Pharmacosmos, Exh. 1022, p. 18
`
`

`

`~·USPTO Assignments on the Web
`
`EXHIBIT A
`
`Page 1 of l
`
`United States Patentand Trademark Office
`·Home I Site Indexlsearch I Guides I Contacts I eBusiness I eBiz alerts I News I Help
`Assignments on the W.eb > Patent Query
`
`Patent Assignment Abstract of Title
`NOTE:Results 'display only for issued patents and published applications.
`For pending or abandoned applications please consult USPTO staff.
`
`Appllcatlon #: 10531895
`
`Filing Dt: 12/14/2005
`
`Total Assignments: 1
`Patent#: 7612109
`Issue Dt: 11/03/2009
`Publication #: 20060205691
`Pub Ot: 09/14/2006
`Inventors: Peter Geisser, Erik Phlllpp, Walter Richie
`Title: Wl\TER~SOLUBLE IRON·CARBOHYDR.ATE COMPLEXES, PRODUCTION THEREOF, AND·MEDlCAMENTS CONTAINING
`SAID COMPLEXES
`Assignment: 1
`Reel/Frame: 02306610144
`Recorded: 08/07/2009
`Conveyance: ASSIGNMENT OF AS~IGNORS INTEREST (SEE DOCUMENT FOR DETAILS).
`Assignors: GEISSER. PEIER
`Exec Dt:. 03/10/2005
`Exec Dt: 05/02/2005
`PHILIPP. ERTK
`Exec Dt: 05/02/2005
`RlCHLE. WALTER
`Assignee: VIFOR CINTERNATIONALl AG
`RECHENSTRASSE 37
`ST. GALLEN, SWITZERLAND 9001
`Correspondent:. KENNETH A.CLARK
`23755 LORAIN ROAD, SUITE 200
`NORTH OLMSTED,.OH44070
`
`Pages: 2
`
`Search RosvltG as of: 07/16/201311:21 AM
`II.you have·any comments or questions eoncemln9 tha·.data displayed, contact PRO I Assignments al 571-272'3350. v.2.3:3
`Web interfac.e last modlned: Apr 6, 2013 v.2.3,3
`·
`
`I .HOME I INDEX I SEARCH I eBUSINESS I CONTACT US I PRIVACY STATEMENT
`
`http://assignments.uspto.gov/assignments/q?db=pat&qt=pat&reel=&frame=&pat=7612 l 09 ... 7118/2013
`
`Pharmacosmos, Exh. 1022, p. 19
`
`

`

`•'
`
`EXHIBIT B
`EXHIBIT B
`
`Pharmacosmos, Exh. 1022, p. 20
`
`Pharmacosmos, Exh. 1022, p. 20
`
`

`

`•'
`
`EXHIBIT B
`
`PATENT- POWER OF ATTORNEY
`OR
`REVOCATION OF POWER OF ATTORNEY
`WITH ANEW POWER OF ATTORNEY
`AND
`CHANGE OF CORRESPONDENCEADDRESS
`
`Tille
`
`17271.;00007-US
`
`PTOISB/S1A (12-08)
`Approved for use through 11/30/201i. OMB OS51-0035
`U.S. Patenl and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Pa"""-"ork Reduction Act o! 1995, no oersons are reoulred to resoond 10 a collecUon of Information unle.n It dlsDla\1$ a vanci OMB control number.
`7,612, 109 Conf. #5889
`Patent Number
`November 3, 2009
`Issue Dale
`Peter Geiisser
`First Named Inventor
`WATER-SOLUBLE IRON-CARBOHYDRATE
`COMPLEXES, PRODUCTION THEREOF, ANO
`MEDICAMENTS CONTAINING SAW
`COMPLEXES
`Attorney Dockal No;
`I hereby· revoke all previous powers of·attorney given In the above-Identified patent
`D A Power of Attorney Is submitted herewith.
`OR
`~ I hereby appoint Practitionor(s) associated with the following Customer Number as my/our
`attorney(s) or agent{s) with respect to the patent Identified above, and to transact·all·buslnass In
`the Unlled·S\ates Patent and Trademark Office connected therewith:
`·
`
`I
`D I hereby ilppolnl PractlUoner(s) named below:as my/our attorney(s) or agent(s) with respect to the patent identified
`
`OR
`
`above·, and !o.transa.ct all business In· the United States Patent and Trademark Office connected therewith:
`Registration
`RoglstraUon
`Nvmbcr
`Number
`
`Practltloner(s).Name
`
`Prac:tltioner(s) Name
`
`23416
`
`I
`
`Please recognize or·change the correspondence.address for the above-Identified patent.to:
`
`· O~h~ address associated with Customer- Number: C_.
`
`0 The address.associated with the above-menlioned Customer Number.
`I
`
`OR
`
`D Flrm:or
`
`Individual Name
`Address
`
`I
`
`-·
`
`I
`!Slate
`I Telephone I
`
`·--·-----
`---
`
`I Zip
`!Email
`
`l
`I
`
`City
`Counll)'
`I.am tho:
`
`. 0 Inventor,. having ownership of the patent.
`OR
`[RI Patent owner;
`S/oten1ont uilder 37 CFR 3. 73(b) (Forni PTOISB/90) submfttecl }le~Wjih or filed on
`SIGNA TUBE or lnvon\or[dr Vatont Owner
`
`...
`
`·--·~-... --.. ------
`
`Tiiie and Company
`
`D
`
`5287177_1
`
`forms ere submitted.
`
`Signature
`
`Name
`
`/~ /JI)
`-~ - . /.' (
`
`Dale
`
`26.07.2013
`
`::::::=---
`+41 58 851 82 85
`LIGIBEL Jean-Marc - KRONEN®.ERGPliver P. Telephone
`.
`General Cou.nsel
`Head of IP
`VIFOR (INTERNATIONAL) AG
`NOTE.:· Sl9naturos ol atnno lnvontors or patent owners ol.tne enure- mtero&I or thorr repre~ont:11.1ve{s) :iro roquJred. Submn mulliplE' torms II more
`lhan one slgnature Is required, see below'.
`'Total or
`
`Pharmacosmos, Exh. 1022, p. 21
`
`

`

`APPLICATION NUMBER
`10/531,895
`
`PILING OR 3 71 (C) DA TB
`12/14/2005
`
`23416
`NOVAK DRUCE CONNOLLY BOVE+ QUIGG LLP
`P 0 BOX 22