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`pa-1583991
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`SIGNATURE or APPLICANT, ATTORNEY, OR AGENT
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`(Customer No. 25226)
`MORRISON & FOERSTER LLP
`
`Signature 7 I’ Im' I
`Catherine M. Polizzi
`April 17. 2013
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`t,
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`40,130
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`i hereby certify that this paper is being deposited with the US, Postal Service as Express Mail, Airbill No. EM 295528087 US. on the date shown
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`Commissioner for Patents. P.O. Box 1450. Alexandria. VA 22313-1450.
`Signature: _
`
`Dated: April 17. 2013
`
`(Shannon Reaney)
`
`-
`
`-
`
`Mylan v. Genentech
`IPR2016-00710
`Merck Ex. 1130, Pg. 1
`
`

`

`D Applicant asserts small entity status. See 37 CFR 1.27m
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`
`I hereby certify that this paper is being deposited with the US. Postal Service as Express Mail, Airbill No. EM 295528087 US, on the date shown
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`Lust
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`um um
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`MA“cation T e um
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`280
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`260
`' The $140 small entity status tiling 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
`
`' we
`
`___lL_FeeDescri fion
`
`Each claim over 20 (including Reissues)
`Each independent claim over 3 (including Reissues)
`Multiple dependent claims
`a
`Total Claims
`Extra Claims
`
`Fee (5)
`
`'
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`
`__Und_is__t§icountedFee W Wit
`80
`40
`20
`420
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`105
`780
`390
`195
`Fee Paid (g)
`Multiple Dependent Claims
`Fee 1;),
`Ege Paid [fl
`
`Merck Ex. 1130, Pg. 2
`
`

`

`I hereby certify that this paper is being deposited with the US. Postal Service as
`Express Mail. Airbill No. EM 295525087 US US. on the date shown below in an
`envelope addressed to: Mail Stop Halch-Waxman PTE. Commissioner for
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`Dated: April 17, 2013
`Signature:
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`a"
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`
`Docket No.: 146392019700
`Client Ref. No.: 10813
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent of: Sharon Erickson et al.
`
`‘
`
`Attorney Docket NO: 146392019700
`
`Patent NO': 7’097’840
`
`Issued: August 29, 2006
`
`Assignees: Genentech, Inc. and I
`ImmunoGen, Inc.
`
`Unit: Office of Patent Legal
`Administration
`
`pa-1580256
`
`A statement executed by an authorized representative of co-owner ImmunoGen, Inc.
`attesting that co-owner Genentech, Inc. is authorized to act as an' agent of ImmunoGen, Inc. for
`extension of the term of United States Letters Patent No. 7,097,840 under 35 U.S.C. § 156 IS
`included as Attachment A.
`12/03/213 CKHLOK
`00000009 031952
`01 FC:1457
`1120.00 D0
`
`Application No: 09/811,123
`
`For: METHODS OF TREATMENT USING
`ANTI—ERBB ANTIBODY—MAYTANSINOID
`
`CONJUGATES — Application for § 156 Patent
`Term Extension
`
`Mail Stop Hatch—Waxman PTE
`Commissioner for Patents
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`APPLICATION FOR EXTENSION OF PATENT TERM UNDER 35 U.S.C. § 156
`
`Dear Madam:
`
`Applicant, Genentech, Inc., hereby submits this application for extension of the term of
`United States Letters Patent No. 7,097,840 under 35 U.S.C. § 156 by providing the following
`information in accordance with the requirements specified in 37 CPR. § 1.740.
`'
`
`09811123
`
`Merck Ex. 1130, Pg. 3
`
`

`

`Patent No.: 7,097,840 '
`
`Docket No.: 146392019700
`Client Ref. No.: 10813
`
`1.
`
`Identification of the Approved Product [§ l.740(a)(1)]
`
`The name of the approved product is KADCYLATM. The name of the active ingredient
`of KADCYLATM is ado-trastuzumab emtansine. Ado-trastuzumab emtansine has also been
`
`referred to as trastuzumab emtansine. Applicant uses the nomenclature ado-trastuzumab
`emtansine, which is the same nomenclature used in the product label for KADCYLATM. Ado—
`trastuzumab emtansine is a HER2-targeted antibody-drug conjugate which contains the
`humanized anti-HERZ IgGl , trastuzumab, covalently linked to the microtubule inhibitory drug
`DMl (the maytansine derivative Nzl-deacetyl-Nzl-(3-mercapto-1—ox0propyl)-maytansine) via the
`stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-l-carboxylate). See
`'
`Description section of product label, provided as Attachment B.
`'
`
`2.
`
`Federal Statute Governing Regulatory Approval of the Approved Product
`l§ 1.740(a)(2)l
`
`The approved product was subject to regulatory review under, inter‘alia, the Public
`Health Service Act (42 U.S.C. § 201 et seq.) and the Federal Food, Drug and Cosmetic Act (21
`U.S.C. § 355 et seq).
`‘
`
`3.
`
`Date of Approval for Commercial Marketing [§ 1.740(a)(3)]
`
`KADCYLATM was approved for commercial marketing or use under § 351 of the Public
`Health Service Act on February 22, 2013.
`
`4.
`
`Identification of Active Ingredient and Certifications Related to Commercial
`Marketing of Approved Product [§ 1.740(a)(4)]
`
`Applicant represents that co-owners Genentech, Inc. and ImmunoGen, Inc. are the
`assignees of the entire interest in and to United States Letters Patent No. 7,097,840 granted to
`Sharon Erickson, Ralph Schwall, Mark Sliwkowski, and Walter Blattler (Erickson et al.) by
`virtue of an assignment of such patent from Sharon Erickson , Ralph Schwall, and Mark
`Sliwkowski to Genentech, Inc., recorded July 19, 2001, at Reel 011977, Frame 0409 and by
`virtue of assignments of such patent from Walter Blattler to ImmunoGen, Inc., recorded
`December 20, 2002, at Reel 013640, Frame 0657 and on April 4, 2003, at Reel 013566, Frame
`0732}
`
`pa-1580256
`
`.(a)
`
`The name of the active ingredient of KADCYLATM is ado-trastuzumab
`emtansine. Ado—trastuzumab emtansine is a HER2-targeted antibody-drug
`conjugate which contains the humanized anti-HER2 IgGl, trastuzumab,
`covalently linked to the microtubule inhibitory drug DMl (the maytansine
`derivative NT—deacetyl-Nzl-(3-mercapto-1-ox0propyl)—maytansine) via the stable
`thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-l-carboxylate). See
`Description section of product label, provided as Attachment B.
`.
`
`' Additionally, a change of address of ImmunoGen, Inc. was recorded March 2, 2010, at Reel
`024006, Frame 0734.
`-
`
`2
`
`Merck Ex. 1130, Pg. 4
`
`

`

`Patent N0.: 7,097,840
`
`Docket N0.: 146392019700
`Client Ref. N0.: 10813
`
`(b)
`
`Applicant certifies that ado—trastuzumab emtansine had not been approved for
`commercial marketing or use under the Federal Food,‘Drug and Cosmetic Act, the
`Public Health Service Act or the Virus-Serum-Toxin Act prior to the approval
`granted on February 22, 2013 to the present Applicant.
`
`Ado-trastuzumab emtansine was approved for commercial marketing pursuant to
`§ 351 of the Public Health Service Act (42 U.S.C. § 262) under Genentech’s
`existing Department of Health and Human Services (DHHS) U.S. License No.
`1048. See ado-trastuzumab'emtansine approval letter, provided as Attachment C.
`
`Statement Regarding Timeliness of Submission of Patent Term Extension Request
`[§ 1.740(a)(5)]
`
`Applicant certifies that this application for patent term extension is being timely
`submitted within the sixty (60) day period permitted for submission specified in 35 U.S.C.
`§ 156(d)(1) and 37 C.F.R. § 1.720(f). The last date on which this application can be submitted is
`April 22, 2013.
`
`6.
`
`Complete Identification of the Patent for Which Extension Is Being Sought
`[§ 1.740(a)(6)]
`
`The complete identification of the patent for which an extension is being sought is as
`follows:
`
`(a)
`
`Names of the inventors:
`
`Sharon Erickson, Ralph Schwall, Mark Sliwkowski,
`and Walter Blattler
`‘
`
`Ado-trastuzumab emtansine has been approved, as a single agent, for the
`treatment of patients with HERZ-positive, metastatic breast cancer who previously
`received trastuzumab and a taxane, separately or in combination. Patients should
`have either: received prior therapy for metastatic disease, or developed disease
`recurrence during or within six months of completing adjuvant therapy. See
`Indications and Usage section of ado-trastuzumab emtansine product label,
`provided as Attachment B.
`
`pa~l 580256
`
`(b)
`
`(c)
`
`((1)
`
`Patent Number:
`
`7,097,840 (“the ‘840 patent”)
`
`Date of Issue:
`
`August 29, 2006
`
`Date of Expiration:
`
`January 27, 2023 (20 years from March 16, 2001
`plus 682 days Patent Term Adjustment)2
`
`.
`
`2 The ‘840 patent received 682 days of Patent Term Adjustment. See the ‘840 patent provided
`as Attachment D.
`
`3
`
`Merck Ex. 1130, Pg. 5
`
`

`

`Patent No.: 7,097,840
`
`.
`
`Docket No.: 146392019700
`Client Ref. No.: 10813
`
`Copy of the Patent for Which an Extension Is Being Sought [§ 1.740(a)(7)]
`
`A copy of the ‘840 patent is provided as Attachment D to the present application.
`
`Copies of Disclaimers, Certificates of Correction, Receipt of Maintenance Fee
`Payment, or Reexamination Certificate [§ 1.740(a)(8)]
`
`(a)
`
`(b)
`
`(c)
`
`The ‘840 patent is not subject to a Terminal Disclaimer.
`
`A copy of a Certificate of Correction issued with respect to the ‘840 patent on
`March 20, 2007 is provided in Attachment E.3
`
`r The ‘840 patent issued on August 29, 2006. The first maintenance fee was paid
`on January 29, 2010 (See Attachment F). The window for paying the second
`maintenance fee opens August 29, 2013 (See Attachment F). Therefore, no
`maintenance fee is currently due for the ‘840 patent.
`
`(d)
`
`The ‘840 patent has not been the subject of a reexamination proceeding and, thus,
`no re-examination certificate has been issued.
`
`Statement Regarding Patent Claims Relative to Approved Product [§ 1.740(a)(9)]
`
`pa-1580256
`
`The statements below are made solely to comply with the requirements of3 7 C.F.R.
`§ 1. 740(a)(9). Applicant notes that, as the MP,E.P. acknowledges, § 1. 740(c)(9) does not
`require an applicant to show whether or how the listed claims would be infringed, and that this
`question cannot be answered without specific knowledge concerning acts performed by third
`parties. As such, these comments are not an assertion or an admission ofApplicant as to the
`scope ofthe listed claims, or whether or how any ofthe listed claims would be infringed, literally
`or under the doctrine ofequivalents, by the manufacture, use, sale, offerfor sale or the
`importation of any product.
`
`(a)
`
`At least claims 1-3, 6-17, 20—26, 28-29 and 42-44 claim the active pharmaceutical
`ingredient in the approved product or the approved product or a method that may
`be used to make or use that ingredient or product.
`'
`
`3 The Patent and Trademark Office (hereafter “the Office”) issued a Certificate of Correction for
`the ‘840 patent on December 12, 2006. On December 13, 2006, the Office sent Patent
`Owners a letter noting that the Certificate of Correction issued on December 12, 2006 listed
`I the incorrect issue date for the patent and was therefore issued in error. A Certificate of
`Correction was issued January 9, 2007, which listed the correct issue date and superseded the
`December 12, 2006 Certificate of Correction. A further Certificate of Correction issued
`March 20, 2007, superseding both the December 12, 2006 and January 9, 2007 Certificates of
`Correction.
`
`4
`
`Merck Ex. 1130, Pg. 6
`
`

`

`Patent No.: 7,097,840
`
`Docket No.: 146392019700
`Client Ref. No.2 10813
`
`(b)
`
`Pursuant to M.P.E.P. § 2753 and 37 C.F.R. § 1.740(a)(9), the following
`explanation is provided which shows how at least one of the above-listed claims
`of the ‘840 patent claim the approved product.
`
`(1)
`
`Description of the approved product
`
`The name of the approved product is KADCYLATM. The name of the active
`ingredient of KADCYLAT.M is ado—trastuzumab emtansine. Ado-trastuzumab
`emtansine is a HER2-targeted antibody-drug conjugate which contains the
`humanized anti-HERZ IgGl, trastuzumab, covalently linked to the microtubule
`inhibitory drug DMl (the maytansine derivative Nzi—deacetyl-Nzi-(3-mercapto-1-
`oxopropyl)—maytansine) via the stable thioether linker MCC (4-[N-
`maleimidomethyl] cyclohexane-l-carboxylate). See Description section of
`product label, provided as Attachment B.
`
`pa- I 580256
`
`The antibody trastuzumab, is a well characterized recombinant monoclonal
`antibody product produced by mammalian (Chinese hamster ovary) cells, and the
`small molecule components (DM1 and MCC) are produced by chemical
`synthesis. Ado-trastuzumab emtansine contains an average of 3.5 DMI molecules
`per antibody. Id.
`‘
`
`Ado-trastuzumab emtansine-has the following chemical structure:
`
`n
`
`Where n ~ 3.5
`DM1/Mab
`
`The bracketed structure is DMl plus MCC which represents the emtansine
`component. The n is, on average, 3.5 DMl molecules per trastuzumab (Mab)
`molecule. .Ia’.
`'
`
`Merck Ex. 1130, Pg. 7
`
`

`

`I Patent No.: 7,097,840
`
`Docket No.: 146392019700
`Client Ref. No.: 10813
`
`Explanation regarding claim 1 ofthe ‘840 patent relative to ado-
`(2)
`trastuzumab emtansine
`
`‘ Claim 1 of the ‘840 patent reads:
`
`“A method for the treatment of a tumor in a mammal, comprising the steps of (1)
`identifying said tumor as being characterized by overexpression of an ErbBZ
`receptor and as being a tumor that does not respond, or responds poorly, to
`treatment with an anti-ErbBZ antibody which binds to the 4D5 epitope and which
`has a growth inhibitory effect on SK-BR-3 cells, and (ii) administering to a
`mammal having said tumor a therapeutically effective amount of a conjugate of
`an anti-ErbB2 antibody which binds to the 4D5 epitope with a maytansinoid.”
`
`pa-1580256
`
`KADCYLATM is indicated, as a single agent, for the treatment of patients with
`HER2-positive, metastatic breast cancer who previously received trastuzumab and
`a taxane, separately or in combination (see Indications and Usage section of ado-
`trastuzumab emtansine product label, Attachment B). The approved use is thus for
`the treatment of a tumor in a mammal.
`
`Detection of HER2 protein overexpression or gene amplification is necessary for
`selection of patients appropriate for KADCYLATM therapy (see HER2 Testing
`section of ado-trastuzumab emtansine product label, Attachment B). HER2 is
`synonymous with “ErbBZ.” See the ‘840 patent, Attachment D, column 6, lines
`54-56. The approved use thus requires identifying the tumor as being
`characterized by overexpression of an ErbB2 receptor;
`
`The approved use of KADCYLATM is for patients who previously received
`trastuzumab and a taxane, separater or in combination (see Indications and
`Usage section of ado-trastuzumab emtansine product label, Attachment B).
`addition, patients should have either: received prior therapy for metastatic
`disease, or developed disease recurrence during or within six months of
`completing adj uvant therapy. Id.
`
`In
`
`Trastuzumab is an anti-ErbBZ antibody also known by its trade name
`HERCEPTIN® (See the ‘840 patent, Attachment D, column 7, lines 1-8).4
`HERCEPTIN® is an anti-ErbB2 antibody which binds to the 4D5 epitope and
`which has a growth inhibitory effect on SK-BR-3 cells (see the ‘840 patent,
`Attachment D, column 2, lines 44-52; column 3, lines 8-14; column 14, lines 35-
`46; Example 2 and Figure 6).
`‘
`
`4 See also drug details for HERCEPTIN®, provided in Attachment G, available at the FDA
`website address:
`
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Set_Cur
`rent_Drug&ApplNo=l O3 792&DrugName=HERCEPTIN&Activelngred=TRASTUZUMAB
`&SponsorApplicant=GENENTECH&ProducthtStatus= 1 &goto=Search. DrugDetails
`6
`
`Merck Ex. 1130, Pg. 8
`
`

`

`Patent No.: 7,097,840
`
`Docket No.: 146392019700
`Client Ref. No.: 10813
`
`Accordingly, the approved use of KADCYLATM is for the treatment of a patient
`whose tumor does not respond, or responds poorly, to treatment with an anti-
`ErbB2 antibody which binds to the 4D5 epitope and which has a growth
`inhibitory effect on SK-BR-3 cells.
`
`Ado-trastuzumab emtansine is an antibody-drug conjugate which contains the
`humanized anti-HER2 IgGl, trastuzumab, covalently linked to the microtubule
`inhibitory drug DMl (the maytansine derivative N2I-deacetyl-Nzi-(3-mercapto-1-
`oxopropyl)—maytansine) via the stable thioether linker MCC (4-[N-
`maleimidomethyl] cyclohexane-l-carboxylate) (see Description section of ado-
`trastuzumab emtansine product label, Attachment B). As stated above,
`trastuzumab is an anti-ErbBZ antibody which binds to the 4D5 epitope.~ DMl is a
`maytansinoid. Id. KADCYLATM is indicated, as a single agent, for the treatment
`of patients with HERZ—positive, metastatic breast cancer who previously received
`trastuzumab and a taxane, separately or in combination (see Indications and
`Usage section of ado—trastuzumab emtansine product label, Attachment B). Ado—
`trastuzumab emtansine is thus a conjugate of an anti—ErbB2 antibody which binds
`to the 4D5 epitope with a maytansinoid and is approved to be administered in a
`therapeutically effective amount to treat breast cancer.
`'
`
`claim 1.
`
`The approved use of ado-trastuzumab emtansine thus meets the limitations of
`
`pa- 1 580256
`
`Merck Ex. 1130, Pg. 9
`
`

`

`Patent No.: 7,097,840
`
`Docket No.: 146392019700
`Client Ref. No.: 10813
`
`Relevant Dates Under 35 U.S.C. § 156 for Determination of Applicable Regulatory
`10.
`Review Period [§ 1.740(a)(10)]
`'
`
`(a)
`
`Patent Issue Date
`
`The ‘840 patent was issued on August 29, 2006.
`
`[ND Effective Date [35 as. C. § 156(g)(1)(B)(i); 37 C.F.R. § 1. 740(a)(10)(i)(A)]
`
`The date that an exemptiOn under § 505(i) of the Federal Food, Drug and
`Cosmetic, Act became effective (Le. , the date that an-investigational new drug
`application (“IND”) became effective) for ado-trastuzumab emtansine was
`January 18, 2006.5 The IND was assigned number 071072.
`
`BLA Submission Date [35 as. C. §156(g)(1)(B)(i); 37 CFR.
`§ 1-740(a)(10){0(3}]
`
`.
`
`The BLA was submitted by Genentech to the FDA on August 24, 2012. The
`BLA was assigned number 125427. A copy of the letter from the FDA
`'
`acknowledging receipt of the BLA and reflecting the BLA submission date is
`provided in Attachment H.
`'
`
`BLA Issue Date [35 Us C. § 156(g)(1)(B)(ii); 37 CFR. § 1. 740(a)(10)(i){C)]
`
`The FDA approved BLA 125427, authorizing the marketing of ado-trastuzumab
`emtansine, on February 22, 2013. Ado-trastuzumab emtansine was approved
`under Department of Health and Human Services (DHHS) U.S. License No.
`1048. A copy of the approval letter from the FDA is provided as Attachment C.
`
`pa-1580256
`
`5 21 CPR. § 312.40(b)(1). The IND was submitted to the FDA on December 16, 2005 and was
`received by the FDA on December 19, 2005. The IND became effective on January 18,
`2006, 30 days after receipt of the IND by the8FDA.
`
`Merck Ex. 1130, Pg. 10
`
`

`

`Patent No.: 7,097,840
`
`Docket No.: 146392019700
`Client Ref. No.2 10813
`
`11.
`
`Summary of Significant Events During Regulatory Review Period [§ 1.740(a)(11)]
`
`Pursuant to 37 CPR. § 1.740(a)(l l), the following provides a brief description of the
`activities of Genentech, Inc. before the FDA in relation to the regulatory review of ado-
`trastuzumab emtansine. The brief description lists significant events that occurred during the
`regulatory review period for the approved product. In several instances, communications to or
`from the FDA are referenced. Pursuant to 37 CPR. § l.740(a)(1l), 21 C.F.R. § 60.20(a), and
`M.P.E,P. § 2753, copies of all such communications are not provided in this application, but can
`be obtained from records maintained by the FDA.
`'
`
`9
`
`On December’16, 2005, Genentech submitted to the FDA an Investigational New
`Drug (IND) application for ado-trastuzumab emtansine. The FDA assigned the
`[ND application number 071072.
`
`On December 16, 2005, Genentech submitted new protocol TDM3 569g for the
`first human clinical trial (Phase I). The protocol indicated that the study would not
`be initiated until an IND covering the clinical trial came into effect.
`
`The Phase I clinical trial was initiated in April of 2006 followed by Phase II and
`Phase III clinical trials.
`'
`
`On May 7, 2007, Genentech submitted new protocol TDM4258g.
`
`‘
`
`On November 2, 2007, Genentech submitted new protocol TDM43 74g.
`
`On May 6, 2008, Genentech submitted new protocol TDM4450g, a revised
`: protocol for TDM4374g, and a change in protocol TDM4258g, Amendment 1.
`
`On August 8, 2008, representatives of Genentech and the FDA participated in an
`End-of-Phase 11 meeting to discuss and agree on the design of the pivotal Phase
`III trial.
`
`On October 15, 2008, Genentech submitted new protocol TDM4370g, a phase 111
`international, multi-center, open-label, randomized study of ado-trastuzumab
`emtansine versus lapatinib plus capecitabine, in patients with HERZ-positive
`unresectable locally advanced breast cancer (LABC) or metastatic breast cancer
`(MBC) who have progression of disease after receiving trastuzumab and a taxane.
`
`On May 15, 2009, Genentech submitted new protocol TDM4688g.
`
`On March 15, 2012 and May 30, 2012 representatives of Genentech and the FDA
`participated in Type C and Type B pre—BLA submission meetings, respectively, to
`discuss information requirements for the BLA and the acceptability of the Phase
`III trial results to serve as the basis for the BLA.
`
`On August 24, 2012, Genentech submitted a BLA for ado-trastuzumab emtansine
`as a single agent for the treatment of patients with human epidermal growth factor
`
`pa-l580256
`
`Merck Ex. 1130, Pg. 11
`
`

`

`Patent No.: 7,097,840
`
`Docket No.: 146392019700
`Client Ref. No.2 10813
`
`I 2 (HER2)-positive unresectable, locally advanced or metastatic breast cancer who
`have received prior treatment with trastuzumab and a taxane.
`
`FDA acknowledged receipt of the BLA for ado-trastuzumab emtansine via a
`communication mailed to Genentech dated October 23, 2012. The letter indicated
`that FDA had assigned the Submission Tracking Number (STN) of BLA 125427
`to the BLA (see Attachment H).
`i
`'
`
`authorization for ado-trastuzumab emtansine (see Attachment C).
`
`On February 22, 2013, FDA approved BLA 125427, issuing marketing
`
`pa-l 580256
`
`Merck Ex. 1130, Pg. 12
`
`

`

`Patent No.: 7,097,840
`
`Docket No.: 146392019700
`Client Ref. No.: 10813
`
`Statement Concerning Eligibility for and Duration of Extension Sought Under 35
`12.
`U.S.C. § 156 [37 C.F.R. § l.740(a)(12)]
`
`(a)
`
`In the opinion of the Applicant, the ‘840 patent is eligible for an extension under
`§ 156 because:
`‘
`
`pa-1580256
`
`the commercial marketing or use of the product, KADCYLATM, after the
`regulatory review period is the first permitted commercial marketing or
`use of the product under the provisions under the Public Health Service
`Act, Section 351, under which such regulatory review occurred (35 U.S.C.
`§ 156(a)(5)(A));
`
`(i)
`
`(ii)
`
`(iii)
`
`(iv)
`
`one or more claims of the ‘840 patent claim the approved product or a
`method of making or using the approved product (35 U,S.C. § 156(a));
`
`the ‘840 patent has not expired before submission of this application (35
`U.S.C. § 156(a)(1));
`
`the term of the ‘840 patent has. not been previously extended on the basis
`of§ 156 (35 U.S.C. § 156(a)(2));
`
`'
`
`the application for extension is submitted by an owner of record or an
`agent authorized to act on behalf of the owner of record in accordance
`with the requirements of paragraphs (1) through (4) of 35 U.S.C. § 156(d)
`and the rules of the Patent and Trademark Office (35 U.S.C. § 156(a)(3));
`
`the product, KADCYLATM, has been subject to a regulatory review period
`before its commercial marketing or use (35 U.S.IC. § 156(a)(4));
`
`no other patent has been extended pursuant to § 156 on the basis of the
`regulatory review process associated with the approved product (35 U.S.C.
`§ 156(c)(4));
`
`the applicant for marketing approval exercised due diligence within the
`meaning of § 156(d)(3) during the period of regulatory review;
`
`the present application is being submitted within the 60-day period
`following the approval date of the approved product, pursuant to § 156(d);
`and
`
`(x)
`
`this application otherwise complies with all requirements of 35 U.S.C.
`§ 156 and applicable rules and procedures.
`
`(b)
`
`The period by which the term of the ‘840 patent is requested by Applicant to be
`extended is 1,277 days (35 U.S.C. § 156(0)).
`'
`11
`
`Merck Ex. 1130, Pg. 13
`
`

`

`Patent No.: 7,097,840
`
`Docket No.2 146392019700
`Client Ref. No.: 10813
`
`(c)
`
`The requested period of extension of term for the ‘840 patent corresponds to the
`regulatory review period that is eligible for extension pursuant to § 156, based on
`the facts and circumstances of the regulatory review associated with the approved
`product and the issuance of the ‘840 patent. The period was determined as
`follows.
`
`(i)
`
`The relevant dates for calculating the regulatory review period, based on
`the events discussed in the section above, are the following:
`
`Exemption under FDCA § 505(i)
`became effective
`
`January 18, 2006
`
`Patent was granted
`
`I
`
`August 29, 2006
`
`Biologics License Application (BLA)
`under PHSA § 351 was submitted
`
`August 24, 2012
`
`BLA was approved
`
`February 22, 2013
`
`pa-1580256
`
`The ‘840 patent was granted during the period specified in
`§ 156(g)(1)(B)(i) (the period of 2,41 1 days calculated from the date of the
`grant of the exemption under § 505(i) of the FDCA (January 18, 2006)
`until the date of submission of the BLA (August 24, 2012)). Pursuant to
`§§ 156(0), the calculated regulatory review period therefore includes a
`component of time between when the patent was granted (August 29,
`2006) and when the BLA was submitted (August 24, 2012) (1/2 of 2,187
`days or 1,094 days).6
`
`The ‘840 patent was granted prior to the start of the period specified in
`§§ 156(g)(1)(B)(ii) (the period from the date of submission of the BLA
`until the date of BLA approval). The number of days which the applicant
`did not act with due diligence is zero (0) days. The regulatory review
`period under § 156(0) therefore includes a component of time between.
`when the BLA was submitted and when the BLA was approved (183
`days).
`
`The period determined according to §§ 156(0) and (g)(1) for the approved
`product is 1,277 days.
`
`The ‘840 patent will expire on January 27, 2023.
`
`The date of approval of the approved product is February 22, 2013.
`
`6 Under 37 C.F.R. § l.775(d)(1)(iii), half days are ignored for purposes of subtraction.
`12
`
`Merck Ex. 1130, Pg. 14
`
`

`

`PatentNo.: 7,097,840
`
`Docket No.1 146392019700
`Client Ref. No.: 10813
`
`(vii)
`
`The date that is fourteen years from the date of approval of the approved
`product is February 22, 2027.
`‘
`
`(viii) The date that is five years from the expiration date of the ‘840 patent is
`January 27, 2028.
`
`(ix)
`
`The date that is provided by adding the number of days determined
`according to §§ 156(c) and (g)(1) for the approved product (1,277 days) to
`the expiration date of the ‘840 patent is July 27, 2026.
`
`The date that is fourteen years from the date of approval of the approved
`product (February 22, 2027) is later than the date that is provided by
`adding the number of days determined according to §§ 156(c) and (g)(1)
`for the approved product to the expiration date of the ‘840 patent (July 27,
`2026). As such, the period by which the patent may be extended is not
`limited by the fourteen-year rule of §156(c)(3).
`
`The date that is five years from the expiration date of the ‘840 patent
`(January 27, 2028) is later than the date that is provided by adding the
`. number of days determined according to §§ 156(c) and (g)(1) for the
`approved product to the expiration date of the ‘840 patent (July 27, 2026).
`As such, the period by which the patent may be extended is not limited by
`the five-year rule of §_156(g)(6)(a).
`
`pa- I 580256
`
`The ‘840 patent issued after the effective date of Public Law No. 98-417.
`As such, the two— or three-year limit of 35 U.S.C. § 156(g)(6)(C) does not
`apply.
`
`13.
`
`Statement Pursuant to 37 C.F.R. § l.740(a)(13)
`
`Pursuant to 37 C.F.R. § 1.740(a)(13), Applicant acknowledges its duty to disclose to the
`Director of the PTO and to the Secretary of Health and Human Services any information which
`is material to the determination of entitlement to the extension sought, particularly as that duty is
`defined in 37 C.F.R. § 1.765.
`
`14.
`
`Applicable Fee [§ 1.740(a)(14)]
`
`Payment of the fee prescribed in 37 C.F.R. § 1.200) for a patent term extension
`application under 35 U.S.C. § 156 is authorized to be charged against deposit account no. 03-
`1952 referencing docket number 146392019700. The undersigned also authorizes any additional
`required fees to be deducted from, or any overpayments to be credited to, deposit account no. 03-
`1952.
`
`Merck Ex. 1130, Pg. 15
`
`

`

`15.
`
`Name and Address for Correspondence [§ 1.740(a)(15)]
`
`Please direct all inquiries, questions, and communications regarding this application for
`term extension to:
`
`Catherine M. Polizzi
`
`Registration No.: 40,130.
`MORRISON & F OERSTER LLP
`
`755 Page Mill Road
`Palo Alto, California 94304-1018
`Phone: 650/813—5651
`Facsimile: 650/494-0792
`
`PatentNo.: 7,097,840