I hereby certify that this paper is being transmlttpd via the Office
`electronic filing system in accordance with 37 CFR § 1.6(a)(4).
`
`Dated: October 6, 2014
`Electronlc Signature for Ruth Lang: IRth Lang]
`
`Docket No.: 146392023400
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent of: Pablo Umafia et al.
`
`Attorney Docket No: 146392023400
`
`Patent No': 6’602’684
`
`Assignee: Roche Glycart AG
`
`Issued: August _5, 2003
`
`Unit: Office of Patent Legal
`Administration
`
`pa-1658389
`
`patent term extension applications concurrently so that Applicant can elect upon receipt of a
`Notice of Final Determination and Requirement of Election as to Which patent to ultimately
`mend in accordance with 37 CPR § 1.785.
`11/14/2314 CKHLGK
`86368833 @31952 f 39294594
`91 muse
`1123.211 131:
`'
`
`Application No: 09/294,584
`
`For: GLYCOSYLATION ENGINEERING OF
`ANTIBODIES FOR IMPROVING ANTIBODY-
`DEPENDENT CELLULAR CYTOTOXIClTY —
`
`Application for § 156 Patent Term Extension
`
`Mail Stop Hatch-Waxman PTE
`Commissioner for Patents
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`SUPPLEMENTAL PAPER
`
`In addition to the above-referenced application for patent term extension for US. Patent No.
`
`6,602,684 based on the November '1, 2013 approval of GAZYVA®, Applicant concurrently
`
`submitted patent term extension applications for US. Patent Numbers 8,021,856 and 7,517,670.
`
`Thus, avtotal of three patent term extension applications were filed based upon the same
`
`regulatory review period for GAZYVA®. It is requested that the Office examine these three
`
`Mylan v. Genentech
`IPR2016-00710
`Merck Ex. 1129, Pg. 1
`
`

`

`Date: October 6, 2014
`
`Respectfully submitted,
`
`IShannon Reaney/
`
`Facsimile: 650/494-0792
`
`For:
`
`Catherine M. Polizzi
`
`Registration N0.: 40,130
`MORRISON & FOERSTER LLP
`
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`Palo Alto, California 94304-1018
`Phone: 650/813-5651
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`
`U.S. Patent No. 6602684
`
`Docket No.: 146392023400
`
`Applicant believes that no fee is due. If there is an associated fee for filing a Supplemental
`
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`
`referencing 146392023400.
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`Shannon Reaney
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`Phone: 650/813—5744 .
`
`pa-1658389
`
`Merck Ex. 1129, Pg. 2
`
`

`

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`PATENT EXT LN.” 3N
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`SIGNATURE OF APPLICANT, ATTORNEY, 0R AGENT
`
`Firm Name
`Signature
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`MORRISON & FOERSTER LLP
`.
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`(Customer No. 25226)
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`t d
`P'
`"n e "am
`
`e
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`.
`.
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`Catherine M. PoliZZI
`
`December 17. 2013
`
`40,130
`
`I hereby certify that this paper is being deposited with the US. Postal Service as Express Mail. Airbiil No. EM 021716856 US, on the date shown
`below in an envelope addressed to:
`‘
`Commissioner for Patents. PO. Box 1450, Alexandria, VA 22313-1450.
`
`Dated: December 17. 2013
`
`'
`
`Signature:
`
`(Shannon Reaney)
`
`Merck Ex. 1129, Pg. 3
`
`

`

`PTO/SB/17(03-13)
`Approved ior use through 01/31/2014. 0MB 065143032
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`105
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`195
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`information and authorization on PTO-2038.
`FEE CALCULATION
`1. BASIC FILING, SEARCH, AND EXAMINATION FEES (U = undiscounted fee; 5 = small entity fee; M = micro entity fee)
`FILING FEES
`SEARCH FEES
`EXAMINATION FEES
`M_i§l
`iii!
`L118 .
`it!) M m §J§l Mil W
`iii)
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`
`A_lzl3____¥L"03ti°nT 9
`70
`140‘
`600
`300
`150
`720
`360
`180
`280
`Utility
`45
`90
`120
`60
`30
`460
`230-
`1157
`180
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`45
`90
`380
`190
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`580
`290
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`2,160
`1,080
`540
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`Reissue
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`260
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`' 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
`
`pa-1620436
`
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`- 20 or HP =
`HP = highest number of total claims paid for, if greater than 20.
`lndep. Claims
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`Extra Claims
`Fee [fl
`=
`X
`- 3 or HP =
`HP = highest number of independent claims paid ior. 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
`tee due is $400 ($200 for small entity) ($100 for mice entity) for each additional 50 sheets or traction thereof. See 35 U.S.C. 41(a)(1)(G) and 37 CFR t.16(s).
`Total Sheets
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`4. OTHER FEE(S)
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`1457 Extension of term of patent
`suamwreo av_
`sagnawre
`‘W m {imam-
`40.130
`renepnone
`(650) 813-5651
`NameiPrint/Type Catherine M. Polii
`' '
`Date
`December17, 2013
`
`Fees Paid m
`
`l hereby certify that this paper is being deposited with the US. Postal Service as Express Mail, Airbill No. EM 021716856 US, on the date shown
`below in an envelope addressed to:
`Commissioner for Patents. P.0. Box 1450, Alexandria, VA 22313-1450.
`
`Dated: December 17. 2013
`
`Signature:
`
`(Shannon Reaney)
`
`Merck Ex. 1129, Pg. 4
`
`

`

`I hereby certify that this paper is being deposited with the US. Postal Service as
`Express Mail, Airbill No. EM 021716856 US, on the date shown below in an
`envelope addressed to: Mail Stop Hatch-Waxman PTE, Commissioner for
`Patents. PO. Box 1450, Alexandria, VA 22313-1450.
`
`Dated: December 17, 2013
`
`Signature: 4“ ‘
`(Shawn Ream“)
`
`.
`
`DOCket N05 146392023400
`Client Ref. NO.: 23437-USl
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent of: Pablo Umafia et a1.
`
`Attorney Docket NO: 146392023400
`
`Patent No‘: 6’602’684
`
`Issued: August 5, 2003
`
`Assignee: Roche Glycart AG
`
`Unit: Office of Patent Legal
`Administration
`
`pa-l6l 9270
`
`A statement executed by authorized representatives of owner, Roche Glycart AG,
`attesting that exclusive licensee, Genentech, Inc., is authorized to act as agent for Roche Glycart
`AG in the submission of a patent term extension application under 35 U.S.C. § 156 for the ’684
`Patent is included as Attachment A.
`
`Application NO: 09/294,584
`
`For: GLYCOSYLATION ENGINEERING OF
`ANTIBODIES FOR IMPROVING ANTIBODY-
`DEPENDENT CELLULAR CYTOTOXICITY —
`
`Application for § 156 Patent Term Extension
`
`Mail Stop Hatch-Waxman PTE
`Commissioner for Patents
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`RECEIVED
`
`DEC 1 7 2013
`PATENT EXTENSION
`OPLA
`
`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. 6,602,684 (the ’684 Patent) under 35 U.S.C. § 156 by providing
`the following information in accordance with the requirements specified in 37 C.F.R. § 1.740.
`
`Merck Ex. 1129, Pg. 5
`
`

`

`Patent No.: 6,602,684
`
`Docket No.: 146392023400
`Client Ref. No.: 23437-US]
`
`1.
`
`Identification of the Approved Product [§ 1.740(a)(l)]
`
`The name of the approved product is GAZYVATM. The name of the active ingredient of
`GAZYVATM is obinutuzumab. Obinutuzumab has also been referred to as GA101. See Klein et
`
`al., mAbs, 2013, 5(1):22-33, abstract, provided as Attachment J. Applicant uses the
`nomenclature Obinutuzumab, which is the same nomenclature used in the product label for
`GAZYVATM. Obinutuzumab is a type II, glycoengineered, humanized anti-CD20 cytolytic
`antibody. See Description section (page 12, section 11) and Highlights of Prescribing
`Information (page 1) of Obinutuzumab Product Label, provided as Attachment B and Klein et
`al., at page 29, right-hand column, second full paragraph (Attachment J).
`'
`
`Federal Statute Governing Regulatory Approval of the Approved Product
`2.
`[§ 1-740(a)(2)]
`
`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.)
`.
`~
`
`Applicant represents that Roche Glycart AG is the assignee of the entire right, title and
`interest in and to United States Letters Patent No. 6,602,684 granted to Pablo Umafia, Joel Jean-
`Mairet, and James E; Bailey (Pablo Umafia et al.), by virtue of the law of Switzerland or an
`assignment of such patent from Pablo Umafia et al. to GlycArt Biotechnology GmbH, recorded
`February 9, 2001, at Reel 011528, Frame 0431, by virtue of company name/entity change to
`GlycArt Biotechnology AG, recorded May 14, 2003, at Reel 014065, Frame 0729, by virtue of
`an assignment from Pablo Umafia et al. to GlycArt Biotechnology AG, recorded April 19, 2004,
`at Reel 015232, Frame 0164,I and by virtue of company name change to Roche Glycart AG,
`recorded September 09, 2011, at Reel 026883, Frame 0831.
`
`.
`
`3.
`
`Date of Approval for Commercial Marketing [§ 1.740(a)(3)]
`
`GAZYVATM was approved for commercial marketing or use under § 351 of the Public
`Health Service Act on November 1, 2013. See Obinutuzumab BLA Approval Letter, provided as
`Attachment C.
`
`4.
`
`Identification of Active Ingredient and Certifications Related to Commercial
`Marketing of Approved Product [§ 1.740(a)(4)]
`
`(a)
`
`The name of the active ingredient of GAZYVATM is obinutuzumab.
`Obinutuzumab is a type II, glycoengineered, humanized anti-CD20 cytolytic
`antibody. See Description section (page 12, section 11) and Highlights of
`Prescribing Information (page 1) of Obinutuzumab Product Label, provided as
`
`l The assignment recorded at the noted location in the Office’s records was originally recorded
`on August 18, 2003, at Reel 014405, Frame 0440. A duplicate copy was recorded at the
`‘
`noted date and location to correct the name of one of the Assignors in the Office’s records.
`2
`
`pa-l6l9270
`
`Merck Ex. 1129, Pg. 6
`
`

`

`Patent N0.: 6,602,684
`
`-
`
`Docket N0.: 146392023400
`Client Ref. N0.: 23437-USl
`
`Attachment B and Klein et al., at page 29, right-hand column, second full
`paragraph (Attachment J).
`
`Obinutuzumab was approved for commercial marketing pursuant to,§ 351 of the
`Public Health Service Act (42 U.S.C. § 262) under Genentech, 1nc.’s existing
`Department of Health and Human Services (DHHS) U.S. License No. 1048. See
`Obinutuzumab BLA 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(1). The last date on which this application can be submitted is
`December 30, 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:
`
`Pablo Umafia, J061 Jean-Mairet, and James E.
`Bailey
`
`Applicant certifies that obinutuzumab 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
`November 1, 2013, to the present Applicant.2
`Obinutuzumab has been approved, in combination with chlorambucil, for the
`treatment of patients with previously untreated chronic lymphocytic leukemia
`(CLL). See Indications and Usage section (page 2, section 1) of Obinutuzumab
`Product Label, provided as Attachment B.
`'
`
`pa-l6 l 9270
`
`Patent Number:
`
`Date of Issue:
`
`6,602,684 (“the ’684 Patent”)
`
`August 5, 2003
`
`Date of Expiration:
`
`April 20, 2019
`
`2 The permission for the commercial marketing or use of obinutuzumab granted on November 1,
`2013, to the present Applicant is also believed to be the first permitted commercial marketing
`or use of a product manufactured under the process claimed in the ‘684 patent.
`3
`
`Merck Ex. 1129, Pg. 7
`
`

`

`Patent No.: 6,602,684
`
`Docket No.: 146392023400
`Client Ref. No.: 23437-US1
`
`Copy of the Patent for Which an Extension Is Being Sought [§ 1.740(a)(7)]
`
`A copy of the ’684 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 ’684 Patent is not subject to a Terminal Disclaimer.
`
`No Certificate of Correction has issued with respect to the ’684 Patent.
`
`The ’684 Patent issued on August 5, 2003. The first and second maintenance fees
`were paid on December 18, 2006 and December 28, 2010, respectively; the
`window for paying the third maintenance fee opens August 5, 2014. See
`Attachment E. Thus, no maintenance fee is currently due for the ’684 Patent.
`
`(d)
`
`The ’684 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-1619270
`
`The statements below are made solely to comply with the requirements of 3 7 CFR.
`§ 1. 740(a)(9). Applicant notes that, as the M.P.E.P. acknowledges, § 1. 740(a)(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 of the 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 ofany product.
`
`'
`
`(a)
`
`At least claims 1, 2, 3,3 5, 6, 7, 8, and 9 claim the active ingredient in the
`approved product or the approved product or a method that may be used to
`manufacture or use that ingredient or product.
`
`Pursuant to M.P.E.P. § 2753 and 37 CPR. § 1.740(a)(9), the following
`explanation is provided which shows how at least one of the above-listed claims
`of the ’684 Patent claims a method of manufacturing the approved product.
`
`(1)
`
`Description ofthe approved product
`
`The name of the approved product is GAZYVATM. The name of the active
`ingredient of GAZYVATM is obinutuzumab. Obinutuzumab is a type II,
`glycoengineered, humanized anti-CD20 cytolytic antibody. See Description
`
`3 The approved product produced by the claimed method includes a mixture of Obinutuzumab
`and fragments thereof.
`
`4
`
`Merck Ex. 1129, Pg. 8
`
`

`

`Patent No.: 6,602,684
`
`Docket No.: 146392023400
`Client Ref. No.2 23437-USl
`
`section (page 12, section II) and Highlights of Prescribing Information (page I)
`of Obinutuzumab Product Label, provided as Attachment B and Klein et al., at
`page 29, right-hand column, second full paragraph (Attachment J).
`
`Explanation regarding claim 1 ofthe ’684 Patent relative to
`(2)
`Obinutuzumab
`'
`
`Claim 1 of the ’684 Patent reads:
`
`pa- I6] 9270
`
`Obinutuzumab is produced in CHO cells in suspension culture. See DescriptiOn
`section (page 12, section 11) and Highlights of Prescribing Information (page 1)
`of Obinutuzumab Product Label, provided as Attachment B; Mossner et al.,
`Blood, 2010, 115:4393-4402, provided as Attachment K, at page 4396, right-hand
`column, second full paragraph. The CHO cells are engineered to overexpress B-
`l,4—N-acetyl-glucosaminyltransferase III (GnT III) by co-transfecting the cells
`with the gene (a nucleic acid) encoding GnT [11. See Mossner er al., provided as
`Attachment K, at page 4394, left-hand column, third paragraph and page 4396,
`right—hand column, second full paragraph; Obinutuzumab BLA, Section 3.2.8.2.3
`Source, History, and Generation, provided as Attachment L. Obinutuzumab
`produced by these engineered CHO host cells is harvested, filtered, and purified.
`See Mossner et al., provided as Attachment K, at page 4394, left-hand column,
`third paragraph; Obinutuzumab BLA, Section 3.2.8.2.2 Cell Culture and Harvest,
`provided as Attachment M. Thus, obinutuzurnab is produced by (a) culturing a
`host cell engineered to express at least one nucleic acid encoding B-(l,4)-N-
`acetylglucosaminyltransferase III (GnT III) under conditions which permit the
`
`A method for producing a polypeptide having increased Fc-mediated cellular
`cytotoxicity in a host cell, comprising:
`
`(a) culturing a host cell engineered to express at least one nucleic acid encoding
`B(1,4) - N - acetylglucosaminyltransferase III (GnT 111) under conditions which
`permit the production of a polypeptide selected from the group consisting of a
`whole antibody molecule, an antibody fragment, and a fusion protein that includes
`the Fc region of an immunoglobulin, wherein said GnT III is expressed in an
`amount sufficient to modify the oligosaccharides in the Fc region of said
`polypeptide produced by said host cell and wherein said polypeptide has
`increased Fc-mediated cellular cytotoxicity as a result of said modification; and
`
`k\
`
`(b) isolating said polypeptide having increased Fc-mediated cellular cytotoxicity.
`
`Obinutuzumab is a humanized monoclonal antibody. (which is a polypeptide)
`based on a human IgG1(K) framework. See Obinutuzumab BLA, Section 328.12
`Structure, provided as Attachment 1. Thus, Obinutuzumab is a polypeptide
`selected from the group consisting of a whole antibody molecule, anantibody
`fragment, and a fusion protein that includes the Fc region of an immunoglobulin.
`
`5
`
`Merck Ex. 1129, Pg. 9
`
`

`

`Patent No.: 6,602,684
`
`Docket No.: 146392023400
`Client Ref. No.: 2343 7-USl
`
`production of the polypeptide (obinutuzumab) and (b) isolating the polypeptide
`(obinutuzumab).
`
`Overexpression of the GnT III and Golgi a-mannosidase II (Man-II) in the CHO
`’ cells producing obinutuzumab leads to accumulation of antibody glycoforms
`containing bisected, nonfucosylated oligosaccharides attached to an asparagine4 in
`the Fc region. See Mossner et al., provided as Attachment K, at page 4396, right-
`hand column, second full paragraph (citing Ferrara et al., J. Biol. Chem. , 2006,
`281(8):5032-5036, provided as Attachment N). GnT III overexpression alone
`causes the modification of oligosaccharides in the Fc regions of antibodies. See
`Ferarra et al., J Biol. Chem, provided as Attachment N, at page 5033, right-hand
`column, through page 5034, left-hand column, and Figure l; Ferarra et al.,
`Biotechnologz and Bioengineering, 2006, 93(5):851-61, provided as Attachment
`0, abstract and page 854, left-hand column, third paragraph. Thus, obinutuzumab
`is produced in a host cell engineered to express GnT III in an amount sufficient to
`modify the oligosaccharides in the Fc region of the polypeptide (obinutuzumab).
`
`pa-l6l9270
`
`The addition to obinutuzumab of a bisecting N—acetylglucosamine (bGlcNAc) (an
`oligosaccharide (see Ferarra et al., J. Biol. Chem, provided as Attachment N, at
`page 5033, Figure 1)) by GnT III overexpression leads to enhanced antibody
`dependent cellular cytotoxicity (ADCC) bioactivity. See Obinutuzumab BLA,
`Section 3.4.2, provided as Attachment P; Mossner et al., (Attachment K), at page
`4393, right-hand column, first paragraph. ADCC is Fc-mediated. See Mossner et
`al., (Attachment K), at page 43 93, right—hand column, first paragraph. Thus,
`obinutuzumab has increased Fc-mediated cellular cytotoxicity as a result of the
`modification of the oligosaccharides in the Fc region.
`
`Thus, the limitations of claim 1 are met.
`
`4 The cited reference refers to this asparagine residue as asparagine (N) 297. This same residue in
`obinutuzumab is sometimes referred to as Asn (asparagine) 299. The difference in
`numbering reflects different numbering conventions (Kabat vs. sequential numbering) See
`Nagelkerken et al., J Immunol, 2004; 173 2993-999 (provided as Attachment Q, at page 994,
`left—hand column, second full paragraph, noting “Kabat nomenclature” (sometimes referred
`to as the EU numbering system) is being used to number asparagine residue N297,
`referencing, Kabat, EA, et al. (1991) Sequences ofProteins ofImmunological Interest, 3rd
`Ed., Vol. 1, National Institutes of Health.
`6
`
`Merck Ex. 1129, Pg. 10
`
`

`

`Patent No.: 6,602,684
`
`Docket No.: 146392023400
`Client Ref. No.: 23437-US1
`
`Relevant Dates Under 35 U.S.C. § 156 for Determination of Applicable Regulatory
`10.
`Review Period [§ l.740(a)(10)]
`
`(a)
`
`Patent Issue Date
`
`The ’684 Patent was issued on August 5, 2003.
`
`pa-1619270
`
`The BLA was submitted by Genentech, Inc., to FDA on April 19, 2013; however,
`FDA listed April 22, 2013 as the Date of Application (see BLA Acknowledgment
`Letter provided in Attachment F). April 22, 2013 is used herein as the BLA
`Submission Date. The BLA was assigned number 125486. A copy of the letter
`from FDA acknowledging receipt of the BLA and reflecting the BLA Application
`' Date is provided in Attachment F.
`
`IND Eflective Date [35 as. C. § 156(g)(1)(B)(i); 37 CFR. § 1. 740(a)(10) (004)]
`
`The date that an exemption under § 505(i) of the Federal Food, Drug and
`Cosmetic Act became effective (i.e., the date that an investigational new drug
`application (“IND”) became effective) for obinutuzumab was March 11, 2009.5
`The IND was assigned number 104405. A copy of the letter from FDA
`acknowledging receipt of the IND and reflecting the IND number and a February
`9, 2009 receipt date is attached as Attachment H.
`
`BLA Submission Date [35 (1.5. C. § 156(g)(1)(B)(z); 37 CFR.
`§ 1. 740(a)(10)(l)(3)]
`
`BLA Issue Date [35 US. C. ,5 156(g)(1)(3)(iz); 37 C.F.R. § 1. 740(a)(10) (i) (C)]
`
`FDA approved BLA 125486, authorizing the marketing of obinutuzumab, on
`November 1, 2013. Obinutuzumab was approved under Department of Health
`and Human Services (DHHS) U.S. License No. 1048. A copy of the
`Obinutuzumab BLA Approval Letter from FDA is provided as Attachment C.
`
`5 21 CPR. § 312.40(b)(1). The IND was submitted to FDA on February 6, 2009 and was
`received by FDA on February 9, 2009. See Attachment H. The IND became effective on
`March 11, 2009, 30 days after receipt of the IND by FDA.
`7
`
`Merck Ex. 1129, Pg. 11
`
`

`

`Patent No.: 6,602,684
`
`‘
`
`'
`
`‘
`
`Docketfio ,1,46§Lf3292:3'400
`Client Ref
`2343:7-US1
`
`11.
`
`Summary of Significant Events During Regulatory
`
`lie-nod
`
`1,2740(a‘i‘(1.1)]
`
`-
`
`On February 6, 2009, Genentech, Inc., submitted to FDA an Investigational New
`Drug (IND) application for anti-CD20 humanized monoclonal antibody GAlOl
`(obinutuzumab). FDA assigned the IND application number 104405. On March
`11, 2009, FDA informed Genentech that BB-IND 104405 is approved and clinical
`trials may proceed. This IND included protocol B021003 Version C.
`
`On July 7, 2009, Genentech, Inc., and FDA participated in a Type B- End of
`Phase 11 Meeting to discuss protocol BO21004/CLL11.
`
`On September 23, 2009, Genentech, Inc., submitted new protocol
`B021004/CLL-11, which formed the basis of approval for obinutuzumab in CLL.
`
`On November 3, 2009, Genentech, Inc., and FDA participated in a Type B End of
`Phase II Teleconference to discuss protocol GAO4753 g.
`
`On September 17, 2010, Genentech, Inc., submitted new protocol GAO4779g.
`
`On November 15, 2010, Genentech, Inc., and FDA participated in a Type B
`Teleconference to discuss Protocols 8021005 and B021223.
`
`Pursuant to 37 C.F.R. § 1.740(a)(1_1), the following provides afi‘b‘fief’ae'sériptiori' arthe'éé‘ti'v‘itieg
`of Genentech, Inc., before FDA in relation to the regulatory review of obinutuzumab. The brief
`description lists significant events that occurred during the regulatory review period for the
`approved product. In several instances, communications to or from FDA are referenced.
`Pursuant to 37 C.F.R. § 1.740(a)(11), 21 C.F.R. § 60.20(a), and M.P.E.P. § 2753, copies ofall
`such communications are not provided in this application, but can be obtained from records
`maintained by FDA.
`
`pa-1619270
`
`On January 20, 2011, Genentech, Inc., submitted new protocol B021005.
`
`On January 27, 2011, Genentech, Inc., submitted new protocol B021223.
`
`On February 25, 2011, Genentech, Inc., submitted new protocol GAO4915 g.
`
`On April 18, 2011, Genentech, Inc., submitted new protocol GAO4768g.
`
`On June 8, 2012, Genentech, Inc., and FDA participated in a Type C Meeting to
`discuss the acceptability of the proposed Statistical Analysis Plan for Protocol
`B021004.
`
`On February 22, 2013, Genentech, Inc., and FDA participated in a Type B Pre-
`BLA meeting.
`‘
`
`On April 19, 2013, Genentech, Inc., submitted a BLA for obinutuzumab in
`combination with chlorambucil for the treatment of patients with previously
`8
`
`Merck Ex. 1129, Pg. 12
`
`

`

`Patent No: 6,602,684
`
`Docket 130.: 14636365§160
`Client Ref. No.: 23437-USl
`
`On May 2, 2013, FDA acknowledged receipt of the BLA for obinutuzumab via a
`communication mailed to Genentech, Inc. The letter indicated that FDA had
`assigned the Submission Tracking Number (STN) of BLA 125486/0 to the BLA.
`See Attachment P.
`
`authorization for obinutuzumab. See Attachment C.
`
`untreated chronic lymphocytic leukemia (CLL), which was given an April 22,
`2013 Application Date by FDA. See Attachment F.
`
`On April 25, 2013, Genentech, Inc., submitted expanded access protocol
`ML28979.
`
`On October 15, 2013, Genentech, Inc., and FDA participated in a Type B Pre-
`sBLA Meeting.
`
`On November 1, 2013, FDA approved BLA 125486/0, issuing marketing
`
`pa-1619270
`
`Merck Ex. 1129, Pg. 13
`
`

`

`Patent No._: 6,602,684
`
`Docket Nos: 131:6?55653366
`Client Ref. No.: 23437-USl
`
`Statement Concerning Eligibility for and Duration of Extension Sought Under 35
`12.
`U.S.C. § 156 [37 C.F.R. § 1.740(a)(12)]
`
`(a)
`
`In the opinion of the Applicant, the ’684 Patent is eligible for an extension under
`§ 156 because:
`
`pa-1619270
`
`the commercial marketing or use of the approved product, GAZYVATM,
`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)
`
`one or more claims of the ’684 Patent claim the approved product or a
`method of manufacturing or using the approved product (35 U.S.C. §
`156(a));
`'
`'
`
`(ii)
`
`(iii)
`
`(iv)
`
`the ’684 Patent has not expired before submission of this application (35
`U.S.C. § 156(a)(1));
`
`the term of the ’684 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 approved product, GAZYVATM, has been subject to a regulatory
`review period before its commercial marketing or use (35 U.S.C. §
`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.
`§ 15663(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
`’
`
`this application otherwise complies with all requirements of 35 U.S.C.
`§ 156 and applicable rules and procedures.
`‘
`
`10
`
`Merck Ex. 1129, Pg. 14
`
`

`

`Patent No.: 6,602,684
`
`Docket No.: 146392023400
`Client Ref No.: 23437-USl
`
`(b)
`
`The period by which the term of the ’684 Patth is requested by Applicant to be
`extended is 946 days (35 U.S.C. § 156(c)).
`
`The requested period of extension of term for the ’684 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 ’684 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:
`
`pa-l6l9270
`
`The ’684 Patent was granted prior to the start date of the period specified
`in § 156(g)(1)(B)(i) (the period of 1504 days calculated from the date of
`the grant of the exemption under § 505(i) of the FDCA (March 11, 2009)
`until the date of submission of the BLA (April 22, 2013)). Pursuant to
`§ l56(c), the calculated regulatory review period therefore includes a
`component of time between the date of the grant of the exemption under
`§ 505(i) of the FDCA (March 11, 2009) and the BLA submission date
`(April 22, 2013) (1/2 of 1504 days or 752 days).
`
`Exemption under FDCA § 505(i)
`became effective
`
`March 11, 2009
`
`Patent was granted
`
`'
`
`August 5, 2003
`
`Biologics License Application (BLA)
`under PHSA § 351 was submitted
`
`April 22, 2013
`
`BLA was approved
`
`November 1, 2013
`
`The ’684 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). The regulatory review period
`under § 156(c) therefore includes a component of time between when the
`BLA was submitted and when the BLA was approved (194 days).
`
`The period determined according to §§ 156(c) and (g)(1) for the approved
`product is 946 days.
`
`The ’684 Patent will expire on April 20, 2019.
`
`The date of approval of the approved product is November 1, 2013.
`
`ll
`
`Merck Ex. 1129, Pg. 15
`
`

`

`Patent No.: 6,602,684
`
`I
`
`Docket No.: 146392023400
`Client Ref. No.: 23437-USl
`
`(vii)
`
`The date that is fourteen years from the date of approval