IN THE UNITED-STATES PATENT AND TRADEMARK OFFICE
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`Attorney Docket No. 11285.0056-00000
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`PATENT
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`In re Application of:
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`John R. Evans et al.
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`Application No.: 12/285,887
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`Filed: October 15, 2008
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`For:
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`FORMULATION
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`Commissioner for Patents
`P.O. Box 1450
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`Alexandria, VA 22313-1450
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`Sir:
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`\;\J\&\/\/'\/\/\/\/
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`Group Art Unit: 1628
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`Examiner: HUI, San Ming R.
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`Confirmation No.: 1199
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`VIA EFS-WEB
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`INFORMATION DISCLOSURE STATEMENT UNDER 37 C.F.R. §1.97{cl
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`A. Documents Listed in the Attached SBl08 Form
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`Pursuant to 37 C.F.R. §§ 1.56 and 1.97(c), Applicants brings to the attention of
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`the Examiner the documents on the attached listing. This Information Disclosure
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`Statement is being filed after the events recited in Section 1.97(b) but, to the
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`undersigned's knowledge, before the mailing date of either a Final action, Quayle
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`action, or a Notice of Allowance. Underthe provisions of 37 C.F.R. § 1.97(c), this
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`Information Disclosure Statement is accompanied by a fee of $180.00 as specified by
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`Section 1.17(p).
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`Applicants respectfully request that the Examiner consider the listed documents
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`and indicate that they were considered by making appropriate notations on the attached
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`form.
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`Astrazeneca Ex. 2136 p. 1
`Mylan Pharms. Inc. V. Astrazeneca AB IPR2016-01326
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`

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`Application No.: 12/285,887
`Attorney Docket No.: 11285.0056-00000
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`B. Teva’s Paragragh IV Letter Dated November 25, 2009
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`The undersigned wishes to make of record the following information. Teva
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`Parenteral Medicines, lnc., (“Teva”) filed Abbreviated New Drug Application (“ANDA”)
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`No. 200479 with the FDA seeking approval of a generic 50 mg/mL Fulvestrant injection.
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`In connection with ANDA No. 200479, Teva sent a letter to AstraZeneca
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`Pharmaceuticals LP dated November 25, 2009, (“Teva’s Letter”) concerning U.S. Patent
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`Nos. 6,774,122 and 7,456,160 (“the ’122 and ’160 patents”).
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`The instant application claims the benefit of priority from each of the ’122 and ’160
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`patents. Teva’s Letter alleges that the ’122 and ’160 patents are obvious in light of,
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`inter alia, Howell et al. (cited in the Information Disclosure Statement filed on June 4,
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`2009) and McLeskey er al. (cited in this Information Disclosure Statement).
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`All documents cited in Teva’s Letter are listed in the table below. To the extent
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`Teva’s Letter provided a pinpoint citation for any of the documents, the citation is also
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`provided below. Otherwise, the phrase “generally” appears when Teva’s Letter referred
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`to the disclosure in the given document without a citation.
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`References cited in Teva’s Paragraph IV Letter Dated November 25, 2009,
`Concerning AstraZeneca’s U.S. Patent Nos. 6,774,122 and 7,456,160
`Reference
`Citation
`
`
`U.S. Patent No. 5,183,814 to Dukes et al., and its
`Generally;
`“European cognate,” European Patent Application
`Col. 3, I. 66 - Col. 4, I. 4;
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`No. EP 0 346 014
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`Col. 6, II. 20-26;
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`Col. 9, II. 15-25;
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`Example 3, col. 11, ll. 1-11
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`Astrazeneca Ex. 2136 p. 2
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`

`
`Application No.: 12/285,887
`Attorney Docket No.: 11285.0056-00000
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`References cited in Teva’s Paragraph IV Letter Dated November 25, 2009,
`Concerniig AstraZeneca’s U.S. Patent Nos. 6,774,122 and 7,456,160
`1
`Citation
`Reference
`L
`U.S. Patent No.4,659,516 to Bowler et al. (and
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`Generally
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`European Patent Application No. EP 0 138 504, which
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`was termed an “equivalent” of U.S. Patent
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`No.4,659,516 in Teva’s Letter)
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`European Patent Application No. EP 0 346 014, which Generally
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`was termed the “European cognate” of U.S. Patent
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`No. 5,183,814 in Teva’s Letter
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`J
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`Howell et al., "Pharmacokinetics, Pharmacological,
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`Generally;
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`and Anti-tumour Effects of the Specific Anti-oestrogen
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`300; 301; 302; 303; 305
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`ICI 182780 in Women with Advanced Breast Cancer,”
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`Figure 2;
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`[Brit J. Cancer 743300-308 (1996).
`McLeskey et al., “Tamoxifen-Resistant Fibroblast
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`L
`Generally;
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`Growth Factor-Transfected MCF-7 Cells are Cross-
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`698
`
`Resistant In Vivo to the Antiestrogen lCl 182,780 and
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`Two Aromatase lnhibitors,” C/in. Cancer Res. 4:697-
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`711 (1998).
`
`|VVake|ing et al., "A Potent Specific Pure Antiestrogen
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`1 Generally;
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`with Clinical. Potential,” Cancer Res., 51:3867-73
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`3869
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`(1991).
`
`l_U.S. Patent No. 4,212,863
`P.K. Gupta and GA. Brazeau (eds), Injectable Drug
`
`+
`Col. 1,
`1E5
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`ll. 30-32
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`Development: Techniques to Reduce Pain and
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`418
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`Irritation. Chapters 11 & 17 lnterpharm Press, Denver,
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`Colorado (1999).
`I_
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`AstraZeneca Pharmaceuticals LP and other AstraZeneca related corporate
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`entities brought suit against Teva and other Teva related corporate entities charging
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`Astrazeneca Ex. 2136 p. 3
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`

`
`Application No.: 12/285,887
`Attorney Docket No.: 11285.0056-00000
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`them with infringement of the ’122 and ’160 patents. The suit was filed on January 7,
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`2010 in the U.S. District Court for the District of Delaware and was assigned Civil Action
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`No. 10-18-JAP.
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`Subsequently, Teva withdrew ANDA No. 200479 and is no longer seeking
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`approval of a generic 50 mg/mL Fulvestrant injection from the FDA. Civil Action No. 10-
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`18-JAP was dismissed without prejudice on June 15, 2011.
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`Unless already of record, all documents cited in the preceding table are being
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`submitted to the Office in the attached SB/O8 form.
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`C. Documents from the prosecution of European Patent Applications
`member of the same family as the instant application
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`Applicants submitted documents from the opposition against European Patent
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`Application No. 01900186.6 with the Information Disclosure Statement filed June 4,
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`2009. Applicants now supplement that submission with documents submitted after the
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`June 4, 2009, Information Disclosure Statement. Applicants are also enclosing the
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`search reports from European Patent Application Nos. 10180667.7 and 10180661.0.
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`European Patent Application Nos. 019001866, 10180667.7, and 10180661.0 are
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`European members of the same patent family as the instant application.
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`This submission does not represent that a search has been made or that no better
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`art exists and does not constitute an admission that each or all of the documents listed
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`in the attached SB/08 form or in the table above are material or constitute "prior art." If
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`the Examiner applies any of the documents as prior art against any claims in the
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`application and Applicant determines that the cited documents do not constitute "prior
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`Astrazeneca Ex. 2136 p. 4
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`

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`Application No.: 12/285,887
`Attorney Docket No.: 11285.0056-00000
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`art" under United States law, applicant reserves the right to present to the office the
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`relevant facts and law regarding the appropriate status of such documents.
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`Applicants further reserve the right to take appropriate action to establish the
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`patentability of the disclosed invention over the listed documents, should one or more of
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`the documents be applied against the claims of the present application.
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`If there is any fee due in connection with the filing of this Statement not included
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`herein, please charge the fee to Deposit Account 06-0916.
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`Dated: June 20,2011
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`Respectfully submitted,
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`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
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`Q 3 /
`\ M
`
`By:
`
`Carlos M. Téllez
`
`Reg. No. 48,638
`(202) 408-4123
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`Astrazeneca Ex. 2136 p. 5
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`

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`
`
`Name of Patentee or
`Applicant of Cited Document
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`Note: Submission of copies of U.S. Patents and published U.S. Patent Applications is not required.
`
`Examiner
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`'
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`Foreign Patent Document
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`Country Code3 Number‘ Kind Code5 (ifknown)
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`Publication Date
`—
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`Pages, Columns, Lines,
`Name of Patentee or
`Applicant of Cited Document Where Relevant Passages
`or Relevant Figures
`App°a'
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`Translations
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`FOREIGN PATENT DOCUMENTS
`
`NONPATENT LITERATURE DOCUMENTS
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s),
`publisher, city and/or country where published.
`McLeskey et al., ‘Tamoxifen-resistant fibroblast growth factor-transfected MCF-7 cells are cross-resistant in
`vivo to the antiestrogen lCl 182,780 and two aromatase inhibitors,” Clin. Cancer Res., 4:697-711 (1998).
`JRF Robertson, et al., "Fulvestrant: pharrnacokinetics and phannacology,” British Journal of Cancer,
`90(1):S7-S10 (2004).
`- John F. R. Robertson, “Fulvestrant (Faslodex® )--how to make a good drug better,” The Oncologist, 12:774-
`734 (2007).
`Search Report for European Patent Application No. 1018o667.7 dated November23, 2010.
`Search Report for European Patent Application No. 10180661.0 dated January 19, 2011.
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`Documents from the Opposition against European Patent Application No. 019001863 from April 21, 2009 to
`September 7, 2009.
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`Examiner
`Signature
`
`Date
`Considered
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`Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through
`EXAMINER:
`citation it not in conformance and not considered.
`Include copy of this form with next communication to applicant.
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`Astrazeneca Ex. 2136 p. 6
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`Application Number
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`Complete if Known
`12/285,887
`
`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
`(Use as many sheets as necessary)
`jjlijj Attorney Docket Number
`
`Filing Date
`M W
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`October 15, 2008
`John R. EVANS
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`San Ming H, Hui
`112ss.oos6-ooooo
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`U.S. PATENTS AND PUBLISHED U.S. PATENT APPLICATIONS
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`Examln_er
`Initials
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`Cite
`No.‘
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`Pages, Columns, Lines, Where
`Issue or
`Document Number
`Relevant Passages or Relevant
`Publication Date
`_
`2
`Figures Appear
`MM_DD_yyyy
`Number-Kind Code (if known)
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