January 12, 2016
`
`VIA EMAIL
`
`Eleanor M. Yost
`Goodwin Procter LLP
`901 New York Avenue, N.W.
`Washington, DC 20001
`
`Brandon M. White
`BMWhite@perkinscoie.com
`D. +1.202.654.6206
`F. +1.202.654.9681
`
`Re: Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd.
`Case Nos. IPR2105-00643, IPR2015-00644 and IPR2015-00830.
`
`Dear Eleanor:
`
`Patent Owner’s Citation to Documents Not of Record
`
`I write regarding IPR2105-00643, IPR2015-00644 and IPR2015-00830.1
`
`A.
`
`Patent Owner has not filed with the Board any of the materials identified in Dr. Grabowski’s
`declaration (Ex. 2133) or identified in Dr. Grabowski’s Documents Relied Upon (Ex. 2106).
`None of these materials are identified in Dr. Grabowski’s declaration as an exhibit.
`
`Patent Owner was required to file any exhibits it intended to rely on with the Board. 37 C.F.R.
`§ 42.6. Accordingly, Petitioners understand that Patent Owner will not rely on any of the
`following materials at the oral hearing in these IPRs or Dr. Grabowski’s opinions which relied
`thereon:
`
` 2015 MS Mid-Year Tracker, FINAL REPORT APPENDIX – SEPTEMBER 2015
` TEVCOP00449084–115
` TEVCOP00450191–93
` TEVCOP00451650–52
` Berndt, E. R., et al., “An Analysis of the Diffusion of New Antidepressants: Variety, Quality,
`and Marketing Efforts,” The Journal of Mental Health Policy and Economics, 2002, Vol. 5,
`No. 1, pp. 3–19
` Cohen, J., et al., “Equivalence of Generic Glatiramer Acetate in Multiple Sclerosis: A
`Randomized Clinical Trial,” JAMA Neurology, October 12, 2015
`
`1 These IPR proceedings were joined by IPR2015-01976, IPR2015-01980 and IPR2015-01981,
`respectively.
`
`
`
`YEDA EXHIBIT NO. 2140
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`

`
`Eleanor M. Yost
`January 12, 2016
`Page 2
`
` Donohue, J. M., et al., “A Decade of Direct-to-Consumer Advertising of Prescription Drugs,”
`The New England Journal of Medicine, 2007, Vol. 357, No. 7, pp. 573–681
` Leffler, K. B., “Persuasion or Information? The Economics of Prescription Drug
`Advertising,” J.L. & Econ., 1981, Vol. 24, No. 1, pp. 45–74
` Thomas, J. R., “Patent Infringement and Experimental Use Under the Hatch-Waxman Act:
`Current Issues,” Congressional Research Service, 2012.
` Venkataraman, S. and Stremersch, S., “The Debate on Influencing Doctors’ Decisions: Are
`Drug Characteristics the Missing Link?” Management Science, 2007, Vol. 53, No. 11, pp.
`1688–1701.
` Wynn D., et al., “Patient Experience with Glatiramer Acetate 40 mg/1 mL Three-Times
`Weekly Treatment for Relapsing-Remitting Multiple Sclerosis: Results from the GLACIER
`Extension Study,” The American Academy of Neurology 2015 Annual Meeting, Washington,
`D.C., April 18–25, 2015
` Biogen, “Above MS™ Program,” available at http://www.tecfidera.com/join-biogensupport/
`(last visited on 11/12/2015)
` California State Board of Pharmacy, “2015 Lawbook for Pharmacy,” available at
`http://www.pharmacy.ca.gov/laws_regs/lawbook.pdf (last visited on 11/16/2015)
` Copaxone® website, available at www.copaxone.com (last visited on 11/12/2015)
` Copaxone® website, “3-TIMES-A-WEEK COPAXONE® 40 MG,” available at
`www.copaxone.com/about-copaxone/copaxone-40-mg (last visited on 11/12/2015)
` Copaxone® website, “COPAXONE® − A proven mix of efficacy, safety, and tolerability in
`relapsing forms of MS,” available at https://www.copaxonehcp.com/about-copaxone (last
`visited on 11/18/2015)
`IMS Health, “Our Company,” available at http://www.imshealth.com/en/about-
`us/ourcompany (last visited on 11/16/2015)
` National Multiple Sclerosis Society, “Definition of MS,” available at
`http://www.nationalmssociety.org/What-is-MS/Definition-of-MS (last visited on 11/12/2015)
` National Multiple Sclerosis Society, “MS Symptoms,” available at
`http://www.nationalmssociety.org/Symptoms-Diagnosis/MS-Symptoms (last visited on
`11/12/2015)
` National Multiple Sclerosis Society, “The MS Disease-Modifying Medications,” January
`2015, available at http://www.nationalmssociety.org/dmd (last visited on 11/12/2015).
` National Multiple Sclerosis Society, “Types of MS,” available at
`http://www.nationalmssociety.org/What-is-MS/Types-of-MS (last visited on 11/12/2015)
` National Multiple Sclerosis Society, “What Is MS?” available at
`http://www.nationalmssociety.org/What-is-MS (last visited on 11/12/2015).
` Sandoz, “GlatopaCare™,” available at http://glatopa.com/glatopa_care/index.shtml (last
`visited on 11/12/2015)
`
`
`
`
`
`YEDA EXHIBIT NO. 2140
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`

`
`Eleanor M. Yost
`January 12, 2016
`Page 3
`
` Sandoz, “GlatopaCare™: Co-Pay Program & Insurance and Benefits Investigation,”
`available at http://www.glatopa.com/glatopa_care/financial_support.shtml (last visited on
`11/12/2015)
` Teva, “Doctor Discussion Guide,” available at
`https://www.copaxone.com/Resources/pdfs/DoctorDiscussionGuide.pdf (last visited on
`11/12/2015)
` Teva, “Informed Treatment Decision Brochure,” available at
`https://www.copaxone.com/Resources/pdfs/Informed_Treatment_Decision_Brochure.pdf
`(last visited on 11/12/2015)
` Teva, “Shared Solutions®,” available at
`https://www.copaxone.com/Resources/pdfs/Shared_Solutions_Brochure.pdf (last visited on
`11/12/2015)
` “Global BioPharmaceuticals: Game Changes in Multiple Sclerosis,” Barclays, March 7, 2014
` “Global Biotechnology,” Credit Suisse, April 4, 2014
` “Global Biotechnology and Pharmaceuticals – AAN 2014,” Credit Suisse, April 30, 2014
` “Multiple Sclerosis: It’s a Revolution! (vs. Evolution),” Credit Suisse, December 12, 2013
` “Spec Pharmaceuticals,” Morgan Stanley, March 3, 2014
` “Teva,” Morgan Stanley, March 14, 2014
` “Teva Pharmaceutical Industries Ltd. (TEVA),” Citi, February 2, 2014
` “Teva Pharmaceutical Industries Ltd. (TEVA),” Citi, April 4, 2014
` Aubagio® label, October 17, 2014
` Avonex® label, August 28, 2014
` Betaseron® label, September 25, 2015
` Copaxone® label, January 28, 2014
` Extavia® label, August, 14, 2009
` Gilenya® label, August 4, 2015
` Glatopa™ label, April 16, 2015
` Lemtrada® label, November 14, 2014
` Novantrone® label, March 23, 2012
` Plegridy® label, August 15, 2014
` Rebif® label, March 10, 2015
` Tecfidera® label, December 3, 2014
` Tysabri® label, May 12, 2015
` U.S. Patent No. 8,377,885
` U.S. Patent No. 8,796,226
`
`IMS Data Cited in Ex. 2108-2114 and 2120-2122
`
`With regard to the IMS data cited in Exhibits 2108-2114 and 2120-2122, Patent Owner was
`obligated to produce the data underlying these exhibits pursuant to 37 C.F.R. § 42.65(a) and Fed.
`
`
`
`YEDA EXHIBIT NO. 2140
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`

`
`Eleanor M. Yost
`January 12, 2016
`Page 4
`
`R. Evid. 1006. Failure to produce the underlying IMS data precludes Exhibits 2108-2114 and
`2120-2122 from being admitted into evidence or given any substantial weight by the Board.
`
`B.
`
`Additional Discovery Requested by Petitioners
`
`While Patent Owner has failed to set forth a proper evidentiary basis for its commercial success
`argument as purportedly set forth in the Response and in Dr. Grabowski’s declaration,
`Petitioners are nonetheless entitled to additional discovery to rebut Dr. Grabowski’s unsupported
`opinions. Pursuant to 37 C.F.R. §42.51(b)(2), Petitioners seek Patent Owner’s agreement to
`produce the discovery outlined below. If agreement cannot be reached, we reserve the right to
`seek permission from the Board to obtain this discovery by motion.
`
`The requested additional discovery outlined below is relevant to the issue of commercial success
`argued by Patent Owner in its Response and in Dr. Grabowski’s declaration. This discovery is
`believed to be in the possession of Patent Owner or its real parties in interest, and is narrowly
`tailored so that it is not overly broad and/or burdensome.
`
`In order to avoid burdening the Board with unnecessary motion practice to obtain this additional
`discovery, Petitioners request that by January 14, 2016 Patent Owner confirms that it will
`provide the requested discovery, and to provide a date on which it will do so that is well in
`advance of Dr. Grabowski’s deposition, scheduled for January 21, 2016.
`
`1.
`
`Promotional and Marketing Expenditures
`
`Petitioners seek production of documents related to promotional and marketing expenditures for
`Copaxone 40 mg/mL and Copaxone 20 mg/mL. Specifically, Petitioners request the following
`additional discovery:
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`Expenditures on samples of Copaxone 40 mg/mL;
`
`Expenditures on journal advertising for Copaxone 40 mg/mL;
`
`Expenditures on direct-to-consumer (DTC) advertising for Copaxone 40 mg/mL;
`and
`
`Expenditures on other marketing efforts for Copaxone 40 mg/mL; and
`
`Documents sufficient to show the comparative level of promotion and marketing
`expenditures for Copaxone 20 mg/mL versus 20 mg/mL.
`
`This additional discovery is issues raised by Patent Owner and its declarant, Dr. Grabowski, that
`the alleged commercial success is not due to the marketing and promotional activities related to
`
`
`
`YEDA EXHIBIT NO. 2140
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`

`
`Eleanor M. Yost
`January 12, 2016
`Page 5
`
`the product. See, e.g., Ex. 2133 at § VI.D; Patent Owner Response at 58 (touting commercial
`success due to patented features).
`
`Petitioners also requires this additional discovery to verify Patent Owners’ statements that
`“[t]otal promotional marketing for Copaxone 40 mg/mL in the year that it launched was only
`0.60 percent of wholesale sales, much lower than the industry average of 18 percent.” Ex. 2133
`at ¶56. The data presented by Dr. Grabowski is only in terms of percent of wholesale sales and
`does not include actual expenditure amounts. This information is believed to be in the
`possession of Patent Owner or its real parties in interest and Dr. Grabowski.
`
`2.
`
`Information on Rebates, Discounts and Coupons
`
`Petitioners seek production of documents related to any patient-directed discounts, rebates,
`coupons and other patient-directed financial programs, including co-pay assistance, related to
`Copaxone 40 mg/mL. Specifically, Petitioners request information on rebates, discounts and
`coupons for Copaxone 40 mg, as well as how those price discounts compare to other MS drugs.
`
`This additional discovery is related to is issues raised by Patent Owner and its declarant, Dr.
`Grabowski, that the alleged commercial success is not due to the marketing and promotional
`activities related to the product. See, e.g., Ex. 2133 at § VI.D; Patent Owner Response at 58
`(touting commercial success due to patented features).
`
`3.
`
`Advertising for Copaxone
`
`Petitioners seek production of documents related to the advertising of Copaxone 20 mg/ml and
`Copaxone 40 mg/ml. Specifically, Petitioners request copies of advertisements (including print
`advertising and social media presentations) made to physicians or patients, including DTC
`advertising, for Copaxone 40 mg. This information was reviewed by Dr. Grabowski (“I have
`reviewed some marketing materials that were circulated by Teva to promote Copaxone 40
`mg/mL” citing to physician brochures and marketing materials targeted at patients at ¶54) and
`will allow Petitioners to determine which characteristics of Copaxone 40 mg are being
`advertised, and whether those characteristics relate to the limitations of the challenged claims.
`
`This additional discovery is issues raised by Patent Owner and its declarant, Dr. Grabowski, that
`the alleged commercial success is not due to the marketing and promotional activities related to
`the product. See, e.g., Ex. 2133 at § VI.D; Patent Owner Response at 58 (touting commercial
`success due to patented features).
`
`4.
`
`Documents Related to Teva’s Switching Strategy
`
`Petitioners seek production of documents related to the advertising of any efforts on behalf of
`Patent Owner or its real parties in interest to convert patients from Copaxone 20 mg/ml to
`
`
`
`YEDA EXHIBIT NO. 2140
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`

`
`Eleanor M. Yost
`January 12, 2016
`Page 6
`
`Copaxone 40 mg/ml. This request includes direct-to-consumer and physician-directed programs
`and communications as well as programs and communications directed to third party payors.
`
`This additional discovery is relevant to issues raised by Patent Owner and its declarant, Dr.
`Grabowski. See, e.g., Ex. 2133 at ¶16 (“The large number of patients that switched from
`Copaxone® 20mg/mL to Copaxone® 40mg/mL following the launch of Copaxone® 40mg/mL
`confirms the preference of patients and physicians for Copaxone® 40mg/mL over Copaxone®
`20mg/mL. Furthermore, the introduction of Copaxone® 40mg/mL appears to have helped
`reverse a decline in Copaxone® 20mg/mL prescriptions that started in 2013 after the
`introduction of new oral competitors.”).
`
`5.
`
`Documents Related to Competition with Glatopa
`
`Petitioners seek production of documents related to efforts by Patent Owner and its real parties in
`interest to compete with Glatopa, including documents related to comparative pricing and
`marketing efforts to distinguish Copaxone in comparison to Glatopa.
`
`This additional discovery is relevant to issues raised by Patent Owner and its declarant, Dr.
`Grabowski. See, e.g., Ex. 2133 at ¶17 (“The flow of new prescriptions for Copaxone®
`40mg/mL after the entry of a generic product for Teva’s Copaxone® 20mg/mL product,
`Glatopa™, further demonstrates that Copaxone® 40mg/mL’s commercial success is due to its
`unique dosing regimen and corresponding benefits. The steady flow of new prescriptions for
`Copaxone® 40mg/mL after the launch of a less expensive generic with the same active
`ingredient indicates that Copaxone® 40mg/mL’s success stems from its patented features and
`three injections per week dosing regimen.”).
`
`We look forward to receiving the requested discovery. Petitioners are available to meet and
`confer on this request.
`
`***
`
`Sincerely,
`/s/ Brandon M. White
`Brandon M. White
`
`Counsel of record
`
`
`cc:
`
`
`
`
`
`YEDA EXHIBIT NO. 2140
`MYLAN PHARM. v YEDA
`IPR2015-00644