G O O D VV i N I F) R O C T E R
`
`Nicholas K. Mitrokostas
`
`617.570.1913
`
`nmitrokostas@goodwinprocter.com
`
`Goodwin Procter LLP
`
`Counselors at Law
`
`Exchange Place
`Boston, MA 02109
`T: 617.570.1000
`F: 617.523.1231
`
`January 19, 2016
`
`VIA E-MAIL
`
`Brandon White, Esq.
`Perkins Coie
`
`700 13th Street, NW
`Suite 600
`
`Washington, DC. 20005-3960
`
`Re: Mylan Pharmaceuticals Inc. V. Yeda Research & Development Co. Ltd. Case Nos.
`IPR2105-00643, IPR2015—00644 and lPR2015—00830.
`
`Dear Brandon,
`
`1 write in further response to your letter of January 12, 2016 regarding Patent Owner’s Declaration of
`Henry G. Grabowski (Ex. 2133).
`
`As we stated to you during our January 15 and 18 teleconferences, Patent Owner intends to rely on the
`materials cited in Dr. Grabowski’s declaration and identified in Dr. Grabowski’s reliance materials (Ex.
`2106), and intends to move the Board for authorization to tile each of these documents as exhibits in the
`above—referenced cases. All but four of these documents are publicly available, with sources clearly
`indicated in Dr. Grabowsl<i’s declaration, and, therefore, Petitioners could have obtained these materials
`from public sources weeks ago. Additionally, all of these documents were produced more than seven
`weeks ago to Petitioners as part of the district court litigation involving these patents (In re. Copaxone
`40 MG Consolidated Cases, CA. No. 1:14-cv-01171—GMS), as set forth below:
`
`Document
`
`Bates Nos.
`
`Date
`Produced
`
`2015 MS Mid-Year Tracker, FINAL REPORT APPENDIX —
`SEPTEMBER 2015
`
`TEVCOP0157661 8-816
`
`11/25/2015
`
`TEVCOP00449084~1 15
`
`TEVCOP00450191—93
`
`ACTIVE/848156931
`
`'l‘EVCOP00449084~1 15
`
`7/15/2015
`
`TEVCOP00450191—93
`
`7/15/2015
`
`PETITIONERS' EXHIBIT NO. 1075 PAGE 1
`
`PETITIONERS' EXHIBIT NO. 1075 PAGE 1
`
`

`
`Brandon White, Esq.
`January 19, 2016
`Page 2
`
`TEVCOP00451650—52
`
`Berndt, E. R., et al., “An Analysis ofthe Diffusion ofNew
`Antidepressants: Variety, Quality, and Marketing Efforts,” The
`Journal of Mental Health Policy and Economics, 2002, Vol. 5, No.
`1, pp. 3—~1 9
`
`TEVCOP0045 1 650~52
`
`7/15/2015
`
`‘
`
`1
`
`1 TEVCOP01574959~75
`
`11/25/2015
`
`Cohen, 1., et al., “Equivalence of Generic Glatiramer Acetate in
`Multiple Sclerosis: A Randomized Clinical Trial,” JA/‘W1
`
`TEVCOP01575383—91
`
`Neurology, October 12, 2015
`
`11/25/2015 1
`1
`
`1l
`
`Donohue, J. M., et al., “A Decade of Direct—to~Consumer
`
`TEVCOP01575461—9
`
`1 1/25/2015
`
`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
`
`TEVCOP015"/’5749—79
`
`1 1/25/2015
`
`
` 1 1/25/2015
`.1 TE\/COP01576314—25
`
` 1 1
`
`Prescription Drug Advertising,” J.L. cf: Econ, 1981, Vol. 24, No. 1,
`pp. 45474
`LEEDEE
`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. 1 1, pp. 1688-1701
`
`TEVCOP01 576465-79
`
`11/25/2015 1
`1
`
`Wynn D., et 211., “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 ofNeurology 2015 Annual /Meeting,
`. Washington, D.C., April 18-25, 2015
`
`Biogen, “Above MST” Program,” available at
`http://www.tecfidera.com/join—biogensupport/ (last visited on
`1 1/12/2015)
`
`California State Board of Pharmacy, “2015 Lawbook for
`Pharmacy,” available at
`http://wwwpharrnacy.ca.gov/laWs_regs/lawbook.pdf (last Visited
`on 11/16/2015)
`
`TEVCOP01576526
`
`11/25/2015
`
`TEVCOPOI 575021—2
`
`1 11/25/2015
`
`TEVCOP01575029-327
`
`11/25/2015
`
`1
`
`Copaxone® Website, available at Www.copaXone.com (last Visited
`on 11/12/2015)
`
`TEVCOP01575459~60
`
`11/25/2015
`
`Copaxone® website, “3—TIl\/IES—A—WEEK COPAXONE® 40
`
`TEVCOP0157544962
`
`11/25/2015
`
`ACTIVE/84815693.]
`
`PETITIONERS' EXHIBIT NO. 1075 PAGE 2
`
`PETITIONERS' EXHIBIT NO. 1075 PAGE 2
`
`

`
`Brandon White, Esq.
`January 19, 2016
`Page 3
`
`MG,” available at www.copaxone.com/about—copaxone/copaXone—
`1 40-mg (last visited on 11/12/2015)
`
`11/18/2015)
`
`Copaxone® website, “COPAXONE® - A proven mix of efficacy,
`safety, and tolerability in relapsing forms of MS,” available at
`https://wwweopaxonehep.com/about-copaxone (last visited on
`i IMS Health, “Our Company,” available at
`httdpz//www.imshealth.com/en/aboutus/ our company (last visited on
`11/16/2015)
`
`vlllational Multiple Sclerosis Society, “Definition ofMS,” available
`at http://wwvwnationalmssociety.org/What-is—MS/Definitiorvof-MS
`(last visited on 11/12/2015)
`
`TEVCOP01575453-8
`
`1 1/25/2015
`
`1
`1
`1
`
`TEVCOP0157/5656-8
`
`1 1/25/2015
`
`TEVCOP0l576850-1
`
`12/4/2015
`
`National Multiple Sclerosis Society, “MS Symptoms,” available at
`http://wwwnationalmssocietyorg/Symptoms—Diagnosis/MS-
`Symptoms (last visited on 11/12/2015)
`
`TEVCOP01575891—5
`
`1 1/25/2015
`
`National Multiple Sclerosis Society, “The MS Disease~Modifying
`Medications,” January 2015, available at
`http://wwwnationalmssociety.org/clmd (last visited on 1 1/12/2015).
`
`TEVCOP01575896~912
`
`1 1/25/2015
`
`1
`
`1 1/25/2015
`
`National Multiple Sclerosis Society, “Types ofMS," available at
`http://wwwnationalmssoeiety.org/What-is—MS/Types~of-MS (last
`visited on 11/12/2015)
`
`TEVCOP01 5759136
`
`National Multiple Sclerosis Society, “What Is MS?” available at
`http://wwvwnationalmssociety.org/What—is—MS (last visited on
`11/12/2015).
`
`rSandoz, “GlatopaCareTM,” available at
`http2//glatopaeom/glatopa_care/index.shtml (last visited on
`1 1/12/2015)
`
`l Sandoz, “G1atopaCareTM: Co—Pay Program & Insurance and
`Benefits Investigation,” available at
`http://wwvvglatopa.com/g1atopa_care/financial_support.shtm1 (last
`visited on 11/12/2015)
`
`l Teva, “Doctor Discussion Guide,” available at
`https://www.copaxone.com/Resources/pdfs/DoctorDiscussionGuide
`.pdf (last visited on 1 1/12/2015)
`
`1 TEVCOP0157591/22
`
`1 1/25/2015
`
`’ TEVCOP015"/6230—l
`
`' 11/25/2015
`
`1
`
`TEVCOP01576228~9
`
`11/25/2015
`
`TEVCOP015”/6272-3
`
`1 1/25/2015
`
`Teva, “Informed Treatment Decision Brochure,” available at
`
`TEVCOP015'/6274-89
`
`1 1/25/2015
`
`AC'§'EVE/848156931
`
`PETITIONERS' EXHIBIT NO. 1075 PAGE 3
`
`PETITIONERS' EXHIBIT NO. 1075 PAGE 3
`
`

`
`1 1
`
`1
`
`Brandon White, Esq.
`January 19, 2016
`Page 4
`
`https://twvwcopaxonecom/Resources/pdfs/lnlbrmed Treatment D
`ecision Brochure.pdf(last visited on 1 1/12/2015)
`
`Teva, “Shared So1utions®,” available at
`https://wwwcopaxone.com/Resources/pdfs/Shared_Solutions__Broc
`hure.pdf(last Visited on 1 1/12/2015)
`
`TEVCOP01576290—3 13
`
`11/25/2015
`
`“Global BioPharmaceuticals: Game Changes in Multiple Sclerosis,” TE'\/COP0l574683—708
`Barciays, March 7, 2014
`
`1 1/25/2015
`
`TEVCOP01574605-12
`1 1/25/2015j
`TEVCOP01574788—95 ‘M111/25/2015
`
`TEVCOP01574605-12
`
`1 1/25/2015
`
`
`
`
`
`1
`
`“Global Biotechnology,” Credit Suisse, April 4, 2014
`
`“Global Biotechnology and Pharmaceuticals -— AAN 2014,” Credit
`Suisse, April 30, 2014
`
`
`“Multiple Sclerosis: lt’s a Revolution! (vs. Evolution),” Credit
`Suzme, December 12, 2013
`
`
`
`1
`
`“Spec Pharmaceuticals,” Morgan Stanley, March 3, 2014
`
`TEVCOPOI 574623-82
`
`1 1/25/2015
`
`“Teva,” /Vlorgcm Star:/ey, March 14, 2014
`
`TEVCOP01574709-39
`
`1 1/25/2015 1
`
`L7‘TeVa Pharmaceutical Industries Ltd. (TEVA),” Cizz‘, February
`L2014
`“Tei/a Pharmaceutical lndustries Ltd. (TEVA),” Cili,Ap
`
`Aubagio® label, October 17, 2014
`
`TEVCOP0157483"/-64
`
`11/25/2015
`
`Avonex® label, August 28, 2014
`
`TEVCOP01574892—951
`
`1 1/25/2015
`
`Betaseron® label, September 25, 2015
`1 Copaxone® label, January 28, 2014
`
`Extavia® label, August, 14, 2009
`
`I Gi1enya® label, August 4, 2015
`
`TEVCOP0l574976-5020
`TEVCOP0395789-820;
`
`TEVCOP01575418—48
`
`1 1/25/2015 ‘
`4/13/2015;
`
`11/25/2015
`
`TEVCOPOI575511-31
`
`11/25/2015
`
`TEVCOP01575563-86
`
`11/25/2015 1
`
`Glatopam label, April 16, 2015
`
`TEVCOP01575587-8
`
`11/25/2015
`
`1 Lemtrada® label, November 14, 2014
`} Novantrone® label, March 23, 2012
`
`TEVCOP01575780-814
`TEVCOP01575938—74
`
`1 1/25/2015
`11/25/2015
`
`AC'1‘1Vl3/84815693.l
`
`PETITIONERS' EXHIBIT NO. 1075 PAGE 4
`
`PETITIONERS' EXHIBIT NO. 1075 PAGE 4
`
`

`
`Brandon White, Esq.
`January 19, 2016
`Page 5
`
`P1egridy® label, August 15, 2014
`Rebif® label, March 10, 2015
`Tecfidera® label, December 3, 2014
`Tysabri® label, May 12, 2015
`US. Patent No. 8,377,885
`US. Patent No. 8,796,226
`IMS Data Cited in Ex. 2108-21 14 and 2120-2122
`
`TEVCOPO1576057-80
`TE\/COP01576105—23
`TEVCOP0l5762S5-71
`TEVCOP01576339—68
`1 TEVCOP01576381-406
`TEVCOP01576408—27
`TEVCOP01575659;
`
`TEVCOP01575660;
`TEVCOP01575734
`
`11/25/2015 i
`11/25/2015
`1 1/25/2015 f
`11/25/2015
`11/25/2015
`11/25/2015 1
`11/25/2015
`
`
`Moreover, Patent Owner authorizes Petitioners to use all of the above-referenced documents in Case
`Nos. 1PR2105—OO643, IPR2015~0()644 and IPR2015-00830, including to cross~exarnine Dr. Grabowski
`at his deposition on Thursday, January 21. As noted above, Petitioners have had all of the Grabowski
`reliance materials in their possession and have had ample opportunity to review and consider them in
`advance of Dr. Grabowski’s deposition.
`In addition, Dr. Grabows1<i’s positions and arguments relating
`to these documents are set forth in detail in his declaration which is an exhibit to this proceeding (EX.
`2133). Finally, Petitioners cannot claim any prejudice from the timing of Patent Owner’s motion
`because any delay in resolving this issue was caused by Petitioners, who failed to notify Patent Owner of
`this dispute until a week ago, despite the fact that they raised a number of other objections to evidence
`shortly after it was filed and served.
`
`Sincerely,
`
`
`
`Nicholas K. Mitrokostas
`
`cc: Counsel of record
`
`AC'E‘1VE/848156931
`
`PETITIONERS' EXHIBIT NO. 1075 PAGE 5
`
`PETITIONERS' EXHIBIT NO. 1075 PAGE 5