UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC. and
`AMNEAL PHARMACEUTICALS LLC
`
`Petitioners
`
`v.
`
`YEDA RESEARCH AND DEVELOPMENT CO. LTD.
`
`Patent Owner
`
`Case IPR2015-00643 (Patent 8,232,250 B2)
`Case IPR2015-00644 (Patent 8,399,413 B2)
`Case IPR2015-00830 (Patent 8,969,302 B2)1,2
`
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1 The word-for-word identical paper is filed in each proceeding identified in the
`
`caption.
`
`2 Cases IPR2015-01976, IPR2015-01980, and IPR2015-01981 have been joined
`
`with IPR2015-00643, IPR2015-00644, and IPR2015-00830, respectively.
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC. and
`AMNEAL PHARMACEUTICALS LLC
`
`Petitioners
`
`v.
`
`YEDA RESEARCH AND DEVELOPMENT CO. LTD.
`
`Patent Owner
`
`Case IPR2015-00643 (Patent 8,232,250 B2)
`Case IPR2015-00644 (Patent 8,399,413 B2)
`Case IPR2015-00830 (Patent 8,969,302 B2)1,2
`
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1 The word-for-word identical paper is filed in each proceeding identified in the
`
`caption.
`
`2 Cases IPR2015-01976, IPR2015-01980, and IPR2015-01981 have been joined
`
`with IPR2015-00643, IPR2015-00644, and IPR2015-00830, respectively.
`
`
`
`
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(c) and Section II.K of the Office Patent Trial
`
`Practice Guide, Patent Owner Yeda Research and Development Co. (“Yeda” or
`
`“Patent Owner”) hereby moves to exclude Exhibits 1068, 1086, 1089, 1098, and
`
`1140 submitted by Petitioners Mylan Pharmaceuticals Inc. and Amneal
`
`Pharmaceuticals LLC (“Petitioners”).
`
`I.
`
`Statement of Precise Relief Requested
`
`Patent Owner seeks to exclude Petitioners’ Exhibits 1068, 1086, 1089, 1098,
`
`and 1140. See 37 C.F.R. § 42.22(a)(1).
`
`Exhibit 1068 is a copy of a 2009 abstract by O. Khan et al., entitled
`
`Glatiramer acetate 20mg subcutaneous twice-weekly versus daily injections:
`
`results of a pilot, prospective, randomised, and rater-blinded clinical and MRI 2-
`
`year study in relapsing-remitting multiple sclerosis, published in MULTIPLE
`
`SCLEROSIS. Petitioners refer to this abstract as “Khan 2009.”
`
`Exhibit 1086 is a printout from the Shared Solutions® website sponsored by
`
`Teva Neuroscience, Inc., which provides online resources and support for
`
`Copaxone® users.
`
`Exhibit 1089 is a copy of a 2009 abstract by O. Khan et al., entitled
`
`Glatiramer acetate 20mg subcutaneous twice-weekly versus daily injections:
`
`results of a pilot, prospective, randomised, and rater-blinded clinical and MRI 2-
`
`
`
`1
`
`
`
`
`
`year study in relapsing-remitting multiple sclerosis, published in MULTIPLE
`
`SCLEROSIS. It is the same abstract identified in Exhibit 1068.3
`
`Exhibit 1098 is a copy of a 2012 article by Lauren LeBano entitled Gray
`
`Matter Atrophy in Multiple Sclerosis: A Longitudinal Study, published in ANNALS
`
`OF NEUROLOGY.
`
`Exhibit 1140 is the redacted transcript of the February 15, 2016 deposition
`
`of Jerry S. Wolinsky, M.D., in connection with the consolidated, related district
`
`court litigation, In re Copaxone 40 mg, Case No. 14-1171-GMS (D. Del.)
`
`(“Wolinsky Deposition Transcript”).
`
`II. Evidence Relied Upon In Support Of This Motion
`
`The evidence relied upon in support of this motion includes: (1) Petitioners’
`
`Reply filed on March 9, 2015 (IPR2015-00643, Paper 58 (“Petitioners’ Reply”));
`
`(2) Patent Owner’s Objections to Evidence Pursuant to 37 C.F.R. § 42.64, filed
`
`March 16, 2016 (id. at Paper 64); (3) the Expert Report of Ari Green, M.D. In
`
`Support Of Petitioner’s Reply To Patent Owner’s Response (Exhibit 1085, or the
`
`“Green Reply Report”); and (4) the transcript of the April 6, 2016 deposition of Ari
`
`Green, M.D. (Exhibit 1142).
`
`
`
`
`3 Exhibit 1068 is the deposition copy of Khan 2009, used in the Deposition of
`
`Edward J. Fox, M.D. (see Ex. 2146 at 86:10-23).
`
`
`
`
`2
`
`
`
`
`
`III.
`
`Identification Of Original Objections
`
`Patent Owner timely objected to Exhibits 1068, 1086, 1089, and 1098 on
`
`March 16, 2016. IPR2015-00643, Paper 64 at ¶¶ 2, 16, 19, 28; see 37 C.F.R.
`
`§ 42.64(b)(1). In its timely-filed objections, Patent Owner maintained that
`
`Exhibits 1068, 1086, 1089, and 1098 were, inter alia, dated after August 20, 2009,
`
`and thus irrelevant under Federal Rules of Evidence (“FRE”) 402 and 403 to the
`
`extent they were relied upon for any teaching prior to August 20, 2009. The
`
`Petitioner did not respond, with supplemental evidence or otherwise, to these
`
`objections.
`
`Petitioners introduced Exhibit 1140 during the deposition of their own
`
`expert, Dr. Ari Green. Exhibit 1142 at 396:12-16. Patent Owner timely objected
`
`to Exhibit 1140 during the deposition as not being part of the record of the
`
`proceeding and outside the scope of Dr. Green’s opinion and Mylan’s Reply.
`
`Exhibit 1142 at 396:6-10 (“Before you ask any further questions, I want to object
`
`to this document being offered. It’s not part of the record in this proceeding. So I
`
`just object to any testimony on the document.”); see also id. at 396:23-397:7. The
`
`Petitioners did not provide evidence to cure this objection at the deposition, as
`
`required by 37 C.F.R. § 42.64(a).
`
`3
`
`
`
`
`
`
`
`
`
`
`IV.
`
`Identification Of Where Evidence Was Relied Upon By Petitioner
`
`Petitioners cite to Exhibits 1068/1089, the 2009 abstract authored by O.
`
`Khan, on pages 17-18 of the Green Reply Report. See Exhibit 1085 at ¶ 32. The
`
`abstract is cited in support of the following assertions made in the Green Reply
`
`Report: “[B]efore the priority date, POSAs had completed a clinical trial
`
`investigating 20 mg administered twice weekly, for a total weekly dose of only 40
`
`mg” and “Although the results suggesting that 20 mg administered twice weekly is
`
`safe, efficacious, and well-tolerated were not officially published until three weeks
`
`after the priority date, [Exhibit 1068/1089] demonstrates that—counter to what
`
`Patent Owner claims—POSAs were motivated before the priority date to explore
`
`less frequent alternative dosing regimens.” Id. This portion of the Green Reply
`
`Report is cited by Petitioners on Pages 9 and 13-14 of the Petitioners’ Reply, in
`
`support of the following statements: “As of 2009, the prior art expressly taught that
`
`less frequent administration of GA was efficacious, and further development was
`
`warranted” (Page 9); “And for the greatest expectation of success, a POSA would
`
`choose a total weekly dose (120 mg) comparable to the known 20 mg daily
`
`regimen (140 mg)” (Pages 13-14); and “[An 80 hour] half-life is consistent with
`
`the clinical data, which suggests that less frequent dosing may be efficacious”
`
`(Page 14).
`
`
`
`
`4
`
`
`
`
`
`Petitioners cite to Exhibit 1086, the web printout from Teva’s ‘Shared
`
`Solutions’ website, on page 9 of the Green Reply Report. See Exhibit 1085 at ¶19.
`
`The abstract is cited in support of the following assertions made in the Green
`
`Reply Report: “GA has long been known to be a forgiving drug, meaning that
`
`some variability in patient compliance will not sacrifice GA’s efficacy, safety, or
`
`tolerability… For example, Teva instructs patients to skip a missed dose rather
`
`than take a double dose, indicating that the therapy’s efficacy will not suffer from
`
`isolated adherence failures.” Id. This portion of the Green Reply Report is cited by
`
`Petitioners on Pages 9, 10, and 14 of the Petitioners’ Reply, in support of the
`
`following statements: “40 mg TIW administration of GA fell precisely in the
`
`middle of a range of doses known in the prior art to be efficacious” (Page 9); “GA
`
`was also well known to be forgiving, meaning occasional missed doses do not
`
`impact efficacy” (Page 10); “Therefore, for a POSA looking to develop a less
`
`frequently administered GA dosing regimen, 40 mg TIW was an obvious choice.”
`
`(Page 10); “And for the greatest expectation of success, a POSA would choose a
`
`total weekly dose (120 mg) comparable to the known 20 mg daily regimen (140
`
`mg)” (Pages 13-14); and “[An 80 hour] half-life is consistent with the clinical data,
`
`which suggests that less frequent dosing may be efficacious” (Page 14).
`
`Petitioners cite to Exhibit 1098, the 2012 article authored by Lauren
`
`LeBano, on pages 64-65 of the Green Reply Report. See Exhibit 1085 at ¶ 96.
`
`
`
`
`5
`
`
`
`
`
`The abstract is cited in support of the following assertions made in the Green
`
`Reply Report: “Before recent improvements in software used to analyze MRI
`
`output, such as introduction of the FreeSurfer software, it was difficult and time
`
`consuming to routinely study gray matter atrophy (as opposed to whole brain
`
`atrophy as measured by brain volume) requiring MRI acquisition capabilities and
`
`post processing analytical capability that were expensive and difficult to deploy in
`
`a multicenter clinical trial.” Id. This portion of the Green Reply Report is cited by
`
`Petitioners on Page 20 of the Petitioners’ Reply, in support of the following
`
`statement: “Finally, as Dr. Green explains, the GALA extension trial finding that
`
`GA slows gray matter brain atrophy was not unexpected.”
`
`Petitioners have not cited to Exhibit 1140 in either its Petition or in its
`
`Reply. Nor do Petitioners cite to Exhibit 1140 in the Green Reply Report.
`
`V. Objections And Explanation Thereof
`
`Exhibits 1068, 1086, 1089, 1098, and 1140 should be excluded for at least
`
`the following reasons.
`
`A. Exhibits 1068/1089 Should Be Excluded Under FRE 402/403
`Petitioners have submitted copies of an abstract by O. Khan et al. as Exhibits
`
`1068 and 1089. Petitioners attempt to use this abstract to prove the state of the art
`
`prior to August 20, 2009 (the shared priority date of the three patents in these
`
`proceedings). Ex. 1085 at ¶ 32 (“Although the results…were not officially
`
`
`
`
`6
`
`
`
`
`
`published until… after the priority date, the Khan 2009 reference demonstrates
`
`that…POSAs were motivated before the priority date to explore less frequent
`
`alternative dosing regimens” (emphasis added)). The Petitioners have not directly
`
`cited to these Exhibits for any other purpose. See supra at IV. Accordingly,
`
`because Petitioners have exclusively used a document that is not prior art and is
`
`dated after August 20, 2009, to establish a purported teaching prior to August 20,
`
`2009, Petitioners’ Exhibits 1068 and 1089 should be excluded as irrelevant.
`
`Further, any possible probative value of Exhibits 1068 and 1089 is substantially
`
`outweighed by a danger of confusing the issues and wasting time.
`
`Exhibit 1086 Should Be Excluded Under FRE 402/403
`
`B.
`Petitioners have submitted a 2016 printout from Teva’s ‘Shared Solutions’
`
`website, which provides online resources and assistance for Copaxone® users, as
`
`Exhibit 1086. Petitioners use this web printout to assert in the Green Reply Report
`
`that “GA has long been known to be a forgiving drug[.]” Ex. 1085 at ¶ 19 (“GA
`
`has long been known to be a forgiving drug, meaning that some variability in
`
`patient compliance will not sacrifice GA’s efficacy, safety, or tolerability. See, e.g.,
`
`Ex. 1004 ¶ 33. For example, Teva instructs patients to skip a missed dose rather
`
`than take a double dose, indicating that the therapy’s efficacy will not suffer from
`
`isolated adherence failures.”). The Petitioners have not directly cited to this
`
`Exhibit for any other purpose. See supra at IV. Accordingly, because Petitioners
`
`
`
`
`7
`
`
`
`
`
`have exclusively used this exhibit, that is not prior art and is dated after August 20,
`
`2009, to establish a purported teaching prior to August 20, 2009, Petitioners’
`
`Exhibit 1086 should be excluded as irrelevant. Further, any possible probative
`
`value of Exhibit 1086 is substantially outweighed by a danger of confusing the
`
`issues and wasting time.
`
`C. Exhibit 1098 Should Be Excluded Under FRE 402/403
`Petitioners have submitted a copy of a 2012 article by Lauren LeBano as
`
`Exhibit 1098. Petitioners, again, have attempted to use this article to prove the
`
`state of the art prior to August 20, 2009. Ex. 1085 at ¶ 96 (“Before recent
`
`improvements in software used to analyze MRI output… it was difficult and time
`
`consuming to routinely study gray matter atrophy…”). The Petitioners have not
`
`directly cited to this Exhibit for any other purpose. See supra at IV. Accordingly,
`
`because Petitioners have exclusively used an article that is not prior art and is dated
`
`after August 20, 2009 for a teaching prior to August 20, 2009, Petitioners’ Exhibit
`
`1098 should be excluded as irrelevant. Further, any possible probative value of
`
`Exhibit 1098 is substantially outweighed by a danger of confusing the issues and
`
`wasting time.
`
`
`
`
`
`
`8
`
`
`
`
`
`D. Exhibit 1140 Should Be Excluded Because It Is Outside The Scope
`Of Mylan’s Reply And Was Not Properly Introduced Into The
`Record.
`
`On April 12, 2016, Petitioners filed new Exhibit 1140 concurrently with the
`
`transcript of the April 6, 2016 deposition of Ari Green, M.D. Exhibit 1140, the
`
`Wolinsky Deposition Transcript from a co-pending district court litigation, was
`
`introduced by Petitioners during redirect examination they conducted of their
`
`expert, Dr. Green, at the conclusion of his deposition. This examination did not
`
`respond to any questioning conducted by Patent Owner and was merely intended
`
`as an improper bootstrap to submit Exhibit 1140. As noted supra, Petitioners did
`
`not cite to this exhibit in their Reply, nor did Petitioners cite to Exhibit 1140 in the
`
`Green Reply Report. Nor have Petitioners sought any relief from the Board to
`
`submit this document as supplemental evidence under 37 C.F.R. § 42.123(b).
`
`Instead, Petitioners chose to shoehorn this exhibit into the deposition of their own
`
`expert after filing their Reply. Exhibit 1140 should be excluded because (a) it is
`
`outside the scope of Mylan’s reply evidence, (b) was improperly introduced during
`
`the Green deposition despite being outside the scope of Patent Owner’s
`
`questioning, and (c) Mylan has not sought permission to submit the document as
`
`supplemental evidence under 37 C.F.R. § 42.123(b), as the rules require.
`
`9
`
`
`
`
`
`
`
`
`
`
`VI. Conclusion
`
`For at least the foregoing reasons, Patent Owner respectfully requests that
`
`this motion be granted and that Petitioners’ Exhibits 1068, 1086, 1089, 1098, and
`
`1140 be excluded.
`
`
`Dated: April 13, 2016
`
`
`
`
`
`
`Respectfully submitted,
`
`/Elizabeth J. Holland/
`Elizabeth J. Holland
`Registration No. 47,657
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10019-1405
`Tel: 212-813-8800
`Fax: 212-355-3333
`
`
`
`
`10
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that I caused the PATENT OWNER’S
`
`MOTION TO EXCLUDE EVIDENCE to be served electronically via e-mail on
`
`April 13, 2016 on the following:
`
`Jeffrey W. Guise
`
`jguise@wsgr.com
`
`Brandon M. White
`
`BMWhite@perkinscoie.com
`
`Shannon Bloodworth
`
`sbloodworth@perkinscoie.com
`
`David Anstaett
`
`DAnstaett@perkinscoie.com
`
`Richard Torczon
`
`rtorczon@wsgr.com
`
`Vince Capuano
`
`vcapuano@duanemorris.com
`
`Christopher Kroon
`
`CSKroon@duanemorris.com
`
`/April E. Weisbruch/
`April E. Weisbruch
`
`Dated:
`
`April 13, 2016
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
