PUBLIC VERSION
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Paper _____
`
`Filed: January 12, 2018
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`ACRUX DDS PTY LTD., ACRUX LIMITED,
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`_______________
`
`Case IPR2017-001901
`Patent 7,214,506 B2
`_______________
`
`
`PETITIONERS’ REPLY IN SUPPORT OF THEIR MOTION TO
`EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`
`
`
`
`
`
`
`
`1 Case IPR2017-01429 has been joined with the instant proceeding.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Paper _____
`
`Filed: January 12, 2018
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`ACRUX DDS PTY LTD., ACRUX LIMITED,
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`_______________
`
`Case IPR2017-001901
`Patent 7,214,506 B2
`_______________
`
`
`PETITIONERS’ REPLY IN SUPPORT OF THEIR MOTION TO
`EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`
`
`
`
`
`
`
`
`1 Case IPR2017-01429 has been joined with the instant proceeding.
`
`
`
`
`
`
`
` PUBLIC VERSION Case IPR2017-00190
`Patent 7,214,506 B2
`
`
`TABLE OF CONTENTS
`
`
`
`TABLE OF AUTHORITIES .................................................................................... ii
`
`INTRODUCTION ........................................................................................... 1
`
`ARGUMENT ................................................................................................... 1
`
`A. Mr. Thomas’s Testimony Does Not Meet the Requirements
`of FRE 702 ............................................................................................ 1
`
`B.
`
`Exhibits 2093, 2095, 2098 and 2099 Should be Excluded ................... 4
`
`
`
`i
`
`I.
`
`II.
`
`
`
`
`
`
`
` PUBLIC VERSION Case IPR2017-00190
`Patent 7,214,506 B2
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`Advanced Med. Optics, Inc. v. Alcon Inc.,
`No. 03-1095, 2005 U.S. Dist. LEXIS 5803 (D. Del. Apr. 7, 2005) ....................... 3
`
`Allergan, Inc. v. Sandoz Inc.,
`818 F. Supp. 2d 974 (E.D. Tex. 2011) .................................................................... 2
`
`Ashland Hosp. Corp. v. Affiliated FM Ins. Co.,
`No. 11-16, 2013 U.S. Dist. LEXIS 88068 (E.D. Ken. June 24, 2013) ................... 2
`
`B/E Aero., Inc. v. C&D Zodiac, Inc.,
`No. 2016-1496, 2017 U.S. App. LEXIS 19106 (Fed. Cir. Oct. 3, 2017) ............... 1
`
`Captioncall, LLC v. Ultratec, Inc.,
`IPR2015-00637, Paper 98 (PTAB Sept. 7, 2016) ...............................................1, 2
`
`Liberty Mutual Ins. Co. v. Progressive Casualty Ins. Co.,
`CBM2012-00002, Paper 66 (PTAB Jan. 23, 2014) ................................................ 1
`
`Merck Sharp & Dohme Corp. v. Hospira, Inc.,
`874 F.3d 724 (Fed. Cir. 2017) ................................................................................ 4
`
`Mylan Pharms Inc. v. Yeda R&D Co., Ltd.,
`IPR2015-00643, Paper 90 (PTAB Dec. 2, 2016) ................................................... 5
`
`Mylan Pharms. Inc. v. Yeda R&D Co. Ltd.,
`IPR2015-00644, Paper 86 (PTAB Aug. 24, 2016) ................................................. 3
`
`Neb. Plastics, Inc. v. Holland Colors Ams., Inc.,
`408 F.3d 410 (8th Cir. 2005) .................................................................................. 2
`
`Prometheus Labs., Inc. v. Roxane Labs., Inc.,
`805 F.3d 1092 (Fed. Cir. 2015) .............................................................................. 3
`
`Torrent Pharms. Ltd. v. Novartis AG,
`IPR2014-00784, Paper 112 (PTAB Sept. 24, 2015) ............................................... 3
`
`
`
`
`
`
`
`ii
`
`
`
` PUBLIC VERSION Case IPR2017-00190
`Patent 7,214,506 B2
`
`
`Rules
`
`Federal Rule of Evidence 402 .................................................................................... 4
`
`Federal Rule of Evidence 702 ................................................................................2, 4
`
`Federal Rule of Evidence 803 .................................................................................... 5
`
`Federal Rule of Evidence 805 .................................................................................... 4
`
`Federal Rule of Evidence 1006 .................................................................................. 4
`
`
`
`iii
`
`
`
` PUBLIC VERSION Case IPR2017-00190
`Patent 7,214,506 B2
`
`
`I.
`
`INTRODUCTION
`
`Acrux DDS PTY Ltd., Acrux Limited, and Argentum Pharmaceuticals LLC
`
`(collectively, “Petitioners”) respectfully submit this Reply in further support of
`
`their Motion to Exclude (Paper No. 51, “Motion”). Patent Owner’s (“PO”)
`
`Opposition (Paper No. 70, “Opp.”) amounts to no more than an improper sur-
`
`reply2 that does not address the majority of arguments presented in the Motion and,
`
`for the reasons discussed in the Motion and below, the Motion should be granted.
`
`II. ARGUMENT
`
`A. Mr. Thomas’s Testimony Does Not Meet the Requirements of FRE 702
`Contrary to PO’s assertions, information relating to marketing strategies
`
`(and including Philidor Rx Services’s business practices) utilized to obtain the
`
`Jublia sales upon which Mr. Thomas relies is relevant to commercial success
`
`because “…not all marketplaces are equal, and… context matters.” Captioncall,
`
`LLC v. Ultratec, Inc., IPR2015-00637, Paper 98, 73 (PTAB Sept. 7, 2016)
`
`(citations omitted). See also, B/E Aero., Inc. v. C&D Zodiac, Inc., No. 2016-1496,
`
`2017 U.S. App. LEXIS 19106, at *15-16 (Fed. Cir. Oct. 3, 2017) (commercial
`
`2 The bulk of PO’s arguments are improper sur-reply. See Opp., 2-4, 6, 8, 9-11;
`
`Liberty Mutual Ins. Co. v. Progressive Casualty Ins. Co., CBM2012-00002, Paper
`
`66, 62 (PTAB Jan. 23, 2014). Petitioners disagree with these improper arguments,
`
`but will not respond to them here.
`
`
`
`1
`
`
`
` PUBLIC VERSION Case IPR2017-00190
`Patent 7,214,506 B2
`
`
`success evidence weak “without… contextual evidence”); Allergan, Inc. v. Sandoz
`
`Inc., 818 F. Supp. 2d 974, 1030 (E.D. Tex. 2011) (rev’d in part on other grounds)
`
`(commercial success evidence lacking in part because it relied on “gross sales
`
`figures without considering… development costs” and marketing incentives).
`
`Mr. Thomas did not consider the costs incurred to obtain Jublia’s alleged
`
`gross sales (Ex. 1507, 39:4-14) or Jublia’s average selling price (id., 36:11-37:16).
`
`He also failed to consider (or investigate) Philidor Rx Services’s inappropriate
`
`sales practices even though they are relevant here. Captioncall, LLC, IPR2015-
`
`00637, Paper 98, 80-82. “An expert opinion that fails to consider the relevant facts
`
`of the case is fundamentally unsupported” and inadmissible. Neb. Plastics, Inc. v.
`
`Holland Colors Ams., Inc., 408 F.3d 410, 416 (8th Cir. 2005). As Mr. Thomas
`
`ignored “inconvenient evidence,” his opinions should be excluded. Ashland Hosp.
`
`Corp. v. Affiliated FM Ins. Co., No. 11-16, 2013 U.S. Dist. LEXIS 88068, at *20
`
`(E.D. Ken. June 24, 2013); FRE 702.
`
`PO next mischaracterizes Petitioners’ argument as requiring that “Mr.
`
`Thomas… personally download data from IMS and Symphony Health…” Opp., 5-
`
`6. Instead, it is Petitioners’ position that Mr. Thomas’s opinions do not meet FRE
`
`702’s requirements because they are based wholly on information generated by
`
`Valeant and Kaken (Exs. 2093 and 2095) and he never performed his own analysis
`
`of it or even investigated whether it was complete or accurate. Motion, 5-7.
`
`
`
`2
`
`
`
` PUBLIC VERSION Case IPR2017-00190
`Patent 7,214,506 B2
`
`
`Advanced Med. Optics, Inc. v. Alcon Inc., No. 03-1095, 2005 U.S. Dist. LEXIS
`
`5803, at *36 (D. Del. Apr. 7, 2005) (expert testimony unreliable when based on
`
`“information… provided exclusively by… a party to the case”) (citation omitted).
`
`Moreover, Mr. Thomas never testified that “he considered [the drugs listed
`
`in the exhibits] suitable comparators” to Jublia (Opp., 6), but rather, that he “relied
`
`on Valeant's definition of the market” and did not perform his own analysis. Ex.
`
`1507, 30:11-12, 33:11-34:5, 72:8-10. In an attempt to rehabilitate Ex. 2093, PO
`
`asserts it “also included the raw Jublia prescription data prior to normalization.”
`
`Opp., 7. However, PO ignores that Mr. Thomas’s corresponding exhibit (Ex.
`
`2099)
`
`
`
`. Compare Ex. 2093 to Ex. 2099.
`
`Even Mr. Thomas admitted that, “to be consistent” all of the data should have been
`
`“normalized,” but does not know if it was or not. Ex. 1507, 48:2-9, 48:16-19,
`
`65:3-66:5. As the data he used to calculate Jublia’s market share “is biased toward
`
`more significant sales of” Jublia, his opinions are unreliable. Torrent Pharms. Ltd.
`
`v. Novartis AG, IPR2014-00784, Paper 112, 29 (PTAB Sept. 24, 2015).
`
`With respect to Mr. Thomas’s nexus opinions, PO never asserts marketing
`
`costs are not relevant, nor could it given the applicable law. Prometheus Labs.,
`
`Inc. v. Roxane Labs., Inc., 805 F.3d 1092, 1101 (Fed. Cir. 2015) (sales “due to…
`
`marketing… price… and… a series of rebates to stimulate sales…”); Mylan
`
`
`
`3
`
`REDACTED
`
`
`
` PUBLIC VERSION Case IPR2017-00190
`Patent 7,214,506 B2
`
`
`Pharms. Inc. v. Yeda R&D Co. Ltd., IPR2015-00644, Paper 86, 28-29 (PTAB Aug.
`
`24, 2016) (no nexus because PO did not account for a more favorable copay,
`
`rebates and discounts in its analysis). Rather, PO argues Mr. Thomas opined
`
`Jublia’s marketing spend was “reasonable” (Opp., 10) even though he never even
`
`requested the actual marketing spend. Ex. 1507, 53:16-56:1. As a result, Mr.
`
`Thomas’s alleged analysis on this point falls far short of FRE 702’s requirements.
`
`Rather than arguing Mr. Thomas’s failure to consider any patent aside from
`
`the ’506 patent in his nexus analysis does not warrant exclusion, PO faults
`
`Petitioners for not presenting its blocking patent argument in the Petition (Opp., 9)
`
`and cites to Merck Sharp & Dohme Corp. v. Hospira, Inc., 874 F.3d 724 (Fed. Cir.
`
`2017) - both points are blatant sur-reply. Petitioners are not arguing his opinions
`
`should be excluded because of the blocking patents argument itself, but, because
`
`he failed to consider if other Jublia patents would affect his nexus conclusions. His
`
`failure renders his nexus opinions unreliable and inadmissible. FRE 702.
`
`B. Exhibits 2093, 2095, 2098 and 2099 Should be Excluded
`Under FRE 1006, Ex. 2093 (and Mr. Thomas’s Ex. 2099) should be
`
`excluded since PO did not provide (or make available to Petitioners) the
`
`underlying Symphony Health data. PO claims that FRE 10063 “mandates… only
`
`3 PO’s assertions that Petitioners “failed to preserve” FRE 402, 805 and 1006
`
`objections (Opp., 11-12, 14-15) ignore that PO did not reveal the identity of Exs.
`
`
`
`4
`
`
`
` PUBLIC VERSION Case IPR2017-00190
`Patent 7,214,506 B2
`
`
`[the underlying document] is admissible” (Opp., 12-13), willfully ignoring that it
`
`also requires the underlying data be made available to the opposing party and that
`
`the summarized data be accurate and non-prejudicial. Mylan Pharms Inc. v. Yeda
`
`R&D Co., Ltd., IPR2015-00643, Paper 90, 38 (PTAB Dec. 2, 2016). Neither of
`
`these requirements has been met. Motion, n. 6; supra, 3.
`
`PO’s argument that its evidentiary declarations cure objections to Exs. 2093
`
`and 2095 (Opp., 13-14) ignores that no testimony was provided to establish how,
`
`when or why the specific information was selected from the underlying data,
`
`, then included in the exhibits. See Exs. 1661; 1664. PO
`
`concedes Ex. 2095 is not a business record because it was created for this
`
`proceeding (Opp., 14). Ex. 2093 also does not qualify as a business record because
`
`the declarant did not testify he generated the document in January 2017. Ex. 1661,
`
`¶ 2. Exs. 2093 and 2095 do not qualify under FRE 803(17) or FRE 803(18)
`
`because they are not themselves qualifying documents, but, at best, are selective
`
`summaries of them. For all of these reasons, and those in the Motion, ¶¶ 9-11 and
`
`20-30 of Ex. 2028, Exs. 2093, 2095, 2098 and 2099 should be excluded.
`
`
`2093 and 2095 or the relationship between the exhibits until after Petitioners’
`
`objections were due. Motion, n.6; Ex. 1666, 2. Thus, it is disingenuous to fault
`
`Petitioners for not lodging objections they could not have known were proper.
`
`
`
`5
`
`REDACTED
`
`
`
` PUBLIC VERSION Case IPR2017-00190
`Patent 7,214,506 B2
`
`
`
`
`
`
`Date: January 12, 2018
`
`
`
`
`
`
`
`
`
`
`
`By:
`
`Respectfully submitted,
`
` /E. Anthony Figg/
`E. Anthony Figg, Reg. No. 27,195
`Counsel for Acrux DDS Pty Ltd
`and Acrux Limited
`
`
` /Shannon M. Lentz/
`By:
`Shannon M. Lentz, Reg. No. 65,382
`
` Counsel for Argentum Pharmaceuticals LLC
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`6
`
`
`
` PUBLIC VERSION Case IPR2017-00190
`Patent 7,214,506 B2
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing PETITIONERS’
`
`REPLY IN SUPPORT OF THEIR MOTION TO EXCLUDE UNDER 37
`C.F.R. § 42.64(c) was served electronically via email on January 12, 2018, in its
`entirety on the following:
`
`
`John D. Livingstone
`john.livingstone@finnegan.com
`KakenIPR@finnegan.com
`Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
`271 17th Street, N.W., Suite 1400
`Atlanta, GA 30363-6209
`
`Naoki Yoshida
`naoki.yoshida@finnegan.com
`Anthony Hartmann
`anthony.hartmann@finnegan.com
`Barbara R. Rudolph, Ph.D.
`barbara.rudolph@finnegan.com
`Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
`901 New York Ave., N.W.
`Washington, DC 20001-4413
`
`Toan P. Vo
`toan.vo@bausch.com
`Valeant Pharmaceuticals North America LLC
`1400 N. Goodman Street
`Rochester, NY 14609
`
`Teresa Stanek Rea
`TRea@Crowell.com
`Shannon M. Lentz
`SLentz@Crowell.com
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Ave, NW
`Washington, DC 20004-2595
`
`
`
`
`7
`
`
`
` PUBLIC VERSION Case IPR2017-00190
`Patent 7,214,506 B2
`
`
`
`Tyler C. Liu
`TLiu@agpharm.com
`Argentum Pharmaceuticals, LLC
`
`
`
`
`/E. Anthony Figg/
`E. Anthony Figg, Reg. No. 27,195
`Aydin H. Harston, Reg. No. 65,249
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`607 14th St., N.W., Suite 800
`Washington, DC 20005
`Phone: 202-783-6040 | Fax: 202-783-6031
`
`
`
`By:
`
`
`
`
`
`
`
`
`
` Counsel for Acrux DDS Pty Ltd
`
`
`and Acrux Limited
`
`8
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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
