UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.
`Petitioner
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`v.
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`QUALICAPS CO. LTD.
`Patent Owner
`
`Case IPR2017-00203
`Patent No. 6,649,180
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`PETITIONER MYLAN PHARMACEUTICALS INC.’S MOTION FOR
`ADDITIONAL DISCOVERY UNDER 37 C.F.R. § 42.51(b)(2)
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`MYLAN PHARMACEUTICALS INC.
`Petitioner
`
`v.
`
`QUALICAPS CO. LTD.
`Patent Owner
`
`Case IPR2017-00203
`Patent No. 6,649,180
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`
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`PETITIONER MYLAN PHARMACEUTICALS INC.’S MOTION FOR
`ADDITIONAL DISCOVERY UNDER 37 C.F.R. § 42.51(b)(2)
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`Petitioner Mylan Pharmaceuticals Inc. (“Petitioner”) submits this Motion for
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`Additional Discovery under 37 C.F.R. 42.51(b)(2), requesting the deposition of
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`Mr. Masaru Tanjoh, whose Declaration Patent Owner relied on in its Response.
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`Petitioner also seeks production of all documents in Patent Owner and/or Mr.
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`Tanjoh’s possession, custody, or control, supporting or refuting Patent Owner’s
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`assertion that the invention of the U.S. Patent 6,649,180 (“the ‘180 patent”) yielded
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`unexpected results. Because Mr. Tanjoh has been deposed, and Patent Owner has
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`offered some, but not all of his deposition for use here in lieu of the Board ordering
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`his deposition, Petitioner would alternatively request the Board simply order Patent
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`Owner produce the entirety of the deposition with exhibits including any portion or
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`document marked confidential. An extremely unburdensome request.
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`I.
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`BACKGROUND
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`In Patent Owner’s Response (Paper 26), Patent Owner argues that Petitioner
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`has not rebutted Patent Owner’s evidence of secondary considerations of non-
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`obviousness—namely, unexpected results. (Id. at pp. 28-37.) Patent Owner
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`alleges the challenged claims of the ‘180 patent “reflect the inventors’ surprising
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`discovery that controlling the degree of HPO/MO substitution in HPMC more
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`stringently than that required by the pharmacopeia results in capsules whose
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`appearance does not deteriorate after prolonged storage.” (Paper 26 at 28-29
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`(citing Declaration of Jason T. McConville, Ex. 2028, at ¶ 94; Ex. 1001 at 6:15-
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`1
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`28.) In support of this argument, Patent Owner and its expert, Dr. McConville,
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`point to a declaration submitted by Mr. Tanjoh during prosecution of the ‘180
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`patent. (See Paper 26 at pp. 31-37; Ex. 2028 at ¶ 99-100 (citing Tanjoh
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`Declaration (Ex. 1010 at 105-108)).) In this declaration, Mr. Tanjoh asserts, in
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`relevant part, that “controlling the total content of methoxyl and hydroxypropoxyl
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`groups in the hydroxypropoxyl methyl cellulose to 23-37.6 is effective for
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`preventing the gelling aid from precipitating on the capsule surface.” Ex. 1010 at
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`107. Dr. McConville asserts that the importance of the claimed ranges is
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`confirmed by Mr. Tanjoh’s prosecution history declaration. (Ex. 2028 at ¶ 99-100
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`(citing ’180 patent at 5:26 to 6:20; Tanjoh Declaration at 106–7).) He concludes
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`that “the POSA would have found this result surprising an unexpected . . . .” (Id.)
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`Given Patent Owner and Dr. McConville’s reliance on Mr. Tanjoh’s
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`declaration to support their critical secondary considerations case, Petitioner
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`requested Patent Owner present Mr. Tanjoh for cross-examination. (See July 25,
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`2017 Email from Jonathan Olinger, attached hereto as Ex. 1021). Patent Owner
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`has refused to produce Mr. Tanjoh for deposition and has not provided the basis for
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`its refusal. (See August 4, 2017 Email from Jessica Parezo, attached hereto as Ex.
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`1022.) Patent Owner, however, has offered to consent to using the Mr. Tanjoh’s
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`March 2017 deposition testimony from the related litigation (Civil Action Nos.
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`2:15-cv-1471; 2:15-cv-1740 (E.D. Tex.)) in this proceeding, but has refused to
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`2
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`permit the filing of those deposition exhibits marked “Restricted-Attorney’s Eyes
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`Only.” (See August 10, 2017 Email from Jessica Parezo, attached hereto as Ex.
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`1023.) Petitioner requested a conference with the Board on August 3, 2017, and
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`received authority to file the instant motion that same day.
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`II. LEGAL STANDARD
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`37 C.F.R. § 42.51 provides that “[w]here the parties fail to agree [to
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`additional discovery], a party may move for additional discovery. The moving
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`party must show that such additional discovery is in the interests of justice.” The
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`Board has provided the following five factors for such analysis: (Factor 1) whether
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`there is more than a possibility and mere allegation that something useful will be
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`uncovered; (Factor 2) whether the requested discovery seeks litigation positions
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`and underlying basis; (Factor 3); whether the requesting party has the ability to
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`generate equivalent information by other means; (Factor 4) whether the requested
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`discovery is easily understandable; (Factor 5) and, whether the requested discovery
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`is not overly burdensome. See Garmin Int’l Inc. et al. v. Cuozzo Speed Techs.
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`LLC, Case IPR2012-00001, Paper 26 (PTAB March 5, 2013).
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`Petitioner submits that all five Garmin factors support granting the relief.
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`III. ARGUMENT
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`A.
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`There is more than a Mere Possibility that Something Useful will
`be Uncovered from Mr. Tanjoh’s Deposition and Related
`Documents Will Result in Useful Information
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`3
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`As discussed, Patent Owner and Dr. McConville rely on Mr. Tanjoh’s
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`declaration as evidence of the surprising and “unexpected results” of the claimed
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`invention in an effort to outweigh the prima facie case of obviousness from
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`overlapping ranges. (See Paper 26 at pp. 31-37; Ex. 2028 at ¶¶ 99-100 (citing
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`Tanjoh Declaration (Ex. 1010 at 105-108)).) Because the patent claims an upper
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`bound of 37.6%, which is within the prior art’s range of substitution, the surprising
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`or unexpected result of the narrowed range must be supported by evidence of the
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`criticality of the bound and not simply that the bound represents a matter of mere
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`degree. Thus, the inventor’s self-serving testimony that the claim possesses
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`surprising or unexpected import would properly be tested with cross-examination
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`testimony concerning if and to what extent testing existed to show the critical
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`nature of the range boundaries, including evidence that no such evidence exists.
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`This is the type of examination needed to weigh, much less credit, ex parte, self-
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`serving assertions of “objective” indicia of non-obviousness.
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`Further, secondary considerations were at issue in the district court
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`litigation. There, pursuant to Federal Rule of Civil Procedure 30(b)(6), Petitioner
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`served a notice on Patent Owner for a witness to testify regarding “[s]econdary
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`considerations or objective indicia of non-obviousness, if any, relating to the
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`patent-in-suit, including, but not limited to . . . unexpected results.” (See Amended
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`30(b)(6) Notice to Qualicaps, attached as Ex. 1024). Patent Owner designated Mr.
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`4
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`Tanjoh, undoubtedly within Patent Owner’s control, to testify on this topic. (See
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`March 21, 2017 Email from Kennedy, excerpts attached hereto as Ex. 1025.) This
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`shows Mr. Tanjoh is viewed by Patent Owner as having useful testimony on this
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`matter. Due to Patent Owner’s designation of certain testimony from Mr. Tanjoh’s
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`deposition as Confidential, Restricted-Attorneys’ Eyes Only, and Restricted—
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`Outside Attorney’s Eyes Only, Petitioner cannot comment on the content of the
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`deposition testimony. (See April 25, 2017 Email from Kathyrn Bi, excerpts
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`attached hereto as Ex. 1026.) Patent Owner should not be permitted to hide behind
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`its confidentiality designations to suggest otherwise.
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`Given the nature of examination needed to determine the weight and
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`measure of the declarant’s assertions of surprising or unexpected results, such
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`testimony could be procured either from requiring Mr. Tanjoh to sit for deposition
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`with documents related to his experimentation or an order requiring production of
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`the complete deposition transcript including testimony and documents designated
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`confidential by Patent Owner.
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`B.
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`Petitioner Does Not Seek Patent Owner’s Litigation Positions and
`the Underlying Basis for Those Positions
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`Petitioner and Patent Owner have already exchanged expert reports
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`regarding invalidity and completed expert discovery in the district court litigation.
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`(See May 19, 2017 Amended Docket Control Order, attached hereto as Ex. 1027.)
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`Thus, Petitioner already has Patent Owner’s litigation positions on invalidity.
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`5
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`C.
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`Petitioner does not have the Opportunity to Generate Complete,
`Equivalent Information by Other Means
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`Although Petitioner has had the opportunity to depose Mr. Tanjoh in the
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`related district court litigation, given Patent Owner’s position that exhibits marked
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`as Restricted - Attorneys’ Eyes Only cannot be submitted with the deposition
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`transcript, the deposition transcript would be incomplete. Patent Owner’s position
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`in this case is not to rebut the prima facie case of obviousness, but rather to rely on
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`secondary considerations by showing unexpected results via the inventor’s
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`declaration, which is addressed in the deposition transcript and exhibits thereto.
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`Given the specific Ground instituted in this Petition and Patent Owner’s position,
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`the Board cannot fully evaluate the issues without a complete record on this issue.
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`The Congressional mandate for inter partes Review limited discovery “to
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`evidence directly related to factual assertions advanced by either party.” Senate
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`Debate – 157 Cong. Rec. S1360-S1394, at S1376. The testimony and supporting
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`documentary evidence concerning the inventors work that ultimately led to the
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`patent-at-issue, and serves as the Patent Owner’s only evidence of secondary
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`considerations to the prima facie case of obviousness based on overlapping ranges,
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`is thus directly related to Patent Owner’s factual assertions. As such, the
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`foundation, context, and facts underlying Mr. Tanjoh’s Declaration easily could be
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`made available in these proceedings via deposition or production of Mr. Tanjoh’s
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`deposition from the district court litigation. Without a complete record, the Board
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`6
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`cannot evaluate the conviction and credibility of Mr. Tanjoh’s evidence of
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`unexpected results versus its bald, prosecution-inspired assertion. Thus, unless
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`Patent Owner produces Mr. Tanjoh for cross-examination in this case and produces
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`the documents supporting its assertion of unexpected results, Petitioner cannot
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`generate complete, equivalent information by other means.
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`D.
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`Petitioner’s Request Is Easily Understandable
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`Petitioner requests (1) the deposition of Mr. Tanjoh regarding statements
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`made in his declaration submitted during prosecution of the ‘180 patent; and (2) all
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`documents in Patent Owner and/or Mr. Tanjoh’s possession, custody, or control
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`that support or refute its assertion of unexpected results. The fact that Patent
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`Owner can understand such requests is supported by the fact that Patent Owner
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`responded to similar requests in the underlying district court litigation and offered
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`Mr. Tanjoh’s deposition from the district court litigation for use in this matter with
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`eviscerating and truth shielding restrictions.
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`E.
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`Petitioner’s Requests Are Not Overly Burdensome to Answer
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`Although Petitioner understands that Mr. Tanjoh lives in Japan, Patent
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`Owner has already produced him for deposition in the related district court
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`litigation in the United States. If truly a burden, the Board need only order
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`production of the complete, unrestricted district court deposition and exhibits.
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`Thus, Patent Owner cannot contend that the request now is overly burdensome.
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`7
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`Dated: August 11, 2017
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`Respectfully submitted,
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`Lead Counsel
`Mitchell G. Stockwell
`Reg. No. 39,389
`mstockwell@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton
`LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
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`By: s/Mitchell G. Stockwell
`Mitchell G. Stockwell
`Registration No. 39,389
`Lead Counsel for Petitioner
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`
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`Back-Up Counsel
`D. Clay Holloway
`Reg. No. 58,011
`cholloway@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
`
`Jonathan D. Olinger (pro hac vice)
`jolinger@killpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
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`8
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that on August 11, 2017 a copy of the
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`foregoing Petitioner Mylan Pharmaceuticals Inc.’s Objections to Patent Owner’s
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`Evidence Pursuant to 37 C.F.R. § 42.64 was served by electronic mail by
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`agreement of the parties on the following counsel of record for Patent Owner.
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`Jessica L. Parezo (jparezo@cov.com)
`Andrea G. Reister( areister@cov.com)
`Scott E. Kamholz (skamholz@cov.com)
`Michael N. Kennedy (mkennedy@cov.com)
`Megan P. Keane (mkeane@cov.com)
`Covington & Burling LLP
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
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`MaryAnne Armstrong (maa@bskb.com)
`Lynde F. Herzbach (lynde.herzbach@bskb.com)
`Birch, Stewart, Kolasch & Birch, LLP
`8110 Gatehouse Road, Suite 100 East
`Falls Church, VA 22042
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`Dated: August 11, 2017
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`By: s/Mitchell G. Stockwell
`Mitchell G. Stockwell
`Registration No. 39,389
`Lead Counsel for Petitioner
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`9
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