UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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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 RESPONSE TO
`PATENT OWNER’S IDENTIFICATION OF NEW ARGUMENTS
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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
`
`
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S RESPONSE TO
`PATENT OWNER’S IDENTIFICATION OF NEW ARGUMENTS
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`Patent Owner’s Request Fundamentally Ignores the Burden of
`Producing Evidence Associated with Alleging Unexpected Results.
`While the ultimate burden of persuasion on establishing invalidity lies with
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`I.
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`Petitioner, the initial burden of production on secondary considerations, and with
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`that nexus, lies with Patent Owner. J Squared, Inc. v. Sauder Mfg. Co., 2016 WL
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`3541199, *16 (PTAB Jun. 27, 2016) (“The burden of showing that there is a nexus
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`lies with the patent owner.”). Producing evidence of nexus in this proceeding is a
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`prerequisite for Patent Owner to argue any secondary considerations outweighs the
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`prima facie case, where the burden of persuasion lies with Petitioner. Petroleum
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`Geo-Services Inc. v. Westerngenco LLC, 2015 WL 1276706, *16 (PTAB Mar. 17,
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`2015) (“Patent Owner’s citations . . . and respective arguments for legal
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`insufficiency of the Petition are premature, as the evidence of secondary indicia of
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`non-obviousness must be first developed in this proceeding by Patent Owner.”)
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`(emphasis added). The Federal Circuit’s en banc decision in Aqua Products
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`confirms the shifting burden within obviousness is proper. Aqua Prods., Inc. v.
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`Matal, 2015-1177 Slip. Op., p. 22-23 (Fed. Cir. Oct. 4, 2017). Only once Patent
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`Owner’ evidence is presented can the shifting burdens in obviousness be followed.
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`In re Cyclobenzaprine Patent Lit., 676 F.3d 1063, 1078-80 (Fed. Cir. 2012).
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`Each of Patent Owner’s positions would require Petitioner to assert responsive
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`argument and evidence concerning Patent Owner’s nexus case before Patent Owner
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`ever makes its case. In these proceedings, Patent Owner claims nexus ought be
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`1
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`presumed. Paper 26 at 37. In organic prosecution, Patent Owner made no attempt
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`
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`at showing nexus, presumed or otherwise, despite the MPEP requiring it to do so.
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`See MPEP Sec. 2145. All the Tanjoh declaration (the alleged showing of unexpected
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`results) does is reproduce the experiment of Table 1 of the ‘180 patent. Ex. 1010, at
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`100-108. Petitioner demonstrated producing clear, precipitate free capsules was not
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`an unexpected property of using HPMC. Paper 1, at 51-55. Patent Owner’s
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`Response, and subsequent deposition of its expert, confirmed Patent Owner
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`possesses no evidence of solving a problem by difference in kind and not degree.
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`II. The Reply Was Responsive to Patent Owner’s Nexus Presumption and
`Lack of Evidence that the Inventors Solved a Problem.
`Petitioner demonstrated that the art was motivated to make clear capsules and
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`obtaining them was expected. Paper 1, at 55 (“a capsule with an HPMC base and
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`the claimed percentages of [HPO] and [MO] groups result in the clarity and stability
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`that is a purported object of the invention …”). In its response, Patent Owner raised
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`an argument that the inventors “discovered a surprising problem and invented an
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`unexpected solution.” Paper 26, at 31. But in his deposition, Patent Owner’s expert
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`stated that whether the cloud spotting (what Patent Owner argues was the problem)
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`and the precipitates of Table 1 and the Tanjoh Declaration (the data allegedly
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`supporting the notion the problem was solved) were the same thing was an
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`assumption, but not his assumption. Paper 38, at 19. Thus, the Reply was the first
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`time Petitioner could rebut Patent Owner’s argument by pointing to the absence of
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`2
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`evidence as to the nexus claim. Thus, the Reply was foundationally proper and
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`directly responsive to Patent Owner’s arguments on its burden of showing nexus.
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`Patent Owner next argues that Petitioner admitted cloud spotting and
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`potassium chloride (gelling aid) precipitation were the same thing. But as Patent
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`Owner’s doctored “quote” on page 1 shows, Petitioner showed capsule shells free
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`of precipitation were known and expected but Petitioner certainly never postulated
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`the precipitates were the “gelling aid.” Only after Patent Owner argued its evidence
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`supports nexus, and that evidence explored, could Petitioner satisfy its burden.
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`III. Patent Owner Had to Present Evidence of Criticality before Petitioner
`Could Rebut It.
`For its second and third complaints, Patent Owner again ignores its burden to
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`produce evidence showing a problem was solved and that it was a difference of kind
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`and not mere degree. Petitioner explained in Paper 1 at pages 52-53 the prior art
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`taught clear, spot free capsules. It was first disclosed in Paper 26 at page 36-37 that
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`Patent Owner contended 37.6% (the upper end of the claimed range) creates “a
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`property lacking from [the prior art]….” But Table 1 confirms 37.6% still has
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`precipitation, though measured subjectively. Thus, the Reply was the first time
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`Petitioner could address Patent Owner’s lack of evidence that 37.6% demonstrated
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`a “solution” or that whatever resulted from choosing 37.6% was anything more than
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`an subjective improvement on appearance (Paper 1 at 52-53 showed clear capsules
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`are a motivation) and thus merely a difference in degree. Paper 38, p. 20-21.
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`3
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`Dated: October 13, 2017
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`Respectfully submitted,
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`
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`By: s/Mitchell G. Stockwell
`Mitchell G. Stockwell
`Registration No. 39,389
`Lead Counsel for Petitioner
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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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`
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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
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`4
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that on August 30, 2017 a copy of the
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`foregoing Petitioner Mylan Pharmaceuticals Inc.’s Motion to Withdraw Counsel
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`was served by electronic mail by agreement of the parties on the following counsel
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`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
`
`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: October 13, 2017
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`
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`By: s/Mitchell G. Stockwell
`Mitchell G. Stockwell
`Registration No. 39,389
`Lead Counsel for Petitioner
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`5
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