`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`AMNEAL PHARMACEUTICALS LLC AND
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioners,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`
`_____________________
`
`Case IPR2019-00207
`
`Patent 9,517,219 B2
`_____________________
`
`PETITIONERS’ MOTION FOR ADDITIONAL DISCOVERY PURSUANT
`TO 37 C.F.R. § 42.51(b)(2)
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`
`
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`IPR2019-00207
`Patent 9,517,219 B2
`Pursuant to 37 C.F.R. § 42.51(b)(2) and the Board’s October 11, 2019 Order
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`(Paper 24) authorizing this motion, Amneal respectfully requests that the Board
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`order Patent Owner Almirall LLC (“Almirall”) to:
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`
`
`
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`Make co-inventor Dr. Kevin S. Warner, on whose declaration Almirall is
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`relying in this proceeding, available for deposition; and
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`Produce the transcripts of Dr. Warner’s deposition from the district court
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`litigation involving the same U.S. Patent No. 9,517,219 (“the ’219 patent”)
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`that is challenged here.1
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`Dr. David Osborne, one of Almirall’s expert declarants in this case, relies on
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`inventor Dr. Warner’s declaration from prosecution, as the sole basis for alleged
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`unexpected results. EX2057, ¶¶173-194 (citing AMN1017, 289-293). In his
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`prosecution declaration, Dr. Warner compares a 7.5% dapsone formulation
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`containing Carbopol to a 7.5% dapsone formulation containing Sepineo, and
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`presents his observations as to the differences between those formulations.
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`Additional discovery in the form of Dr. Warner’s deposition here and
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`production of Dr. Warner’s deposition transcript from the related litigation is
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`necessary so that Amneal can fully prepare its Reply to Almirall’s Response and to
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`defend against Almirall’s allegations of purported unexpected results. Dr. Warner’s
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`declaration omits many necessary details, so Dr. Warner’s deposition testimony is
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`1 Almirall LLC v. Taro Pharmas. Indus. Ltd., 17-663 (D. Del.).
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`IPR2019-00207
`Patent 9,517,219 B2
`needed to fill those gaps in his declaration. For example, Dr. Warner’s observation
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`that the dapsone/carbopol formulation showed “undesired polymer aggregates” is
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`purely subjective. Without an objective measure, this Board cannot determine what
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`Dr. Warner viewed was “undesired” aggregates. Moreover, how Dr. Warner
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`prepared the dapsone/carbopol and dapsone/Sepineo compositions—information
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`not found in the declaration—is relevant to whether Dr. Warner’s observations are
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`attributable to differences in the formulations or differences in the preparation
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`process like the prior art teaches.
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`Only Dr. Warner knows this information. Dr. Osborne merely regurgitates
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`what Dr. Warner said and Dr. Osborne otherwise has no personal knowledge of the
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`information contained in Dr. Warner’s declaration. Dr. Osborne cannot fill the
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`gaps in Dr. Warner’s declaration. Moreover, the requested additional discovery
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`does not present any undue prejudice or burden to Almirall. Accordingly, in the
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`interests of justice Amneal requires Dr. Warner’s deposition testimony to fill the
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`gaps in his declaration.
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`As explained below, Amneal’s request meets the five factors set forth in
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`Garmin Int’l, Inc. v. Cuozzo Speed Tech. L.L.C., IPR2012-00001, Paper 26
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`(P.T.A.B. Mar. 5, 2013) for requesting additional discovery. See 37 C.F.R. §
`
`42.51(b)(2). To the extent that the Board is disinclined to grant Amneal’s request,
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`then Amneal submits that all statements in Dr. Warner’s declaration are relied
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`IPR2019-00207
`Patent 9,517,219 B2
`upon for their truth and are, therefore, inadmissible hearsay, or are otherwise
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`entitled to little or no weight.
`
`I.
`
`FACTUAL BACKGROUND
`
`Almirall filed its Patent Owner Response (Paper 20) on August 9, 2019. On
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`August 15, 2019, counsel for Almirall emailed counsel for Amneal, offering Dr.
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`Leon Kircik for deposition. Ex. 1036, 7-8. On August 22, 2019, counsel for
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`Almirall offered Dr. David Osborne for deposition. Id. at 7. Almirall only offered
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`two of the three declarants Almirall relied upon. On September 13, counsel for
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`Amneal requested dates to depose Almirall’s third declarant, Dr. Warner, and
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`requested that Almirall produce Dr. Warner’s deposition transcript from the related
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`district court action over the ’219 patent. See Ex. 1036, 4; Paper 1, 64-65. Almirall
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`responded by questioning why Dr. Warner’s testimony was needed, to which
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`Amneal immediately explained that the only evidence in support of Almirall’s
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`alleged unexpected results allegations came from Dr. Warner’s declaration. Id. at
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`3-4.
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`Having heard nothing from Almirall for nearly three weeks, Amneal again
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`followed up on October 2 regarding Dr. Warner’s deposition and transcript. Ex.
`
`1036, 2. Almirall waited two more days before informing counsel for Amneal that
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`Almirall would refuse to make Dr. Warner available for deposition and would
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`refuse to produce Dr. Warner’s deposition transcript from the Taro action, but did
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`IPR2019-00207
`Patent 9,517,219 B2
`not explain any prejudice or burden supporting its refusal. Id. Within 4 days,
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`counsel for Amneal emailed the Board requesting a call to obtain authorization to
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`file this motion. Ex. 1037, 1. The Board authorized Amneal’s motion on October
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`11, 2019.
`
`II. THE INTERESTS OF JUSTICE SUPPORT GRANTING
`ADDITIONAL DISCOVERY BECAUSE AMNEAL’S REQUEST
`SATISFIES ALL FIVE GARMIN FACTORS.
`
`A. Garmin Factor 1 favors Amneal: there is more than a mere
`possibility that Dr. Warner’s prior testimony and any new
`testimony will provide useful information.
`The first Garmin factor favors Amneal, which requires that there is more
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`than a mere possibility that something useful will be discovered. Between his
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`requested testimony in this case and his prior testimony in the related district court
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`action, Amneal will obtain relevant and useful information. The Board has
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`previously granted additional discovery when, as here, information necessary for a
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`scientific analysis are absent. For example, in Mylan Pharmas. Inc. v. Allergan,
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`Inc., IPR2016-01127, Paper 28 (P.T.A.B. May 31, 2017), the Board found that
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`“underlying data is necessary to evaluate” data relied on by patent owner and was
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`appropriate additional discovery. Id., 3.
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`Here, Dr. Warner was the sole observer of the information contained in his
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`declaration. And his declaration forms the sole basis for Almirall’s allegations of
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`purported unexpected results. No other witness will be able to provide the
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`IPR2019-00207
`Patent 9,517,219 B2
`information Dr. Warner possesses that underlies his declaration. For example, Dr.
`
`Warner’s prior testimony and/or new testimony will elucidate what he meant by
`
`saying “undesired polymer aggregates” and only he will be able to describe what
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`that formulation looked like. Additionally, only Dr. Warner will be able to inform
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`Amneal of how the dapsone/carbopol and dapsone/Sepineo formulations were
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`prepared.
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`Almirall’s arguments in rebuttal all fail because they are not well grounded
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`in the facts. Based on the Board call, Almirall may argue against this factor on one
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`of three grounds: that the discovery sought is not relevant; that Dr. Warner did not
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`testify about his declaration in the district court action; and that it seeks
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`confidential information. Each argument is meritless.
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`First, Almirall may argue that Dr. Warner’s testimony is irrelevant. But there
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`can be no doubt that Dr. Warner’s knowledge regarding his declaration is
`
`relevant—that declaration is the only reason that the ’219 patent ever issued, and it
`
`is the sole evidence of unexpected results that Almirall relies on. Nor can Almirall
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`dispute that Dr. Warner is the sole person who possesses the information that
`
`Amneal seeks or that this information is irrelevant. The prior art taught that the
`
`preparation process can impact both formation of polymer aggregates and the
`
`particle size of any undissolved dapsone. Thus, understanding Dr. Warner’s
`
`observations relating to the formation of polymer aggregates and smaller particle
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`IPR2019-00207
`Patent 9,517,219 B2
`sizes for undissolved dapsone is useful to determine whether differences in the
`
`formulations versus differences in the preparation process account for Dr.
`
`Warner’s observations.
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`Second, Almirall may also try to argue that Dr. Warner’s deposition in the
`
`related district court action is not relevant. This would be incorrect. Invalidity was
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`a central issue in that case and it is highly unlikely that counsel for Taro (the
`
`defendant there) deposed Dr. Warner without questioning him on the declaration
`
`he submitted to gain allowance of the ’219 patent that was asserted in that case.
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`Moreover, there is no prejudice or burden to Almirall in producing the transcript.
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`Third, Almirall could argue that confidentiality concerns weigh against
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`additional discovery. But the Board has a standard, default protective order
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`available to the parties if any of the information is indeed confidential.
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`Accordingly, the first Garmin factor weighs in Amneal’s favor.
`
`B. Garmin Factors 2-5 support production of the additional
`discovery.
`
`Garmin factors 2-5 equally support Amneal’s request. These factors ask
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`whether the movant (2) seeks to uncover an opponent’s litigation position; (3)
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`seeks information that could be uncovered through other means; (4) seeks
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`information that is easily understood; and (5) seeks information that is limited in
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`scope and not unduly burdensome.
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`Factors 2-4: The discovery sought has nothing to do with Almirall’s
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`IPR2019-00207
`Patent 9,517,219 B2
`litigation position. There is no other way for Amneal to obtain this discovery as Dr.
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`Osborne has no personal knowledge and Almirall’s allegations of unexpected
`
`results rely upon Dr. Warner’s declaration where only he knows what occurred.
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`And the requested information is easily understood as Amneal seeks basic factual
`
`information about how his compositions were prepared and what he observed.
`
`Factor 5: Amneal’s request is both limited in scope and not unduly
`
`burdensome. As explained just above, the discovery sought is narrow in scope:
`
`Amneal seeks only a deposition of Dr. Warner concerning his declaration. In
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`addition, a prior deposition transcript already exists as Dr. Warner was deposed in
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`the related Taro action. Almirall LLC v. Taro Pharmas. Indus. Ltd., 17-663, Dkt.
`
`No. 80 (D. Del. June 1, 2018) (Notice of Deposition of Kevin S. Warner). Also,
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`Amneal’s request is not unduly burdensome. Even though Dr. Warner might not be
`
`employed at Almirall, Dr. Warner nevertheless still presented for deposition in the
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`Taro action in July 2018. Ex. 1038, 232. Dr. Warner’s cooperation in the district
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`court action, and expected cooperation in this proceeding, are not surprising
`
`because inventor assignment agreements typically include provisions obligating
`
`the inventor to participate in any defense proceedings of the subject patent.
`
`This proceeding is no different from the Taro litigation, as Amneal simply
`
`seeks the deposition of Dr. Warner similar to how Almirall made him available
`
`previously. As for Amneal’s request for Dr. Warner’s deposition transcript from
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`IPR2019-00207
`Patent 9,517,219 B2
`the Taro action, that request simply seeks the production of a handful of
`
`documents (the transcript and any exhibits thereto) and is not burdensome.
`
`Almirall may argue that Amneal allegedly “delayed” in seeking Dr.
`
`Warner’s deposition. This argument would be contrary to the parties’ interactions,
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`as immediately following a few weeks to review Almirall’s POR, supporting
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`declarations, and other exhibits, Amneal made its request. As Almirall is the
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`proponent of Dr. Warner’s testimony, it was Almirall’s obligation to provide Dr.
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`Warner for deposition. Once it became clear that Almirall did not offer Dr. Warner
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`for deposition, Amneal acted promptly and requested the deposition from
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`Almirall’s counsel. It was then Almirall, not Amneal, that delayed providing a final
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`answer to Amneal’s request for Dr. Warner’s deposition for weeks. Any “burden”
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`to Almirall in producing this witness is of its own making.
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`Accordingly, Garmin factor 5 does not weigh in favor of denial.
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`III. THE PRIOR INSTANCES DENYING SIMILAR REQUESTS FOR
`DEPOSITION OF PROSECUTION DECLARANTS ARE
`INAPPOSITE.
`
`The Board has previously denied several requests for additional discovery
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`that are similar to Amneal’s, but each of those decisions turns on facts not present
`
`here. In Amneal Pharmas. LLC v. Endo Pharmas., IPR2014-00360, Paper 39 (Dec.
`
`3, 2014) and Mexichem Amanco Holdings v. Honeywell Int’l, Inc., IPR2013-
`
`00576, Paper 36 (Sept. 5, 2014), the Board denied deposition of a prosecution
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`IPR2019-00207
`Patent 9,517,219 B2
`declaration from related patents—not the patent at issue in the IPR. IPR2014-
`
`00360, Paper 39, 2; IPR2013-00576, Paper 36, 1. Here, the Warner Declaration
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`was submitted during prosecution of—and is the sole basis of issuance for—the
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`’219 patent.
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`Likewise, in each of Amneal, Mexichem, and Praxair Distrib., Inc. v. Ino
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`Therapeutics LLC, IPR2015-00529, Paper 33 (Dec. 22, 2015), the declarant was no
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`longer within the patent owner’s control. IPR2014-00360, Paper 39, 4; IPR2013-
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`00576, Paper 36, 2; IPR2015-00529, Paper 33, 1. As stated above, Dr. Warner is
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`likely within Almirall’s control.
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`Finally, if the Board is disinclined to grant Amneal’s request, the Board
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`should follow the guidance of the prior decisions on this issue and give Dr.
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`Warner’s declaration little to no weight because his out-of-court statements are
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`relied upon for their truth and he was not subject to cross-examination. See, e.g.,
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`Amneal Pharms. LLC v. Endo Pharmas., IPR2014-00360, Paper 39 (Dec. 3, 2014);
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`Praxair Distrib., Inc. v. Ino Therapeutics LLC, IPR2015-00529, Paper 33 (Dec. 22,
`
`2015); Mexichem Amanco Holdings v. Honeywell Int’l, Inc., IPR2013-00576,
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`Paper 36 (Sept. 5, 2014).
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`IV. CONCLUSION
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`For the foregoing reasons, Amneal respectfully asks the Board to grant
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`Amneal’s request to depose Dr. Warner and for Almirall to produce to Amneal the
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`IPR2019-00207
`Patent 9,517,219 B2
`deposition transcript (and exhibits) of Dr. Warner’s deposition in the Taro action.
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`
`
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`Date: October 18, 2019
`1100 New York Avenue, N.W.
`Washington, DC 20005-3934
`(202) 371-2600
`
`
`
`Dennies Varughese, Pharm.D.
`Registration No. 61,868
`Attorney for Petitioners
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`
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`V. CERTIFICATE OF SERVICE (37 C.F.R. §§ 42.6(E))
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`The undersigned hereby certifies that the above-captioned "Petitioners’
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`Motion for Additional Discovery Pursuant to 37 C.F.R. 42.51(b)(2)," were served
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`in their entirety on October 18, 2019, via email on the following:
`
`James Trainor: jtrainor@fenwick.com
`Vanessa Park-Thompson: vpark-thompson@fenwick.com
`Elizabeth Hagan: ehagan@fenwick.com
`Jennifer Bush: jbush@fenwick.com
`
`
`
`
`
` Respectfully submitted,
`
`
`
`
`Date: October 18, 2019
`
`_______________________
` Dennies Varughese, Pharm.D.
`Lead Counsel for Petitioners
`1100 New York Avenue, N.W. Registration No. 61,868
`Washington, D.C.20005-3934
`
`(202) 371-2600
`
`
`
`
`
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