Trials@uspto.gov
`571.272.7822
`
`Paper No. 31
`
` Filed: October 4, 2018
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GRÜNENTHAL GMBH,
`Petitioner,
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`Patent Owner.
`____________
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`____________
`
`Before TONI R. SCHEINER, GRACE KARAFFA OBERMANN, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`ORDER
`Denying Petitioner’s Motion to Compel Routine Discovery
`And Denying Petitioner’s Motion for Additional Discovery
`37 C.F.R. §§ 42.51, 42.65, 42.224
`
`
`
`
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`

`

`PGR2018-00001
`Patent 9,539,268 B2
`
`
`
`This is a post grant review of claims 3–30 of U.S. Patent 9,539,268
`B2 (“the ’268 patent”). Paper 17, 38. We authorized Petitioner to file a
`combined Motion to Compel Routine Discovery and Motion for Additional
`Discovery. Paper 27, 3 (Order authorizing motion); see Paper 28
`(Petitioner’s combined motion (“Mot.”)); Paper 30 (Patent Owner’s
`opposition to the combined motion (“Opp.”)). For reasons that follow, we
`deny that combined motion.
`
`The Discovery Dispute
`On the same day that Patent Owner filed its Response (Paper 22,
`
`“Resp.”) to the Petition, Patent Owner filed also Exhibit 2026, a document
`titled “AXS-02 (disodium zoledronate tetrahydrate) Phase 1 Results
`Summary.”1 The Response does not cite Exhibit 2026. See Resp. The
`supporting declaration of Dr. William Wargin, however, refers to that
`exhibit and contains extensive information alleged to pertain to that Phase I
`study. Ex. 2017 ¶¶ 54–78.
`Petitioner asserts that documents pertaining to a Phase III study
`(hereinafter “the Phase III documents”) 2 are inconsistent with a position
`taken by Patent Owner in the Response. Mot. 1–2 (citing Resp. 35); see
`Ex. 1091 (press release); Ex. 1092 (FDA guidance). Accordingly, Petitioner
`
`
`1 Although each page of Exhibit 2026 is marked “Confidential,” Patent
`Owner filed that document without any restriction on public access.
`2 As an initial matter, Patent Owner argues that the Phase III documents are
`not adequately defined in a “single set of clearly articulated requests.”
`Opp. 1. We determine that Petitioner identifies the Phase III documents
`with sufficient particularity for purposes of the combined motion, given the
`limited information available to Petitioner regarding the documents. Mot. 1
`(seeking “documents sufficient to show the complete results of the
`CREATE-1 phase III clinical trial”); see Ex. 1091 (press release).
`
`2
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`PGR2018-00001
`Patent 9,539,268 B2
`
`
`seeks to compel the production of the Phase III documents as routine
`discovery. See Mot. 1–3; 37 C.F.R. § 42.51(b)(1)(iii). Patent Owner avers
`that the Phase III documents are not subject to routine discovery and refuses
`to produce them. Opp. 2, 5.
`Petitioner, in the alternative, requests production of the Phase III
`documents as additional discovery. Mot. 3–5. Petitioner further seeks
`additional discovery pertaining to individuals allegedly consulted by
`Dr. Wargin in connection with the Phase I study (hereinafter “the Phase I
`individuals”).3 Id. at 5–7. Patent Owner disagrees that additional discovery,
`pertaining to the Phase III documents or the Phase I individuals, is warranted
`given the facts and circumstances of this case. Opp. 5–7.
`We first address Petitioner’s Motion to Compel Routine Discovery of
`the Phase III documents. We then turn to Petitioner’s Motion for Additional
`Discovery pertaining to the Phase III documents and the Phase I individuals.
`
`Denying Petitioner’s Motion to Compel Routine Discovery
`Petitioner argues that the Phase III documents should be produced as
`
`routine discovery because they reflect information “inconsistent with a
`position advanced by” Patent Owner. Mot. 3 (quoting Rule 42.51(b)(1)(iii)).
`In that regard, Petitioner directs us to Patent Owner’s allegation, reflected in
`the Response, that the salt forms of zoledronic acid “can have a higher
`bioavailability than the diacid form, and that dosage forms having this
`
`3 The Board granted Petitioner’s request to move for additional discovery
`pertaining to the Phase I individuals during a telephonic conference call
`conducted on September 12, 2018; however, we inadvertently failed to
`mention that component of Petitioner’s discovery request in our Order
`memorializing the call. Paper 27. Accordingly, we reject Patent Owner’s
`contention that this component of Petitioner’s discovery request “should be
`denied as not authorized by the Board’s order.” Opp. 6 (citing Paper 27).
`
`3
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`PGR2018-00001
`Patent 9,539,268 B2
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`bioavailability range are effective in treating disease.” Id. at 1–2 (quoting
`Resp. 35). Petitioner further observes that Patent Owner’s own witness,
`Dr. Wargin, asserts in his declaration that the claimed invention “teaches
`that ‘an effective bioavailability range for oral zoledronic acid is about 1.1%
`to about 4%.’” Id. at 2 (emphasis in original) (quoting Ex. 2017 ¶ 19).
`Petitioner acknowledges that the Phase III documents relate to the
`“treatment of a specific condition called complex regional pain syndrome, or
`CRPS.” Opp. 2 (citing Ex. 1091). In Petitioner’s view, the Phase III
`documents establish that the claimed invention is ineffective “for treating
`CRPS.” Mot. 2. Significantly, however, none of the challenged claims of
`the ’268 patent includes “treatment of CRPS as a limitation” and neither
`Patent Owner nor Dr. Wargin asserts that the claimed invention is effective
`for treating CRPS. Opp. 2. Claims 3–22 relate to “[a] method of treating
`arthritis” whereas claims 23–30 “cover ‘[a] pharmaceutical dosage form for
`oral administration’” not limited to any particular condition or disease. Id.
`(emphasis in original) (quotation omitted); see Ex. 1001, claims 3–30.
`The press release advanced by Petitioner in support of its motion to
`compel routine discovery of the Phase III documents confirms the utility of
`the claimed dosage form for modulating bone resorption in osteoarthritis, a
`condition discussed in the specification of the ’268 patent. Opp. 3 (citing
`Ex. 1091 and Ex. 1001, 2:52–67). Neither Patent Owner nor Dr. Wargin
`purports “to make the rather grandiose claim of efficacy for treating all
`conditions or maladies.” Opp. 4 (emphasis omitted). We agree with Patent
`Owner that Dr. Wargin’s testimony, taken in context, does not include “a
`claim of efficacy for treating every condition known to man,” including
`CRPS. Id.; Ex. 2017 ¶¶ 54–78.
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`PGR2018-00001
`Patent 9,539,268 B2
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`Given that the Phase III documents purportedly establish that the
`claimed dosage form is ineffective only “for treating CRPS” (Mot. 2), on
`this record, we discern no inconsistency between a position taken by Patent
`Owner (or Dr. Wargin) and the information allegedly reflected in the
`Phase III documents. Petitioner does not show that the Phase III documents
`are subject to routine discovery as inconsistent with a position taken by
`Patent Owner in this proceeding. Accordingly, we deny Petitioner’s Motion
`to Compel Routine Discovery of the Phase III documents.
`
`Denying Petitioner’s Motion for Additional Discovery
`Petitioner asserts, and we agree, that “additional discovery of
`
`‘evidence directly related to factual assertions advanced by either party’ may
`be granted” during a post grant review “upon a ‘showing of good cause.’”
`Mot. 3–4 (citing 37 C.F.R. ¶ 42.224). Applying the good cause standard,
`however, we are not persuaded that Petitioner demonstrates, at this time, that
`good cause exists for securing additional discovery of information pertaining
`to the Phase III documents or the Phase I individuals. See Bloomberg Inc. v.
`Markets-Alert Pty Ltd., CBM2013-00005, Paper 32 at 2-3 (P.T.A.B. May
`29, 2013) (precedential); Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
`IPR2012-00001, Paper 26 at 4 (P.T.A.B. Mar. 5, 2013) (precedential)
`(discussing factors that bear on the “good cause” standard).
`Regarding the Phase III documents, Petitioner does not advance “a
`specific factual reason” that supports production of them, aside from “the
`debunked notion that” those documents are “inconsistent with a position
`advanced by Patent Owner.” Opp. 5 (quotation and emphasis omitted); see
`Mot. 4 (arguing that the Phase III documents “plainly exist and contradict
`[Patent Owner’s] assertions”). Two other pending reviews before the Board,
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`PGR2018-00001
`Patent 9,539,268 B2
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`moreover, involve challenges brought by Petitioner against “Patent Owner’s
`patents that do have claims expressly directed to treating CRPS,” which
`suggests that Petitioner may have an opportunity to seek discovery of the
`Phase III documents in those other proceedings. Id. at 5–6 (emphasis in
`original) (citing Case PGR2018-00062 and Case PGR2018-00092). Further,
`given that Petitioner already has access to Dr. Wargin’s extensive
`declaration testimony pertaining to the Phase I study (Ex. 2017 ¶¶ 54–78), a
`summary of results pertaining to the Phase I study (Ex. 2026), and a press
`release describing the Phase III study (Exhibit 1091), we agree with Patent
`Owner that Petitioner already is in possession of information adequate to
`pursue its legitimate discovery needs in this case “through the traditional
`means provided under [our] rules;” namely, “cross-examination of the
`declarant, Dr. Wargin” without need of additional discovery of the Phase III
`documents. Opp. 6. Accordingly, we deny Petitioner’s Motion for
`Additional Discovery of the Phase III documents.
`Regarding the Phase I individuals, we agree with Patent Owner that
`Petitioner may not “demand to interrogate every lab technician involved in
`performing” tests pertaining to the Phase I study, or “demand [] district
`court-style discovery” related to those individuals. Opp. 7. Here, however,
`Dr. Wargin does not even name the Phase I individuals in his declaration.
`Ex. 2017 ¶¶ 54–78. But Dr. Wargin admits to having been “provided access
`to individuals” having “personal knowledge” of the Phase I study (id. ¶ 54)
`and suggests that those individuals conveyed to him extensive information
`pertaining to the Phase I study. Id. ¶¶ 54–78.
`At this stage of the proceeding, Petitioner has not cross-examined
`Dr. Wargin to discover the names of the individuals or identify, with any
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`PGR2018-00001
`Patent 9,539,268 B2
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`specificity, a set of documents that may be the subject of an appropriately
`narrow, targeted motion for additional discovery. Mot. 5–7. In other words,
`Petitioner lacks information, at this time, adequate to support a successful
`request for additional discovery pertaining to the Phase I individuals.
`Accordingly, we deny Petitioner’s Motion for Additional Discovery as it
`pertains to the Phase I individuals, with the understanding that, after cross-
`examining Dr. Wargin, Petitioner may seek authorization (by arranging a
`phone call with the panel and counsel for all parties) to renew this request.
`
`
`ORDER
`
`It is
`ORDERED that we deny Petitioner’s Motion to Compel Routine
`Discovery of the Phase III documents;
`FURTHER ORDERED that we deny Petitioner’s Motion for
`Additional Discovery of the Phase III documents; and
`FURTHER ORDERED that we deny Petitioner’s Motion for
`Additional Discovery pertaining to the Phase I individuals, with the
`understanding that, after cross-examining Dr. Wargin, Petitioner may seek
`authorization (by arranging a phone call with the panel and counsel for all
`parties) to renew this request.
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`PGR2018-00001
`Patent 9,539,268 B2
`
`
`For PETITIONER:
`Bruce Haas
`grunenthalpgr@fchs.com
`
`Stephen Yam
`syam@fchs.com
`
`
`For PATENT OWNER:
`Brent Johnson
`bjohnson@mabr.com
`
`Parrish Freeman
`pfreeman@mabr.com
`
`
`
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`8
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