Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 33
`Entered: May 11, 2018
`
`
`NON-PUBLIC VERSION – PROTECTIVE ORDER MATERIAL
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`TARO PHARMACEUTICALS U.S.A., INC.,
`Petitioner,
`v.
`APOTEX TECHNOLOGIES, INC.,
`Patent Owner.
`
`Case IPR2017-01446
`Patent 7,049,328 B2
`
`
`Before LORA M. GREEN, JEFFREY N. FREDMAN, and
`ZHENYU YANG, Administrative Patent Judges.
`
`FREDMAN, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Petitioner’s Motion for Additional Discovery
`37 C.F.R. § 42.51(b)(2),
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`
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`Tel: 571-272-7822
`
`Paper 33
`Entered: May 11, 2018
`
`
`NON-PUBLIC VERSION – PROTECTIVE ORDER MATERIAL
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`
`
`TARO PHARMACEUTICALS U.S.A., INC.,
`Petitioner,
`v.
`APOTEX TECHNOLOGIES, INC.,
`Patent Owner.
`
`Case IPR2017-01446
`Patent 7,049,328 B2
`
`
`Before LORA M. GREEN, JEFFREY N. FREDMAN, and
`ZHENYU YANG, Administrative Patent Judges.
`
`FREDMAN, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Petitioner’s Motion for Additional Discovery
`37 C.F.R. § 42.51(b)(2),
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`
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`
`IPR2017-01446
`Patent 7,049,328 B2
`
`
`INTRODUCTION
`I.
`With authorization of the Board, Paper 18, Taro Pharmaceuticals
`U.S.A., Inc. (“Petitioner”) filed redacted and public versions of a motion for
`additional discovery relating to Exhibits 1037–1045 and 1047–1049. Papers
`22, 24 (“Mot.”). Apotex Technologies, Inc. (“Patent Owner”) filed redacted
`and public versions of an opposition to the Motion. Papers 29, 30 (“Opp.”).
`In the motion, Petitioner explains that these documents were generated
`during litigation in parallel litigation related to the ’328 patent, ApoPharma
`Inc. v. Taro Pharmaceutical Industries, Ltd., No. 2:16-cv-00528, currently
`pending in the District Court for the Eastern District of Texas – Marshall
`Division.
`Petitioner asserts these documents are both relevant to, and
`inconsistent with, positions advanced by Patent Owner in the Patent Owner
`Response (Paper 17; “PO Resp.”). Mot. 1. Petitioner seeks to compel
`Patent Owner to produce these documents in this proceeding because the
`District Court’s protective order prevents Petitioner from entering the
`documents into the instant proceeding. For the reasons that follow, we grant
`Petitioner’s Motion. Mot. 6–7.
`II. ANALYSIS
`A party seeking discovery beyond what is expressly permitted by our
`rules must establish that such additional discovery is “necessary in the
`interest of justice.” 35 U.S.C. § 316(a)(5); see also 37 C.F.R. § 42.51(b)(2)
`(“The moving party must show that such additional discovery is in the
`interest of justice.”). Discovery in an inter partes review proceeding is more
`limited than in district court patent litigation, as Congress intended our
`proceedings to provide a more efficient and cost-effective alternative to such
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`IPR2017-01446
`Patent 7,049,328 B2
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`litigation. H. Rep. No. 112–98 at 45–48 (2011). Thus, we take a
`conservative approach to granting additional discovery. 154 Cong. Rec.
`S9988–89 (daily ed. Sept. 27, 2008) (statement of Sen. Kyl).
`The Board has identified five factors (the “Garmin Factors”) to be
`considered in determining whether additional discovery is in the interest of
`justice. See Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC, Case IPR2012–
`00001, slip op. at 6–7 (PTAB Mar. 5, 2013) (Paper 26) (precedential)
`(“Garmin”).
`A. Garmin Factor 1 – “More Than A Possibility And Mere
`Allegation”
`The first Garmin Factor requires that the party seeking additional
`discovery establish that it already is in possession of a threshold amount of
`evidence or reasoning tending to show beyond speculation that something
`useful will be uncovered. Garmin at 6.
`In support of its assertion that the proposed Requests for Additional
`Discovery will uncover documents favorable to its position, Petitioner
`asserts that the documents “filed as Exhibits 1037–1045 and 1047–1049[],
`contain statements inconsistent with positions taken by Apotex during the
`IPR.” Mot. 6. Patent Owner responds that Petitioner’s proposed discovery
`request “is not relevant to the issues at hand – namely what is taught by the
`prior art” and “Exs. 1037–1045 and 1047–1049 are not relevant to this
`proceeding because, as described above, they are not inconsistent with
`Apotex’s positions.” Opp. 6–7.
`To demonstrate the relevance of the documents, Petitioner first points
`out that Patent Owner contends there was “significant disagreement in the
`scientific community” as to whether deferiprone could be safely
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`IPR2017-01446
`Patent 7,049,328 B2
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`administered. Mot. 2 (citing PO Resp. 5). Petitioner points to an asserted
`inconsistent statement in Exhibit 1040,
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`Ex. 1040, 1.1 Additionally, Petitioner points to
`Exhibit 1042
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`Petitioner next points out that Patent Owner “now contends that the
`Primary References ‘do not explicitly or inherently disclose administering
`deferiprone to blood transfusion-dependent patients having iron-induced
`cardiac disease’ (PO Resp. at 26) because those patients’ cardiac disease
`may have had a different cause. (Id. at 26, 30.)” Mot. 3. Petitioner points to
`asserted inconsistent statements in Exhibits 1042, 1045, and 1047. Mot. 34.
`In Exhibit 1042, Petitioner points to
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`1 We recognize that, consistent with Patent Owner’s position, a dispute
`between Dr. Olivieri and other researchers constitutes disagreement in the
`scientific community (see Opp. 3), but Exhibits 1037–1040 and 1042
`provide
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`4
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`IPR2017-01446
`Patent 7,049,328 B2
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` Similarly, in Exhibit 1045,
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` are
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`therefore reasonably understood as inconsistent with Patent Owner’s
`position that patients undergoing transfusion treated with deferiprone in the
`Primary References did not inherently have iron-induced cardiac disease
`requiring treatment.
`Patent Owner responds
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`Opp. 4.
`We are persuaded that requiring Patent Owner to produce evidence as
`to whether an “inherent result must inevitably result” as required by In re
`Montgomery, 677 F.3d 1375, 1380 (Fed. Cir. 2012) that may be inconsistent
`with Patent Owner’s position in the instant proceeding is in the interests of
`justice. We do not find Patent Owner’s argument that the evidence does not
`directly address the Primary References to be persuasive, because the
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`IPR2017-01446
`Patent 7,049,328 B2
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`evidence is relevant to Patent Owner’s underlying argument that the Primary
`References do not inherently anticipate the claims of the ’328 patent. Patent
`Owner’s argument as to whether the documents are able to contradict
`existing positions or evidence, when both parties already know the contents
`of the documents, goes more to the weight to be given to the documents,
`rather than the first Garmin factor. After weighing Petitioner and Patent
`Owner’s arguments, we are persuaded that the information sought has value
`in informing the analysis of Patent Owner’s positions relative to the Primary
`References.
`Petitioner lastly points out that Patent Owner “takes the position that
`the 75/mg/kg/day dose of deferiprone disclosed in the prior art is not
`necessarily an effective dose of deferiprone to reduce cardiac iron levels.
`(PO Resp. at 37, 41-42.) This position is inconsistent with
` Mot. 5. Patent Owner responds
`and therefore cannot be
`inconsistent with Apotex’s position that the Primary References do no
`inherently disclose that 75 mg/kg/day is an effective dose to reduce cardiac
`iron levels.” Opp. 5.
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`6
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`IPR2017-01446
`Patent 7,049,328 B2
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`
`We are again persuaded that the production of evidence by Patent
`Owner related to whether an “inherent result must inevitably result,”
`Montgomery, 677 F.3d at 1380, that is inconsistent with Patent Owner’s
`position is in the interests of justice. The evidence is relevant to Patent
`Owner’s underlying argument that the Primary References do not inherently
`anticipate the claims of the ’328 patent. After weighing Petitioner and
`Patent Owner’s arguments, we are persuaded that the information sought
`will have value in informing the analysis of Patent Owner’s positions
`relative to the Primary References.
`Having considered the arguments in the Motion and Opposition, we
`find that Petitioner has established persuasively that it already is in
`possession of a threshold amount of evidence or reasoning tending to show
`beyond speculation that something useful will be uncovered.
`B. Garmin Factor 2 – “Litigation Positions And Underlying Basis”
`Garmin Factor 2 is directed toward whether the requested discovery
`overlaps with Patent Owner’s litigation positions or their underlying basis
`for those positions. “Asking for the other party’s litigation positions and the
`underlying basis for those positions is not necessary in the interest of
`justice.” Garmin at 6.
`Petitioner asserts it “does not seek litigation positions or their
`underlying basis; indeed, Petitioner is already in possession of the Patent
`Owner Response which lays out Patent Owner’s litigation positions.” Mot.
`6. Patent Owner does not contend that litigation positions are at issue. Opp.
`6–7. Review of the proposed Requests for Additional Discovery reveals that
`the discovery request does not seek Patent Owner’s litigation positions or the
`underlying basis for those positions.
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`IPR2017-01446
`Patent 7,049,328 B2
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`C. Garmin Factor 3 – “Ability To Generate Equivalent
`Information By Other Means”
`Garmin Factor 3 is directed toward whether another means exists for
`obtaining the requested discovery. Garmin at 6. Petitioner asserts that “due
`to the district court’s protective order, Taro is unable to generate these
`documents or their equivalent by means other than the Board’s order to
`Apotex to produce the documents in this proceeding.” Mot. 6–7. Patent
`Owner asserts that Petitioner “has not explained why it is incapable of
`advancing its own arguments regarding the teachings of the Primary
`References in the absence of Apotex’s highly confidential litigation
`documents.” Opp. 7.
`It is unclear how Patent Owner suggests that Petitioner demonstrate
`inconsistencies between Patent Owner’s assertions in the Patent Owner
`Response and Exhibits 1037–1045 and 1047–1049 subject to the District
`Court’s protective order other than by a discovery request making these
`documents of record in this proceeding. As Petitioner correctly notes, the
`District Court protective order precludes any other mode of obtaining these
`documents. See Mot. 6–7. Accordingly, we are persuaded that Petitioner
`has sufficiently satisfied Garmin Factor 3.
`D. Garmin Factor 4 – “Easily Understandable Instructions”
`Garmin Factor 4 requires considering whether the questions asserted
`in the proposed Requests for Admission are easily understandable. Garmin
`at 6. Petitioner asserts “the instructions to produce thirteen specifically
`identified documents are easily understandable.” Mot. 7. Patent Owner
`does not challenge this factor. See Opp. 7.
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`IPR2017-01446
`Patent 7,049,328 B2
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`E. Garmin Factor 5 – “Requests Not Overly Burdensome To
`Answer”
`Garmin Factor 5 prohibits discovery requests that are overly
`burdensome to answer and requires such discovery to be sensible and
`responsibly tailored according to a genuine need. Garmin at 7. Petitioner
`asserts that the proposed Requests for Admission are not overly burdensome
`because “the documents ‘are already in possession of Petitioner’ and
`Petitioner is merely requesting ‘permission to use those documents’ in this
`proceeding.” Mot. 7. Patent Owner does not challenge this factor. See Opp.
`7.
`
`Petitioner’s request here does not impose a burden on Patent Owner to
`produce documents, because those documents are already in possession of
`Petitioner. Rather, Petitioner’s request is, effectively, for permission to use
`those documents, which request is not overly burdensome to answer.
`Having considered the Motion and Opposition, along with the evidence
`proffered in support of the proposed Requests for Admission, we are
`persuaded that Petitioner has satisfied the five Garmin Factors and met its
`burden of showing that the additional discovery sought is necessary in the
`interest of justice.
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`III. CONCLUSION
`For the reasons discussed above, we conclude that Petitioner’s Motion
`has met the “necessary in the interest of justice” standard for the proposed
`Requests for Additional Discovery.
`Because, in a concurrently entered Decision on the Motions to Seal,
`we authorize the parties to file a renewed Motion, this Decision is designated
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`IPR2017-01446
`Patent 7,049,328 B2
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`as “Parties and Board Only” in the PTAB E2E system. The parties shall file
`jointly a proposed redacted version of the Decision. The redactions should
`account for the strong public policy in favor of making all information,
`including confidential information relied upon in a decision in an inter
`partes review, available to the public. See Office Patent Trial Practice
`Guide, 77 Fed. Reg. at 48,760–61.
`IV. ORDER
`
`Accordingly, it is:
`ORDERED that Petitioner’s Motion for Additional Discovery is
`granted; and
`FURTHER ORDERED that the parties shall file jointly, within ten
`(10) business days of the Decision, a proposed redacted version of this
`Decision Granting Petitioner’s Motion for Additional Discovery.
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`10
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`IPR2017-01446
`Patent 7,049,328 B2
`
`PETITIONER:
`Huiya Wu
`Sara Fink
`GOODWIN PROCTER LLP
`hwu@goodwinlaw.com
`sfink@goodwinlaw.com
`
`PATENT OWNER:
`W. Blake Coblentz
`Aaron S. Lukas
`COZEN O’CONNOR
`WCoblentz@cozen.com
`ALukas@cozen.com
`
`11
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