Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`
`
` Paper No. 39
`
` Entered: December 31, 2019
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC, AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC, and MYLAN
`PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`____________
`
`IPR2019-002071
`Patent 9,517,219 B2
`____________
`
`
`Before SUSAN L. C. MITCHELL and RYAN H. FLAX, Administrative
`Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`
`ORDER
`Granting Patent Owner’s Motion for Additional Discovery
`37 C.F.R. § 42.51(b)(2)
`
`
`
`
`
`
`1 Cases IPR2019-00207 and IPR2019-01095 have been joined in this
`proceeding.
`
`
`571.272.7822
`
`
`
`
`
`
`
` Paper No. 39
`
` Entered: December 31, 2019
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC, AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC, and MYLAN
`PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`____________
`
`IPR2019-002071
`Patent 9,517,219 B2
`____________
`
`
`Before SUSAN L. C. MITCHELL and RYAN H. FLAX, Administrative
`Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`
`ORDER
`Granting Patent Owner’s Motion for Additional Discovery
`37 C.F.R. § 42.51(b)(2)
`
`
`
`
`
`
`1 Cases IPR2019-00207 and IPR2019-01095 have been joined in this
`proceeding.
`
`
`
`IPR2019-00207
`Patent 9,517,219 B2
`
`I.
`
`INTRODUCTION
`On October 18, 2019, Amneal Pharmaceuticals LLC and Amneal
`Pharmaceuticals of New York, LLC (collectively “Petitioner”) filed an
`authorized Motion for Additional Discovery. Paper 26 (“Pet. Mot.”). On
`October 25, 2019, Patent Owner filed an authorized Opposition to this
`Motion (corrected). Paper 27 (“PO Opp.”). For the reasons discussed
`below, Petitioner’s Motion is granted.
`As described in our Trial Practice Guide, in trials before the Board,
`“[d]iscovery is a tool to develop a fair record and to aid the Board in
`assessing the credibility of witnesses” and “discovery before the Board is
`focused on what the parties reasonably need to respond to the grounds raised
`by an opponent.” See Office Patent Trial Practice Guide, 84 Fed. Reg.
`64,280, § I.F (Nov. 21, 2019) (“Trial Practice Guide”). By rule, such
`discovery is divided into routine and additional discovery, the former
`category requiring production of a party’s cited exhibits, cross-examination
`of witnesses, and if not previously served, evidence relevant to information
`inconsistent with a position advanced by the producing party during the
`proceeding. 37 C.F.R. § 42.51(b)(1). The latter category, additional
`discovery, is directed to non-routine discovery that should be allowed in the
`interests of justice. Id. § 42.51(b)(2); see also 35 U.S.C. § 316(a)(5).
`We conclude the additional discovery sought by Petitioner should be
`authorized in the interests of justice, as discussed below. Regarding the
`authorization of additional discovery, the Board set forth factors for
`consideration in Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC, IPR2012-
`00001, Paper 26 at 6–7 (PTAB Mar. 5, 2013) (precedential), which are:
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`IPR2019-00207
`Patent 9,517,219 B2
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`
`Factor 1: Whether there is more than a possibility and mere
`allegation that something useful will be found and whether the
`party requesting discovery is already in possession of evidence
`tending to show beyond speculation that something useful will
`be discovered;
`Factor 2: Whether the party requesting discovery is seeking its
`opponent’s litigation positions and underlying basis for those
`positions;
`Factor 3: Whether the party requesting discovery has the
`ability to generate equivalent information by other means;
`Factor 4: Whether the party requesting discovery has presented
`easily understandable instructions and questions; and
`Factor 5: Whether the request for discovery is overly
`burdensome to answer or sensible and reasonably tailored
`according to a genuine need.
`II. DISCUSSION
`Petitioner seeks additional discovery in the form of the deposition of
`Dr. Kevin S. Warner and the production of Dr. Warner’s deposition
`transcripts from a related district court litigation, Almirall LLC v. Taro
`Pharmas. Indus. Ltd., 17-663 (D. Del.) (the “related district court
`litigation”), involving U.S. Patent No. 9,571,219 (“the ’219 patent”)
`challenged here. See Pet. Mot. 1; see also Paper 3, 64 (Petitioner’s
`Mandatory Notices); Paper 5, 2 (Patent Owner’s Mandatory Notices).
`Petitioner argues that Patent Owner has asserted that the claims of the ’219
`patent are non-obvious based on evidence of unexpected results and has
`submitted a Declaration of Dr. David Osborne (Ex. 2057) in support of this
`argument, but that Dr. Osborne’s sole basis for this opinion on unexpected
`results is Dr. Warner’s declaration dated February 2, 2015 (Ex. 1017, 289–
`293 (“Warner Declaration”)), which was submitted during the prosecution of
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`IPR2019-00207
`Patent 9,517,219 B2
`
`the ’219 patent (having previously been submitted during the prosecution of
`its parent application 14/082,955).
`Patent Owner opposes the sought additional discovery. PO Opp. 1.
`Patent Owner argues that the Warner Declaration is publically available and
`itself provides sufficient information to assess the results reported therein,
`and Dr. Warner’s further deposition would not provide useful information.
`Id. Further, Patent Owner argues that the transcripts from the related district
`court litigation are not relevant because that litigation concerned a different
`product (accused of infringement). Id.
`A. GARMIN FACTOR 1–MORE THAN A POSSIBILITY AND MERE
`ALLEGATION; BEYOND SPECULATION
`Petitioner argues that Dr. Warner is the source of “information
`necessary for a scientific analysis,” which is “‘necessary to evaluate’ data
`relied on by [P]atent [O]wner” it its case for non-obviousness based on
`secondary indicia thereof. Pet. Mot. 4. Petitioner contends “Dr. Warner was
`the sole observer of the information contained in his declaration,” which is
`“the sole basis for Almirall’s allegations of [and Dr. Osborne’s opinions on]
`purported unexpected results.” Id. Petitioner argues Dr. Warner has
`information on and can explain the data that underlies his declaration, in
`particular, regarding “undesired polymer aggregates” and how his discussed
`compositions were prepared. Id. at 5. Petitioner argues that this makes
`Dr. Warner’s knowledge relevant. Id. Petitioner argues that Dr. Warner
`testified in the related district court litigation regarding the validity of the
`’219 patent’s claims, which makes the transcripts thereof also relevant here.
`Id. at 6.
`Patent Owner argues Petitioner’s request for a deposition is
`speculative because the data sought is already provided by the Warner
`
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`IPR2019-00207
`Patent 9,517,219 B2
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`Declaration (visual observations, data on particle size). PO Opp. 4–5.
`Patent Owner argues Petitioner’s request for transcript(s) is speculative
`because Petitioner does not know whether such testimony is useful (Patent
`Owner noted Dr. Warner was not designated in the related district court
`litigation to testify on validity, secondary considerations, objective indicia,
`unexpected results, or any similar concept). Id. at 3, 5.
`We agree with Petitioner that its requests for discovery outlined above
`are not merely speculative, but are tailored, based on Petitioner’s knowledge,
`to obtain the limited production of relevant evidence on objective indicia of
`non-obviousness. Hence, we conclude Petitioner is in possession of a
`threshold amount of evidence or reasoning tending to show beyond
`speculation that something useful will be uncovered in the requested specific
`documents and testimony concerning Dr. Warner’s position on and evidence
`regarding unexpected results. Garmin, IPR2012-00001, Paper 26 at 7.
`B. GARMIN FACTOR 2–LITIGATION POSITIONS
`Petitioner argues that the sought discovery “has nothing to do with
`[Patent Owner’s] litigation position[s].” Pet. Mot. 6. Patent Owner makes
`no argument opposing Petitioner’s position on this factor.
`Petitioner’s sought discovery is tailored to and relates to Patent
`Owner’s specific defenses regarding patentability that are relevant here. It is
`not apparent why the production of existing transcripts or cross examination
`on unexpected results would inappropriately reveal any litigation position of
`Patent Owner that is not relevant.
`C. GARMIN FACTOR 3–ABILITY TO GENERATE EQUIVALENT
`INFORMATION BY OTHER MEANS
`Petitioner argues that “[t]here is no other way for [it] to obtain this
`discovery as Dr. Osborne has no personal knowledge and [Patent Owner’s]
`
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`IPR2019-00207
`Patent 9,517,219 B2
`
`allegations of unexpected results rely upon Dr. Warner’s declaration where
`only he knows what occurred.” Pet. Mot. 7. Patent Owner makes no
`argument on this factor.
`We agree with Petitioner; Patent Owner and its former witness (in the
`related district court litigation), Dr. Warner, appear to be the only sources for
`the sought discovery of the factual information presented in Dr. Warner’s
`declaration upon which Dr. Osborne relies. We note Patent Owner describes
`the Warner Declaration as “a short declaration from an inventor, Dr. Warner,
`submitted during the prosecution of the ’219 patent” that “reports data and
`test results from Dr. Warner’s own experiments and experiments under his
`supervision.” This is an accurate description, which supports the grant of
`additional discovery here to explore the factual underpinnings of that
`declaration upon which Patent Owner relies. As noted by Petitioner,
`Dr. Warner’s Declaration is the main, if not sole, basis for Patent Owner’s
`expert’s (Dr. Osborne) position on unexpected results evidencing non-
`obviousness. See Ex. 2057 ¶¶ 173–194. The brevity of Dr. Warner’s
`Declaration (it is essentially two (2) pages long) and its import to an issue
`central to this proceeding warrants further elaboration from its author.
`D. GARMIN FACTOR 4: EASILY UNDERSTANDABLE REQUESTS
`Petitioner argues its request for discovery is easily understood because
`it merely “seeks basic factual information about how [Dr. Warner’s]
`compositions were prepared and what he observed.” Patent Owner does not
`refute Petitioner’s rationale here.
`We agree with Petitioner that its discovery requests are
`understandable. They are specific as to the relevant subject matter, the
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`IPR2019-00207
`Patent 9,517,219 B2
`
`relevant and limited number of documents to be produced, and the tailored
`deposition sought.
`E. GARMIN FACTOR 5–OVERLY BURDENSOME OR SENSIBLE AND
`REASONABLY TAILORED
`Petitioner argues its sought discovery is limited and not unduly
`burdensome on Patent Owner because of its narrow scope. Pet. Mot. 7.
`Petitioner argues that the sought transcripts already exist and can be easily
`produced here. Id. Petitioner argues the deposition request is also not
`overly burdensome because, “[e]ven though Dr. Warner might not be
`employed at Almirall, [he] nevertheless [was] still [similarly] presented for
`deposition in the” related district court litigation “in July 2018.” Id. (citing
`Ex. 1038, 232 (Proposed Joint Pretrial Order – Warner deposition
`designations)). Petitioner argues it similarly seeks Dr. Warner’s deposition
`here. Id.
`Patent Owner argues Petitioner’s request is burdensome in view of the
`schedule of the proceedings (Patent Owner Reply due November 1, 2019;
`Petitioner Sur-Reply Due December 13, 2019; and Oral Argument set for
`February 7, 2020). PO Opp. 5. Patent Owner also argues Petitioner delayed
`making the discovery requests at issue. Id. at 6.
`The Board is sensitive to the schedule issues identified by Patent
`Owner and, therefore, grants limited additional briefing to each party as
`noted below. There is essentially no burden on Patent Owner in producing
`the transcripts requested, which should be produced immediately. Although
`there is some burden on Patent Owner and the witness in participating in a
`deposition of Dr. Warner, we conclude it is warranted in the interests of
`justice because of Patent Owner’s reliance on Dr. Warner’s terse declaration
`in arguing unexpected results and non-obviousness. Patent Owner should
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`IPR2019-00207
`Patent 9,517,219 B2
`
`make Dr. Warner available for deposition by January 17, 2020, that is, in
`enough time prior to the scheduled oral argument for any necessary further
`briefing and submission of new evidence to be made.
`III. CONCLUSION
`We remind the parties that if any confidential information is filed in
`this matter, a motion to seal should be concurrently filed with a proposed
`protective order, such as the default protective order in Appendix B of the
`Board’s Trial Practice Guide. 37 C.F.R. §§ 42.14 and 42.54. No such
`motion has as yet been filed and no protective order is in effect in this
`proceeding.
`We find that the Garmin factors favor granting Petitioner’s requested
`discovery, as set forth above and Petitioner has made a sufficient showing to
`justify its requested additional discovery. We authorize Petitioner’s tailored
`requests for document production and deposition of Dr. Warner and set the
`deadline for such discovery at January 17, 2020. Furthermore, we authorize
`further briefing by the parties, as set forth below.
`For the foregoing reasons, it is
`ORDERED that Petitioner’s Motion for Additional Discovery is
`granted;
`FUTHER ORDERED that the discovery sought in Petitioner’s
`requests for production of transcripts from Dr. Kevin S. Warner’s
`deposition(s) in the related district court litigation is granted and should be
`produced forthwith;
`FURTHER ORDERED that the discovery sought in Petitioner’s
`requests for the deposition of Dr. Kevin S. Warner is granted;
`
`8
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`IPR2019-00207
`Patent 9,517,219 B2
`
`
`FURTHER ORDERED that the above-ordered discovery shall be
`completed by January 17, 2020; and
`FURTHER ORDERED that Petitioner is authorized to file by January
`24, 2020, ten (10) pages of further briefing addressing only, and new
`exhibits directed only to, evidence obtained in the above-granted additional
`discovery; and
`FURTHER ORDERED that Patent Owner is authorized to file by
`January 31, 2020, ten (10) pages of further briefing addressing arguments
`and evidence presented in the aforementioned Petitioner’s further briefing, if
`submitted.
`
`
`
`
`9
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`
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`IPR2019-00207
`Patent 9,517,219 B2
`
`For PETITIONERS:
`
`Representing Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of
`New York, LLC:
`
`Dennies Varughese
`Adam LaRock
`Tyler Liu
`Sterne, Kessler, Goldstein & Fox P.L.L.C.
`dvarughe-ptab@skgf.com
`alarock-ptab@skgf.com
`tliu-ptab@skgf.com
`
`Representing Mylan Pharmaceuticals Inc.:
`
`Jitendra Malik
`Alissa Pacchioli
`Lance Soderstrom
`Heike Radeke
`Katten Muchin Rosenman LLP
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`lance.soderstrom@kattenlaw.com
`heike.radeke@kattenlaw.com
`
`
`For PATENT OWNER:
`
`James Trainor
`Elizabeth Hagan
`Fenwick & West LLP
`jtrainor@fenwick.com
`ehagan@fenwick.com
`
`
`
`10
`
`
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