Trials@uspto.gov
`571-272-7822
`
`Paper: 24
`Date: April 11, 2023
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MILTENYI BIOMEDICINE GmbH and MILTENYI BIOTEC INC.
`Petitioner
`v.
`
`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
`Patent Owner
`
`____________
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`____________
`
`
`Before ULRIKE W. JENKS, SUSAN L. C. MITCHELL, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge
`
`
`
`ORDER
`Granting Petitioner’s Motion for Additional Discovery
`37 C.F.R. § 42.51(b)(2)
`
`
`571-272-7822
`
`Paper: 24
`Date: April 11, 2023
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MILTENYI BIOMEDICINE GmbH and MILTENYI BIOTEC INC.
`Petitioner
`v.
`
`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
`Patent Owner
`
`____________
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`____________
`
`
`Before ULRIKE W. JENKS, SUSAN L. C. MITCHELL, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge
`
`
`
`ORDER
`Granting Petitioner’s Motion for Additional Discovery
`37 C.F.R. § 42.51(b)(2)
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`INTRODUCTION AND BACKGROUND
`I.
`Pursuant to our authorization (Exhibit 3001), 1 Petitioner Miltenyi
`Biomedicine GmbH and Miltenyi Biotec Inc. (collectively, “Petitioner”)
`filed a motion for additional discovery (Paper 20, “Mot.”). Patent Owner,
`The Trustees of the University of Pennsylvania filed an opposition. (Paper
`21, “Opp.”).
`As Ground 4, Petitioner challenges all claims as obvious in view of a
`number of references, including Porter, 2 a New England Journal of Medicine
`Brief Report published within one year of the critical date, and reporting on
`a patient treated in a clinical trial of CART-cells. See e.g., Paper 1 (Petition),
`4; Paper 9 (Institution Decision), 24–25. Among the authors of Porter, only
`Dr. Adam Bagg is not listed as an inventor of the challenged patents.
`Relying on the Dr. Bagg’s Declaration (Exhibit 2044), Patent Owner argues
`that Porter is not prior art under 35 U.S.C § 103(a), because Dr. Bagg did not
`make a requisite inventive contribution in Porter and merely “perform[ed]
`‘assay[s] and testing’ at the inventors’ instruction.” See Opp. 8; Paper 18
`(Patent Owner’s Response), 29 (second alteration in original). As such, the
`scope of Dr. Bagg’s contribution to Porter is determinative of whether Porter
`qualifies as prior art.
`
`
`1 Similar Exhibits and Papers are of record in both cases. We cite to those of
`IPR2022-00852 for convenience.
`2 Exhibit 1012, Porter et al., Chimeric Antigen Receptor–Modified T Cells in
`Chronic Lymphoid Leukemia, 365 N. ENGL J. MED. 725 (2011) and
`supplementary materials, Exhibit 1013 (collectively, “Porter”).
`
`
`2
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`Patent Owner has agreed to make Dr. Bagg available for deposition.
`Opp. 13. 3 Petitioner further seeks, as additional discovery, documents from
`Dr. Bagg falling under three Requests for Production (“Requests”) which, it
`contends, “are narrowly tailored to Dr. Bagg’s involvement in determining
`anti-tumor efficacy and the reasons he is a co-author and co-investigator of
`Porter.” Mot. 1. In particular, Petitioner seeks:
`
`REQUEST FOR PRODUCTION NO. 1:
`All documents showing your involvement in determinations of
`remission for patients in the Porter study.
`REQUEST FOR PRODUCTION NO. 2:
`All documents showing your involvement in determinations
`that patients in the Porter study experienced a reduction in the
`frequency or severity of at least one clinically relevant sign or
`symptom of the disease.
`REQUEST FOR PRODUCTION NO. 3:
`All documents showing your contributions to Porter or
`explaining or documenting the reasons that you were included
`as a co-author of Porter.
`Id. at Appendix A, 13–14.
`
`II. ANALYSIS
`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 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.
`
`
`3Patent Owner does not dispute that “Dr. Bagg was employed by Patent
`Owner at the relevant time and is still employed there today.” Mot. 3; see
`Ex. 2044 ¶¶ 4–5.
`
`3
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`27, 2008) (statement of Sen. Kyl). Accordingly, 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.”).
`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”). In assessing Petitioner’s motion, we address those factors
`below.
`
`Factor 1 – There must be more than a possibility and mere allegation that
`something useful will be discovered.
`Pursuant to factor 1, we consider whether Petitioner is already in
`possession of a threshold amount of evidence or reasoning tending to show
`beyond speculation that something useful will be uncovered via the
`requested discovery. Garmin, IPR2012-00001, Paper 26, at 7. “Useful” in
`this context does not mean merely “relevant” and/or “admissible.” Id.
`Rather, it means favorable in substantive value to a contention of the party
`moving for discovery. Id.
`Petitioner argues that the requested discovery is necessary in the
`interest of justice if, as Patent Owner contends, the claims require a showing
`of effectiveness of CAR-T therapy as disclosed in Porter. Mot. 2–3. In this
`respect, Petitioner asserts that, “[b]ased on publicly available information, it
`appears that Dr. Bagg was responsible in Porter for at least determining
`minimal residual disease (‘MRD’) after treatment.” Id. at 3 (citing Ex. 2013,
`
`4
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`36–37; Ex. 1013, Section 3.3). Petitioner further argues that the “requested
`discovery is necessary to determine the credibility of Patent Owner’s
`contention that Dr. Bagg essentially acted as mere lab technician” and to
`determine whether he applied his extensive expertise in the relevant field “to
`make independent judgments about the CAR-T effectiveness disclosed in
`Porter.” Id. at 4–5.
`In response, Patent Owner points out that merely performing tests that
`demonstrate efficacy does not necessarily equate to an inventive
`contribution. Opp. 10–11 (citing e.g., Burroughs Wellcome Co. v. Barr
`Labs., Inc., 828 F.Supp. 1208, 1210–12 (E.D.N.C. 1993), aff’d, 40 F.3d
`1223 (Fed. Cir. 1994).). Moreover, referencing Dr. Bagg’s extensive
`credentials and experience, Patent Owner argues that “scientists aiding with
`assessment of efficacy can act as more than the canonical ‘pair of hands’
`without being co-inventors.” Opp. 11–12 (citing Burroughs, 40 F.3d at
`1230).
`Patent Owner’s points are well taken. We, nevertheless, find that
`additional discovery is appropriate to determine whether Dr. Bagg’s
`contributions to Porter fall entirely within the confines of Burroughs.
`Moreover, in assessing Dr. Bagg’s credibility regarding the scope and
`content of his contributions, we agree with Petitioner that “[d]eposing
`Dr. Bagg about his memories from twelve years ago is unlikely to be as
`reliable as documents from that time period,” which may also “refresh
`Dr. Bagg’s recollection from that time.” Mot. 6 (citation omitted).
`Accordingly, Factor 1 favors Petitioner.
`
`
`
`5
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`Factor 2 – A party may not seek another’s litigation positions or the
`underlying basis for those positions.
`Neither party contends that the proposed Requests seek litigation
`positions or the underlying basis for those positions. Mot. 5; Opp. 12. As
`such, Factor 2 is neutral or slightly favorable to Petitioner.
`
`Factor 3 – A party should not seek information that reasonably can be
`generated without a discovery request.
`With respect to factor three, Patent Owner asserts that “Dr. Bagg will
`be made available for deposition, and Petitioner’s will have the opportunity
`to cross-examine him and explore their theories in that forum.” Opp. 13.
`Petitioner argues that Dr. Bagg’s declaration is unaccompanied by any
`supporting documentation. Mot. 5–6. Petitioner further contends that
`because the events in Porter occurred some twelve years ago, documentation
`from that time may be more reliable than Dr. Bagg’s memory, and may be
`necessary to refresh his recollection. See id. at 6. As such, Factor 3 is
`moderately favorable to Petitioner.
`
`Factor 4 – Instructions and questions should be easily understandable.
`Petitioner contends that its “discovery requests are specific and easily
`understandable.” Mot. 6. Other than as to breadth, discussed in connection
`with Factor 5, Patent Owner does not contend that the instructions and
`questions are not easily understandable. As such, Factor 4 slightly favors
`Petitioner.
`
`Factor 5 – The discovery requests must not be overly burdensome to answer.
`Petitioner argues that its “requests are limited to one study, one
`article, and one physician.” Mot. 7. Moreover, Petitioner contends, “in
`preparing Dr. Bagg’s declaration, Patent Owner likely has already searched
`
`6
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`for documents that would be responsive to Petitioner’s discovery request,”
`and had indicated that it was in possession of “documents that support what
`Dr. Bagg stated in his declaration.”4 Id. Accordingly, Petitioner asserts, “[i]t
`would be no burden to produce these documents.” Id.
`Patent Owner appears to interpret the Requests as requiring the
`collection and redaction of extensive raw patient data, including electronic
`medical records, relating to the clinical trial discussed in Porter. See Opp.
`13–14. To the extent that the Requests encompass such scope, we agree
`with Patent Owner that such an undertaking would be burdensome. We,
`instead, construe Petitioner’s Requests to exclude individual patient data
`files and electronic medical records.
`Patent Owner also contends that “Dr. Bagg and the inventors are
`faculty members or former staff of Patent Owner,” and points us to its
`“Policy on Privacy in the Electronic Environment” as “reflect[ing] the
`different considerations of an academic setting relative to other patentees.”
`Opp. 14 (citing Ex. 2082). Patent Owner does not, however, explain
`adequately the relevance of this policy document, nor persuade us that a
`search of faculty documents would impose an undue burden as contemplated
`by Garmin.
`As such, and in view of our reading of the proposed Requests,
`Factor 5 weighs in favor of Petitioner.
`
`
`4 Patent Owner does not contest these assertions. See generally, Opp.
`
`7
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`CONCLUSION
`Upon review of the parties’ arguments and supporting evidence in
`view of the Garmin factors, we conclude that it is in the interests of justice
`to grant Petitioner’s motion for additional discovery.
`
`ORDER
`In consideration of the foregoing, it is hereby
`ORDERED that Petitioner’s Motion for Additional Discovery is
`granted;
`FURTHER ORDERED that, within 5 business days of this Order,
`Patent Owner shall produce non-privileged documents referenced by its
`counsel as those “that support what Dr. Bagg stated in his declaration” (see
`Mot. 7);
`FURTHER ORDERED that Patent Owner shall produce any
`remaining discovery encompassed by Petitioner’s Requests For Production
`Nos: 1–3 no less than 5 business days prior to Dr. Bagg’s deposition, or at a
`time that is mutually agreeable to the parties.
`
`
`
`
`
`
`
`
`
`
`
`8
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`
`For PETITIONER:
`Yite John Lu
`Gary Frischling
`MILBANK LLP
`jlu@milbank.com
`gfrischling@milbank.com
`
`
`For PATENT OWNER:
`
`Brian R. Landry
`Kathryn Doyle
`Alireza Behrooz
`SAUL EWING ARNSTEIN & LEHR LLP
`brian.landry@saul.com
`kathryn.doyle@saul.com
`alireza.behrooz@saul.com
`
`
`Thomas S. Fletcher
`Jessamyn Berniker
`David M. Krinsky
`WILLIAMS & CONNOLLY LLP
`tfletcher@wc.com
`jberniker@wc.com
`dkrinsky@wc.com
`
`9
`
`
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