U.S. Patent Nos. 9,518,123 and 9,540,445
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`MILTENYI BIOMEDICINE GmbH and MILTENYI BIOTEC INC.,
`
`Petitioners,
`
`v.
`
`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA,
`
`Patent Owner.
`
`Case No.: IPR2022-00852
`U.S. Patent No. 9,518,123
`Case No.: IPR2022-00855
`U.S. Patent No. 9,540,445
`
`
`
`
`
`PETITIONER’S MOTION FOR ADDITIONAL DISCOVERY
`
`
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`MILTENYI BIOMEDICINE GmbH and MILTENYI BIOTEC INC.,
`
`Petitioners,
`
`v.
`
`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA,
`
`Patent Owner.
`
`Case No.: IPR2022-00852
`U.S. Patent No. 9,518,123
`Case No.: IPR2022-00855
`U.S. Patent No. 9,540,445
`
`
`
`
`
`PETITIONER’S MOTION FOR ADDITIONAL DISCOVERY
`
`
`
`
`
`
`
`
`
`
`U.S. Patent Nos. 9,518,123 and 9,540,445
`
`Pursuant to the Board’s authorization email to counsel dated March 7, 2023,
`
`Petitioner moves for discovery seeking documents relating to Dr. Adam Bagg’s
`
`declaration (Ex. 2044) and his contributions as a co-author and co-investigator of
`
`Exhibit 1012, Porter et al., Chimeric Antigen Receptor–Modified T Cells in Chronic
`
`Lymphoid Leukemia, 365 N. ENGL J. MED. 725 (2011) and its supplementary
`
`materials, Exhibit 1013 (collectively, “Porter”).
`
`Petitioner’s three Requests for Document Production are attached as an
`
`appendix. They 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.
`
`Porter is a publication predating the priority date. Dr. Bagg is a co-author of
`
`Porter but is not named as inventor of the challenged patents. The requested
`
`discovery is highly relevant to whether Porter is prior art, i.e., whether the relevant
`
`content of Porter includes the work of Dr. Bagg or is entirely attributable to the
`
`named inventors of the challenged patents. Google LLC v. IPA Techs. Inc., IPR2019-
`
`00731, 2020 WL 5582275, at *5 (PTAB Sept. 16, 2020) (“In determining whether a
`
`reference is the work of the challenged patent's named inventor(s), the inquiry
`
`focuses on whether the relevant content of the reference—‘which includes the
`
`design, trial, and analysis of results’—was solely the work of the inventor(s).”).
`
`Porter is the main reference in Ground 4. Given the importance of Porter,
`
`narrow document discovery should be allowed to mount a full and fair determination
`
`
`
`1
`
`
`
`U.S. Patent Nos. 9,518,123 and 9,540,445
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`of the unpatentability. Petitioner’s motion should be granted under the Garmin
`
`factors, which are addressed below.
`
`I.
`
`NECESSARY IN THE INTERESTS OF JUSTICE.
`
`The Board may grant additional discovery where necessary “in the interests
`
`of justice,” 37 C.F.R. § 42.51(b)(2)(i), as it is here. In assessing whether to grant
`
`additional discovery, the Board applies a five factor “necessary in the interest of
`
`justice” standard. See Garmin Int’l v. Cuozzo Speed Techs, IPR2012-00001, Paper
`
`26 at 6-7 (PTAB Mar. 5, 2013). All Garmin factors support granting this motion.
`
`A. Garmin Factor 1: More Than a Possibility or Mere Allegation
`That the Requested Discovery Will Yield Useful Information.
`
`Patent Owner’s Responses argue that (1) the claims require a showing of
`
`effectiveness of CAR-T therapy and (2) the prior art fails to show that. See e.g.,
`
`IPR2022-00855, POR, Paper 20 at 18 (arguing the claims require a showing of
`
`“therapeutic or prophylactic benefit”); IPR2022-0852, POR, Paper 18 at 34 (“In
`
`addition, the POSA would have expected that CAR-T cells would not replicate well
`
`in humans and would thus have limited, transient effects, if any.”). Petitioner
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`disagrees that the claims require a showing of effectiveness.
`
`But if the claims do require a showing of effectiveness, then Petitioner’s
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`requested discovery is necessary in the interest of justice. Porter teaches that CAR-T
`
`therapy was effective in several respects, including: reduction of tumor cells,
`
`
`
`2
`
`
`
`U.S. Patent Nos. 9,518,123 and 9,540,445
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`reduction of tumor size, and reduction of clinical symptoms. See e.g., Ex. 1012 at
`
`727 (“no evidence of CLL in the bone marrow”), id. (“flow-cytometric analysis
`
`showed no residual CLL”), id. at 728 (“contrast-enhanced CT” of tumors), id. at 725
`
`(“Remission was ongoing 10 months after treatment.”). Additional discovery is
`
`needed to show that Dr. Bagg, a physician and the sole hematopathologist listed as
`
`a co-author and co-investigator on Porter, substantively contributed to the
`
`determination of effectiveness disclosed in Porter.
`
`Only Patent Owner possesses documentation of Dr. Bagg’s full contributions
`
`to Porter. Dr. Bagg was employed by Patent Owner at the relevant time and is still
`
`employed there today. Based on limited publicly available information, it appears
`
`that Dr. Bagg was responsible in Porter for at least determining minimal residual
`
`disease (“MRD”) after treatment. See e.g., Ex. 2013 at 36 (“MRD assessments by
`
`Dr. Bagg”); id. at 37 (“MRD assessments by Dr. Bagg”). MRD assessment is,
`
`according to the Porter protocol, one endpoint for determining “anti-tumor responses
`
`to CART-19 cell infusions.” Ex. 1013, Section 3.3.
`
`Patent Owner submitted a declaration from Dr. Bagg (Ex. 2044) with its PORs
`
`to try to remove Porter as prior art. The declaration states that Dr. Bagg “determined
`
`the laboratory result indicating remission.” Ex. 2044 at ¶8. The PORs argue that Dr.
`
`Bagg was merely “performing ‘assay[s] and testing’ at the inventors’ instruction.”
`
`E.g., IPR2022-0852, Paper 18 at 29.
`
`
`
`3
`
`
`
`U.S. Patent Nos. 9,518,123 and 9,540,445
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`Petitioner’s requested discovery is necessary to determine the credibility of
`
`Patent Owner’s contention that Dr. Bagg essentially acted as a mere lab technician.
`
`Patent Owner contends that Dr. Bagg’s role was limited to “performing ‘assay[s]
`
`and testing at the inventors’ instruction,” but that is routine work which would not
`
`warrant inclusion as a co-investigator and co-author. The criteria for authorship
`
`provided by the International Committee of Medical Journal Editors states, in
`
`relevant part, that an author must have made “substantial contributions to the
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`conception or design of the work; or the acquisition, analysis, or interpretation of
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`data for the work.” Defining the Role of Authors and Contributors, ICMJE, available
`
`at: https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defi
`
`ning-the-role-of-authors-and-contributors.html. Petitioner’s discovery request is
`
`necessary to show that Dr. Bagg was not simply a technician implementing the
`
`inventors’ instructions, as Patent Owners contend, but that he made “substantial
`
`contributions” to portions of Porter relevant to the challenged claims.
`
`The requested discovery is also necessary to show that Dr. Bagg applied his
`
`expertise to make independent judgments about the CAR-T effectiveness disclosed
`
`in Porter. Dr. Bagg is an academic researcher and hematopathologist, which requires
`
`many years of specialized training after medical school. He had extensive T-cell
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`expertise at the time of Porter, for example, authoring commentary on antigen B-cell
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`and T-cell receptor gene rearrangements, particularly in T-cell lymphoma. Bagg,
`
`
`
`4
`
`
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`U.S. Patent Nos. 9,518,123 and 9,540,445
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`Immunoglobulin and T-Cell Receptor Gene Rearrangements: Minding Your B’s and
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`T’s in Assessing Lineage and Clonality in Neoplastic Lymphoproliferative
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`Disorders, 8 J. MOL. DIAGN. 426 (2006).
`
`B. Garmin Factor 2: Petitioner Does Not Seek Patent Owner’s
`Litigation Positions or Their Underlying Basis.
`
`None of the proposed requests for production seek Patent Owner’s litigation
`
`positions or their underlying basis. There is no co-pending litigation. This second
`
`Garmin factor also favors Petitioner.
`
`C. Garmin Factor 3: Petitioner Cannot Generate Equivalent
`Information by Other Means.
`
`The third Garmin factor also favors Petitioner as the discovery requests
`
`narrowly target information available only in Patent Owner’s possession. The
`
`requested documents, which will likely be in the form of emails, clinical notes, and
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`clinical and laboratory reports prepared by Dr. Bagg, are not available publicly.
`
`While Patent Owner has agreed to a future deposition of Dr. Bagg, “a
`
`deposition is not a substitute for responding to requests for production of
`
`documents.” Penn Nat'l Mut. Cas. Ins. Co. v. Virginia Elec. & Power Co., No. 2:20-
`
`CV-66-BO, 2021 WL 6203177, at *4 (E.D.N.C. May 19, 2021). Dr. Bagg’s
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`deposition testimony may be as non-specific and conclusory as his declaration
`
`testimony was. There were no documents submitted with Dr. Bagg’s declaration to
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`either support or show any inconsistencies with the declaration’s conclusory
`
`
`
`5
`
`
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`U.S. Patent Nos. 9,518,123 and 9,540,445
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`statements. See Ex. 2044, ¶7 (“all of the portions of Porter cited by the Petitioners
`
`reflect the work of my co-authors and not me”). Here, as in Penn National, the
`
`moving party has “received very little documentation of work performed.” 2021 WL
`
`6203177, at *4. Document discovery requests are appropriate in conjunction with a
`
`deposition because documents allowed the receiving party to “more thoroughly
`
`question [the witness] about the documents at his deposition.” See id.
`
`In addition, Porter is a publication from twelve years ago. Deposing Dr. Bagg
`
`about his memories from twelve years ago is unlikely to be as reliable as documents
`
`from that time period. See Pugh v. Cmty. Health Sys., Inc., No. 5:20-CV-00630, 2021
`
`WL 75805, at *2 (E.D. Pa. Jan. 8, 2021) (allowing RFPs because “witness testimony
`
`regarding the exact times [the witnesses] worked in 2014 are likely to be far less
`
`reliable than the requested documents”). The requested documents may also be
`
`necessary to refresh Dr. Bagg’s recollection from that time.
`
`D. Garmin Factors 4 and 5: Petitioner’s Requests Are Easily
`Understandable and Are Not Overly Burdensome.
`
`The fourth and fifth Garmin factors also favor Petitioner. The submitted
`
`discovery requests are specific and easily understandable. Petitioner’s RFP No. 1
`
`seeks documents showing Dr. Bagg’s involvement in determinations of remission
`
`for patients in Porter. Petitioner’s RFP No. 2 seeks documents showing Dr. Bagg’s
`
`involvement in determinations in the Porter study that patients experienced a
`
`
`
`6
`
`
`
`U.S. Patent Nos. 9,518,123 and 9,540,445
`
`reduction in the frequency or severity of at least one clinically relevant sign or
`
`symptom of the disease, tracking Patent Owner’s proposed claim construction in
`
`IPR2022-00855. Petitioner’s RFP No. 3 seeks documents showing why Dr. Bagg
`
`was included as a co-author.
`
`Here, unlike in Garmin, the requests do not require significant expenditure of
`
`resources searching through an enormous amount of data over a broad period of
`
`time. Petitioner’s requests are limited to one study, one article, and one physician.
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`During a meet and confer, Patent Owner verbally confirmed that responsive
`
`documents were in its possession, specifically referring to “documents that support
`
`what Dr. Bagg stated in his declaration.” Indeed, in preparing Dr. Bagg’s
`
`declaration, Patent Owner likely has already searched for documents that would be
`
`responsive to Petitioner’s discovery request. It would be no burden to produce these
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`documents.
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`On patient medical privacy concerns, Petitioner is not requesting the personal
`
`information of patients; a redacted copy of the records, with personally-identifying
`
`information obscured, will suffice. This is no different than what is done routinely
`
`when reporting patient-level data in journals.
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`II. CONCLUSION
`
`The interests of justice dictate granting Petitioner’s motion.
`
`
`
`
`
`7
`
`
`
`Dated: March 21, 2023
`
`U.S. Patent Nos. 9,518,123 and 9,540,445
`
`ORRICK, HERRINGTON & SUTCLIFFE LLP
`
`
`
`
`
`/Yite John Lu/
`By:
`Yite John Lu
`Lead Counsel for Petitioner
`Reg. No. 63158
`355 South Grand Avenue, Suite 2700
`Los Angeles, CA 90071
`T: (213) 629-2020
`F: (213) 612-2499
`Email: PTABDocketL2Y7@orrick.com
`
`Gary N. Frischling
`Reg. No. 35515
`355 South Grand Avenue, Suite 2700
`Los Angeles, CA 90071
`T: (213) 629-2020
`F: (213) 612-2499
`Email: PTABDocketG2F1@orrick.com
`
`David I. Gindler
`To be pro hac vice
`355 South Grand Avenue, Suite 2700
`Los Angeles, CA 90071
`T: (213) 629-2020
`F: (213) 612-2499
`Email: PTABDocketG3D7@orrick.com
`
`
`Attorneys for Petitioners
`
`
`
`
`
`
`8
`
`
`
`U.S. Patent Nos. 9,518,123 and 9,540,445
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`APPENDIX A
`
`
`
`
`
`9
`
`
`
`U.S. Patent Nos. 9,518,123 and 9,540,445
`
`Pursuant to Federal Rule of Civil Procedure 26(a) and the Patent Board’s Scheduling
`
`Order, Miltenyi Biomedicine GmbH and Miltenyi Biotec Inc. (collectively,
`
`“Petitioner”) hereby requests that The Trustees of the University of Pennsylvania
`
`(“Patent Owner”) respond to the following requests for production (the “Requests
`
`and, each, a “Request”) within 30 days of service in accordance with the following
`
`Definitions and Instructions.
`
`DEFINITIONS
`
`1.
`
`“The Trustees of the University of Pennsylvania.” means The Trustees of the
`
`University of Pennsylvania and its subsidiaries, divisions, predecessor and successor
`
`companies, affiliates, and each of its employees, members, agents, officers,
`
`directors, and all other persons acting or purporting to act for any of them or on their
`
`behalf or under their control or direction.
`
`2.
`
`“Patent Owner,” “You,” or “Your” means The Trustees of the University of
`
`Pennsylvania.
`
`3.
`
`’445 Patent means U.S. Patent No. 9,540,445. ‘123 Patent means U.S. Patent
`
`No. 9,518,123.
`
`Dr. Bagg means Dr. Adam Bagg.
`
`Bagg Declaration means Exhibit 2044, the Declaration of Dr. Adam Bagg.
`
`10
`
`4.
`
`5.
`
`
`
`
`
`U.S. Patent Nos. 9,518,123 and 9,540,445
`
`“Porter” means David L. Porter et al., Chimeric Antigen Receptor–Modified
`
`6.
`
`T Cells in Chronic Lymphoid Leukemia, 365 N. ENGL J. MED. 725 (2011) and its
`
`supplementary material.
`
`7.
`
`“And” and “or” shall be construed either disjunctively or conjunctively as
`
`necessary to bring within the scope of the category all documents that otherwise
`
`might be construed to be outside of its scope.
`
`8.
`
`“All,” “each,” and “any” mean one or more and shall be construed as all and
`
`any.
`
`9.
`
`“Communication” means any transmissions of information of any kind,
`
`orally, in writing, or in any other manner, and any documents reflecting the time,
`
`place, participants or contents of such transmissions.
`
`10.
`
`“Document” means anything within the scope of Rule 34 of the Federal Rules
`
`of Civil Procedure, including all types of electronically stored information and
`
`tangible things.
`
`11.
`
`“Including” means including but not limited to.
`
`12.
`
`“Person” means any natural person, or any business, legal or governmental
`
`entity, or association.
`
`
`
`11
`
`
`
`U.S. Patent Nos. 9,518,123 and 9,540,445
`
`
`INSTRUCTIONS
`
`In responding and producing documents and things responsive to these Requests,
`
`you shall comply with the Board’s Scheduling Order and the limitations on
`
`discovery set forth in the Federal Rules of Civil Procedure and the following
`
`instructions:
`
`1.
`
`All Documents that respond, in whole or in part, to any portion of any Request
`
`shall be produced in their entirety, including all attachments and enclosures thereto.
`
`2.
`
`The Requests are intended to cover all Documents and things in Your
`
`possession, or subject to Your custody and control, or available to You wherever
`
`such Documents and things are located, including, but not limited to, any of Your or
`
`Your attorneys’ or affiliates’ offices.
`
`3.
`
`Documents and things shall be produced in separate files designated by
`
`reference to the specific Request to which they are responsive.
`
`4.
`
`If information otherwise discoverable under the Federal Rules of Civil
`
`Procedure is withheld pursuant to a claim that it is privileged, subject to protection
`
`as trial preparation material, or otherwise immune from disclosure, such claim shall
`
`be made expressly and the nature of the Documents, Communications, or things not
`
`
`
`12
`
`
`
`U.S. Patent Nos. 9,518,123 and 9,540,445
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`produced or disclosed shall be described in a manner that will enable Plaintiff to
`
`assess the applicability of the privilege or protection.
`
`5.
`
`Pursuant to Federal Rule of Civil Procedure Rule 26(e), any response shall be
`
`seasonably amended if You obtain information which indicates that the prior
`
`response was incorrect or, though the response was correct when made, it is no
`
`longer correct.
`
`6.
`
`No Request is intended to limit or otherwise define any other Request.
`
`REQUESTS FOR PRODUCTION
`
`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.
`
`
`
`
`
`
`
`13
`
`
`
`REQUEST FOR PRODUCTION NO. 3:
`
`U.S. Patent Nos. 9,518,123 and 9,540,445
`
`
`All documents showing your contributions to Porter or explaining or documenting
`the reasons that you were included as a co-author of Porter.
`
`
`
`
`
`14
`
`
`
`U.S. Patent Nos. 9,518,123 and 9,540,445
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that on March 21, 2023, a copy of the following
`
`was served in its entirety via electronic mail, upon the following attorneys of
`
`record for the Patent Owner:
`
`brian.landry@saul.com
`IPGroupMailbox@saul.com
`
`kathryn.doyle@saul.com
`
`alireza.behrooz@saul.com
`
`tfletcher@wc.com
`NovartisCART@wc.com
`
`Brian R. Landry
`SAUL EWING ARNSTEIN & LEHR LLP
`131 Dartmouth Street, Suite 501
`Boston, MA 02116
`
`Kathryn Doyle
`SAUL EWING ARNSTEIN & LEHR LLP
`Centre Square Way
`1500 Market Street, 38th Floor
`Philadelphia, PA 19102
`
`Alireza Behrooz
`SAUL EWING ARNSTEIN & LEHR LLP
`1919 Pennsylvania Avenue, N.W., Suite 550
`Washington, D.C. 20006
`
`Thomas S. Fletcher
`Jessamyn S. Berniker
`David M. Krinsky
`David M. Horniak
`Kathryn S. Kayali
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue SW
`Washington, DC 20024
`
`
`Attorneys for Patent Owner The Trustees of the University of Pennsylvania
`
` /Elaine Ke/
` Elaine Ke
`
`
`
`
`
`15
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`
`
`
`
`
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