`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`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)
`
`PATENT OWNER’S OPPOSITION TO PETITIONERS’
`MOTION FOR ADDITIONAL DISCOVERY
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`41417243.2
`
`
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`PATENT OWNER’S EXHIBIT LIST
`
`Reference
`Jason Fagone, Has Carl June Found a Key to Fighting Cancer?,
`PHILA. MAG. (Aug. 1, 2013).
`Denise Grady, An Immune System Trained to Kill Cancer, N.Y. TIMES
`(Sept. 12, 2011),
`https://www.nytimes.com/2011/09/13/health/13gene.html.
`Jasone Fagone, Walt Keller, Leukemia Survivor, Has Passed, PHILA.
`MAG. (Feb. 20, 2014),
`https://www.phillymag.com/news/2014/02/20/walt-keller-leukemia-
`survivor-obituary-1953-2014/.
`Gina Kolata, A Cancer Treatment Makes Leukemia Vanish, but Creates
`More Mysteries, N.Y. TIMES (Feb. 2, 2022),
`https://www.nytimes.com/2022/02/02/health/leukemia-car-t-
`immunotherapy.html.
`Denise Grady, In Girl’s Last Hope, Altered Immune Cells Beat
`Leukemia, N.Y. TIMES (Dec. 9, 2012),
`https://www.nytimes.com/2012/12/10/health/a-breakthrough-against-
`leukemia-using-altered-t-cells.html.
`Denise Grady, F.D.A. Approves First Gene-Altering Leukemia
`Treatment, Costing $475,000, N.Y. TIMES (Aug. 30, 2017),
`https://www.nytimes.com/2017/08/30/health/gene-therapy-cancer.html.
`FOOD AND DRUG ADMIN., FDA APPROVAL BRINGS FIRST GENE THERAPY
`TO THE UNITED STATES (Aug. 30, 2017), https://www.fda.gov/news-
`events/press-announcements/fda-approval-brings-first-gene-therapy-
`united-states.
`FOOD AND DRUG ADMIN., BREAKTHROUGH THERAPY (Jan. 4, 2018),
`https://www.fda.gov/patients/fast-track-breakthrough-therapy-
`accelerated-approval-priority-review/breakthrough-therapy.
`FOOD AND DRUG ADMIN., PRIORITY REVIEW (Jan. 4, 2018),
`https://www.fda.gov/patients/fast-track-breakthrough-therapy-
`accelerated-approval-priority-review/priority-review.
`Barbara Savoldo et al., CD28 costimulation improves expansion and
`persistence of chimeric antigen receptor-modified T cells in lymphoma
`patients, 121 J. CLINICAL INVESTIGATION 1822 (2011).
`Brian G. Till et al., Adoptive immunotherapy for indolent non-Hodgkin
`lymphoma and mantle cell lymphoma using genetically modified
`autologous CD20-specific T cells, 112 BLOOD 2261 (2008).
`
`Ex.
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`
`
`1
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`Renier J. Brentjens et al., Safety and persistence of adoptively
`transferred autologous CD19-targeted T cells in patients with relapsed
`or chemotherapy refractory B-cell leukemias, 118 BLOOD 4817 (2011).
`Renier Brentjens et al., Treatment of chronic lymphocytic leukemia
`with genetically targeted autologous T cells: case report of an
`unforeseen adverse event in a phase I clinical trial, 18 MOLECULAR
`THERAPY 666 (2010).
`Renier J. Brentjens et al., A Phase I Trial for the Treatment of Chemo
`refractory Chronic Lymphocytic Leukemia with CD19-Targeted
`Autologous T Cells, 16 MOLECULAR THERAPY S15 (2008).
`Jennifer Couzin-Frankel, The dizzying journey to a new cancer arsenal,
`340 SCI. 1514 (2013).
`Jennifer Couzin-Frankel, Breakthrough of the Year 2013: Cancer
`Immunotherapy, 342 SCI. 1432 (2013).
`David L. Porter et al., Chimeric Antigen Receptor Modified T Cells
`Directed Against CD 19 (CTL0l 9 cells) Have Long-Term Persistence
`And Induce Durable Responses In Relapsed, Refractory CLL, 122
`BLOOD 4162 (2013).
`David L. Porter et al., Randomized, Phase II Dose Optimization Study
`Of Chimeric Antigen Receptor Modified T Cells Directed Against CD
`19 (CTL019) In Patients With Relapsed Refractory CLL, 122 BLOOD
`873 (2013).
`Stephan A. Grupp et al., T Cells Engineered With A Chimeric Antigen
`Receptor (CAR) Targeting CD 19 (CTL0l 9) Produce Significant In
`Vivo Proliferation, Complete Responses And Long-Term Persistence
`Without GVHD In Children And Adults With Relapsed, Refractory
`ALL, 122 BLOOD 67 (2013).
`James N. Kochenderfer et al., B-cell depletion and remissions of
`malignancy along with cytokine-associated toxicity in a clinical trial of
`anti-CD 19 chimeric-antigen-receptor transduced T cells, 119 BLOOD
`2709 (2012).
`Carl June Named One of Time’s 100 Most Influential People in the
`World, PENN MEDICINE (Apr. 26, 2018),
`https://pathology.med.upenn.edu/news/carl-june-named-one-times-
`100-most-influential-people-world.
`Holly Auer, Penn Medicine Immunotherapy Pioneer Carl June, MD,
`Awarded 2015 Paul Ehrlich and Ludwig Darmstaedter Prize, PENN
`TODAY (Mar. 11, 2015), https://penntoday.upenn.edu/news/penn-
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`
`
`2
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`2023
`
`2024
`
`2025
`
`2026
`
`medicine-immunotherapy-pioneer-carl-june-md-awarded-2015-paul-
`ehrlich-and-ludwig-darmstaed.
`Andrew Pollock, Setting the Body’s ‘Serial Killers’ Loose on Cancer,
`N.Y. TIMES (Aug. 1, 2016),
`https://www.nytimes.com/2016/08/02/health/cancer-cell-therapy-
`immune-system.html.
`2015 Watanabe Award Winner Carl H. June, IND. CLINICAL AND
`TRANSLATIONAL SCIS. INST., https://indianactsi.org/awards/watanabe-
`award-winners/2015-watanabe-award-winner-carl-h-june/ (last visited
`July 12, 2022).
`Agilent Presents Thought Leader Award to Drs. Carl H. June and
`Michael Milone, AGILENT TECHS. INC. (Nov. 17, 2020),
`https://www.agilent.com/about/newsroom/presrel/2020/17nov-
`ca20030.html.
`Information Disclosure Statement Initialed by Examiner (Apr. 18,
`2016), U.S. Patent Application No. 14,997,136.
`Information Disclosure Statement Initialed by Examiner (Apr. 18,
`2027
`2016), U.S. Patent Application No. 14,997,136.
`2028 World Intell. Prop. Org. Patent Application No. WO 02/077029 A2.
`Pilot Study for Patients with Chemotherapy Resistant or Refractory
`CD19 Leukemia and Lymphoma (CART-19), CLINICALTRIALS.GOV
`(April 29, 2009),
`[http://web.archive.org/web/20090903002304/http://clinicaltrials.gov/c
`t2/show/NCT00891215].
`2030 Amendments to the Claims (Nov. 13, 2018), U.S. Patent Application
`No. 15,353,899.
`Steven A. Rosenberg et al., Use of Tumor-Infiltrating Lymphocytes and
`Interleukin-2 in the Immunotherapy of Patients with Metastatic
`Melanoma, 319 NEW ENG. J. MED. 1676 (1988).
`Michael C. Jensen et al., Antitransgene Rejection Responses Contribute
`to Attenuated Persistence of Adoptively Transferred CD20/CD19-
`Specific Chimeric Antigen Receptor Redirected T Cells in Humans, 16
`BIOLOGY BLOOD AND MARROW TRANSPLANTATION 1245 (2010).
`Richard A. Morgan et al., Case Report of a Serious Adverse Event
`Following the Administration of T Cells Transduced With a Chimeric
`Antigen Receptor Recognizing ERBB2, 18 MOLECULAR THERAPY 843
`(2010).
`
`2029
`
`2031
`
`2032
`
`2033
`
`
`
`3
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`2034
`
`2035
`
`2036
`
`2038
`
`2039
`
`2040
`
`2041
`
`David L. Porter et al., A phase 1 trial of donor lymphocyte infusions
`expanded and activated ex vivo via CD3/CD28 costimulation, 107
`BLOOD 1325 (2006).
`Grazyna Lipowska-Bhalla, Targeted immunotherapy of cancer with
`CAR T cells: achievements and challenges, 61 CANCER IMMUNOLOGY,
`IMMUNOTHERAPY 953 (2012).
`Latest paper from the father of CAR-T: CAR-T really completely cured
`cancer, MEDICALTREND.ORG,
`https://medicaltrend.org/2022/02/03/latest-paper-from-the-father-of-
`car-t-car-t-really-completely-cured-cancer/ (last visited July 13, 2022).
`2037 Bipulendu Jena et al., Redirecting T-cell specificity by introducing a
`tumor-specific chimeric antigen receptor, 116 BLOOD 1035 (2010).
`Michael H. Kershaw et al., A Phase I Study on Adoptive
`Immunotherapy Using Gene-Modified T Cells for Ovarian Cancer, 12
`CLINICAL CANCER RSCH. 6106 (2006).
`Cor H.J. Lamers et al., Treatment of Metastatic Renal Cell Carcinoma
`With Autologous T-Lymphocytes Genetically Retargeted Against
`Carbonic Anhydrase IX: First Clinical Experience, 24 J. CLINICAL
`ONCOLOGY e20 (2006).
`ASH honors Bruce R. Blazar, M.D., and Carl H. June, M.D., with 2012
`Ernest Beutler Lecture and Prize, SCIENCEX (Aug. 27, 2012),
`https://sciencex.com/wire-news/107531358/ash-honors-bruce-r-blazar-
`md-and-carl-h-june-md-with-2012-ernest.html.
`Renier J. Brentjens et al., Genetically Targeted T Cells Eradicate
`Systemic Acute Lymphoblastic Leukemia Xenografts, 13 CLINICAL
`CANCER RSCH. 5426 (2007).
`2042 U.S. Patent No. 7,402,431.
`Cancer treatment myths: Any truth to these common beliefs?, MAYO
`CLINIC (March 22, 2022), https://www.mayoclinic.org/diseases-
`conditions/cancer/in-depth/cancer/art-20046762.
`2044 Adam Bagg Aff., July 19, 2022.
`SITC Smalley Award 2013 Recipient, SOC’Y FOR IMMUNOTHERAPY OF
`CANCER, https://www.sitcancer.org/funding/named-funds-and-
`awards2/smalley/2013 (last visited July 19, 2022).
`AAI-Steinman Award for Human Immunology Research Past
`Recipients, AM. ASS’N OF IMMUNOLOGISTS,
`https://www.aai.org/Awards/Career-Awards/AAI-Steinman-Award-
`for-Human-Immunology-Research/Past-Recipients.aspx (last visited
`July 19, 2022).
`
`2043
`
`2045
`
`2046
`
`
`
`4
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`2050
`
`2051
`
`2054
`
`2048 Decl. of Thomas S. Fletcher, Nov. 8, 2022.
`2049
`Search Results of Clinical Trials Associated with Dr. Richard P.
`Junghans, CLINICALTRIALS.GOV (Jan. 12, 2023),
`https://beta.clinicaltrials.gov/search?distance=SO&term=Richard
`Junghans.
`Recombinant DNA Advisory Committee Minutes of Meeting, US DEP’T
`OF HEALTH & HUM. SERVS., (Feb. 10, 2003).
`Recombinant DNA Advisory Committee Minutes of Meeting, US DEP’T
`OF HEALTH & HUM. SERVS., (Mar. 16, 2005).
`2052 Hildegund C.J. Ertl et al., Considerations for the Clinical Application
`of Chimeric Antigen Receptor (CAR) T Cells: Observations from a
`Recombinant DNA Advisory Committee (RAC) Symposium June 15,
`2010, 71 CANCER RES. 1 (2011).
`2053 Augusto C. Ochoa et al., Immune Defects in T Cells
`From Cancer Patients: Parallels in Infectious Diseases, in CURRENT
`CLINICAL ONCOLOGY: CANCER IMMUNOTHERAPY AT THE CROSSROADS:
`HOW TUMORS EVADE IMMUNITY AND WHAT CAN BE DONE 35 (J. H.
`Finke & R. M. Bukowski eds., 2004).
`Peter S. Kim et al., Features of responding T cells in cancer and
`chronic infection, 22 CURRENT OPINION IN IMMUNOLOGY 223 (2010).
`2055 Marta Czesnikiewicz-Guzik et al., T cell subset-specific susceptibility
`to aging, 127 CLINICAL IMMUNOLOGY 107 (2008).
`Jonathan E. Benjamin et al., Biology and clinical effects of natural
`killer cells in allogeneic transplantation, 22 CURRENT OPINION IN
`ONCOLOGY 130 (2010).
`Elisabeth Ersvaer et al., Intensive chemotherapy for acute myeloid
`leukemia differentially affects circulating TC1, TH1, TH17 and TREG
`cells, 11 BMC IMMUNOLOGY 1 (2010).
`2058 Miroslaw J. Szczepanski, Increased Frequency and Suppression by
`Regulatory T Cells in Patients with Acute Myelogenous Leukemia, 15
`CLINICAL CANCER RSCH. 3325 (2009).
`Sabine Mumprecht et al., Programmed death 1 signaling on chronic
`myeloid leukemia–specific T cells results in T-cell exhaustion and
`disease progression, 114 BLOOD 1528 (2009).
`2060 Gideon Gross et al., Expression of immunoglobulin-T-cell receptor
`chimeric molecules as functional receptors with antibody-type
`specificity, 86 IMMUNOLOGY 10024 (1989).
`
`2056
`
`2057
`
`2059
`
`
`
`5
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`2064
`
`2061 Anna Kruschinski et al., Engineering antigen-specific primary human
`NK cells against HER-2 positive carcinomas, 105 PROC. OF THE NAT’L
`ACAD. OF THE SCIS. 17481 (2008).
`2062 Olan Dolezal et al., ScFv multimers of the anti-neuraminidase antibody
`NC10: shortening of the linker in single-chain Fv fragment assembled
`in VL to VH orientation drives the formation of dimers, trimers,
`tetramers and higher molecular mass multimers, 13 PROTEIN ENG’G
`565 (2000).
`2063 Michael C. Milone et al., Chimeric Receptor Containing CD137 Signal
`Transduction Domains Mediate Enhanced Survival of T Cells and
`Increased Antileukemic Efficacy In Vivo: Supplementary Materials and
`Methods, 17 MOLECULAR THERAPY 1453 (2009).
`T. Sutlu et al., Natural killer cell-based immunotherapy in cancer:
`current insights and future prospects, 266 J. INTERNAL MED. 154
`(2009).
`2065 Chihaya Imai et al., Genetic modification of primary natural killer cells
`overcomes inhibitory signals and induces specific killing of leukemic
`cells, 106 BLOOD 376 (2005).
`2066 Curriculum Vitae of Robert S. Negrin, M.D. (Feb. 10, 2023).
`2067 Hollie J. Pegram et al., Adoptive Transfer of Gene-Modified Primary
`NK Cells Can Specifically Inhibit Tumor Progression In Vivo, 181 THE
`J. IMMUNOLOGY 3449 (2008).
`Loredana Ruggeri et al., Effectiveness of donor natural killer cell
`alloreactivity in mismatched hematopoietic transplants, 295 SCI. 2097
`(2002).
`2069 Güllü Görgün et al., Chronic lymphocytic leukemia cells induce
`changes in gene expression of CD4 and CD8 T cells, 115 J. CLINICAL
`INVESTIGATION 1797 (2005).
`Transcript of Deposition of Richard P. Junghans, Ph.D., M.D. (Jan. 13,
`2023).
`2071 Declaration of Robert S. Negrin, M.D. (Feb. 13, 2023).
`2072
`John Carroll, Novartis may still be grappling with Kymriah sales, but
`historic CAR-T promise still shines through 5-year data,
`ENDPOINTSNEWS (June 13, 2022), https://endpts.com/novartis-may-
`still-be-grappling-with-kymriah-sales-but-historic-car-t-promise-still-
`shines-through-5-year-data/.
`2073 Veronique Blanc et al., SAR3419: An Anti-CD19-Maytansinoid
`Immunoconjugate for the Treatment of B-Cell Malignancies, 17
`CLINICAL CANCER RSCH. 6448 (2011).
`
`2068
`
`2070
`
`
`
`6
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`2076
`
`2077
`
`2074 Robert T. Abraham et al., Jurkat T cells and development of the
`T-cell receptor signalling paradigm, 4 NATURE REVS. IMMUNOLOGY
`301 (2004).
`2075 Rebekah R. Bartelt et al., Comparison of T Cell Receptor-Induced
`Proximal Signaling and Downstream Functions in Immortalized
`and Primary T Cells, 4 PLOS ONE 1 (2009).
`Zhaosheng Lin et al., Comparative Microarray Analysis of Gene
`Expression During Activation of Human Peripheral Blood T Cells
`and Leukemic Jurkat T Cells, 83 LAB’Y INVESTIGATION 765 (2003).
`Louis Gioia et al., A genome-wide survey of mutations in
`the Jurkat cell line, 19 BMC GENOMICS 1 (2018).
`2078 Michael C. Milone et al., Corrigendum to “Chimeric Receptors
`Containing CD137 Signal Transduction Domains Mediate Enhanced
`Survival of T Cells and Increased Antileukemic Efficacy In Vivo,” 23
`MOLECULAR THERAPY 1278 (2015).
`2079 Kymriah®: Highlights of Prescribing Information, NOVARTIS PHARMS.
`CORP. (May 2022).
`Jacqueline Corrigan-Curay et al., T-Cell Immunotherapy:
`Looking Forward, 22 MOLECULAR THERAPY 1564 (2014).
`Steven C. Katz et al., Phase I Hepatic Immunotherapy for Metastases
`study of intra-arterial chimeric antigen receptor modified T cell
`therapy for CEA+ liver metastases, 21 CLINICAL CANCER RSCH. 1
`(2015).
`2082 University of Pennsylvania’s Policy on Privacy in the Electronic
`Environment
`
`2080
`
`2081
`
`
`
`
`
`
`
`
`
`7
`
`
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`Petitioners again come to the Board asserting that there is something improper
`
`about Dr. Bagg’s hematopathology assessments resulting in co-authorship of Porter
`
`(EX1012) but not inventorship of the challenged patents. The Board should reject this
`
`Motion for additional discovery, consistent with having repeatedly declined to adopt
`
`Petitioners’ theory. IPR2022-00853, Paper 11 at 29-33 (denying institution, in part,
`
`because “we are not persuaded that Petitioner can establish that Porter qualifies as
`
`prior art under §102(a)”); IPR2022-00855, Paper 10 at 28.
`
`The motion for additional discovery is based on at least two clear legal errors.
`
`First, it relies on Dr. Bagg’s credentials and inclusion as a co-author to again
`
`posit that Dr. Bagg must have made an inventive contribution in Porter. This
`
`misapprehends the invention, the conception and reduction to practice of which were
`
`separate from Dr. Bagg’s follow-up work. And it further ignores the law for over 100
`
`years that credentialed scientists like Dr. Bagg can assist inventors in reducing an
`
`invention to practice without becoming inventors.
`
`Second, Petitioners presuppose that they are entitled to district-court-style
`
`discovery in an IPR. Petitioners fail to cite any Board precedent applying the Garmin
`
`factors and instead rely on district court discovery rulings. But this Board has long
`
`recognized Congress’s intent that discovery in IPRs be minimal. During the parties’
`
`meet and confer, Patent Owner specifically inquired whether Petitioners were aware
`
`
`
`8
`
`
`
`of any Board precedent authorizing discovery anywhere near the requested scope.
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`Petitioners had none to cite then, and their Motion is equally silent on that point.
`
`Petitioners’ burdensome requests are readily distinguishable from the limited
`
`discovery authorized by the Board in other IPRs.
`
`I.
`
`
`
`Legal Standard
`
`The parties agree that the Garmin factors control. See Garmin Int’l v. Cuozzo
`
`Speed Techs, IPR2012-00001, Paper 26 at 6-7 (PTAB Mar. 5, 2013). However,
`
`Petitioners’ citation to Garmin ignores the Board’s recognition in Apple v. Achates
`
`that additional discovery in IPRs is “less than what is normally available in district
`
`court patent litigation,” for “Congress intended inter partes review to be a quick and
`
`cost effective alternative to litigation.” Apple Inc. v. Achates Reference Publ’g, Inc.,
`
`IPR2013-00080, Paper 18 at 3 (PTAB Apr. 3, 2013). See also Garmin at 5.
`
`II. Garmin Factor 1: Petitioners’ assertions are wrong and fail to show more
`
`than a possibility or mere allegation that discovery will yield useful information.
`
`A.
`
`Petitioners fail to link Dr. Bagg’s work in Porter to the claims.
`
`Petitioners base their request for documents on the premise that Dr. Bagg
`
`“substantively contributed to the determination of effectiveness.” Mot. 2-3. The
`
`Petition pointed to, and Petitioners again highlight, Porter’s disclosure of remission
`
`“ten months after treatment.” ‘852 Pet. 59 & ‘855 Pet. 76 (emphasis added) (citing
`
`EX1012, 727); see Mot. 3 (discussing EX2044). But Petitioners never explain how
`
`
`
`9
`
`
`
`any assessment Dr. Bagg helped perform was necessary to, let alone part of
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`conceiving—or even reducing to practice (which would be irrelevant in any case)—a
`
`claim to a composition having an “anti-tumor effect.” Nor do Petitioners mention, let
`
`alone rebut, the evidence that the laboratory results Dr. Bagg generated (within the
`
`ordinary course of his role as a laboratory-based pathologist and at the request and
`
`direction of his co-authors) regarding remission were “subsequent to and distinct from
`
`appreciation of an ‘anti-tumor effect,’” IPR2022-00852, Paper 18 at 29 (emphasis
`
`added). Petitioners have not demonstrated that Dr. Bagg’s work would constitute
`
`inventorship even if the requested discovery were to establish that Dr. Bagg was not
`
`“a mere lab technician,” Mot. 4. That alone defeats Garmin factor 1.
`
`wB. Petitioners’ hypothesis is wrong as a matter of law.
`
`Furthermore, even a “substantial contribution to [...] the acquisition, analysis, or
`
`interpretation of data for the work” under the cited ICMJE framework for authorship
`
`is legally insufficient to render Porter the work of another. “An inventor may use the
`
`services, ideas, and aid of others in the process of perfecting his invention without
`
`losing his right to a patent.” Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758
`
`F.2d 613, 624 (Fed. Cir. 1985).
`
`
`
`Indeed, the fact pattern alleged here—an attempt to invalidate an invention
`
`based on the involvement of others in assessing efficacy—has been repeatedly
`
`rejected by courts of all levels for over a century. E.g., Minerals Separation v. Hyde,
`
`
`
`10
`
`
`
`242 U.S. 261 (1916). For example, the defendant in Burroughs Wellcome Co. v. Barr
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`Laboratories, Inc. sought to invalidate claims directed to methods of treating HIV by
`
`asserting that NIH scientists who performed tests that demonstrated efficacy were co-
`
`inventors. Burroughs Wellcome Co. v. Barr Labs., Inc., 828 F.Supp. 1208, 1210-11
`
`(E.D.N.C. 1993). Both the district court and the Federal Circuit rejected this attempt,
`
`with the district court stating, “The court does not believe that the phrase ‘definite and
`
`permanent idea’ requires that the BW Co. inventors know that AZT would be effective
`
`in treating humans having AIDS. For conception to be complete, the law does not
`
`require an idea to be proven to actually work.” Id. at 1212 (emphasis in original),
`
`aff’d, 40 F.3d 1223 (Fed. Cir. 1994). Of relevance to Petitioners’ “mere lab
`
`technician” characterization, Mot. 4, the Federal Circuit noted that that scientists
`
`aiding with assessment of efficacy can act as more than the canonical “pair of hands”
`
`without being co-inventors. 40 F.3d at 1230.
`
`
`
`Moreover, Dr. Bagg’s credentials and experience do not create any tension with
`
`the proper inventorship. Even an accomplished pathologist such as Dr. Bagg can act
`
`on others’ (such as a Principal Investigator’s) behalf, just like the doctoral-level NIH
`
`scientists in Burroughs Wellcome. 828 F.Supp. at 1213 (E.D.N.C. 1993). Similarly,
`
`the Board’s predecessor rejected a pre-A.I.A. § 102(f) assertion where work relating
`
`to expression of the EPO gene in mammalian host cells and isolation of the EPO
`
`glycoprotein expression product were each led by two non-inventive colleagues (each
`
`
`
`11
`
`
`
`having a Ph.D.). Fritsch v. Lin, 1991 WL 332570 at *3 (B.P.A.I. 1991).
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`C. Google’s “design, trial, and analysis of results” quote is taken out of context.
`
`
`
`Petitioners cite Google LLC v. IPA Techs. for the proposition that, “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).” Mot. 1.
`
`Google did not purport to suggest a blanket rule that any analysis of any results
`
`referenced in a paper would be dispositive of the inventorship inquiry. Google, like
`
`other cases, focused on the particular facts at hand and who conceived of the
`
`invention. Moreover, the quoted language actually comes from Allergan, Inc. v.
`
`Apotex Inc., 754 F.3d 952, 969 (Fed. Cir. 2014)—a citation Petitioners omit. In that
`
`case, the patent owner belatedly attempted to disqualify references by asserting that
`
`they described the work of a named inventor who was not even listed as a co-author
`
`on one of them. Id. at 968-70. The Court rejected that attempt on the basis of a
`
`number of facts. The Court’s reference to the “design, trial, and analysis of results”
`
`did not purport to set forth the test of whether the reference described “the work of
`
`another,” but was rather a description of the content of the references at issue. Id. at
`
`969.
`
`III. Garmin Factor 2: This factor is undisputedly inapplicable and thus neutral.
`
`IV. Garmin Factor 3: Equivalent information is available by deposition.
`
`Petitioners cite to district-court decisions such as Penn National and Pugh for
`
`
`
`12
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`the proposition that depositions are not a substitute for document discovery. But those
`
`decisions are entirely inapposite here, where the Board has consistently held that
`
`sweeping district-court-style document discovery is not available in IPRs in the first
`
`place. See, e.g., Garmin and Apple, infra. Penn National’s statement regarding
`
`whether a deposition would be an adequate substitute for something Petitioners have
`
`no entitlement to in the first place in this forum is therefore entirely beside the point.
`
`Nonetheless, consistent with the Board’s rules, Dr. Bagg will be made available
`
`for deposition, and Petitioners will have the opportunity to cross-examine him and
`
`explore their theories in that forum. As such, Petitioners are able to “generate
`
`equivalent information by other means” as contemplated by Garmin factor 3.
`
`V. Garmin Factors 4 & 5: The requests are broad and overly burdensome.
`
`
`
`Petitioners have not cited any decision by the Board authorizing document
`
`discovery of a scope similar to that requested here. Petitioners’ requests seek all
`
`documents in Patent Owner’s possession showing Dr. Bagg’s “contributions to
`
`Porter” as well as his “involvement in” various determinations regarding numerous
`
`patients a decade ago. Contrary to Petitioner’s characterizations, these requests would
`
`be broad even in district court; IPR discovery, when permitted, is far more targeted.
`
`Additionally, the “documents” sought include information which may
`
`necessarily be derived from individual patient medical records. The burden is thus
`
`compounded by the need for redaction. For example, if Dr. Bagg accessed Patent
`
`
`
`13
`
`
`
`Owner’s electronic medical records platform in 2006 to make his determinations,
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`Patent Owner would need to collect those records (e.g., as “showing [his] involvement
`
`in determinations of remission”). This is a materially different undertaking than the
`
`submission of selected patient-level data in a journal article such as Porter (which
`
`Petitioners have and, of course, can review in preparation for Dr. Bagg’s deposition)
`
`and is barred by 55 Pa. Code § 5100.35(b)(1) without a court order.
`
`
`
`Even if patient-level information can be derived from study documents or data
`
`sets outside of electronic medical records, these documents are more than ten years
`
`old and are unduly burdensome to locate and obtain through a paper and electronic
`
`record search, and also unduly burdensome to review. Dr. Bagg and the inventors are
`
`faculty members or former staff of Patent Owner. Patent Owner’s Policy on Privacy
`
`in the Electronic Environment reflects the different considerations of an academic
`
`setting relative to other patentees. EX2082. Collecting faculty documents such as e-
`
`mail from Patent Owner’s faculty would further impose a “burden on human
`
`resources” under Garmin by either requiring the relevant faculty members to step
`
`away from their patient-care and research responsibilities to review any archives with
`
`University counsel or by employing other procedures under Patent Owner’s policy.
`
`
`
`
`
` VII. Conclusion
`
`The Board should reject Petitioners’ attempt to contravene Congressional
`
`guidance and turn these (and future) IPRs into discovery-intensive affairs resembling
`
`
`
`14
`
`
`
`district-court litigation.
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`Dated: April 4, 2023
`
`Respectfully submitted,
`
`By:
`
`
`Jessamyn S. Berniker (Reg. No.
`72,328)
`David M. Krinsky (Reg. No. 72,339)
`Thomas S. Fletcher (Reg. No.
`72,383)
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue SW
`Washington, DC 20024
`Tel: (202) 434-5000
`jberniker@wc.com
`dkrinsky@wc.com
`tfletcher@wc.com
`
`
`Backup Counsel for Real Party in
`Interest and Licensee Novartis
`Pharma AG
`
`/Brian R. Landry/
`Brian Landry (Reg. No. 62,074)
`SAUL EWING LLP
`131 Dartmouth Street, Suite 501
`Boston, MA 02116
`Tel: (617) 912-0969
`brian.landry@saul.com
`
`Counsel for Patent Owner
`
`Kathryn Doyle (Reg. No. 36,317)
`SAUL EWING LLP
`Centre Square West
`1500 Market Street, 38th Floor
`Philadelphia, PA 19102
`Tel: (215) 972-7734
`kathryn.doyle@saul.com
`
`Alireza Behrooz (Reg. No. 60,882)
`SAUL EWING LLP
`1919 Pennsylvania Avenue, N.W.,
`Suite 550
`Washington, DC 20006-3434
`Tel: (202) 295-6687
`alireza.behrooz@saul.com
`Backup Counsel for Patent Owner
`
`15
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`Certification of Service Under 37 C.F.R. § 42.6(e)(4)
`
`
`The undersigned hereby certifies that the Patent Owner’s Opposition to Petitioners’
`
`Motion for Additional Discovery was served in its entirety by filing through the Patent
`
`Trial and Appeal Case Tracking System (P-TACTS), as well as providing a courtesy
`
`copy via e-mail to the following attorneys of record for Petitioners listed below:
`
`Yite John Lu
`
`Gary N. Frischling
`
`
`
`PTABDocketL2Y7@orrick.com
`
`PTABDocketG2F1@orrick.com
`
`Date: April 4, 2023
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`By: /Brian R. Landry/
`Reg. No. 62,074
`
`
`
`16
`
`