IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
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`HOPEWELL PHARMA VENTURES, INC.
`Petitioner,
`v.
`MERCK SERONO S.A.,
`Patent Owner.
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`___________________
`
`Case IPR2023-00481
`Patent No. 8,377,903
`___________________
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`PETITIONER’S OBJECTIONS TO EVIDENCE
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`HOPEWELL PHARMA VENTURES, INC.
`Petitioner,
`v.
`MERCK SERONO S.A.,
`Patent Owner.
`
`___________________
`
`Case IPR2023-00481
`Patent No. 8,377,903
`___________________
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`PETITIONER’S OBJECTIONS TO EVIDENCE
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`IPR2023-00481
`U.S. Patent No. 8,377,903
`Petitioner, Hopewell Pharma Ventures, Inc., objects under the Federal Rules
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`of Evidence (FRE) and 37 C.F.R. § 42.64(b)(1) to the admissibility of Exhibits
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`2013, 2030–2043, 2048–2052, 2054–2058, 2060–2063, and 2070 (the “Challenged
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`Evidence”), filed by Patent Owner Merck Serono S.A., on December 21, 2023,
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`with its Patent Owner’s Response (“Response”). Petitioner timely files its
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`Objections within five business days of the date of service. 37 C.F.R. §
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`42.64(b)(1). Petitioner files these Objections to provide notice to Patent Owner that
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`Petitioner may move to exclude the Challenged Evidence under 37 C.F.R. §
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`42.64(c), unless cured by Patent Owner.
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`I.
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`IDENTIFICATION OF GROUNDS FOR OBJECTIONS
`A. Exhibit 2013
`Exhibit 2013 purports to be an article by D. S. Goodin et al., “Disease
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`Modifying Therapies in Multiple Sclerosis,” in American Academy of Neurology
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`58 (2002). Petitioner objects to Exhibit 2013 under FRE 901 because Patent Owner
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`fails to provide sufficient evidence indicating the origin or publication of the
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`document, and accordingly fails to provide sufficient information regarding its
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`authenticity. Petitioner also objects to Exhibit 2013 as containing inadmissible
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`hearsay under FRE 801 and 802. Patent Owner relies upon it for the truth of the
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`matter asserted. See e.g., Response, at 28, 53. Petitioner also objects to Exhibit
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`2013 because it is incomplete. Petitioner did not submit the “Supplementary
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`- 1 -
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`IPR2023-00481
`U.S. Patent No. 8,377,903
`Material” referred to on page 1 of Exhibit 2013. Therefore, Exhibit 2013 is not a
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`“duplicate” as defined by FRE 1001(e) insofar as the exhibit is not “a counterpart
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`… that accurately reproduces the original.”
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`Exhibit 2030
`B.
`Exhibit 2030 is an article by J. C. Sipe et al., “Development of Cladribine
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`Treatment in Multiple Sclerosis,” in Multiple Sclerosis 1 (1996). Petitioner objects
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`to Exhibit 2030 as containing inadmissible hearsay under FRE 801 and 802. Patent
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`Owner relies upon it for the truth of the matter asserted. See e.g., Response, at 50.
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`C. Exhibit 2031
`Exhibit 2031 is an excerpt from a chapter by John Noseworthy et al.,
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`“Disease-Modifying Treatments in Multiple Sclerosis,” in McCalpine’s Multiple
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`Sclerosis (4th ed. 2005). Petitioner objects to Exhibit 2031 as containing
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`inadmissible hearsay under FRE 801 and 802. Patent Owner relies upon it for the
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`truth of the matter asserted. See e.g., Response, at 1, 41, 47, 59.
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`D. Exhibit 2032
`Exhibit 2032 is an article by K. Rammohan et al., “The Development of
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`Cladribine Tablets for the Treatment of Multiple Sclerosis,” in Drugs 80 (2020).
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`Petitioner objects to Exhibit 2032 as containing inadmissible hearsay under FRE
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`801 and 802. Patent Owner relies upon it for the truth of the matter asserted. See
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`e.g., Response, at 4, 62, 63.
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`IPR2023-00481
`U.S. Patent No. 8,377,903
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`Exhibit 2033
`E.
`Exhibit 2033 is an article by G. Giovannoni et al., “A Placebo-Controlled
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`Trial of Oral Cladribine for Relapsing Multiple Sclerosis,” in New England
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`Journal of Medicine 362 (2010). Petitioner objects to Exhibit 2033 as containing
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`inadmissible hearsay under FRE 801 and 802. Patent Owner relies upon it for the
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`truth of the matter asserted. See e.g., Response, at 8, 59, 64, 65.
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`Exhibit 2034
`F.
`Exhibit 2034 is a supplementary index to an article by G. Giovannoni et al.,
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`“A Placebo-Controlled Trial of Oral Cladribine for Relapsing Multiple Sclerosis,”
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`in New England Journal of Medicine 362 (2010). Petitioner objects to Exhibit 2034
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`as containing inadmissible hearsay under FRE 801 and 802. Patent Owner relies
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`upon it for the truth of the matter asserted. See e.g., Response, at 64–65.
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`G. Exhibit 2035
`Exhibit 2035 is an article by G. Giovannoni et al., “Safety and Efficacy of
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`Cladribine Tablets in Patients with Relapsing-Remitting Multiple Sclerosis:
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`Results from the Randomized Extension Trial of the CLARITY Study,” in
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`Multiple Sclerosis Journal 24 (2018). Petitioner objects to Exhibit 2035 as
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`containing inadmissible hearsay under FRE 801 and 802. Patent Owner relies upon
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`it for the truth of the matter asserted. See e.g., Response, at 8, 60–62, 64.
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`H. Exhibit 2036
`Exhibit 2036 is an article by G. Giovannoni et al., “Long-Term Follow-Up
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`IPR2023-00481
`U.S. Patent No. 8,377,903
`of Patients with Relapsing Multiple Sclerosis from the CLARITY/CLARITY
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`Extension Cohort of CLASSIC-MS: An Ambispective Study,” in Multiple
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`Sclerosis Journal 29 (2023). Petitioner objects to Exhibit 2036 as containing
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`inadmissible hearsay under FRE 801 and 802. Patent Owner relies upon it for the
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`truth of the matter asserted. See e.g., Response, at 1, 61.
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`Exhibit 2037
`I.
`Exhibit 2037 is an article by A. Miller et al., “Current and Investigational
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`Therapies Used to Alter the Course of Disease in Multiple Sclerosis,” in Southern
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`Medicine Journal 90 (1997). Petitioner objects to Exhibit 2037 as containing
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`inadmissible hearsay under FRE 801 and 802. Patent Owner relies upon it for the
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`truth of the matter asserted. See e.g., Response, at 29.
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`Exhibit 2038
`J.
`Exhibit 2038 is a website publication by Fierce Biotech. Petitioner objects to
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`Exhibit 2038 as containing inadmissible hearsay under FRE 801 and 802. Patent
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`Owner relies upon it for the truth of the matter asserted. See e.g., Response, at 60.
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`K. Exhibit 2040
`Exhibit 2040 is a press release by the U.S. Food and Drug Administration.
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`Petitioner objects to Exhibit 2040 as containing inadmissible hearsay under FRE
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`801 and 802. Patent Owner relies upon it for the truth of the matter asserted. See
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`e.g., Response, at 64–65.
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`IPR2023-00481
`U.S. Patent No. 8,377,903
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`Exhibit 2041
`L.
`Exhibit 2041 is a website publication by ClinicalTrials.gov. Petitioner
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`objects to Exhibit 2041 as containing inadmissible hearsay under FRE 801 and
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`802. Patent Owner relies upon it for the truth of the matter asserted. See e.g.,
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`Response, at 64–65.
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`M. Exhibit 2042
`Exhibit 2042 is a website publication by Neurology Live. Petitioner objects
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`to Exhibit 2042 as inadmissible hearsay under FRE 801 and 802. Patent Owner
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`relies upon it for the truth of the matter asserted. See e.g., Response, at 60, 62, 63.
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`N. Exhibit 2043
`Exhibit 2043 is an article by J. Liliemark et al., “On the Bioavailability of
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`Oral and Subcutaneous 2-Chloro-2’-Deoxydenosine in Humans: Alternative
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`Routes of Administration,” in Journal of Clinical Oncology 10 (1992). Petitioner
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`objects to Exhibit 2043 as inadmissible hearsay under FRE 801 and 802. Patent
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`Owner relies upon it for the truth of the matter asserted. See e.g., Response, at 49.
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`O. Exhibit 2048
`Exhibit 2048 is a 2002 Product Development and License Agreement
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`between IVAX International GMBH and Ares Trading S.A. Petitioner objects to
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`Exhibit 2048 because it contains redacted portions and is incomplete. Therefore,
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`Exhibit 2048 is not a “duplicate” as defined by FRE 1001(e) insofar as the exhibit
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`is not “a counterpart … that accurately reproduces the original.”
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`IPR2023-00481
`U.S. Patent No. 8,377,903
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`Exhibit 2049
`P.
`Exhibit 2049 purports to be an email dated December 17, 2003 titled
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`Cladribine Briefing Document. Petitioner objects to Exhibit 2049 as inadmissible
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`hearsay under FRE 801 and 802. Patent Owner relies upon it for the truth of the
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`matter asserted. See e.g., Response, at 60, 62, 63.
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`Q. Exhibit 2050
`Exhibit 2050 purports to be meeting minutes dated August 27, 2003 for the
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`Oral Cladribine for MS Project Joint Meeting. Petitioner objects to Exhibit 2050 as
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`inadmissible hearsay under FRE 801 and 802. Patent Owner relies upon it for the
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`truth of the matter asserted. See e.g., Response, at 14, 15.
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`R. Exhibit 2051
`Exhibit 2051 is the declaration of Fred D. Lublin, M.D. Petitioner objects to
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`¶¶18–28 and 185 of this declaration because they are not relevant. Patent Owner
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`does not rely upon or even cite to these substantive paragraphs in the Response,
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`rendering Dr. Lublin’s testimony in these paragraphs irrelevant under FRE 401.
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`Petitioner therefore objects to these paragraphs under FRE 402. Petitioner also
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`objects to this testimony under FRE 403 because it has no probative value, creates
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`unfair prejudice to Petitioner, and will confuse the issues and waste the Board’s
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`time.
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`
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`Exhibit 2052
`S.
`Exhibit 2052 is the declaration of Bernd Meibohm, Dr. rer. nat. Petitioner
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`IPR2023-00481
`U.S. Patent No. 8,377,903
`objects to ¶¶21–34, 36–45, 47–56, 58–63, 70–72, 74, 76–80, 91–92, and 94 of this
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`declaration because they are not relevant. Patent Owner does not rely upon or even
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`cite to these substantive paragraphs in the Response, rendering Dr. Meibohm’s
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`testimony in these paragraphs irrelevant under FRE 401. Petitioner therefore
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`objects to these paragraphs under FRE 402. Petitioner also objects to this testimony
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`under FRE 403 because it has no probative value, creates unfair prejudice to
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`Petitioner, and will confuse the issues and waste the Board’s time.
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`Exhibit 2054
`T.
`Exhibit 2054 is the declaration of Nicholas Bodor, Ph.D. Petitioner objects
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`to ¶¶11–17, 19–21, and 23–25 of this declaration because they are not relevant.
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`Patent Owner does not rely upon or even cite to these substantive paragraphs in the
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`Response, rendering Dr. Bodor’s testimony in these paragraphs irrelevant under
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`FRE 401. Petitioner therefore objects to these paragraphs under FRE 402.
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`Petitioner also objects to this testimony under FRE 403 because it has no probative
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`value, creates unfair prejudice to Petitioner, and will confuse the issues and waste
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`the Board’s time.
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`U. Exhibit 2055
`Exhibit 2055 is the declaration of Yogesh Dandiker, Ph.D. Petitioner objects
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`to ¶¶12–13, 19, and 21–22 of this declaration because they are not relevant. Patent
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`Owner does not rely upon or even cite to these substantive paragraphs in the
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`IPR2023-00481
`U.S. Patent No. 8,377,903
`Response, rendering Dr. Dandiker’s testimony in these paragraphs irrelevant under
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`FRE 401. Petitioner therefore objects to these paragraphs under FRE 402.
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`Petitioner also objects to this testimony under FRE 403 because it has no probative
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`value, creates unfair prejudice to Petitioner, and will confuse the issues and waste
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`the Board’s time.
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`V. Exhibit 2056
`Exhibit 2056 purports to be a press release issued by Serono S.A. Petitioner
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`objects to Exhibit 2056 as containing inadmissible hearsay under FRE 801 and
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`802. Patent Owner relies upon it for the truth of the matter asserted. See e.g.,
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`Response, at 13. Petitioner also objects to Exhibit 2056 under FRE 901 because
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`Patent Owner fails to provide sufficient evidence indicating the origin or
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`publication of the document, and accordingly fails to provide sufficient
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`information regarding its authenticity.
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`W. Exhibit 2057
`Exhibit 2057 purports to be a S.E.C. Form 20-F, filed by Serono S.A.
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`Petitioner objects to Exhibit 2057 as containing inadmissible hearsay under FRE
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`801 and 802. Patent Owner relies upon it for the truth of the matter asserted. See
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`e.g., Response, at 13. Petitioner also objects to Exhibit 2057 under FRE 901
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`because Patent Owner fails to provide sufficient evidence indicating the origin or
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`publication of the document, and accordingly fails to provide sufficient
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`IPR2023-00481
`U.S. Patent No. 8,377,903
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`information regarding its authenticity.
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`X. Exhibit 2058
`Exhibit 2058 purports to be an article published by the Wall Street Journal.
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`Petitioner objects to Exhibit 2058 as containing inadmissible hearsay under FRE
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`801 and 802. Patent Owner relies upon it for the truth of the matter asserted. See
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`e.g., Response, at 13. Petitioner also objects to Exhibit 2058 under FRE 901
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`because Patent Owner fails to provide sufficient evidence indicating the origin or
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`publication of the document, and accordingly fails to provide sufficient
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`information regarding its authenticity.
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`Y. Exhibit 2060
`Exhibit 2060 is a website publication by Fierce Pharma. Petitioner objects to
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`Exhibit 2060 because it is not relevant. Patent Owner does not rely on or even cite
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`this publication in the Response, rendering the publication irrelevant under FRE
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`401. Petitioner therefore objects to this publication under FRE 402. Petitioner also
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`objects to this testimony under FRE 403 because it has no probative value, creates
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`unfair prejudice to Petitioner, and will confuse the issues and waste the Board’s
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`time.
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`Exhibit 2061
`Z.
`Exhibit 2061 is an article by the Canadian Cooperative Multiple Sclerosis
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`Study Group, “The Canadian Cooperative Trial of Cyclophosphamide and Plasma
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`Exchange in Progressive Multiple Sclerosis,” in The Lancet 337 (1991). Petitioner
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`- 9 -
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`IPR2023-00481
`U.S. Patent No. 8,377,903
`objects to Exhibit 2061 because it is not relevant. Patent Owner does not rely on or
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`even cite this publication in the Response, rendering the publication irrelevant
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`under FRE 401. Petitioner therefore objects to this publication under FRE 402.
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`Petitioner also objects to this testimony under FRE 403 because it has no probative
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`value, creates unfair prejudice to Petitioner, and will confuse the issues and waste
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`the Board’s time.
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`AA. Exhibit 2062
`Exhibit 2062 is an excerpt from an article by J. W. Hainer et al., “Dosing in
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`Heavy-Weight/Obese Patients with the LMWH, Tinzaparin: A Pharmacodynamic
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`Study,” in Thromb Haemost 817 (2002). Petitioner objects to Exhibit 2062 because
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`it is not relevant. Patent Owner does not rely on or even cite this publication in the
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`Response, rendering the publication irrelevant under FRE 401. Petitioner therefore
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`objects to this publication under FRE 402.
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`BB. Exhibit 2063
`Exhibit 2063 is an excerpt from the chapter “Clinical Pharmacodynamics &
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`Pharmacokinetics,” in Textbook of Therapeutics: Drug and Disease Management
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`(8th Ed. 2006). Petitioner objects to Exhibit 2063 because it is not relevant. Patent
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`Owner does not rely on or even cite this publication in the Response, rendering the
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`publication irrelevant under FRE 401. Petitioner therefore objects to this
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`publication under FRE 402.
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`IPR2023-00481
`U.S. Patent No. 8,377,903
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`CC. Exhibit 2070
`Exhibit 2070 is a website publication from Mavenclad. Petitioner objects to
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`Exhibit 2070 because it is not relevant. Patent Owner does not rely on or even cite
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`this publication in the Response, rendering the publication irrelevant under FRE
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`401. Petitioner therefore objects to this publication under FRE 402. Petitioner also
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`objects to Exhibit 2070 under FRE 901 because Patent Owner fails to provide
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`sufficient evidence indicating the origin or publication of the document, and
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`accordingly fails to provide sufficient information regarding its authenticity.
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`II. CONCLUSION
`To the extent Patent Owner fails to correct the defects associated with the
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`Challenged Evidence in view of Petitioner’s objections herein, Petitioner may file
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`a motion to exclude the Challenged Evidence under 37 C.F.R. § 42.64(c).
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`Date: 12/29/2023
`1101 K Street, NW
`10th Floor
`Washington, DC 20005
`(202) 371-2600
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`
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`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`/Eldora L. Ellison/
`
`Eldora L. Ellison, Ph.D., Esq.
`Registration No. 39,967
`Lead Attorney for Petitioner
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`IPR2023-00481
`U.S. Patent No. 8,377,903
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`The undersigned hereby certifies that the above-captioned PETITIONER’S
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`OBJECTIONS TO EVIDENCE was served in its entirety on December 29,
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`2023, upon the following parties via email:
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`Emily R. Whelan (Lead Counsel)
`Deric Geng (Back-up Counsel)
`Cindy Kan (Back-up Counsel)
`David Bassett (Back-up Counsel)
`Vinita Ferrera (Back-up Counsel)
`WILMER CUTLER PICKERING HALE AND DORR LLP
`emily.whelan@wilmerhale.com
`deric.geng@wilmerhale.com
`cindy.kan@wilmerhale.com
`David.Bassett@wilmerhale.com
`Vinita.Ferrera@wilmerhale.com
`WHMerckMavencladIPRs@wilmerhale.com
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`/Eldora L. Ellison/
`
`Eldora L. Ellison, Ph.D., Esq.
`Registration No. 39,967
`Lead Attorney for Petitioner
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`
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`Dated: December 29, 2023
`1101 K Street, NW
`10th Floor
`Washington, DC 20005
`(202) 371-2600
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`
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`21590348.1
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