Case 7:20-cv-08255-PMH Document 181-9 Filed 07/19/24 Page 1 of 6
`Case 7:20-cv-08255-PMH Document 181-9
`Filed 07/19/24
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`EXHIBIT 8
`EXHIBIT 8
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`Case 7:20-cv-08255-PMH Document 181-9
`Filed 07/19/24
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`EXHIBIT 8
`EXHIBIT 8
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`Case 7:20-cv-08255-PMH Document 181-9 Filed 07/19/24 Page 2 of 6
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`HIGHLY CONFIDENTIAL
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF NEW YORK
`
`ALLELE BIOTECHNOLOGY AND
`PHARMACEUTICALS, INC.,
`
`Plaintiff,
`
`
`
`
`
`
`
`v.
`
`REGENERON PHARMACEUTICALS,
`INC.,
`
`
`
`
`
`Defendant.
`
`Civil Action No. 7:20-cv-08255 (PMH)
`(AEK)
`
`RESPONSIVE EXPERT REPORT OF JOHN C. JAROSZ
`
`December 22, 2023
`
`
`
`
`
`
`
`
`
`Case 7:20-cv-08255-PMH Document 181-9 Filed 07/19/24 Page 3 of 6
`Case 7:20-cv-08255-PMH Document 181-9
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`HIGHLY CONFIDENTIAL
`
`a a
`
`IREDACTED
`
`}
`
`50.
`
`According to Dr. Baum, Regeneron worked on a REDACTED
`
`| also understand that no commercial product was developed as a result of the
`
`IREDACTED
`
`and that the uses of mNeonGreen in that project were not related to
`
`information for submission to the FDA.!”°
`
`4.
`
`Summary Timeline
`
`51.
`
`The below timeline summarizes many of the key events that occurred across
`
`Regeneron’s IN=s—yequa)
`
`, COVID-19 project, andgaXeqysy)
`
`- This
`
`timeline is not meant to be comprehensive, but rather to highlight important events relative to
`
`Regeneron’s various projects.
`
`120 Schneiderheinze Deposition, at pp. 28-29: Baum 10/20/2022 Deposition. at p. 132; Klinman Report, at p. 41.
`
`121
`
`Jimenez Report, at p. 78.
`
`122° Baum 10/20/2022 Deposition, at pp. 21-22.
`
`123 Baum 10/20/2022 Deposition, at p. 21.
`
`24 Baum 10/20/2022 Deposition, at pp. 21-22.
`
`125° Klinman Report, at pp. 56-57; Poats Deposition,at p. 48.
`
`24
`
`
`
`Case 7:20-cv-08255-PMH Document 181-9 Filed 07/19/24 Page 4 of 6
`Case 7:20-cv-08255-PMH Document 181-9
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`HIGHLY CONFIDENTIAL
`
` toes
`
`Raat auetiil
`REDACTED
`First accused use of mNeonGreen’”®
`REDACTED]
`[1]
`mNeonGreen used asme ror ia Ep
`REDACTED§
`[2]
`[3] oe FirstuseofmNeonGreenbyRegenerorQs)
`IREDACTED|taathe COVID-19 project (which
`eventually became REGEN-COV):'”* developmental
`work begins on neutralization assay!””
`Lead antibody candidates for REGEN-COV
`(REGN10933 and REGN10987)selected using
`
`_neutralizationassayswithmNeonGreen’”
`
`
`
`
`[4]
`
`[5]
`
`ewer
`
`
`REDACTED
`
`COVID-19 Project
`
`COVID-19 Project
`
`COVID-19 Project
`
`[6]
`
`June 10, 2020
`
`PhaseI/II trial begins for REGEN-COV??
`
`COVID-19 Project
`
`[7]
`
`June 16, 2020
`
`PhaseIII trial begins for REGEN-COV3
`
`[8] |
`15)ens=o
`[9] me
`Do)
`
`tl) a
`12] Geen
`
`—————————
`
`[13]
`
`REDACTED
`
`IREDACTED
`
`CI
`
`LastuseNeaGa wIREDACTED§
`
`"
`
`AC
`
`|
`
`COVID-19 Project
`
`Ft
`COVID-19Project
`COVID-19 Project
`
`COVID-19 Project
`COVID-19Project
`
`ees
`
`as
`
` [14]
`
`REDACTED]
`
`|
`
`26 Baum 10/20/2022 Deposition, at p. 14; Fulton Deposition,at p. 35.
`
`27 Fulton Deposition, at p. 44.
`
`128 See, e.g., REGN-AB-00055369-370. at 369. See also Baum 10/20/2022 Deposition, at pp. 38, 41, Exhibit 3, at
`p. 2; Klinman Report, at p. 33.
`
`129 Baum 10/20/2022 Deposition, at pp. 41-43.
`
`130 Baum 10/20/2022 Deposition, at pp. 56-59. 118, Exhibit 3, at p. 3.
`
`131 Schneiderheinze Deposition, at pp. 12-14; Baum 10/20/2022 Deposition, Exhibit 3A,at pp. 3-4.
`
`132 https://classic.clinicaltrials.gov/ct2/show/NCT04426695 (viewed June 28, 2023).
`
`133 https://classic.clinicaltrials.gow/ct2/show/NCT04425629 (viewed June 28, 2023).
`
`134 Klinman Report, at p. 56; Baum 10/20/2022 Deposition. at p. 25.
`
`135° Baum 10/20/2022 Deposition, Exhibit 3A,at pp. 4-5.
`
`25
`
`
`
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`Case 7:20-cv-08255-PMH Document 181-9
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`HIGHLY CONFIDENTIAL
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`Asdiscussed in Section ILD,there is a wide variety of fluorescent proteins available to researchers,
`
`who make their selections based on different traits and specific project needs.”
`
`183.
`
`Regeneron’s use of mNeonGreen was strictly limited to INSDNegiS.
`
`]
`
`LT COVID-19 Project Use, andsisipyNeqa=
`
`As such, Regeneron has
`
`
`
`
`ET «ich. vile having achieved significant
`
`not generated any sales directly from mNeonGreen |S ByNegaSB) |
`
`success in the marketplace,*”° has already been accounted for in my discussion of Georgia-Pacific
`
`Factor 6, above.
`
`184.
`
`Taken together, these factors have a neutral impact on the hypothetical negotiation.
`
`&.
`
`Factor 9 — The utility and advantages of the patent property over the
`old modesor devices, if any, that had been used for working out
`similar results.
`
`And
`
`Factor 10 — The nature of the patented invention; the character of the
`commercial embodimentof it as owned and producedbythelicensor;
`and the benefits to those who haveused the invention.
`
`185.
`
`The nature and extent of the benefits associated with the patented property were
`
`discussed above. I understand from Dr. Jimenez, Dr.
`
`a
`
`r.F t
`
`[REDACTEDRant
`
`have been an acceptable alternative that would have been easily and quickly substitutable by
`
`Shaner
`2023):
`12,
`(viewed September
`373 https://blog.addgene.org/which-fluorescent-protein-should-i-use
`Deposition, at pp. 51-53.
`
`376
`
`82
`
`
`
`Case 7:20-cv-08255-PMH Document 181-9 Filed 07/19/24 Page 6 of 6
`Case 7:20-cv-08255-PMH Document 181-9
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`HIGHLY CONFIDENTIAL
`
`°
`
`He failed to appropriately account for important differences between the 2021
`
`Allele/Pfizer Settlement Agreement and the hypothetical license here.
`
`292. My quantitative analysis suggests reasonable royalty damages in the range of
`
`IREDACTED|(based on the Licensing Comparables Approach) andxispyNeqasB,
`
`(based on the Design-Around Cost Approach).°® My qualitative analysis of the Georgia-Pacific
`
`Factors suggests a reasonable royalty damages a
`
`REDACTED
`
`)
`
`suggested by my quantitative analysis.° Assuming the Patent-at-Issue is found to be valid,
`
`enforceable, and infringed, the appropriate reasona
`
`t
`
`REDACTED
`
`)
`
`and Regeneron’s ability to design-around the Patent-at-Issue suggests it may,
`
`
`im fact, be
`
`293.
`
`This report is based on the information that was available to me as of the date of
`
`this report and summarizes the opinions that I have formed to date. I may revise, supplement, or
`
`expand my opinions, if necessary and allowed, based on further review and analysis of information
`
`and opinions provided to me beforetrial.
`
`John C. Jarosz
`December 22, 2023
`
`363 Tab 3.
`
`Tab 3. If the Court determines that Regeneron’s COVID-19 Project Use is covered by the statutory safe harbor,
`then the Licensing Comparables Approach suggests a benchmark range ofp, {By\@agSB)
`and the Design-
`Around Approach suggestsx= DyGgESD,
`
`If the Court determines that Regeneron’s COVID-19 ProjectUse is covered by the statutory safe harbor, then the
`appropriate reasonable royalty here is|i=—yNeaSR)
`)
`
`565
`
`130
`
`
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