`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`IN RE OZEMPIC (SEMAGLUTIDE) PATENT
`LITIGATION
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`C.A. No. 22-md-3038-CFC
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`CONFIDENTIAL
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`NOVO NORDISK INC. AND NOVO
`NORDISK A/S,
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`Plaintiffs/Counterclaim Defendants,
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`v.
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`RIO BIOPHARMACEUTICALS INC., et al.,
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`
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`Defendants/Counterclaim Plaintiffs.
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`NOVO NORDISK INC. AND NOVO
`NORDISK A/S,
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`Plaintiffs/Counterclaim Defendants,
`v.
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`MYLAN PHARMACEUTICALS INC.,
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`Defendants/Counterclaim Plaintiffs.
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`
`
`
`C.A. No. 22-294-CFC
`
`C.A. No. 22-cv-1040-CFC
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`REPLY EXPERT REPORT OF DR. PAUL DALBY
`REGARDING INVALIDITY OF U.S. PATENT NO. 10,335,462
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`Novo Nordisk Exhibit 2651
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
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`I.
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`Introduction
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`1.
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`I am the same Paul Dalby who submitted an opening report in the
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`above-referenced proceeding on March 19, 2024. I submit this reply expert report
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`on behalf of Rio Biopharmaceuticals Inc. and EMS S/A (collectively “Rio”), Zydus
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`Worldwide DMCC, Zydus Pharmaceuticals (USA) Inc., and Zydus Lifesciences
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`Limited, (collectively “Zydus”), and Mylan Pharmaceuticals Inc.1 (“Mylan”)
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`(collectively, “Defendants”) 2 to respond to certain opinions expressed in the rebuttal
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`report of Dr. Patrick Sinko, submitted on behalf of Plaintiffs Novo Nordisk, Inc. and
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`Novo Nordisk A/S (collectively, “Plaintiffs” or “Novo”). As I did in my opening
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`report, I address only claims 4, 5, and 7 of the ’462 patent, which relate to my
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`technical area of expertise.
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`1 I understand that Mylan has agreed not to pursue by motion or at trial in this
`litigation any grounds of invalidity instituted in IPR2023-00724 against the
`originally issued claims of the ’462 patent unless a change of law otherwise permits.
`Accordingly, with respect to my reports, I understand that Mylan will not pursue by
`motion or at trial in this litigation the prior art combination of WO ’537 in view of
`Lovshin.
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`2 In my opening report, I noted that I was also retained by Dr. Reddy’s Laboratories,
`Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, “DRL”) and Sun
`Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries, Inc. (collectively,
`“Sun”). However, I was informed that DRL and Sun do not adopt my opinions,
`including those in my opening report, because they stipulated in related proceedings
`not to pursue such arguments in this case.
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`- 1 -
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`CONFIDENTIAL
`
`Novo Nordisk Exhibit 2651
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
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`2. My curriculum vitae, submitted with my opening report, is current. See
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`Dalby Op. Rep. Ex. A. A list of matters where I have provided deposition or trial
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`testimony in the last four years was attached to my opening report as Exhibit B.
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`3.
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`In addition to the materials identified in my opening report, and in
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`addition to my education, training, and experience, I have considered the materials
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`cited in Dr. Sinko’s rebuttal report, and the materials in Exhibit C to my opening
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`report.3
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`4.
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`The scope of my work and my compensation have not changed since I
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`submitted my opening report on March 19, 2024. Neither the amount of my
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`compensation nor the fact that I am being compensated has altered the opinions that
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`I have given in this report. My compensation is in no way dependent on the outcome
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`of this proceeding.
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`II. Legal Standards
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`5.
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`As explained in my opening report, in preparing and forming my
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`opinions, I have been informed of certain legal principles. Dalby Op. Rep. ¶¶ 18-24.
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`I have applied my understanding of those principles and taken them into account
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`when forming the opinions described in this report.
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`3 I have considered only the sections of Dr. Sinko’s rebuttal report that respond to
`my opening report, along with the materials cited in those sections. This does not
`indicate that I agree with any opinions expressed by Dr. Sinko elsewhere in his
`report, or any of Novo’s other expert witnesses’ reports.
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`– 2 –
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`CONFIDENTIAL
`
`Novo Nordisk Exhibit 2651
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
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`I declare under penalty of perjury that the factual statements contained in this
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`report are known by me or believed by me to be correct.
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`Dated: July 16, 2024
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`By:
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` Dr. Paul Dalby
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`– 39 –
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`CONFIDENTIAL
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`Novo Nordisk Exhibit 2651
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
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