`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`IN RE OZEMPIC (SEMAGLUTIDE) PATENT
`LITIGATION
`
`C.A. No. 22-md-3038-CFC
`
`CONFIDENTIAL
`
`NOVO NORDISK INC. AND NOVO
`NORDISK A/S,
`
`
`
`
`
`
`Plaintiffs/Counterclaim Defendants,
`
`v.
`
`
`RIO BIOPHARMACEUTICALS INC., et al.,
`
`
`
`Defendants/Counterclaim Plaintiffs.
`
`
`
`
`
`NOVO NORDISK INC. AND NOVO
`NORDISK A/S,
`
`Plaintiffs/Counterclaim Defendants,
`v.
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`Defendants/Counterclaim Plaintiffs.
`
`
`
`
`C.A. No. 22-294-CFC
`
`C.A. No. 22-cv-1040-CFC
`
`REPLY EXPERT REPORT OF DR. PAUL DALBY
`REGARDING INVALIDITY OF U.S. PATENT NO. 10,335,462
`
`
`
`
`
`Novo Nordisk Exhibit 2651
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`
`
`I.
`
`Introduction
`
`1.
`
`I am the same Paul Dalby who submitted an opening report in the
`
`above-referenced proceeding on March 19, 2024. I submit this reply expert report
`
`on behalf of Rio Biopharmaceuticals Inc. and EMS S/A (collectively “Rio”), Zydus
`
`Worldwide DMCC, Zydus Pharmaceuticals (USA) Inc., and Zydus Lifesciences
`
`Limited, (collectively “Zydus”), and Mylan Pharmaceuticals Inc.1 (“Mylan”)
`
`(collectively, “Defendants”) 2 to respond to certain opinions expressed in the rebuttal
`
`report of Dr. Patrick Sinko, submitted on behalf of Plaintiffs Novo Nordisk, Inc. and
`
`Novo Nordisk A/S (collectively, “Plaintiffs” or “Novo”). As I did in my opening
`
`report, I address only claims 4, 5, and 7 of the ’462 patent, which relate to my
`
`technical area of expertise.
`
`
`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.
`
`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.
`
`- 1 -
`
`CONFIDENTIAL
`
`Novo Nordisk Exhibit 2651
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`
`
`2. My curriculum vitae, submitted with my opening report, is current. See
`
`Dalby Op. Rep. Ex. A. A list of matters where I have provided deposition or trial
`
`testimony in the last four years was attached to my opening report as Exhibit B.
`
`3.
`
`In addition to the materials identified in my opening report, and in
`
`addition to my education, training, and experience, I have considered the materials
`
`cited in Dr. Sinko’s rebuttal report, and the materials in Exhibit C to my opening
`
`report.3
`
`4.
`
`The scope of my work and my compensation have not changed since I
`
`submitted my opening report on March 19, 2024. Neither the amount of my
`
`compensation nor the fact that I am being compensated has altered the opinions that
`
`I have given in this report. My compensation is in no way dependent on the outcome
`
`of this proceeding.
`
`II. Legal Standards
`
`5.
`
`As explained in my opening report, in preparing and forming my
`
`opinions, I have been informed of certain legal principles. Dalby Op. Rep. ¶¶ 18-24.
`
`I have applied my understanding of those principles and taken them into account
`
`when forming the opinions described in this report.
`
`
`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.
`
`– 2 –
`
`CONFIDENTIAL
`
`Novo Nordisk Exhibit 2651
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`
`
`I declare under penalty of perjury that the factual statements contained in this
`
`report are known by me or believed by me to be correct.
`
`Dated: July 16, 2024
`
`By:
`
`
`
`
`
`
`
`
`
`
`
`
` Dr. Paul Dalby
`
`
`
`
`– 39 –
`
`CONFIDENTIAL
`
`Novo Nordisk Exhibit 2651
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`
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