`
`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
`
`No. 22-md-3038-CFC
`
`No. 22-cv-294-CFC
`CONSOLIDATED
`ANDA CASE
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`CONFIDENTIAL
`
`No. 22-cv-1040-CFC
`ANDA CASE
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`CONFIDENTIAL
`
`IN RE: OZEMPIC (SEMAGLUTIDE)
`PATENT LITIGATION
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`
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`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
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`Plaintiffs/Counterclaim
`Defendants,
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`v.
`
`
`RIO BIOPHARMACEUTICALS INC. et al.,
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`Defendants/Counterclaim
`Plaintiffs.
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`
`
`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
`
`Plaintiffs/Counterclaim
`Defendants,
`
`v.
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`Defendant/Counterclaim
`Plaintiff.
`
`
`
`REPLY EXPERT REPORT OF DR. JOHN BANTLE
`REGARDING INVALIDITY OF U.S. PATENT NO. 10,335,462
`
`
`
`
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`Novo Nordisk Exhibit 2650
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
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`
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`
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`1.
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`I am the same Dr. John Bantle who submitted an opening report
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`dated March 19, 2024, in this litigation. See generally OPENING EXPERT REPORT
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`OF DR. JOHN BANTLE REGARDING INVALIDITY OF U.S. PATENT NO. 10,335,462
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`(“Opening Report” or “Op. Rpt.”), dated March 19, 2024. I submit this reply
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`report on behalf of defendants Mylan Pharmaceuticals Inc., Dr. Reddy’s
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`Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc., Rio Biopharmaceuticals
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`Inc. and EMS S/A; Sun Pharmaceutical Industries Ltd. and Sun
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`Pharmaceutical Industries, Inc.; and Zydus Worldwide DMCC, Zydus
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`Pharmaceuticals (USA) Inc., and Zydus Lifesciences Limited to respond to
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`certain opinions expressed by Dr. Michael Trautmann on behalf of Novo
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`Nordisk Inc. and Novo Nordisk A/S (“Novo”), related to invalidity of the
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`claims of U.S. Patent No. 10,335,462 (“’462 patent”).1 Specifically, in this report
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`I respond to Dr. Trautmann’s opinions in the REBUTTAL EXPERT REPORT OF
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`MICHAEL E. TRAUTMANN, M.D. REGARDING VALIDITY OF U.S. PATENT NO.
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`10,335,462 (“Trautmann Report” or “Trautmann Rpt.”), served June 3, 2024.
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`
`1 I understand that Dr. Reddy’s and Sun do not adopt my opinions as they relate
`to anticipation or obviousness of the ’462 patent, see also Op. Rpt. §§ IX.A and
`IX.B, because they stipulated in related proceedings not to pursue such
`arguments in this case. I also understand that Mylan Pharmaceuticals Inc. will
`not pursue by motion or at trial in this litigation anticipation of the claims of the
`’462 patent by WO ’421 or Lovshin or obviousness of the claims of the ’462
`patent by WO ’537 in view of Lovshin, see also Op. Rpt. §§ IX.A.1, IX.A.3, and
`IX.B.3, unless a change in law otherwise permits.
`
`
`
`1
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`Novo Nordisk Exhibit 2650
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
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`
`
`
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`2. My education and experience are described in my Opening Report,
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`and my curriculum vitae submitted with my opening report is current. See Op.
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`Rpt. at 1 and Ex. A.
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`3. As noted in my Opening Report, I was retained as a technical expert
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`to provide opinions related to the ’462 patent. I receive $400 per hour plus
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`expenses for consulting and expert report work. My compensation is in no way
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`tied to the outcome of this case or to the content of this report.
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`4.
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`In the previous four years, I provided testimony in the proceedings
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`listed in my Opening Report.
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`I.
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`BASIS OF OPINIONS AND MATERIALS CONSIDERED
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`5.
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`To reach the conclusions and opinions described in my report, I
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`considered certain materials recited in the Trautmann Report, the materials
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`recited in Exhibit B to my Opening Report, any materials cited in my Opening
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`Report and not otherwise identified in Exhibit B to that report, the materials
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`recited in Exhibit A to this report, any materials cited in this report and not
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`otherwise identified in Exhibit A to this report (such as materials already cited
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`by Dr. Trautmann), and my education, training, experience.
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`II.
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`SUMMARY OF OPINIONS
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`6. As noted in my Opening Report, my opinions are limited to the
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`treatment of diabetes with semaglutide, as claimed in the ’462 patent. I present
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`
`
`2
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`Novo Nordisk Exhibit 2650
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
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`
`
`
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` I
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` declare that all statements made herein of my knowledge are true, and
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`that all statements made on information and belief are believed to be true, and
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`that these statements were made with the knowledge that willful false statements
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`and the like so made are punishable by fine or imprisonment, or both, under
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`Section 1001 of Title 18 of the United States Code.
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`Dated: July 16, 2024
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`
`
`By:
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`
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`Dr. John Bantle
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`
`
`
`
`275
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`Novo Nordisk Exhibit 2650
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
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`