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