`
`_______________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________________________________________
`
`TWI PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`MERCK SERONO SA,
`Patent Owner.
`_________________________________________________
`
`Case IPR2023-00049
`Patent 7,713,947
`
`Case IPR2023-00050
`Patent 8,377,903
`____________________________________________________
`
`DECLARATION OF CINDY KAN
`IN SUPPORT OF EXHIBITS 2037, 2038, 2043, 2062, 2063, and 2064
`
`Merck 2068
`TWi v Merck
`IPR2023-00049
`
`
`
`
`
`
`
`
`I, Cindy Kan, declare as follows:
`
`IPR2023-00049, IPR2023-00050
` U.S. Patent Nos. 7,713,947 & 8,377,903
`
`1.
`
`I am an attorney at the law firm of Wilmer Cutler Pickering Hale and
`
`Dorr LLP in New York, NY, which represents the patent owner Merck Serono
`
`S.A. in the following Inter Partes Review proceedings: IPR2023-00049 and
`
`IPR2023-00050.
`
`2.
`
`Exhibit 2037 is a true and accurate copy of a printout of the webpage
`
`appearing at https://www.fiercebiotech.com/biotech/merck-receives-complete-
`
`response-letter-from-fda-on-cladribine-tablets-new-drug-application retrieved on
`
`March 12, 2024.
`
`3.
`
`Exhibit 2038 is a true and accurate copy of a printout of the webpage
`
`appearing at https://www.neurologylive.com/view/shortcommitment-dosing-
`
`regimen-gives-cladribine-an-advantage-in-ms retrieved on November 10, 2023.
`
`4.
`
`Exhibit 2043 is a true and accurate copy of a printout of the webpage
`
`appearing at https://www.fda.gov/news-events/press-announcements/fda-approves-
`
`new-oral-treatment-multiple-sclerosis retrieved on November 25, 2023.
`
`5.
`
`Exhibit 2062 is a true and accurate copy of a printout of the webpage
`
`appearing at
`
`https://web.archive.org/web/20220119143645/https://www.fiercepharma.com/phar
`
`ma/better-8-years-late-than-never-merck-kgaa-nabs-fda-nod-for-ms-drug-
`
`
`
`
`2
`
`
`
`
`
`
`mavenclad retrieved on December 18, 2023. This exhibit was prepared under my
`
`IPR2023-00049, IPR2023-00050
` U.S. Patent Nos. 7,713,947 & 8,377,903
`
`supervision by searching the Wayback Machine for the URL of Exhibit 2060 and
`
`selecting the capture at January 19, 2022 at 14:36:45 GMT. This date and time are
`
`included in the URL of Exhibit 2060.
`
`6.
`
`Exhibit 2063 is a true and accurate copy of a printout of the webpage
`
`appearing at https://clinicaltrials.gov/study/NCT00213135 and of the webpage
`
`appearing at https://clinicaltrials.gov/study/NCT00213135?tab=history&a=13
`
`retrieved on November 25, 2023.
`
`7.
`
`Exhibit 2064 is a true and accurate copy of a printout of the webpage
`
`appearing at
`
`https://web.archive.org/web/20231004232146/https://www.mavenclad.com/en/ho
`
`me/why-mavenclad/safety-and-side-effects.html retrieved on December 19, 2023.
`
`This exhibit was prepared under my supervision by searching the Wayback
`
`Machine for the URL of Exhibit 2064 selecting the capture at October 4, 2023 at
`
`23:21:46 GMT. This date and time are included in the URL of Exhibit 2064.
`
`8.
`
`In signing this declaration, I understand that the declaration will be
`
`filed as evidence in a contested case before the Patent Trial and Appeal Board of
`
`the United States Patent and Trademark Office. I acknowledge that I may be
`
`subject to cross-examination in this case and that cross-examination will take place
`
`
`
`
`3
`
`
`
`
`
`
`within the United States. If cross-examination is required of me, I will appear for
`
`IPR2023-00049, IPR2023-00050
` U.S. Patent Nos. 7,713,947 & 8,377,903
`
`cross-examination within the United States during the time allotted for cross-
`
`examination.
`
`9.
`
`I hereby 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: March 12, 2024
`
`
`
`By: /Cindy Kan/
`
`Cindy Kan
`WILMER CUTLER PICKERING HALE
`AND DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`Tel: (212) 295-6470
`E-mail: cindy.kan@wilmerhale.com
`
`
`
`
`4
`
`
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