`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`MYLAN INSTITUTIONAL LLC,
`Petitioner,
`
`v.
`
`NOVO NORDISK A/S,
`Patent Owner.
`______________
`
`Case IPR2020-00324
`Patent 8,114,833
`______________
`
`DECLARATION OF DAVID NOLAN
`
`Novo Nordisk Ex. 2025, P. 1
`Mylan Institutional v. Novo Nordisk
`IPR2020-00324
`
`
`
`IPR2020-00324
`Patent 8,114,833 B2
`I, David Nolan, hereby declare as follows:
`1.
`I submit this Declaration in support of the Patent Owner Response of
`
`Novo Nordisk A/S (“Novo Nordisk”) in IPR2020-00324 of U.S. Patent No.
`
`8,114,833 (the “’833 patent”).
`
`2.
`
`I have personal knowledge of all information set forth in this
`
`declaration unless I specifically note otherwise.
`
`3.
`
`I am a full-time employee of Novo Nordisk, and I am not being
`
`separately compensated for my work preparing this declaration.
`
`4.
`
`I received a Master of Science in engineering from the Technical
`
`University of Denmark in 2006. While a student at the Technical University of
`
`Denmark, I joined Novo Nordisk in 2003 as a Student Assistant in the
`
`Pharmaceutics, Biopharm Department.
`
`5.
`
`I have been employed by Novo Nordisk since 2003. I worked as a
`
`Student Assistant until 2006, when I became a Chemist in the Biopharm DP Support
`
`Department. Over the years I held a variety of positions within Novo Nordisk, until
`
`in 2013, I became a Department Manager in the Analytical Department. Then, in
`
`2018, I assumed my present role of Director, Injectable Formulation Development.
`
`As Director, Injectable Formulation Development at Novo Nordisk, I am responsible
`
`for development of formulations for new injectable drug products.
`
`1
`
`Novo Nordisk Ex. 2025, P. 2
`Mylan Institutional v. Novo Nordisk
`IPR2020-00324
`
`
`
`IPR2020-00324
`Patent 8,114,833 B2
`6.
`Based on my 17 years of experience working at Novo Nordisk, I have
`
`personal knowledge about how Novo Nordisk keeps business records including
`
`reports and raw data, as well as the practices and protocols for ensuring the accurate
`
`reporting of such data. As part of my responsibilities as a Student Assistant, I
`
`reviewed data referenced in reports for accuracy. Pursuant to Novo Nordisk’s
`
`ordinary practice at the time, the scientist who drafted the report would provide me
`
`with archive boxes that contained printouts of the raw data from the experiments
`
`referenced in the report. I would then check whether the data referred to in the report
`
`matched the printouts of raw data from the archive boxes.
`
`7.
`
`One of the scientists with whom I worked while I was a Student
`
`Assistant was Dr. Tina Pedersen. Dr. Pedersen drafted the report entitled “NN2211:
`
`Physical and Chemical Stability of 5 mg/ml NNC 90-1170, pH 7.85, in Presence of
`
`Different Isotonic Agents,” dated April 22, 2003, which was given an internal report
`
`No. 03433088 (“April 22, 2003 Report”). (Ex2068.) Reports such as the April 22,
`
`2003 Report were generated at Novo Nordisk as part of our normal business practice.
`
`8.
`
`Dr. Pedersen asked me to conduct the data review for the April 22, 2003
`
`Report. I reviewed the underlying data in the April 22, 2003 Report for accuracy by
`
`comparing the data in the report against the printouts of raw data provided to me in
`
`the archive boxes. On April 23, 2003, I signed page 2 of the April 22, 2003 Report
`
`to indicate that I had checked the data reported in the report for accuracy, in
`
`2
`
`Novo Nordisk Ex. 2025, P. 3
`Mylan Institutional v. Novo Nordisk
`IPR2020-00324
`
`
`
`IPR2020-00324
`Patent 8,114,833 B2
`accordance with the standard procedure of our formulation group at Novo Nordisk.
`
`(Ex2068 at 2.)
`
`9.
`
`I confirm that the business record cited in my declaration (Ex2068) is a
`
`true and accurate copy of the original record created and maintained by Novo
`
`Nordisk in the manner described above in the ordinary course of business.
`
`3
`
`Novo Nordisk Ex. 2025, P. 4
`Mylan Institutional v. Novo Nordisk
`IPR2020-00324
`
`
`
`Novo Nordisk Ex. 2025, P. 5
`Mylan Institutional v. Novo Nordisk
`IPR2020-00324
`
`
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