`______________
`
`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.
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`8,114,833 (the “’833 patent”).
`
`2.
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`I have personal knowledge of all information set forth in this
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`declaration unless I specifically note otherwise.
`
`3.
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`I am a full-time employee of Novo Nordisk, and I am not being
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`separately compensated for my work preparing this declaration.
`
`4.
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`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
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`Pharmaceutics, Biopharm Department.
`
`5.
`
`I have been employed by Novo Nordisk since 2003. I worked as a
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`Student Assistant until 2006, when I became a Chemist in the Biopharm DP Support
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`Department. Over the years I held a variety of positions within Novo Nordisk, until
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`in 2013, I became a Department Manager in the Analytical Department. Then, in
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`2018, I assumed my present role of Director, Injectable Formulation Development.
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`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
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`personal knowledge about how Novo Nordisk keeps business records including
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`reports and raw data, as well as the practices and protocols for ensuring the accurate
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`reporting of such data. As part of my responsibilities as a Student Assistant, I
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`reviewed data referenced in reports for accuracy. Pursuant to Novo Nordisk’s
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`ordinary practice at the time, the scientist who drafted the report would provide me
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`with archive boxes that contained printouts of the raw data from the experiments
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`referenced in the report. I would then check whether the data referred to in the report
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`matched the printouts of raw data from the archive boxes.
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`7.
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`One of the scientists with whom I worked while I was a Student
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`Assistant was Dr. Tina Pedersen. Dr. Pedersen drafted the report entitled “NN2211:
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`Physical and Chemical Stability of 5 mg/ml NNC 90-1170, pH 7.85, in Presence of
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`Different Isotonic Agents,” dated April 22, 2003, which was given an internal report
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`No. 03433088 (“April 22, 2003 Report”). (Ex2068.) Reports such as the April 22,
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`2003 Report were generated at Novo Nordisk as part of our normal business practice.
`
`8.
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`Dr. Pedersen asked me to conduct the data review for the April 22, 2003
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`Report. I reviewed the underlying data in the April 22, 2003 Report for accuracy by
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`comparing the data in the report against the printouts of raw data provided to me in
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`the archive boxes. On April 23, 2003, I signed page 2 of the April 22, 2003 Report
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`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.
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`(Ex2068 at 2.)
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`9.
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`I confirm that the business record cited in my declaration (Ex2068) is a
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`true and accurate copy of the original record created and maintained by Novo
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`Nordisk in the manner described above in the ordinary course of business.
`
`3
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`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
`
`