UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`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 TINA BJELDSKOV PEDERSEN, PH.D.
`
`
`
`Novo Nordisk Ex. 2024, P. 1
`Mylan Institutional v. Novo Nordisk
`IPR2020-00324
`
`
`______________
`
`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 TINA BJELDSKOV PEDERSEN, PH.D.
`
`
`
`Novo Nordisk Ex. 2024, P. 1
`Mylan Institutional v. Novo Nordisk
`IPR2020-00324
`
`
`
`IPR2020-00324
`Patent 8,114,833 B2
`I, Tina Bjeldskov Pedersen, hereby declare as follows:
`1.
`I am an inventor named in U.S. Patent No. 8,114,833 (the “’833
`
`patent”) owned by Novo Nordisk A/S (“Novo Nordisk”).
`
`2.
`
`I have personal knowledge of the 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 my Ph.D. from the University of Copenhagen in 2002. I
`
`began working at Novo Nordisk in 2001 as a Research Scientist within the
`
`formulation development of injectables. In 2006, I advanced to Team Leader within
`
`the formulation development of injectables. In 2011, I transitioned to Team Leader
`
`within oral formulation development. In 2015, I became the Head/Director for Oral
`
`Formulation Research, which is the position I hold today.
`
`5.
`
`As Director for Oral Formulation Research at Novo Nordisk, I am
`
`responsible for a department that provides and progresses state-of-the-art oral
`
`formulation technology platforms for our oral project pipeline.
`
`6.
`
`I have about 19 years of experience formulating drug products,
`
`including more than 19 years of experience working with peptides and proteins for
`
`clinical use.
`
`1
`
`Novo Nordisk Ex. 2024, P. 2
`Mylan Institutional v. Novo Nordisk
`IPR2020-00324
`
`
`
`IPR2020-00324
`Patent 8,114,833 B2
`I was a member of the Novo Nordisk formulation team tasked with
`7.
`
`developing an injectable liraglutide formulation (the “liraglutide project”). The
`
`documents cited in this declaration were generated in the normal course of business
`
`at Novo Nordisk in connection with our work on the liraglutide project.
`
`8.
`
`In the ordinary course of business, and in connection with our work on
`
`the liraglutide project, we regularly corresponded by e-mail. I confirm that Ex2051
`
`is an e-mail chain with an earliest email dated December 19, 2001. I confirm that I
`
`received all e-mails in the chain dated January 23, 2002 and earlier due to the fact
`
`that I was copied into the e-mail chain on January 2, 2002. Ex2051 is a true and
`
`accurate copy of an original record that was prepared and kept in the course of
`
`regularly conducted business activity of Novo Nordisk, as well as a certified English
`
`translation thereof. The e-mail messages in the chain that I received (dated from
`
`December 19, 2001 to January 23, 2002) contained in Ex2051 were created at or
`
`near the time of the activities described therein.
`
`9.
`
`In the ordinary course of business, and in connection with our work on
`
`the liraglutide project, I made a presentation at the April 4, 2002 NN2211
`
`Formulation and Production Group Meeting, which both Dr. Engelund and I
`
`attended. Details of the meeting were memorialized in meeting minutes (“04-04-02
`
`Meeting Minutes”). (Ex2055.) The 04-04-02 Meeting Minutes were generated in
`
`accordance with Novo Nordisk’s usual practice. My attendance at the meeting is
`
`2
`
`Novo Nordisk Ex. 2024, P. 3
`Mylan Institutional v. Novo Nordisk
`IPR2020-00324
`
`
`
`IPR2020-00324
`Patent 8,114,833 B2
`indicated by my initials on the 04-04-02 Meeting Minutes. (See Ex2055 at 2, 12.)1
`
`At Novo Nordisk, employees are identified by initials. “Kot” refers to Dr. Engelund
`
`and “TinP” refers to me. The 04-04-02 Meeting Minutes were created at or near the
`
`time of the activities set forth therein. I confirm that Ex2055 is a true and accurate
`
`copy of the 04-04-02 Meeting Minutes, which is an original record that was kept in
`
`the course of regularly conducted business activity of Novo Nordisk, as well as a
`
`certified English translation thereof.
`
`10.
`
`In connection with our work on the liraglutide project, I authored and
`
`signed a protocol entitled: “Investigation of Several Alternative Isotonic Agents for
`
`the NN2211 Drug Product (Continuation of Protocol No. 02433030),” which is
`
`dated June 3, 2002 (“June 3, 2002 Drop Test Protocol”). (Ex2057.) The June 3,
`
`2002 Drop Test Protocol was given internal report number “02433195.” The June
`
`3, 2002 Drop Test Protocol was created at or near the time of the work set forth
`
`therein and summarized the drop test as well as the related results. Protocols such
`
`as the June 3, 2002 Drop Test Protocol, and the protocols identified below in
`
`paragraphs 11 and 13, are generated at Novo Nordisk as part of our normal business
`
`practice. I confirm that Ex2057 is a true and accurate copy of the June 3, 2002 Drop
`
`
`1 In citing to a Danish language Exhibit, I have provided the page number of the
`
`original Danish language document and the certified English translation thereof.
`
`
`
`3
`
`Novo Nordisk Ex. 2024, P. 4
`Mylan Institutional v. Novo Nordisk
`IPR2020-00324
`
`
`
`IPR2020-00324
`Patent 8,114,833 B2
`Test Protocol, which is an original record that was prepared and kept in the course
`
`of regularly conducted business activity of Novo Nordisk, as well as a certified
`
`English translation thereof.
`
`11.
`
`In connection with our work on the liraglutide project, I authored and
`
`signed a protocol entitled: “Protocol: Study of Potential Clogging of Needles Placed
`
`on NovoPen® with Various Isotonicity Agents (Supersedes Protocol No. 02433148
`
`and 02433162),” which is dated June 5, 2002 (“June 5, 2002 Clogging Test
`
`Protocol”). (Ex2058.) The June 5, 2002 Clogging Test Protocol was given an
`
`internal report number of “02433229.” The June 5, 2002 Clogging Test Protocol
`
`was created at or near the time of the work set forth therein and summarized the
`
`clogging test as well as the related results. I confirm that Ex2058 is a true and
`
`accurate copy of the June 5, 2002 Clogging Test Protocol, which is an original record
`
`that was prepared and kept in the course of regularly conducted business activity of
`
`Novo Nordisk, as well as a certified English translation thereof.
`
`12.
`
`In connection with our work on the liraglutide project, I received a
`
`memo from Peter Buus entitled “Testing of Isotonic Agents for NN2211,” and dated
`
`June 27, 2002 (“June 27, 2002 Simulated Filling Test Memo”). (Ex2059.) The
`
`June 27, 2002 Simulated Filling Test Memo was created at or near the time of the
`
`work set forth therein. Memoranda like the June 27, 2002 Simulated Filling Test
`
`Memo are generated at Novo Nordisk as part of our normal business practice. The
`
`
`
`4
`
`Novo Nordisk Ex. 2024, P. 5
`Mylan Institutional v. Novo Nordisk
`IPR2020-00324
`
`
`
`IPR2020-00324
`Patent 8,114,833 B2
`June 27, 2002 Simulated Filling Test Memo was generated in accordance with Novo
`
`Nordisk’s usual practice. I confirm that Ex2059 is a true and accurate copy of the
`
`June 27, 2002 Simulated Filling Test Memo, which is an original record that was
`
`prepared and kept in the course of regularly conducted business activity of Novo
`
`Nordisk, as well as a certified English translation thereof.
`
`13.
`
`In connection with our work on the liraglutide project, I approved and
`
`signed a protocol entitled: “Protocol: Alternative Isotonic Agents to Mannitol: Test
`
`of Physical and Chemical Stability of NNC90-1170,” which is dated July 23, 2002
`
`(“July 23, 2002 Physical and Chemical Stability Test Protocol”). (Ex2060.) The
`
`July 23, 2002 Physical and Chemical Stability Test Protocol was given an internal
`
`report number of “02433277.” The July 23, 2002 Physical and Chemical Stability
`
`Test Protocol was created at or near the time of the work set forth therein. I confirm
`
`that Ex2060 is a true and accurate copy of the July 23, 2002 Physical and Chemical
`
`Stability Test Protocol, which is an original record that was prepared and kept in the
`
`course of regularly conducted business activity of Novo Nordisk, as well as a
`
`certified English translation thereof.
`
`14. While working on the liraglutide project, and during the ordinary course
`
`of business at Novo Nordisk, we sometimes created PowerPoints that were presented
`
`during team meetings. One such PowerPoint was entitled “NN2211 Design Review:
`
`Final Formulation for Phase 3 Clinical Trials,” dated November 29, 2002 (“NN2211
`
`
`
`5
`
`Novo Nordisk Ex. 2024, P. 6
`Mylan Institutional v. Novo Nordisk
`IPR2020-00324
`
`
`
`IPR2020-00324
`Patent 8,114,833 B2
`Design Review PowerPoint”). (Ex2064.) The NN2211 Design Review PowerPoint
`
`was generated in accordance with Novo Nordisk’s usual practice. The NN2211
`
`Design Review PowerPoint was created at or near the time of the activities set forth
`
`therein. I confirm that Ex2064 is a true and accurate copy of the NN2211 Design
`
`Review PowerPoint, which is an original record that was prepared and kept in the
`
`course of regularly conducted business activity of Novo Nordisk.
`
`15.
`
`In connection with our work on the liraglutide project, I authored a
`
`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 I
`
`signed on April 23, 2003 on page 2, indicating that I am its author (“April 22, 2003
`
`Report”). (Ex2068.) The April 22, 2003 Report was given an internal report number
`
`of “03433088.” The April 22, 2003 Report was generated in accordance with Novo
`
`Nordisk’s usual practice, and included protocols, results, and conclusions from the
`
`studies summarized therein. I included analysis of the physical stability results on
`
`pages 10 to 13, with the underlying data in Tables 1 to 9, and I included analysis of
`
`the chemical stability results on pages 13 to 16, with the underlying data in Tables
`
`10 to 18 of the April 22, 2003 Report. As part of our normal business practice at
`
`Novo Nordisk, I asked David Nolan to check the data in the April 22, 2003 Report.
`
`I provided the April 22, 2003 Report and printouts of the raw data cited therein to
`
`Mr. Nolan, in accordance with standard Novo Nordisk practice. Mr. Nolan signed
`
`
`
`6
`
`Novo Nordisk Ex. 2024, P. 7
`Mylan Institutional v. Novo Nordisk
`IPR2020-00324
`
`
`
`IPR2020-00324
`Patent 8,114,833 B2
`page 2, indicating his review, in accordance with the standard procedure of our
`
`formulation group at Novo Nordisk. The April 22, 2003 Report was created at or
`
`near the time of the activities set forth therein. I confirm that Ex2068 is a true and
`
`accurate copy of the April 22, 2003 Report, which is an original record that was
`
`prepared and kept in the course of regularly conducted business activity of Novo
`
`Nordisk.
`
`16.
`
`In connection with our work on the liraglutide project, I authored a
`
`report entitled “Liraglutide – Simulated Filling Experiments, Drop and Clogging
`
`Tests of Replacements Candidates for Mannitol,” dated June 27, 2003, which was
`
`given internal report number “03433177” (“June 27, 2003 Report”). (Ex. 2072.) I
`
`authored the June 27, 2003 Report as part of our normal business practice at Novo
`
`Nordisk. I signed page 2 of the report, indicating that I am its author. As part of
`
`Novo Nordisk’s normal practice, the June 27, 2003 Report contained underlying data
`
`including photos as well as references to the protocols, memos, and reports from the
`
`experiments summarized in this report. The June 27, 2003 Report was created at or
`
`near the time of the activities set forth therein. I confirm that Ex2072 is a true and
`
`accurate copy of the June 27, 2003 Report, which is an original record that was
`
`prepared and kept in the course of regularly conducted business activity of Novo
`
`Nordisk.
`
`
`
`
`
`7
`
`Novo Nordisk Ex. 2024, P. 8
`Mylan Institutional v. Novo Nordisk
`IPR2020-00324
`
`
`
`Novo Nordisk Ex. 2024, P. 9
`Mylan Institutional v. Novo Nordisk
`IPR2020-00324
`
`
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