IPR2023-00724
`U.S. Patent 10,335,462
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`NOVO NORDISK A/S,
`Patent Owner
`______________________
`Case IPR2023-00724
`Patent 10,335,462
`______________________
`
`DECLARATION OF CHRISTINE B. JENSEN, M.D., PH.D.
`
`PROTECTIVE ORDER MATERIAL
`
`Novo Nordisk Exhibit 2050
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`U.S. Patent 10,335,462
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`NOVO NORDISK A/S,
`Patent Owner
`______________________
`Case IPR2023-00724
`Patent 10,335,462
`______________________
`
`DECLARATION OF CHRISTINE B. JENSEN, M.D., PH.D.
`
`PROTECTIVE ORDER MATERIAL
`
`Novo Nordisk Exhibit 2050
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
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`IPR2023-00724
`U.S. Patent 10,335,462
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`TABLE OF CONTENTS
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`I. BRos ssc wer scrresrzce sccmsea ER ICSU4
`Il.
`|My Conception of Treating Type-2 Diabetes with Once-Weekly
`Subcutaneous Administrations of 1.0 mg Semaglutide by March 17, 2010,
`and No Later Than May 28, 2010....0.....00..occccecccececceecceesceeeceeeescecesseeesseesesees 7
`A. March 17, 2010.02.20. cee cececcceccecccecceceecceeceeceeeceeeceeseceeeeeeeeeceseeeeeneeeseesees 10
`
`Bi
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`bey OR DO ice erence merce comer enereo 14
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`PROTECTIVE ORDER MATERIAL
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`1
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`Novo Nordisk Exhibit 2050
`Mylan Pharms.Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
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`IPR2023-00724
`U.S. Patent 10,335,462
`I, Dr. Christine B. Jensen, hereby declare under penalty of perjury:
`
`1.
`
`I am the Christine B. Jensen identified as the sole inventor on U.S.
`
`Patent No. 10,335,462 (the “’462 Patent”), entitled “Use of Long-Acting GLP-1
`
`1
`Peptides.” EX1001 (’462 Patent), 1.0F
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`2.
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`3.
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`I am a citizen of Denmark, and I reside in Copenhagen, Denmark.
`
`I understand that the subject matter at issue in the ’462 Patent
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`encompasses, in part, the following three claims:
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`1. A method for treating type 2 diabetes, comprising
`administering semaglutide once weekly in an amount
`of 1.0 mg to a subject in need thereof.
`2. The method according to claim 1, wherein the
`semaglutide
`is
`administered
`by
`parenteral
`administration.
`3. The method according to claim 2, wherein the solution
`is administered by subcutaneous injection.
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`1 All subsequent exhibits cited herein have a single sheet appended before the start
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`of the cited documents, which I understand identifies the underlying metadata of
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`each cited document. My statements that I recognize the documents as true and
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`correct copies, or that the documents were made and kept in the ordinary course of
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`business, apply to the documents themselves, not the appended metadata readout.
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`2
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`PROTECTIVE ORDER MATERIAL
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`Novo Nordisk Exhibit 2050
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
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`IPR2023-00724
`U.S. Patent 10,335,462
`I assigned my interest in the ’462 Patent to Novo Nordisk A/S, which
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`4.
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`issued on September 19, 2017.
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`5.
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`In this declaration, I provide my recollection of certain events and
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`activities relating to the development of the subject matter of the ’462 Patent and the
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`invention in the claims. Many of these events and activities took place over a decade
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`ago, some as many as 15 years ago. As described below, some of my recollections
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`regarding the relevant individuals, documents, and events are specific, and some are
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`more general. Except as otherwise indicated, I have personal knowledge of the facts
`
`set forth in this Declaration. All statements herein made of my own knowledge are
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`true and all statements made on information and belief are believed to be true. If
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`called upon to do so, I would testify competently thereto.
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`6.
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`As detailed further below in Section II, while I was working at Novo
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`Nordisk, based in Denmark, I came to the firm view that once-weekly dosage of 1.0
`
`mg semaglutide administered subcutaneously would be an appropriate treatment (or
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`maintenance) dose for patients with type-2 diabetes by March 17, 2010, and in any
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`event no later than May 28, 2010, when that treatment dose was the subject of a final
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`recommendation for use in Phase 3 trials. I reached the firm view that such a
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`treatment dose would provide the right balance of efficacy and tolerability in
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`lowering HbA1c levels for patients with type-2 diabetes and, among other things, I
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`3
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`PROTECTIVE ORDER MATERIAL
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`Novo Nordisk Exhibit 2050
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
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`IPR2023-00724
`U.S. Patent 10,335,462
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`Background
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`9.
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`I am a medical doctor who in the period between September 1, 2007
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`I.
`
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`and January 30, 2016 served in a drug development role at Novo Nordisk. I earned
`
`my M.D. in 1996 and Ph.D. in 2002, both from the University of Copenhagen in
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`Denmark. After that, I was a Postdoctoral Research Fellow at in the Joslin Diabetes
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`4
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`PROTECTIVE ORDER MATERIAL
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`Novo Nordisk Exhibit 2050
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
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`IPR2023-00724
`U.S. Patent 10,335,462
`Center at Harvard University from 2002 through 2004, and then continued my
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`Postdoctoral Research at the Steno Diabetes Center in Copenhagen through July
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`2007. I am currently a Senior Alliance Director in the Early Innovation, Outreach
`
`and Alliances area at Novo Nordisk.
`
`10.
`
`In September 2007, I started working at Novo Nordisk. My title then
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`was International Medical Director, and I was part of Novo Nordisk’s Medical and
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`Science Team. At that time, Novo Nordisk was preparing to report results from its
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`first in-human study of semaglutide, NN9535-1820 (the “1820 Trial”), a Phase 1
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`study involving healthy male volunteers. My new responsibilities involved
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`shepherding the clinical development strategy and clinical development plan for
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`semaglutide for diabetes going forward.
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`11. By
`
`, I had begun work on designing a Phase 2 dose range-
`
`finding study. The purpose of the study was to determine the once-weekly
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`subcutaneous dose range of semaglutide that would be effective and tolerated in
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`patients with type-2 diabetes. In addition to designing and executing this Phase 2
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`study, I was also responsible for analyzing, interpreting, and reporting the resulting
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`data.
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`12. My Phase 2 dose range-finding study was given the internal identifier
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`NN9535-1821 (the “1821 Trial”) and
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`the ClinicalTrials.gov identifier of
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`5
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`PROTECTIVE ORDER MATERIAL
`
`Novo Nordisk Exhibit 2050
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
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`
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`IPR2023-00724
`U.S. Patent 10,335,462
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`NCT00696657 (“NCT657”).
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`The study commenced in June 2008 and was
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`completed in February 2009. It tested once-weekly subcutaneous administrations of
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`semaglutide at 0.1 mg, 0.2 mg, 0.4 mg, and 0.8 mg, and dose escalated regimens
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`with treatment doses of 0.8 mg and 1.6 mg, in men and women-not-of-childbearing-
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`potential diagnosed with type-2 diabetes. The resulting data, which were obtained
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`by Po (and incorporated, in part, into the specification of the °462
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`ee
`ee
`13. a. which I have reviewed,is a true and correct copy of the
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`slide presentation,ae. that my team andI prepared and shared at
`on incrnenES>
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`a S
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`S1 sic202 cecognizeI 2
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`and correct copy of that email. Based on my knowledgeof the 1821 Trial, I confirm
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`the email and attached presentation were madeand kept in the regular and ordinary
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`PROTECTIVE ORDER MATERIAL
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`6
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`Novo Nordisk Exhibit 2050
`Mylan Pharms.Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
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`IPR2023-00724
`U.S. Patent 10,335,462
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`my team and I concludedthat, in comparisonto liraglutide
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`(another GLP-1 analog developed by Novo Nordisk), once-weekly doses of 0.4 mg
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`semaglutide provided comparable efficacy on glycemic control to daily doses of
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`liraglutide at 1.2 mg, and once-weekly doses of 0.8 mg or 1.6 mg of semaglutide
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`brought more subjects to target than daily doses ofliraglutide at 1.8 mg. ie
`BEThese results were kept confidential and non-public.
`
`If. My Conception of Treating Type-2 Diabetes with Once-Weekly Subcuta-
`neous Administrationsof 1.0 mg Semaglutide by March 17, 2010, and No
`Later Than May 28, 2010
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`14. After the data from the Phase 2 dose range-finding study were
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`confidentially shared within Novo Nordisk ona. I recall there was zm
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`’.
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`course of Novo Nordisk’s business, at or near the date appearing on the documents,
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`by persons with knowledgeofthe facts and opinionsstated therein.
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`PROTECTIVE ORDER MATERIAL
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`7
`
`Novo Nordisk Exhibit 2050
`Mylan Pharms.Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
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`
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`IPR2023-00724
`U.S. Patent 10,335,462
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`—".
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`reviewed,is a true and correct copy of an po that I received and have stored on
`my computer, inwich
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`==Qoe —_ afe]<ioO
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`16.
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`The results of the 1821 Trial indicated to me that treatment dose-
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`dependently reduced HbA;, within the tested dose range, meaning increased doses
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`led to greater reductions of HbA. a The results also indicated to me
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`that increasing doses of semaglutide, using no or minimal doseescalation, led to
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`PROTECTIVE ORDER MATERIAL
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`§
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`Novo Nordisk Exhibit 2050
`Mylan Pharms.Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
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`IPR2023-00724
`U.S. Patent 10,335,462
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`decreased tolerability and thus increased rates of subjects withdrawing from the
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`$y
`ae data showed that the proportion of subjects withdrawing from the
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`1821 Trial due to gastrointestinal side effects, such as nausea and vomiting, was
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`dose-dependent. ee During this period of time, I wasI
`ee
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`a V
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`7. po which I have reviewed, is a true and correct copy of a
`confidential slide deck stored on my computer,an thati
`I52222
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`onrTrt~i‘OSCSY whichis the type of slide that I would have typically
`prepared for such presentations,es
`ee
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`> This presentation deck was made and keptin the regular and ordinary course of
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`Novo Nordisk’s business, at or near the date appearing on the document, and I had
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`knowledgeof the facts and opinionsstated therein at the time I madethis presenta-
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`tion.
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`PROTECTIVE ORDER MATERIAL
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`9
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`Novo Nordisk Exhibit 2050
`Mylan Pharms.Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00010
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`
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`IPR2023-00724
`U.S. Patent 10,335,462
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`>L March 17, 2010
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`by persons with knowledge ofthe facts and opinions containedtherein at the time,
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`and made and keptin the regular and ordinary course of Novo Nordisk’s business.
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`was made
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`PROTECTIVE ORDER MATERIAL
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`10
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`Novo Nordisk Exhibit 2050
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00011
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`
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`IPR2023-00724
`U.S. Patent 10,335,462
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`PROTECTIVE ORDER MATERIAL
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`ll
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`Novo Nordisk Exhibit 2050
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00012
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`IPR2023-00724
`U.S. Patent 10,335,462
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`N _
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`po and based on my experience and expertise, I concluded that a once-
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`weekly 1.0 mg dose, administered subcutaneously and preceded by 4 weeks dosing
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`at 0.25 mg and 4 weeksat 0.5 mg, would be a viable treatmentdosefor treating type-
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`2 diabetes because
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`ES3:
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`> These| were made and keptin the regular and ordinary course of
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`Novo Nordisk’s business,at or near the date appearing on the document, by persons
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`with knowledge of the facts and opinionsstated therein at the time the models were
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`made. Based on my duties as the Medical Directorat the time, I know that it was a
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`regular practice at Novo Nordisk to communicate
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`PROTECTIVE ORDER MATERIAL
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`12
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`Novo Nordisk Exhibit 2050
`Mylan Pharms.Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00013
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`
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`IPR2023-00724
`U.S. Patent 10,335,462
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`© ThisSs was made andkept in the regular and ordinary course of Novo
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`Nordisk’s business, on my computer, at or near the date appearing on the document,
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`and I had knowledge of the facts and opinionsstated therein at the time I madethis
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`presentation. Suchslide presentations were a common way of communicating with
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`our advisory boards.
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`PROTECTIVE ORDER MATERIAL
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`13
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`Novo Nordisk Exhibit 2050
`Mylan Pharms.Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00014
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`
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`IPR2023-00724
`U.S. Patent 10,335,462
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`for the once-weekly 1.0 mg treatment dose, the slide deck also included, among
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`© --=aO Los|rg otSoO
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`As support
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`B. May28,2010
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`23.
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`I have reviewed a set of documents that were contemporaneously or
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`near-contemporaneously made in relation to a May 28, 2010 a)
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`PROTECTIVE ORDER MATERIAL
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`14
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`Novo Nordisk Exhibit 2050
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00015
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`
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`IPR2023-00724
`U.S. Patent 10,335,462
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`7 ThesePo were made andkeptin the regular and ordinary
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`course of Novo Nordisk’s business, typically made a few daysprior to the scheduled
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`meeting, by persons with knowledgeof the facts and opinionsstated therein.
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`PROTECTIVE ORDER MATERIAL
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`Be,
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`Novo Nordisk Exhibit 2050
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00016
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`
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`IPR2023-00724
`U.S. Patent 10,335,462
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`, which I have reviewed,is a true and correct copy of that
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`were made andkept in the
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`regular and ordinary course of Novo Nordisk’s business, at or near the date appear-
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`ing on the email, by persons with knowledge ofthe facts and opinionsstated therein.
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`PROTECTIVE ORDER MATERIAL
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`16
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`Novo Nordisk Exhibit 2050
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00017
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`IPR2023-00724
`U.S. Patent 10,335,462
`also id., 13, 15 te. As the Medical Director, I would have
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`presented on my treatment dose of 1.0 mg once-weekly
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`° Thesea were madeand keptin the regular and ordinary course of
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`Novo Nordisk’s business, at or near the date of the meeting, by persons with
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`knowledge of the facts and opinionsstated therein.
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`PROTECTIVE ORDER MATERIAL
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`17
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`Novo Nordisk Exhibit 2050
`Mylan Pharms.Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00018
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`IPR2023-00724
`U.S. Patent 10,335,462
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`PROTECTIVE ORDER MATERIAL
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`18
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`Novo Nordisk Exhibit 2050
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00019
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`U.S. Patent 10,335,462
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`PROTECTIVE ORDER MATERIAL
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`Novo Nordisk Exhibit 2050
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`U.S. Patent 10,335,462
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`Novo Nordisk Exhibit 2050
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`IPR2023-00724
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`PROTECTIVE ORDER MATERIAL
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`DA
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`Novo Nordisk Exhibit 2050
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`Novo Nordisk Exhibit 2050
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`Novo Nordisk Exhibit 2050
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`IPR2023-00724
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`IPR2023-00724
`U.S. Patent 10,335,462
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`I have been warned that willful false statements and the like are punishable by fine
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`or imprisonment, or both (18 U.S.C. 1001) and may jeopardize the validity of the
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`patentat issue in this proceeding, I declare under penalty of perjury under the laws
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`of the United States of America that the foregoingis true and correct.
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`Executed on January 17, 2024 at Copenhagen, Denmark.
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`Novo Nordisk Exhibit 2050
`Mylan Pharms.Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`IPR2023-00724
`U.S. Patent 10,335,462
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`Christine B. Jensen, M.D., Ph.D.
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`Novo Nordisk Exhibit 2050
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