Peter Tessier - December 4, 2020
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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` MYLAN INSTITUTIONAL : Case No.
` LLC, : IPR2020-00324
` Petitioner :
` : U.S. Patent No.
` vs. : 8,114,833
` :
` NOVO NORDISK A/S, :
` Patent Owner :
` * * *
` FRIDAY, DECEMBER 4, 2020
` CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
` * * *
`
` Videotaped deposition of PETER TESSIER, taken
`remotely, commencing at 9:05 a.m. before Susan L.
`Ciminelli, Registered Professional Reporter,
`Certified Realtime Reporter.
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`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
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`Page 1
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` MYLAN INSTITUTIONAL : Case No.
` LLC, : IPR2020-00324
` Petitioner :
` : U.S. Patent No.
` vs. : 8,114,833
` :
` NOVO NORDISK A/S, :
` Patent Owner :
` * * *
` FRIDAY, DECEMBER 4, 2020
` CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
` * * *
`
` Videotaped deposition of PETER TESSIER, taken
`remotely, commencing at 9:05 a.m. before Susan L.
`Ciminelli, Registered Professional Reporter,
`Certified Realtime Reporter.
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`Peter Tessier - December 4, 2020
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`APPEARANCES (all appearing remotely):
` PERKINS COIE, LLP
` EMILY J. GREB, ESQ.
` LARA DUEPPEN, ESQ.
` MATTHEW GREINERT, ESQ.
` 33 East Main Street
` Suite 201
` Madison, Wisconsin 53703
` (608) 663-7494
` egreb@perkinscoie.com
` Representing the Petitioner Mylan
` Institutional
`
` PERKINS COIE LLP
` BRANDON M. WHITE, ESQ.
` 700 13th Street, NW
` Suite 800
` Washington, D.C. 20005
` (202) 654.6206
` bmwhite@perkinscoie.com
` Representing the Petitioner Mylan
` Institutional
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`Peter Tessier - December 4, 2020
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`APPEARANCES (Continued):
` WINSTON & STRAWN, LLP
` SHARON LIN, ESQ.
` JOVIAL WONG, ESQ.
` 1901 L Street NW
` Washington, D.C. 20036
` (202) 282-5756
` slin@winston.com
` Representing the Petitioner Pfizer
` Incorporated
`
` FENWICK & WEST, LLP
` RYAN JOHNSON, ESQ.
` 902 Broadway
` Suite 14
` New York, New York 10010
` (212) 430-2746
` ryan.johnson@fenwick.com
` Representing the Patent Owner and the
` Witness
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`Peter Tessier - December 4, 2020
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` ALSO PRESENT:
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`Peter Tessier - December 4, 2020
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` P R O C E E D I N G S
` THE VIDEOGRAPHER: Good morning. My name
`is Chris Gibson, and I'm with BlueBear Solutions. I
`will not be in the same room as the witness, nor
`will the court reporter, Sue Ciminelli. Thus, I
`will be recording this deposition remotely, and the
`court reporter will swear the witness in remotely.
` This is the start of the remote
`video-recorded deposition of Peter Tessier, in the
`case of Mylan Institutional LLC versus Novo Nordisk
`A/S, Case Number IPR2020-00324.
` We are now on the record. Today's date is
`December 4th, 2020. The time is now 9:05 a.m.,
`Eastern Standard Time. Could the attorneys please
`make voice introductions?
` MR. WHITE: For Petitioner, this is
`Brandon White from Perkins Coie. Also with me from
`Perkins Coie are Emily Greb and Lara Dueppen. And
`from Mylan, Matt Greinert.
` MR. JOHNSON: Ryan Johnson from Fenwick &
`West for the Patent Owner, Novo Nordisk.
` MS. LIN: This is Sharon Lin from Winston
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`Peter Tessier - December 4, 2020
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`& Strawn, on behalf of Petitioner Pfizer,
`Incorporated.
` THE VIDEOGRAPHER: Are there any
`stipulations or announcements from either party?
` MR. WHITE: Nothing from Petitioner.
` MR. JOHNSON: Nothing from Patent Owner.
` THE VIDEOGRAPHER: Okay. Court reporter,
`could you please swear in the witness?
`Whereupon,
` PETER M. TESSIER, Ph.D.,
`was called as a witness, and having been duly sworn,
`was examined and testified as follows:
` CROSS-EXAMINATION
`BY MR. WHITE:
` Q So good morning, Dr. Tessier.
` A Good morning.
` Q Am I saying that correctly? Is it
`Tessier?
` A We say Tessier.
` Q Tessier. I'll try to get that right, when
`I had Tessier in my mind, so I apologize if I have
`the accent in the wrong place. Could you please
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`Peter Tessier - December 4, 2020
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`state your full name for the record?
` A Peter Matthew Tessier.
` Q And you understand that you're here today
`to testify about the declaration you submitted in
`the Mylan v. Novo IPR, is that right?
` A That's right.
` Q Do you have a copy of your declaration
`with you, a hard copy?
` A I do.
` Q Do you have any other materials besides
`your declaration?
` A I do. Would you like me to list them?
` Q List them, generally, if you can. I don't
`think we need to --
` A Okay. Let's see. I have the expert
`declaration of Laird Forrest, so this is Mylan
`Exhibit 1002. And then I have a -- let's see, I
`have IPR papers, so that includes the petition.
`This is Mylan's petition, the patent owner's
`preliminary response, and the institution decision.
` And then I have a collection of exhibits,
`some of which are Mylan exhibits that I cited in my
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`Peter Tessier - December 4, 2020
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`Page 8
`report. And then I have the Patent Owner's exhibits
`that I cite in my report.
` Q Okay. Throughout the course of the day,
`we'll be referring to a number of those exhibits.
`The videographer will place them on the screen.
`They will be also probably placed in the chat
`function, where you can download an electronic copy,
`if you would like, or you're free to look at your
`hard copies, whatever is easiest for you, okay?
` A Okay.
` Q And have you been deposed before?
` A I have.
` Q How many times?
` A I don't know exactly.
` Q Can you approximate how many times?
` A I would estimate approximately four times.
` Q Were those all patent cases?
` A I don't know exactly.
` Q Were any of those for Novo Nordisk?
` A Yes.
` Q And was that part of the litigation
`adverse to Teva related to liraglutide?
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`Peter Tessier - December 4, 2020
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` A Yes.
` Q Have you testified on behalf of Novo
`Nordisk in any other cases?
` A Not to my knowledge, no.
` Q Since you've been deposed before, have you
`done a remote deposition before, like we're doing
`today?
` A I have not.
` Q Okay. So I'm sure you're familiar with
`the general ground rules, but we'll go over a few of
`them, just to make sure we're on the same page. I
`ask that you -- when I ask a question, your response
`is an oral response, rather than a head nod or an
`"uh-huh," so the court reporter can have a clear
`record, which I think is even more important when we
`have the video. Is that okay?
` A Yes.
` Q And when we're over video, it's often
`difficult to know when one person is done and the
`other person begins, but I will try to not talk over
`you and interrupt you. If I interrupt your answer,
`please let me know, and I'm happy to let you
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`Peter Tessier - December 4, 2020
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`Page 10
`continue. It's not intentional. And I ask that you
`also kind of let me finish my question, and then you
`can answer. Is that okay?
` A Yes.
` Q Your attorney may have some objections to
`some of my questions. Unless he instructs you not
`to answer, you can answer, to the extent you can.
`Do you understand that?
` A Yes.
` Q If there is anything about my question
`that's unclear, or there is any document you wish to
`see to help you answer the question, please let me
`know. I will try to either rephrase my question,
`clarify my question, or get you the material you
`need. Is that okay?
` A Yes.
` Q If throughout the deposition there are any
`technical issues that would impede your ability to
`testify, or otherwise proceed with this deposition,
`please let me know. We have a technician on the
`line, who can help with any issues that may arise.
`And we can certainly take a break to square out any
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`Peter Tessier - December 4, 2020
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`of those issues. Is that okay?
` A Yes.
` Q And do you understand while -- during my
`questioning today, you are not supposed to discuss
`the substance of your testimony with your attorneys?
` A I understand that.
` Q Okay. Generally, without revealing your
`conversations with your counsel, what did you do to
`prepare for your deposition today?
` MR. JOHNSON: And, Dr. Tessier, as
`Mr. White stated, just start by answering that
`question very generally.
` THE WITNESS: I reviewed my declaration.
`I reviewed exhibits related to my declaration. I
`met with my lawyers at Fenwick, and went over those
`materials.
`BY MR. WHITE:
` Q Other than the attorneys, did you speak
`with anyone else in preparation for your deposition?
` A No.
` Q Have you identified any errors or mistakes
`in your declaration that you believe need to be
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`Peter Tessier - December 4, 2020
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`corrected?
` A No.
` (Exhibit No. 2022 was referred to.)
`BY MR. WHITE:
` Q I'm looking at your declaration, Exhibit
`2022. And looking at -- I'm looking at paragraph
`109. And my question is, you are not offering any
`opinion in this case that the preambles of claims
`23, 26, and 29 are limitations, is that correct?
` MR. JOHNSON: Counsel, do you want him
`to -- do you want him to be looking at that
`paragraph that you're referring to there or --
` MR. WHITE: No. He can, if he wants to.
`BY MR. WHITE:
` Q My question is, are you offering any --
`you're not offering any opinions in this case that
`the preambles of claims 23, 26, and 29 are
`limitations, is that correct?
` A I'm not even sure where to start on that.
`So if you want, we can start on the paragraph you're
`referring to. So could you tell me what paragraph,
`so I could refer to that?
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`Peter Tessier - December 4, 2020
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` Q Paragraphs 109 and 110.
` A Okay, I'm at paragraph 109. I see 110.
`Okay, so I see those. And then you're asking me
`about the preambles to specific claims, so I'd need
`to look at those claims, if you want me to answer
`that. Would you like me to -- just to be able to
`answer this, I'd have to look at the claim. So
`could I look at the exhibit?
` Q Sure. Do you know which exhibit that is?
` A I don't. What's the number?
` Q The '833 patent is Exhibit 1001.
` (Exhibit No. 1001 was referred to.)
` THE WITNESS: Okay. So which was the
`first claim you mentioned?
`BY MR. WHITE:
` Q Claim 23.
` A Okay. Let's see. So you're asking if I'm
`giving an opinion on whether the preamble to claim
`23 -- so the preamble reads, "a method for reducing
`deposits on production equipment during production
`of GLP-1 agonist formulation."
` In my opinion, is that a limitation? So
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`Peter Tessier - December 4, 2020
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`Page 14
`the paragraphs you referred me to in my declaration,
`109 and 110 -- so 109 says -- so I say that I
`understand that Mylan has sought to construe
`differently any claim terms of the '833 patent, but
`has argued the preamble should be constructed as
`nonlimiting. Okay.
` So I disagree with that. So I believe
`they are limiting. And then you asked me about 110,
`and that recites those preambles. So my opinion
`would be that they're limiting.
` Q And you didn't offer any analysis to
`support that opinion in your declaration, did you?
` A I don't know.
` Q You reviewed the district court's claim
`construction order, is that correct? That's Exhibit
`2082.
` (Exhibit No. 2082 was referred to.)
` THE WITNESS: 2082. Could I look at that?
`BY MR. WHITE:
` Q Sure.
` A Okay. So I have Novo Exhibit 2082 in
`front of me now.
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`Peter Tessier - December 4, 2020
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`Page 15
` Q So my question is, you reviewed that claim
`construction order, correct?
` A That's correct. Sorry, just to be clear,
`I said, that's correct.
` Q Okay. You did not review the transcript
`of the oral argument that led to this order, is that
`correct?
` A I don't know.
` MR. JOHNSON: Objection, foundation.
` THE WITNESS: And just -- my response was,
`I don't know.
`BY MR. WHITE:
` Q All right. Do you still have the '833
`patent in front of you?
` A I don't. Would you like me to get it?
` Q Yes, please.
` A Okay.
` Q And I am looking at the claims that are
`beginning on page 21 of Exhibit 1001.
` A Okay.
` Q Claim 1 does not have any requirement that
`the pharmaceutical formulation be isotonic, is that
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`Peter Tessier - December 4, 2020
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`correct?
` MR. JOHNSON: Objection, calls for a legal
`conclusion.
` THE WITNESS: So I think, as a POSA, I
`would look at this document we're looking at, in the
`'833 patent, and this patent seems to prominently
`involve isotonic agents. So I would read this claim
`in the context of the overall patent. It does not
`say in claim 1 that claim 1 requires the formulation
`to be isotonic.
`BY MR. WHITE:
` Q So you would agree that isotonicity is not
`an element of claim 1, is that correct?
` MR. JOHNSON: Objection, calls for a legal
`conclusion.
` THE WITNESS: No.
`BY MR. WHITE:
` Q No, that that's incorrect, or no, it's not
`a limitation?
` MR. JOHNSON: Same objection.
` THE WITNESS: I don't know. I'd have
`to -- I don't understand the question.
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`BY MR. WHITE:
` Q Let me ask a new question. Maybe we can
`clarify. Does claim 1 require that the
`pharmaceutical formulation that is claimed be
`isotonic?
` MR. JOHNSON: Objection, calls for a legal
`conclusion.
` THE WITNESS: As a POSA, I would read
`claim 1 in the context of this patent, which
`involves isotonicity agents. And therefore, when I
`come to claim 1, I would be thinking of evaluating
`the claim, which includes an isotonicity agent, and
`I'd evaluate it. And I would see that the words --
`it does not require -- there is no statement that
`requires the formulation to be isotonic, although
`there are isotonic agents in the claim.
`BY MR. WHITE:
` Q Okay. And when you say there is an
`isotonic agent in the claim, what are you referring
`to?
` MR. JOHNSON: Objection to form.
` THE WITNESS: As a POSA, I would have
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`Page 18
`evaluated the entire patent, and looked at what the
`patent defines as isotonic agents. And therefore, I
`would have went and reviewed the specification, and
`reviewed the list of agents that are listed. And
`then I would have reviewed the examples. And I
`would conclude that propylene glycol is -- in claim
`1 is listed as an isotonic agent.
`BY MR. WHITE:
` Q And that's how a person of skill in the
`art would read the patent claims in any patent,
`correct?
` MR. JOHNSON: Objection, calls for a legal
`conclusion.
` THE WITNESS: Yes.
`BY MR. WHITE:
` Q There is nothing in claim 1 that limits
`the claim to any particular scale of manufacture, is
`that correct?
` MR. JOHNSON: Objection, calls for a legal
`conclusion.
` THE WITNESS: If I evaluated claim 1, and
`I was interested in the scale of manufacture, how it
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`Page 19
`relates to the scale of manufacture, I would view it
`in the context of the patent, and of the
`specification and examples. And so I would
`understand the overall intent of the inventors, and
`how they are using this formulation, how they're
`manufacturing it and producing it. In claim 1,
`there is no mention of the scale of manufacture.
`BY MR. WHITE:
` Q So claim 1 would cover bench scale
`manufacture of pharmaceutical formulations, correct?
` MR. JOHNSON: Same objection.
` THE WITNESS: I don't know what "bench
`scale manufacture" means.
`BY MR. WHITE:
` Q Claim 1 would cover small -- well, let me
`ask a different question.
` You understand that the inventors here
`purportedly discovered an issue with mannitol
`crystallization
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` MR. JOHNSON: Objection form.
` THE WITNESS: I don't -- I don't know that
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`BY MR. WHITE:
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` A I do see that sentence.
` Q And what was your basis for that
`understanding?
` A I don't know the particulars. I would
`assume they are -- this, to my understanding, is
`related to the references cited before and after
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`that statement.
` Q So do you understand claim 1 encompasses
`industrial scale manufacture of liraglutide
`formulations?
` MR. JOHNSON: Objection, calls for legal
`conclusion.
` THE WITNESS: When I evaluate claim 1 as a
`POSA, I read it as a formulation claim. I read it
`as a claim of a pharmaceutical formulation, with
`specific components in it, and in specific ranges.
`So as a POSA, I don't read this, thinking about
`scale of manufacture. I think of it is as a
`formulation claim, laying out the specific details
`of the formulation.
`BY MR. WHITE:
` Q And claim 1 is not -- claim 1 of the '833
`patent is not limited to any method of
`administration of the pharmaceutical formulation,
`correct?
` MR. JOHNSON: Same objection.
` THE WITNESS: Claim 1 -- I would evaluate
`claim 1 in the context of the entire patent. And so
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`Page 22
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`when I do that, and you asked me about
`administration, I simply looked through the patent.
`I looked through the figures. I see needles in
`multiple figures. I see the title, talking about
`injection devices. I read about subcutaneous
`delivery. I read about pens that are made for
`subcutaneous delivery. I read about examples with
`pens for subcutaneous injection.
` And when I get to claim 1, and I see a
`pharmaceutical formulation, I'm thinking that it is
`intended for subcutaneous delivery, but the words
`subcutaneous delivery or the delivery method are not
`in claim 1.
`BY MR. WHITE:
` Q Claim 1 is not limited to a pharmaceutical
`formulation intended for chronic use, is that
`correct?
` MR. JOHNSON: Same objection.
` THE WITNESS: When I evaluate claim 1 in
`the context of the patent, and I look at the
`different problems that were being attempted to
`solve, and I look at that claim 1 has a GLP-1
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`Page 23
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`agonist, and I understand how GLP-1 agonists are
`used in the most common pharmaceutical application,
`which is chronic administration.
` And then I look at the examples, and I see
`interest in multiple injections, and trying to solve
`a problem related to multiple injections and
`clogging, I think of applications that relate to
`chronic use. But when I read claim 1, I don't see
`anything about chronic use.
`BY MR. WHITE:
` Q Claim 1 does not require that propylene
`glycol be an isotonicity agent in the formulation,
`is that correct?
` MR. JOHNSON: Objection, calls for a legal
`conclusion.
` THE WITNESS: To the best of my
`understanding, when I reviewed this patent, I saw
`that propylene glycol was being referenced as an
`isotonicity agent. So as a POSA, when I evaluate
`this, and I see that propylene glycol is in claim 1,
`my understanding is that, in claim 1, propylene
`glycol is being used -- the intent of the use is to
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`use it as an isotonicity agent.
`BY MR. WHITE:
` Q But that is not -- it's not required by
`the claims to be an isotonicity agent, is that
`correct?
` MR. JOHNSON: Objection, asked and
`answered.
` THE WITNESS: Claim 1 does not use the
`words "isotonicity agent." I would agree with that.
`BY MR. WHITE:
` Q And claim 1 does not require the
`pharmaceutical formulation to be efficacious to
`treat any particular disease, is that right?
` MR. JOHNSON: Objection, calls for a legal
`conclusion.
` THE WITNESS: So related to the question,
`my understanding is Novo Nordisk makes
`diabetes-related drugs, including GLP-1. And the
`purpose of this patent was to solve particular
`problems related to clogs and deposits. And so my
`understanding is that claim 1 aims to solve that
`problem. And it's a pharmaceutical formulation, so
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`Page 25
`I would assume -- I don't have any reason to doubt
`that the pharmaceutical formulation being claimed
`here would be effective.
`BY MR. WHITE:
` Q But it's not required by claim 1 to be
`effective to treat any disease, is that correct?
` MR. JOHNSON: Objection, asked and
`answered.
` THE WITNESS: Claim 1 says a
`pharmaceutical formulation, and I assume that it's
`effective.
`BY MR. WHITE:
` Q And my question, is that efficacy required
`by the claims?
` MR. JOHNSON: Objection, asked and
`answered.
` THE WITNESS: Well, there is no specific
`effectiveness specified in the claims. It does say
`it's a pharmaceutical formulation, and I have no
`reason to doubt that it wouldn't be effective, given
`that it has an active ingredient, a GLP-1 agonist.
`And a POSA would understand GLP-1 agonists are used
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`Page 26
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`for certain applications, so I have no reason to
`doubt it wouldn't be effective.
`BY MR. WHITE:
` Q I think my question is a little bit
`different. I understand that you believe the
`formulation may be effective. My question is, is
`that required by claim 1?
` MR. JOHNSON: Objection to form.
`Objection, asked and answered.
` THE WITNESS: To answer that, I would need
`to know what the definition of a pharmaceutical
`formulation is. I'd have to read the specification
`to understand if that was defined. And I'm happy to
`do that, if you'd like me to.
`BY MR. WHITE:
` Q What -- in preparing your declaration,
`what was your understanding of what the term
`"pharmaceutical formulation" means?
` MR. JOHNSON: Objection, calls for legal
`conclusion.
` THE WITNESS: I don't recall.
`BY MR. WHITE:
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`Peter Tessier - December 4, 2020
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`Page 27
` Q So as you sit here today, you do not have
`an understanding of what the term "pharmaceutical
`formulation" means in claim 1 of the '833 patent?
` MR. JOHNSON: Objection, legal conclusion.
` THE WITNESS: The term "pharmaceutical
`formulation" is a very general term. And as a POSA,
`I would seek to understand a more specific meaning
`of that. And so if you'd like me to, I'm happy to
`review the '833 patent to better understand what is
`meant by that specific term.
`BY MR. WHITE:
` Q I don't want you to do any further
`analysis than you've already done, in terms of
`preparing your report. I'm just trying to
`understand how you understood that term when you
`prepared your report. Do you recall what your
`understanding of the term was when you prepared your
`declaration in this case?
` MR. JOHNSON: Objection, asked and
`answered.
` THE WITNESS: I don't recall.
`BY MR. WHITE:
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`Peter Tessier - December 4, 2020
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`Page 28
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` Q Okay. Does claim 1 include any
`requirements that the pharmaceutical formulation be
`either physically or chemically stable?
` MR. JOHNSON: Objection, legal conclusion.
` THE WITNESS: Sorry. Could you repeat
`that? I caught most of it, but I missed the first
`part.
`BY MR. WHITE:
` Q No problem. Does claim 1 include any
`requirement that the pharmaceutical formulation be
`chemically or physically stable?
` MR. JOHNSON: Objection, legal conclusion.
` THE WITNESS: While the words physical and
`chemical stability are not in claim 1, I would have
`to evaluate that, in terms of the way a
`pharmaceutical formulation is defined in the '833
`patent. Because it's possible that a POSA, when
`they see that, or depending on how it's defined in
`the patent, there is an understanding that that may
`or may not convey that the formulation is physically
`and chemically stable.
`BY MR. WHITE:
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`Peter Tessier - December 4, 2020
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`Page 29
` Q When you prepared your declaration in this
`case, did you have an understanding of whether or
`not the term "pharmaceutical formulation" includes a
`physical or chemical stability requirement?
` MR. JOHNSON: Objection, form, outside the
`scope.
` THE WITNESS: I don't recall.
`BY MR. WHITE:
` Q You offer, in your declaration, opinions
`related to the issue of unexpected results. Do you
`recall that?
` A I do generally recall that, yes.
` Q Okay. Do you understand that unexpected
`results require the claimed invention -- strike
`that.
` Do you understand, to determine whether
`there are unexpected results, the claimed invention
`is compared to the closest prior art?
` MR. JOHNSON: Objection, legal conclusion.
` THE WITNESS: That generally sounds right
`to me, yes.
`BY MR. WHITE:
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`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
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`Peter Tessier - December 4, 2020
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