1
`
`- VOLUME 1 -
`
`IN THE UNITED STATES DISTRICT COURT
`
`IN AND FOR THE DISTRICT OF DELAWARE
`
`CIVIL ACTION
`
`SANOFI AVENTIS U.S. LLC,
`SANOFI AVENTIS DEUTSCHLAND
`and SANOFI-AVENTIS WINTHROP
`INDUSTRIES,
`
`Plaintiffs,
`
`vs.
`
`MERCK SHARP & DOHME
`CORPORATION,
`
`Defendant.
`
`NO. 16-812 (RGA)
`
`Wilmington, Delaware
`Tuesday, May 29, 2018
`8:30 o'clock, a.m.
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`17
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`BEFORE: HONORABLE RICHARD G. ANDREWS, U.S.D.C.J.
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`18
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`19
`
`APPEARANCES:
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`20
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`21
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`22
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`23
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`24
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`25
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`FISH & RICHARDSON P.C.
`BY: MARTINA A. HUFNAL, ESQ.
`
`-and-
`
`Leonard A. Dibbs
`Valerie J. Gunning
`Official Court Reporters
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`1 of 138 sheets
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`Sanofi Exhibit 2225.001
`Mylan v. Sanofi
`IPR2018-01676
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`

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`66
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`69
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`Moskow - direct
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`Sanofi, would you like to call a witness?
`
`MR. MARSILLO: Angela Moskow.
`... ANGELA MOSKOW, having duly
`
`sworn as a witness, was examined and
`
`testified as
`
`follows ...
`
`1
`2
`3
`4
`5
`6
`DIRECT EXAMINATION
`7 BY MR. MARSILLO:
`8 Q.
`9
`
`Good morning, Ms. Moskow.
`
`A.
`
`Good morning.
`
`Are you presently employed?
`
`I'm self-employed.
`
`And what type of business do you have?
`
`I have a healthcare marketing consultancy.
`
`10 Q.
`11
`A.
`Yes, I am.
`12 Q. Where are you presently employed?
`13 A.
`14 Q.
`15
`A.
`16 Q.
`So prior to starting your own business, what was your
`17 most recent employment?
`18
`A.
`19 Q.
`And for how long did you work for Sanofi?
`I started working for Sanofi in August of 1990. And I
`20
`A.
`21 was continuously employed until the end of April 2017.
`22
`I apologize for my voice.
`23 Q.
`24
`So understanding that your roles and responsibilities
`25 changed during that time, can you briefly describe the roles
`
`I worked for Sanofi.
`
`It's quite all right.
`
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`18 of 138 sheets
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`Sanofi Exhibit 2225.002
`Mylan v. Sanofi
`IPR2018-01676
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`

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`Moskow - direct
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`1 and responsibilities that you had at Sanofi during your
`2
`tenure?
`3 A.
`Yes, I started in our sales organization and then
`4 moved over into our marketing area, which is where the
`
`5 majority of my career was spent. And then finished up in
`
`the corporate affairs area.
`6
`7 Q.
`And during your time at Sanofi, did you work with any
`8 particular product or products?
`9 A.
`Yes, predominantly I worked with our Glargine
`10 portfolio, which included both Lantus and Apidra.
`
`1 A.
`2 Q.
`3 A.
`
`Yes.
`
`And where?
`
`The first country to launch was Germany, and that was
`
`4
`in June of 2000.
`5 Q.
`And in obtaining approval to market Lantus in the
`6 United States, did Sanofi submit data from clinical trials
`7
`to the FDA?
`8 A.
`9 Q.
`
`So prior to launch of Lantus in the United States,
`
`Yes.
`
`10 were you aware of any data in those clinical trials or from
`
`So what is Lantus?
`
`Lantus is a 24-hour basal insulin also known as
`
`11 Q.
`12 A.
`13
`insulin glargine, which is used to treat diabetes.
`14 Q.
`And as far as your roles and responsibilities, did you
`15 develop a general understanding of Lantus, including its
`16 active ingredients and properties?
`
`17 A.
`18 Q.
`
`Yes, I did.
`
`So what is an insulin glargine?
`
`19 A.
`Insulin glargine is a molecule that was designed to be
`20 an insulin to have some different properties like to last
`21
`longer over a 24-hour period and to mimic more what the
`22 pancreas does for a basal or background break.
`23 Q.
`24
`25 A.
`
`So you mentioned that Lantus is 24 hours.
`
`What do you mean by 24-hour Lantus?
`
`So, if a patient who has diabetes with one injection,
`
`I had a bunch of responsibilities. Initially market
`
`No.
`
`So what, if any, responsibilities did you have with
`
`11 Sanofi's year-long experience with Lantus in Germany, or
`12
`from any other source, that indicated to you that there were
`13 any issues concerning cloudiness in the Lantus formulation?
`14 A.
`15 Q.
`16
`respect to the launch of Lantus?
`17 A.
`18
`research to understand what were the unmet needs in the
`19 marketplace, in the diabetes marketplace. Then
`20 understanding the product labeling that we were going to
`21 have for Lantus. And then looking at what were the messages
`22 or materials that we wanted to build around the launch to
`23 communicate the benefits of Lantus moving forward.
`24 Q.
`So what was the method that Sanofi selected to
`25 communicate Lantus in the marketplace?
`
`Moskow - direct
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`Moskow - direct
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`the Lantus profile would last for them, and would work to
`
`1
`2
`lower their glucose for a full 24 hours.
`3 Q.
`4
`
`And you also used the term "basal."
`
`What do you mean, the "Lantus with basal insulin"?
`
`5 A.
`In patients who have do not have diabetes, or people
`6 who do not have diabetes, the pancreas is always making a
`7 certain amount of insulin that the body needs, so that's
`8 your basal or your background rate that is present.
`9 Q.
`
`So going back to your work at Sanofi, specifically
`
`The primary method was 24-hour control.
`
`1 A.
`2
`So because Lantus was a new insulin, and there wasn't
`3 one that lasted 24 hours with one injection, that's the area
`4
`that we really wanted to focus on.
`5 Q. Was Lantus the first long-acting basal insulin
`6
`
`formulation launched in the U.S. market?
`
`Yes.
`
`7 A.
`8 Q.
`Now, after the launch of Lantus in the United States,
`9 were you made aware of any information that indicated that
`
`10 with respect to Lantus, what positions did you have related
`
`10
`
`there were issues relating to the cloudiness of the Lantus
`
`I started initially as a promotional manager, which is
`
`role that supports the Products Manager that were getting
`
`ready to launch Lantus.
`I then moved into a Product Manager role right before
`
`indicated that there were issues concerning cloudiness in
`
`11
`formulation in its vials?
`12 A.
`Yes, we were.
`13 Q. What information were you made aware that that
`14
`15
`the Lantus vials?
`16 A.
`Shortly after the launch of Lantus in the United
`17 States, there were complaints as far as coming into the
`18 company, where patients would identify that they had a vial
`19 of Lantus that they would see white particles or
`20 participants, or it looks cloudy. And this was certainly a
`21 concern.
`22 Q.
`23 A.
`24 Q.
`And as far as your responsibilities, were you made
`25 aware of those complaints?
`
`And did Sanofi track those complaints?
`
`Yes.
`
`11
`to Lantus.
`12 A.
`13
`14
`15
`16
`the launch of Lantus, and then held multiple roles on the
`17 Lantus brand up until the last five years that I was the
`18 head of the Marketing Department for Lantus.
`19 Q. When was Lantus launched in the United States?
`20 A.
`21 Q.
`22
`launched in the United States?
`23 A.
`24 Q.
`25
`
`May of 2001.
`
`And in what format was Lantus marketed when it was
`
`It was launched in the 10 millimeter vials.
`
`Prior to the launch in the United States, had it been
`
`launched elsewhere?
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`Mylan v. Sanofi
`IPR2018-01676
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`

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`Moskow - direct
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`I was.
`
`1 A.
`2 Q.
`Approximately how many complaints did Sanofi receive
`3 within that first year or so?
`4 A.
`Over the first year I think it was about 150.
`5 Q.
`6
`7 A. Well, the first reason they were a concern is, we
`8
`didn't know why it was happening. So we first needed to
`9 understand why was this happening.
`10 Q. Were there any concerns about how the complaints of
`
`And why were the complaints of cloudy vials a concern
`
`for Sanofi?
`
`Yes, absolutely?
`
`Now, in your deposition in this matter, you testified
`
`11 cloudiness in the vials would affect the Lantus brand?
`12 A.
`13 Q.
`14
`that the complaints about cloudiness were more of a signal
`15
`16
`What do you mean by that?
`17 A. When the complaints first starting coming in, the
`number was not very high, especially when you look at the
`
`than an issue.
`
`18
`19
`number of complaints per thousands of vials that were in the
`20 marketplace.
`21
`So I think of it more as a signal. Something that we
`22
`needed to investigate and to understand. As time went on,
`23
`24
`25
`
`though, the complaints continued to increase.
`
`And, so, certainly the company looked at this as an
`
`issue that needed to be addressed.
`
`investigating, did any member of the groups that you just
`
`describe state that they were immediately aware of what the
`
`1
`2
`3
`cause of the cloudiness in the vials was?
`4 A.
`No, that's why we were trying to understand the
`5 situation.
`6 Q.
`And did you continue to receive complaints concerning
`7
`cloudiness in the Lantus vials after that first year or so?
`8
`Yes, we did.
`A.
`9 Q. Would you turn with me to Defendant's Exhibit 194.
`(Defendant's Exhibit No. 194 was admitted into
`
`10
`
`11 evidence.)
`12 BY MR. MARSILLO:
`13 Q.
`It's also on the screen.
`14 A. Yes.
`15 Q. What is that document?
`16
`This is an internal report that was prepared to give
`A.
`-- it was an executive overview during the time period, May
`17
`18
`2003. The number of complaints that were coming in
`19
`20
`21
`particular type of complaint.
`22 Q.
`And if we turn to page 3, there's a chart of the
`23 complaints at least during the time period shown?
`24 A. Yes.
`25 Q.
`Now, did Sanofi communicate with the FDA concerning
`
`there were adverse events that were associated with this
`
`associated with this issue of turbidity. And then also if
`
`Moskow - direct
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`Now, did you know what a field alert is?
`
`1 cloudiness in the Lantus vials?
`2 A. Yes.
`3 Q. Were you kept apprised of those communications?
`4 A.
`Yes, I was.
`5 Q.
`6 A.
`I do.
`7 Q. What is a field alert?
`8 A.
`A field alert is when a company has information about
`9
`one of theirs products that is currently marketed to the
`10 public. And if there is something that they are seeing,
`
`11 that they feel they need to alert the FDA to get an issue of
`12 a field alert.
`13 Q.
`And when the field alert issued with respect to the
`14 cloudiness in the Lantus vial?
`15 A. Yes.
`16 Q. When?
`17 A.
`I'm sorry?
`18 Q. When?
`19 A.
`June of 2001.
`20 Q.
`21
`connection with complaints regarding cloudiness in the
`22
`Lantus vial?
`23 A.
`Yes, I did.
`24 Q. What was your understanding as to what the FDA could
`25 do in response to concern about cloudiness in the Lantus
`20 of 138 sheets
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`And did you have concerns about the FDA's response in
`
`So what did Sanofi do in response to receiving the
`
`There were multiple things that were done.
`
`The -- of course the first thing we wanted to
`
`understand was why, so we had several different parts of the
`
`organization investigate why was this happening, why were we
`
`getting the complaint of cloudy vials.
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`stay under refrigeration from Sanofi to our wholesalers,
`
`retailers, and then ultimately to the patient, we wanted to
`
`understand was there a breakdown where the product was not
`
`refrigerated and not kept within the specifications that are
`
`required.
`
`There were others in the company that were looking at
`
`the batches that were coming into the U.S. to see whether
`
`1 Q.
`2
`complaints concerning cloudiness in the Lantus vial?
`3 A.
`4
`5
`6
`7
`8
`One of the areas that I was working on specifically
`9 was understanding our distribution channel. And knowing
`10
`that Lantus is a different insulin, and that it needs to
`11
`12
`13
`14
`15
`16
`17
`18
`there was something different about these batches versus
`19 what was happening in Europe.
`20
`We also had a group that was looking at the needle,
`21
`22
`23
`24
`to understand what exactly was happening.
`25 Q.
`
`and was there some type of contaminant that was being put
`
`into the vial when the needle was going into the vial.
`
`So certainly a lot of different things that we needed
`
`So when these complaints came in, and Sanofi started
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`IPR2018-01676
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`Moskow - direct
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`1 vial?
`2
`The FDA has a lot of different things they can do. We
`A.
`3 certainly wanted to keep the conversations private in
`4 sharing the information that we had. The FDA couldn't
`5 decide that they were going to issue a public communication,
`6 which we were at the beginning of a launch in trying to
`7 establish the brand and that certainly could be detrimental.
`8
`The FDA also had the power to potentially do a recall
`9 which could be detrimental or even pull the product off the
`10 market if they felt strongly about it which, of course,
`11 would have been catastrophic for the Lantus brand at that
`12
`time.
`13 Q.
`14
`15
`As far as you know, were any of those complaints
`16 publicly disclosed?
`17 A. No.
`18 Q.
`Now, what did Sanofi ultimately decide to do after
`19 completing its investigation in the cloudiness in the Lantus
`20 vial?
`21 A.
`22
`team, we decided that it would be the best solution, and
`23 what was presented to the organization was to reformulate
`24 Lantus in a vial.
`25
`
`And we talked about some of the complaints that Sanofi
`
`received.
`
`After we completed the investigation with the project
`
`Q.
`
`And did Sanofi submit a supplemental NDA concerning
`
`A.
`
`There were two.
`
`1 A. Yes.
`2 Q. What format?
`3
`4
`One was the reusable pen device which is called Lantus
`5 OptiClik and the other was a disposable pen device called
`6 Lantus SoloSTAR.
`7 Q.
`8 United States?
`9 A.
`
`And is OptiClik still distributed by Sanofi in the
`
`It is not.
`
`10 Q. Why did Sanofi discontinue distributing the OptiClik?
`
`Now, did Sanofi receive any complaints of cloudiness
`
`It was lack of market demands here in the United
`11
`A.
`12 States.
`13 Q.
`14
`in either the SoloSTAR pen device or the OptiClik pen
`15 device?
`16 A. No.
`17 Q.
`And the -- if I'm correct, Ms. Moskow, each of those
`18 pen devices contain a cartridge that has a formulation in
`19
`it?
`20
`A.
`21 Q.
`And what is the formulation that is used in the Lantus
`22 SoloSTAR?
`23
`24
`in the United States in 2000.
`25 Q.
`
`That is correct.
`
`A.
`
`It is the original formulation that was approved here
`
`You mentioned SoloSTAR.
`
`Moskow - direct
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`Moskow - direct
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`Q.
`
`And how much time elapsed between the start of the
`
`investigation into the cloudiness in the Lantus vial and
`
`submission of the supplemental NDA?
`
`its reformulated Lantus?
`2 A. Yes.
`3
`4
`5
`6
`A.
`It was about three years.
`7 Q. What, if any, effect did the change in the formulation
`8
`have on the number of complaints that Sanofi received with
`9
`
`respect to cloudiness in its vials?
`
`10
`
`A.
`
`They dramatically decreased.
`
`As if?
`
`11 Q.
`12
`MR. MARSILLO: If we can take a look at
`13 Plaintiff's Exhibit 722?
`14
`(Plaintiff's Exhibit No. 722 was admitted into
`
`15 evidence.)
`16 BY MR. MARSILLO:
`17 Q.
`It's also on the screen.
`18 A. Yes.
`19
`Q. What is Plaintiff's Exhibit 722?
`20
`This is a chart which was compared and looked at over
`A.
`21 the years after the reformulation was into the U.S.
`22 marketplace. The number of complaints and how they
`23 decreased over time.
`24 Q.
`Now, besides marketing Lantus in the vial format, did
`25 Sanofi market Lantus in any other format?
`
`Is SoloSTAR still distributed by Sanofi?
`
`1
`2
`Yes, it is.
`A.
`3 Q. And who designed SoloSTAR?
`4 A. We worked with a firm out of the United Kingdom called
`5 DCA.
`6 Q.
`7
`8 A.
`9 Q.
`10 Lantus OptiClik launched?
`
`I'm sorry.
`
`When was SoloSTAR launched?
`
`It was launched until July of 2007.
`
`And you may have mentioned this, but when was the
`
`In January of 2015 -- sorry -- 2005. January of 2005.
`
`11 A.
`12 Q.
`So OptiClik was still on the market at the time that
`13 SoloSTAR launched?
`
`launched?
`
`14
`A.
`Yes, it was.
`15 Q. Were there any other injections pens on the market
`16 besides Lantus OptiClik and Lantus SoloSTAR, when SoloSTAR
`17
`18
`Yes, there were multiple pens on the market from a
`A.
`19 competitive standpoint. Two that we paid close attention to
`20 were the Flexpen by Nova Nordis and also Lilly's disposable
`21 pen.
`22 Q.
`23
`the launch of SoloSTAR?
`24 A.
`25
`
`And what were your responsibilities with respect to
`
`I was leading the marketing team that was responsible
`
`for the launch of the Lantus SoloSTAR.
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`them.
`
`has the lowest injection for the easiest button to be able
`
`to push to deliver that dose we felt was very important
`
`And are the features that you were just describing
`
`Now, as far as you were aware, was the Lantus SoloSTAR
`
`the first pen to have that combination of features?
`
`Yes, it was.
`
`(Pause)
`
`1
`The fact that with the Lantus SoloSTAR, if a patient
`2 needed 20 units and there were only 15 than units left in
`3
`the SoloSTAR, they couldn't dial past that 15 units, so
`4 again it would insure they would get the correct dose for
`5
`6
`And then the other thing that we were excited about
`7 bringing to the market was people with diabetes have
`8 extraneous issues sometimes. And, so, having a device that
`9
`10
`11
`also.
`12 Q.
`13
`identified on pages 6 and 7 of the launch book?
`14 A. Yes.
`15 Q.
`16
`17
`A.
`18 Q.
`If you will turn back with me to page 5 of the launch
`19 book.
`20
`21
`That is section on the Lantus SoloSTAR strategy, and a
`22 middle section, strategic levers.
`23
`Do you see that?
`24 A. Yes.
`25 Q.
`
`And so what did you as the lead of the marketing team
`
`for the launch of SoloSTAR?
`
`1 Q.
`2
`3
`A. We built a lot of strategy. We also built the
`4 materials that updated the information that sales
`5 representatives would use with their customers when they
`6 were talking to them. And then we also built a plan for a
`7
`8
`representatives.
`9 Q.
`
`launch meeting which required training materials for the
`
`If you'll have a look at Plaintiff's Exhibit 705?
`
`10 A. Yes.
`
`Lantus SoloSTAR was, and how it was built, as well as the
`
`strategy and approved sources of references for the type of
`
`(Plaintiff's Exhibit No. 705 was admitted into
`11
`12 evidence.)
`13 BY MR. MARSILLO:
`14 Q. What's Plaintiff's 705?
`15 A.
`This is the launch book that was prepared for us to be
`16 able to train our sales associates on understanding what
`17
`18
`19
`things that we could talk about with Lantus SoloSTAR.
`20 Q.
`And you supervised the creation of the SoloSTAR launch
`21 book?
`22 A.
`23 Q.
`24
`25 A.
`
`I did.
`
`If you'll turn with me to page 3.
`
`What is being conveyed on page 3?
`
`The first thing we wanted to share with the sales
`
`And there's language, "Use Lantus SoloSTAR to expand
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`force was that this was a pen that was not an adaptation of
`
`something. It was built from the ground up.
`So it took several years, and it also had input from
`thousands of patients, and thousands of physicians on what
`
`1
`2
`3
`4
`5
`types of things would like to see if they were going to
`6 design a pen device.
`7
`8
`9
`10 market that was launched.
`
`And wanted to share this through all that research and
`
`building the pen from the ground, that we felt we had the
`
`best combination all the features of any pen that was on the
`
`1 the number of HCP's writing Lantus. Destroy the
`2 Flexpen/Lillypen barrier."
`3
`Do you see that?
`4 A. Yes.
`5 Q. What was meant by "Destroy the Flexpen/Lillypen
`6 barrier"?
`7 A.
`So I'd like to read -- this was an internal document
`8 and this was internal strategy that we were speaking to, but
`9 one of the things that we were hearing from physicians in
`10
`
`the market was that they loved Lantus, but we had
`
`So what are the features that you just referred to?
`
`A.
`
`So there were a lot of different features. And that's
`
`one of the things that made Lantus SoloSTAR very exciting.
`
`One was that this was the first injection device where
`
`Having a larger doses and being able to take those
`
`larger doses with just one injection, that was an innovation
`
`that we were very excited about.
`
`11 Q.
`12
`13
`14
`15
`patients would be able to inject themselves one time,
`16 especially when one was Type II diabetes.
`17
`18
`19
`20
`The other thing that we were really looking to do was
`21 to make using SoloSTAR very easy. And so the ease of a
`22
`23
`24
`25
`
`patient getting the right dose with that being how they
`
`dial-up the dose. The fact that if they need ten units and
`
`they slip and go to 12 units, they can then dial back to ten
`
`units to get the appropriate dose for them.
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`had -- we were told this was a better device at the time.
`
`And they were making decisions to write Levemir, even
`
`though they felt Lantus was a better insulin for their
`
`patients because of that, the Flexpen.
`
`11 competitors on the market such as Levemir and Flexpen that
`12
`13
`14
`15
`16
`So this is just speaking to the fact that we could
`17 break down this barrier. This wasn't going to be an
`18 objection in the marketplace any longer with the
`19
`introduction of Lantus SoloSTAR.
`20 Q.
`21
`22
`23
`MR. MARSILLO: With Your Honor's permission, I
`24 would like to hand the witness a SoloSTAR pen?
`25
`
`Now, did you familiarize yourself with how to operate
`
`the SoloSTAR pen?
`
`A.
`
`Yes, I did.
`
`THE COURT: Sure.
`
`05/30/2018 02:16:45 AM
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`22 of 138 sheets
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`Sanofi Exhibit 2225.006
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Moskow - direct
`
`Moskow - direct
`
`86
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`88
`
`1
`2
`3 evidence.)
`4
`5
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`9
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`MR. MARSILLO: This is Plaintiff's Exhibit 1421.
`
`(Plaintiff's Exhibit No. 1421 was admitted into
`
`MR. MARSILLO: Your Honor?
`
`THE COURT: If I could just ask one question of
`
`the witness. I wanted to make sure I understood the answer.
`
`When SoloSTAR was launched in the U.S., did
`
`it have the original Lantus formulation or Lantus
`
`reformulation in it?
`
`10
`
`THE WITNESS: It had the original formulation.
`
`THE COURT: Okay.
`11
`12 BY MR. MARSILLO:
`13 Q.
`So I've handed you Plaintiff's 1411, Ms. Moskow, the
`14 Lantus SoloSTAR pen.
`15
`Can you just briefly describe for the Court how a
`16 patient would dial a dose or inject a dose?
`17
`Yes, the first thing the patient would do, which we
`A.
`18 don't have in the courtroom today, but we would put a needle
`19 on the end. We're not going to do that today.
`20
`Then the patient would dial-up. They would make sure
`21
`that the pen was at zero and then they would dial up one
`22 unit, and push those out, which it's really called priming
`Then they would -- it was reset to zero --
`23
`the pen.
`24 and then they would just dial-up by clicking, say, to ten
`25
`units. Put their thumb on the end, decide whether they were
`
`1
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`And so several patients were given a SoloSTAR device
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`and a Flexpen device, a Lilly disposable device, and a
`
`fourth pen. And they were asked to rank them and compare
`
`them on individual features, but then to make a
`
`determination that if they were going to use one device that
`
`they wanted to use moving forward, what would that be, and
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`the choice was the SoloSTAR device.
`
`Q.
`
`You mentioned another study.
`
`Was that the Clarke study?
`
`A.
`
`Q.
`
`Yes.
`
`If you will turn to Plaintiff's 674.
`
`(Plaintiff's Exhibit No. 674 was admitted into
`
`evidence.)
`
`BY MR. MARSILLO:
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Is that the Clarke study?
`
`Yes.
`
`And what were the conclusions of the Clarke study?
`
`The conclusions of the Clarke study were that the
`
`SoloSTAR device could repeatedly deliver a dose with great
`
`accuracy. That's certainly one of the things is expected of
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`a pen. When you dial ten units, that you get an injection
`
`of ten units. So this validated that that was going to be
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`the case.
`
`And then the other thing that this looked at was
`
`injection force. And the injection force for the SoloSTAR
`
`Moskow - direct
`
`Moskow - direct
`
`87
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`89
`
`1
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`going to inject under -- into the arm, into the soft tissue,
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`and then just push down, and they'll hear a click until the
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`dose is delivered.
`
`Q.
`
`Thank you.
`
`Aside from setting forth the features of the SoloSTAR
`
`device, as well as some strategic direction, what other
`
`information was provided in the launch book, or marketing to
`
`a sales person?
`
`A.
`
`For any claims that we are going to make in the
`
`marketplace, we are going to have to have substantiation for
`
`that.
`
`So there were two primary publications that supported
`
`what we were saying about Lantus SoloSTAR. And those were
`
`the trials by Dr. Haak and Dr. Clarke. And in the launch
`
`book we gave the representatives an overview of what those
`
`studies contained.
`
`Q.
`
`So if you will have a look at Plaintiff's 665.
`
`(Plaintiff's Exhibit No. 665 was admitted into
`
`evidence.)
`
`BY MR. MARSILLO:
`
`Q.
`
`Is Plaintiff's 665 the Haak study that you just
`
`referred to?
`
`A.
`
`Yes, this is the Dr. Haak study.
`
`Q. What were the conclusion of Dr. Haak's study?
`
`A.
`
`That's a patient preference study.
`
`Now, how did having the SoloSTAR affect your marketing
`
`1 device was compared to the Flexpen, as well as the Lilly
`2 disposable pen. And was shown to be the least amount of
`3
`injection force required in order to deliver a dose.
`4 Q.
`5
`efforts with respect to the Lantus brand?
`6
`It greatly helped. I would say, you know, it
`A.
`7 maintained the trajectory that we were trying to build for
`8
`the brand with Lantus, but then gave us another tool in
`9 order to really accelerate our sales and our penetration,
`10 especially into the oral marketplace.
`
`You mentioned sales.
`
`A.
`
`11 Q.
`12
`What were the metrics that you tracked in an assessing
`13 whether Lantus products were well-received in the
`14 marketplace?
`15
`Sales was certainly one. We also looked at the number
`16
`of prescriptions and then we would measure our market share
`17 versus competitors.
`18 Q.
`And what were the sales of Lantus' products during
`19 your tenure?
`20
`In our peak year of sales, we were able to attain a
`A.
`21 little over $11 million.
`22 Q.
`$11 million or $11 billion?
`23
`A.
`24 Q.
`25
`
`$11 billion with a B.
`
`All right.
`
`What were the prescriptions for Lantus products during
`
`23 of 138 sheets
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`Sanofi Exhibit 2225.007
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`your tenure?
`
`1
`
`A.
`
`Yes. The final labeling is distributed with the
`
`Moskow - direct
`
`Moskow - cross
`
`A.
`
`During that peak year again, it was about 20 million
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`2 product.
`
`prescriptions that were written.
`
`3 Q.
`
`And Sanofi publicly distributed this with the Lantus
`
`1
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`2
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`3
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`90
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`92
`
`4 Q.
`
`Now, did you also track the number of sales, Sanofi
`
`5 sales of marketing personnel compared with Sanofi
`6 competitors?
`
`7
`
`A.
`
`8 Q.
`
`Yes, we did.
`
`And how did the number of Sanofi's sales and marketing
`
`9 personnel compare with competitors?
`
`10
`
`A.
`
`We were competitive with other companies in the
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`11 diabetes space.
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`product at the time of launch?
`
`4
`5 A.
`
`I'm sorry. I'm having trouble hearing you.
`
`6 Q.
`
`Sanofi publicly distributed this label with the Lantus
`
`7
`
`product at the time of launch; is that correct?
`
`8 A.
`9
`
`Q.
`
`The final labeling, yes.
`
`And you testified again that the Lantus was first
`
`launched in 2001; is that correct?
`
`10
`11 A. May.
`
`12 Q.
`
`And has Sanofi selected the SoloSTAR pen injector with
`
`12 Q.
`
`May 2001. And when somebody purchased the Lantus
`
`13 respect to other drugs?
`14 A.
`
`Yes, actually multiple products now are delivered
`
`file, the label was included; is that right?
`
`13
`14 A. Yes.
`
`15 within SoloSTAR.
`
`Q.
`
`And which products?
`
`16
`17 A.
`18 which was launched in SoloSTAR.
`
`In 2009, Apidra, which is a rapid-acting insulin,
`
`19
`20
`
`In March of 2015, Toujeo, a long-acting insulin was
`
`launched with SoloSTAR.
`
`21
`22 Lantus plus a Glc 1 glucose was launched.
`
`In January of 2017, Sanofi's combination products of
`
`15 Q.
`
`And you testified that after Sanofi launched Lantus,
`
`16 Sanofi began receiving complaints about the stability issues
`17 with the original Lantus formulation; is that correct?
`
`18 A.
`19
`
`particles in the vials.
`
`Yes. We had complaints coming in that there were
`
`20
`21
`22
`
`Q.
`
`And after receiving complaints about the stability
`
`issues, Sanofi did not issue a press release regarding the
`
`stability; is that correct?
`
`23
`24 Admelog was launched in the SoloSTAR device.
`
`And then most recently a rapid-acting insulin called
`
`23 A.
`24
`
`Q.
`
`No, we did not.
`
`And after receiving complaints about stability issues,
`
`25
`
`MR. MARSILLO: Thank you very much.
`
`25 Sanofi didn't do anything specific on the out reach to
`
`Moskow - direct
`
`Moskow - cross
`
`91
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`93
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`prescribers or consumers regarding the stability issue; is
`
`1
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`6
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`18
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`THE COURT: I'm sorry, Ms. Moskow, the sales of
`
`Lantus you said were $11 billion.
`
`Is that the original Lantus, or the reformulated
`
`Lantus, or both together.
`
`THE WITNESS: It's a franchise.
`
`So, it would be the vial with the reformulation,
`
`plus Lantus SoloSTAR with the original formulation.
`
`THE COURT: All right.
`
`So why don't we take our morning break before we
`
`begin our cross-examination. 15 minutes.
`
`(A recess was taken.)
`
`- - -
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`1
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`(Proceedings resumed after the short recess.)
`
`13
`14
`THE COURT: All right. Be seated.
`MS. ANTONS: Good morning. I'm Amanda Antons on 15
`
`behalf of Merck, Your Honor.
`
`THE COURT: Good morning, Ms. Antons.
`
`CROSS-EXAMINATION
`
`19 BY MS. ANTONS:
`20
`21
`
`Q.
`
`Let's go to DTX-924. And this is the, DTX-924 is the
`
`final approved labeling from the FDA for Sanofi's Lantus
`
`product in 2001; is that correct?
`
`22
`23 A. Yes.
`
`24 Q.
`
`And this document was distributed with the Lantus
`
`25 product?
`
`05/30/2018 02:16:45 AM
`
`that correct?
`
`A.
`
`Q.
`
`No. Nothing specific.
`
`And Sanofi received approval from the FDA in
`
`approximately March 2005 to the modified Lantus formulation;
`
`is that correct?
`
`A.
`
`Q.
`
`Yes, the spring of 2005. That's correct.
`
`And there was a time period even after the FDA
`
`approved the Lantus formulation to polysorbate 20 that
`
`Sanofi continued to sell Lantus without polysorbate 20; is
`
`that correct?
`
`A.
`
`Q.
`
`Correct. We continue to sell it today.
`
`And Sanofi didn't begin -- you continued to sell it in
`
`the cartridge; is that correct?
`
`A.
`
`Q.
`
`That's correct.
`
`You do not continue to sell it in a vial; is that
`
`correct?
`
`A.
`
`Q.
`
`That's correct.
`
`And Sanofi began selling the modified formulation
`
`approximately June 2006?
`
`A.
`
`Q.
`
`Yes.
`
`Does that mean between the approval of the modified
`
`formulation and the first sale, there was a gap of
`
`approximately 15 months; is that correct?
`
`A.
`
`Yes.
`
`16
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`17
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`18
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`Sanofi Exhibit 2225.008
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Moskow - cross
`
`94
`
`Yes, we did.
`
`And during that time span, you continued to sell the
`1 Q.
`2 original Lantus formulation in vials; is that correct?
`3
`A.
`4 Q.
`Even after the FDA approved the new formulation of
`5 Lantus, the FDA never told Sanofi to remove the original
`6 Lantus formulation from the market; is that correct?
`
`he has been sequestered.
`
`Lill - direct
`
`96
`
`That's correct. There was no need to.
`
`7
`A.
`8 Q.
`9 something that Sanofi looked at that would accelerate the
`
`You would not say that changing the formulation was
`
`10 sales of Lantus; is that correct?
`
`I wouldn't say that we looked at it to accelerate the
`
`11 A.
`12
`sales. I looked at it more of a long-term risk mitigation
`13 strategy to maintain and then ultimately accelerate sales.
`14 Q.
`And there was no evidence that Sanofi had that the
`15 clouding and the original formulation of Lantus actually
`16
`reduced the sales of its product; is that correct?
`17 A. Correct.
`18 Q.
`19
`formulation and OptiClik because of market demand; is that
`20 correct?
`21 A. Yes.
`22 Q.
`And the first Lantus product that was sold in a pen
`23 was, in fact, the OptiClik device; is that correct?
`24
`A.
`25 Q.
`
`You testified that you discontinued the Lantus
`
`That's correct.
`
`And unlike SoloSTAR, OptiClik was a reusable pen; is
`
`Moskow - cross
`
`95
`
`1 that correct?
`2 A. Yes.
`3 Q.
`And Sanofi performed market research after Lantus
`4 OptiClik was launched; is that correct?
`5 A. Yes.
`6 Q.
`And in that market research, one of the primary
`7 complaints with OptiClik was that OptiClik was difficult to
`8 use, especially changing the cartridge; is that correct?
`9
`
`That is what we heard, yes.
`
`A.
`
`10 Q.
`
`And disposable pens do not require changing the
`
`11
`
`12
`13
`14
`15
`16
`
`cartridge; is that right?
`
`A.
`
`They do not.
`
`MS. ANTONS: No further questions.
`
`THE COURT: All right.
`
`MR. MARSILLO: I have no questions, Your Honor.
`
`THE COURT: All right. Ms. Moskow, you may step
`
`THE WITNESS: Thank you.
`
`THE COURT: Watch your step.
`
`(Witness excused.)
`
`17 down. Tha