H. DERENDORF
`UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
`
` _____________________________
` NEPTUNE GENERICS, LLC
` Petitioner
` v.
` CORCEPT THERAPEUTICS, INC.
` Patent Owner
` _____________________________
` IPR No. 2018-01494
` Patent No. 8,921,348
` _____________________________
`
` DEPOSITION OF DR. HARTMUT DERENDORF
` Washington, D.C.
` August 2, 2019
`
`Reported by: Mary Ann Payonk
`Job No. 163994
`
`TSG Reporting - Worldwide 877-702-9580
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`NEPTUNE GENERICS - Ex. 1037
`Page 1
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`

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` H. DERENDORF
`APPEARANCES:
`ON BEHALF OF PETITIONER:
` CHRISTOPHER MAY, ESQUIRE
` KENNETH GOLDMAN, ESQUIRE
` MASSEY & GAIL
` 1000 Maine Avenue, SW
` Washington, DC 20024
`
`ON BEHALF OF PATENT OWNER and THE WITNESS:
` MICHELLE ERNST, ESQUIRE
` LATHAM & WATKINS
` 885 Third Avenue
` New York, NY 10022
`
`ALSO PRESENT:
` Adolph "Ace" Green, Legal Video
` Specialist
` Joshua Harris, Neptune Generics
` Daniel Wiesner, Quinn Emanuel
`
`Page 5
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` H. DERENDORF
`DR. HARTMUT DERENDORF, 08:52
` called as a witness, having been duly 08:52
` sworn, was examined and testified as 08:52
` follows: 08:52
` EXAMINATION 08:53
`BY MR. MAY: 08:53
` Q. Good morning, Dr. Derendorf. 08:53
` A. Good morning. 08:53
` Q. Have you had your deposition taken 08:53
`before? 08:53
` A. I have. 08:53
` Q. Okay. About how many times? 08:53
` A. Probably 10, 12 times, something like 08:53
`that. 08:53
` Q. Okay. Are any of those for patent 08:53
`cases? 08:53
` A. Yes. 08:53
` Q. Okay. How many? 08:53
` A. Most of them. 08:53
` Q. Okay. So you're an old hand at this. 08:53
` A. I wouldn't -- I've done it before. 08:53
` Q. Okay. Well, let me just quickly go 08:53
`over the ground rules again. I'm sure 08:53
`Ms. Ernst went over them with you when she 08:53
`
` H. DERENDORF
`
` August 2, 2019
` 9:00 a.m.
`
` Deposition of DR. HARTMUT DERENDORF,
`held at the offices of Latham & Watkins LLP,
`555 11th St. N.W., Washington, D.C., pursuant
`to Notice before Mary Ann Payonk, Nationally
`Certified Realtime Reporter and Notary Public
`of the District of Columbia, Commonwealth of
`Virginia, and State of New York.
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` H. DERENDORF
` THE VIDEOGRAPHER: This is the 08:51
` start of tape labeled number 1 in the 08:51
` videotaped deposition of Dr. Hartmut 08:51
` Derendorf in the matter of Neptune 08:51
` Generics LLC v. Corcept Therapeutics, 08:51
` Inc. in the United States Patent and 08:52
` Trademark Office, Case Number 08:52
` IPR2018-01494. 08:52
` This deposition is being held at 08:52
` 555 11th Street Northwest, Washington, 08:52
` D.C. on August 2, 2019 at approximately 08:52
` 8:51. 08:52
` My name is Adolph Green from 08:52
` TSG Reporting, Inc., and I'm the legal 08:52
` video specialist. 08:52
` The court reporter today is Mary 08:52
` Ann Payonk in association with 08:52
` TSG Reporting. 08:52
` Will counsel please introduce 08:52
` yourselves? 08:52
` (Whereupon, counsel placed their 08:52
` appearances on the video record.) 08:52
` THE REPORTER: I'll swear the 08:52
` witness. 08:52
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`NEPTUNE GENERICS - Ex. 1037
`Page 2
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`

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` H. DERENDORF
`talked with you. 08:53
` I'm going to be asking you a series 08:53
`of questions today, and I'd like you to answer 08:53
`those questions as fully and completely as 08:53
`possible. 08:53
` The court reporter here is going to 08:53
`be taking down my questions and your answers. 08:53
` If there's something about my 08:53
`question that you don't understand, please let 08:53
`me know. I can try to rephrase it. But if you 08:53
`don't tell me there's something that you don't 08:53
`understand, I have to assume that you 08:54
`understand the question. 08:54
` Are you with me so far? 08:54
` A. I understand. 08:54
` Q. Okay. I may ask questions that are 08:54
`yes/no. Try to answer them yes/no, because 08:54
`uh-huh's and nods don't show up very well on 08:54
`the transcript. 08:54
` A. I'll try to -- 08:54
` MS. ERNST: I'm just going to 08:54
` object to form. The witness can answer 08:54
` the questions how he chooses to answer 08:54
` the questions. 08:54
`
`Page 8
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` H. DERENDORF
` A. No. 08:55
` Q. Okay. Has a court ever not believed 08:55
`or otherwise found your opinion to be not 08:55
`reliable? 08:55
` A. No. 08:55
` MS. ERNST: Objection, foundation. 08:55
` A. Not that I know of, no. 08:55
` THE REPORTER: And if you could 08:55
` just pause momentarily before you answer 08:55
` so I can get the objection down. 08:55
`BY MR. MAY: 08:55
` Q. When did you agree to serve as an 08:55
`expert in this case? 08:55
` A. Approximately, my guess is a year 08:55
`ago. 08:55
` (Exhibit No. 2014, previously marked, was 08:55
` referenced and indexed.) 08:55
`BY MR. MAY: 08:55
` Q. Okay. About how long did you spend 08:55
`preparing the declaration that you have in 08:55
`front of you, which is Exhibit 2014? 08:55
` A. I don't know exactly. It was over a 08:56
`long period of time, maybe three to four days. 08:56
` Q. Okay. So 25 hours or so? 08:56
`
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` H. DERENDORF
` Q. Okay, which brings me to my next 08:54
`point. Periodically, Ms. Ernst may object to 08:54
`some of my questions. Unless she tells you 08:54
`particularly not to answer the question, I 08:54
`would ask that you go ahead and answer the 08:54
`question. 08:54
` This isn't a memory test. This isn't 08:54
`a torture test of any kind. If you need a 08:54
`break, please let me know. The only thing I 08:54
`would ask is if you have a question pending 08:54
`that you answer the question, and then you're 08:54
`free to take a break. 08:54
` I'll probably be stopping every 60 to 08:54
`90 minutes. I understand that we need to get 08:54
`done a little bit early so I will try to keep 08:54
`breaks brief. 08:54
` A. Appreciate it. 08:54
` Q. All right. Have you ever been 08:54
`convicted of a crime other than a traffic 08:55
`offense? 08:55
` A. No. 08:55
` Q. Okay. Have you brought any documents 08:55
`with you today other than I understand that you 08:55
`have your declaration? 08:55
`
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` H. DERENDORF
` A. Something like that. 08:56
` Q. Okay. And you're being paid $600 an 08:56
`hour for your time during this project? 08:56
` A. Yes. 08:56
` Q. Okay. So about $15,000, roughly? 08:56
` A. Approximately. 08:56
` Q. Okay. Have you worked with 08:56
`mifepristone in the past? 08:56
` A. I have not worked with mifepristone 08:56
`but I have worked extensively with 08:56
`glucocorticoids. 08:56
` Q. Can you give me some examples of the 08:56
`glucocorticoids you've worked with? 08:56
` A. Yes. I've -- my area of expertise is 08:56
`pharmacokinetics and pharmacodynamics, and I've 08:56
`studied the pharmacokinetics and 08:56
`pharmacodynamics of glucocorticoids in 08:56
`different kinds of products, injection, oral, 08:56
`inhalation, and yes. 08:57
` Q. Okay, let me reask the question. 08:57
` Can you give me some examples of 08:57
`specific glucocorticoid drugs that you have 08:57
`worked with in the past? 08:57
` A. Sure. For example, fluticasone 08:57
`
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`NEPTUNE GENERICS - Ex. 1037
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` H. DERENDORF
`propionate, which is sold as Advair, I was 08:57
`involved in the development in collaboration 08:57
`with GSK, Glaxo at the time. And we have done 08:57
`studies for the drug and dose optimization 08:57
`studies, finding out what is the best dose to 08:57
`use. 08:57
` Q. Have you ever taken blood samples as 08:57
`part of your work? 08:57
` MS. ERNST: Objection to form. 08:57
` A. I have analyzed thousands of blood 08:57
`samples. I have never taken blood from an 08:57
`individual subject because that's not my role, 08:57
`but I've worked a lot with blood levels and 08:57
`blood concentrations. 08:58
` Q. And you've also administered 08:58
`metabolite levels in blood samples? 08:58
` A. I have. 08:58
` Q. Can you explain in more detail -- and 08:58
`I understand that in paragraph 5 and 6 you 08:58
`talked a little bit about the sorts of research 08:58
`that you do. I'd like you to explain that to 08:58
`me in a little bit more detail, please. 08:58
` A. Yes. My goal in my research is to 08:58
`find ways to identify the optimum dose of a 08:58
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` H. DERENDORF
` So you measure the concentrations and 09:00
`you model the profiles that you then get and 09:00
`with a final goal to identify the best dose. 09:00
` Q. Okay. Does the pharmacokinetics of a 09:00
`drug depend on the reason that the drug's being 09:00
`taken? 09:00
` MS. ERNST: Objection to form. 09:00
` A. No. 09:00
` Q. I think you also mentioned that you 09:00
`study pharmacodynamics. 09:00
` A. Yes. And that is what the drug does 09:00
`to the body. So it's the desired therapeutic 09:00
`activity that you want to achieve but also the 09:00
`undesired side-effects, so the good and the 09:00
`bad. 09:00
` Q. Have you prepared expert reports or 09:00
`declarations in the past? 09:00
` A. I have. 09:00
` Q. About how many? 09:00
` A. Same number, 10 to 12. 09:01
` Q. Have you testified in court before? 09:01
` A. Yes. 09:01
` Q. How many times? 09:01
` A. I think three times. 09:01
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` H. DERENDORF
`drug for an individual patient that will give 08:58
`you the best risk/benefit ratio so it has the 08:58
`highest probability to work with the least 08:58
`chance of doing harm. 08:58
` Q. So you would consider yourself an 08:58
`expert in the optimization of the use of drugs 08:59
`in the body? 08:59
` A. Yes. 08:59
` MS. ERNST: Objection to form. 08:59
` A. With the focus on pharmacokinetics 08:59
`and pharmacodynamics to identify the best dose 08:59
`that should be used. 08:59
` Q. Okay. Can you explain to me the term 08:59
`"pharmacokinetics"? 08:59
` A. Oh, sure. Pharmacokinetics is what 08:59
`the body does to the drug. So if you take a 08:59
`drug, it is absorbed in your bloodstream. It 08:59
`is then metabolized, chemically changed. It is 08:59
`distributed into the tissues, and it's finally 08:59
`eliminated either through the urine or the 08:59
`bile. And all of these steps can be 08:59
`investigated, and pharmacokinetics is the field 08:59
`that deals with that and does it in 08:59
`quantitative way. 09:00
`
`Page 13
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` H. DERENDORF
` Q. And those were all for patent cases 09:01
`as well? 09:01
` A. Yes. 09:01
` Q. We have talked about this a little 09:01
`bit. Exhibit 2014, which you have in front of 09:01
`you, this is the declaration that you submitted 09:01
`in this matter; correct? 09:01
` A. Yes. 09:01
` Q. Okay. And did you prepare the entire 09:01
`declaration yourself? 09:01
` A. In collaboration with my counsel, 09:01
`yes. 09:01
` Q. Okay. You agree with everything 09:01
`that's written in here when it was written? 09:01
` A. I do. 09:01
` Q. Okay. Do you still agree with 09:01
`everything that's written there? 09:01
` A. I do. 09:01
` Q. Okay. Are there any changes or 09:01
`corrections you want to make to the declaration 09:01
`before we start discussing it? 09:01
` A. No. 09:01
` Q. Okay. So if you could turn to the 09:01
`last page starting with the materials reviewed. 09:01
`
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` H. DERENDORF
` A. Yes. 09:01
` Q. And is this a complete list of the 09:01
`materials that you reviewed in preparing this 09:01
`declaration? 09:01
` A. These are the materials that are 09:02
`specific to this case. Obviously, I also rely 09:02
`on everything that I learned through my 40 09:02
`years of experience. That is also part of my 09:02
`opinion. 09:02
` Q. Okay. So your collective knowledge 09:02
`from working in the field for 40 years. 09:02
` A. Yes. 09:02
` Q. Okay. There aren't any other 09:02
`documents that you relied on for the formation 09:02
`of your opinion. 09:02
` A. No. Again, these are the specific 09:02
`documents for this case that I reviewed. 09:02
` Q. Okay. Have you seen the patent 09:02
`owner's response in this case? 09:02
` A. I don't recall. 09:02
` Q. Okay. 09:02
` (Derendorf Exhibit No. 1 was marked for 09:03
` identification.) 09:03
`BY MR. MAY: 09:03
`
`Page 16
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` H. DERENDORF
` A. Well, he's the clinical expert on the 09:04
`use of this drug, so -- and he deals with 09:04
`patients and expressed that drug level 09:04
`monitoring in this field is not a common 09:04
`practice. 09:05
` Q. Do you deal with patients as part of 09:05
`your research? 09:05
` A. In research, yes, but I don't treat 09:05
`patients. I'm not a medical doctor. 09:05
` Q. Understood. 09:05
` So do you work with medical doctors 09:05
`to treat patients as part of your research? 09:05
` A. Mostly I worked with medical doctors 09:05
`in research studies, so to identify the dose or 09:05
`not so much in treating patients. 09:05
` Q. Okay. Did you have any discussions 09:05
`with Dr. Kalin about his report? 09:05
` A. No. 09:05
` Q. Okay. About your report? 09:05
` A. No. 09:05
` Q. Okay. About anything else having to 09:05
`do with this particular case? 09:05
` A. With Dr. Kalin? 09:05
` Q. Yes. 09:06
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` H. DERENDORF
` Q. And this is the patent owner's 09:03
`response which was filed in this inter partes 09:03
`review on May 20, 2019, and so I'll just ask 09:03
`you to take a quick look at that and see if 09:03
`that refreshes your recollection as to whether 09:03
`or not you've seen this document before. 09:03
` A. I don't think so. 09:03
` Q. So you didn't consider any of the 09:03
`arguments in that document as part of your 09:03
`analysis in this declaration? 09:04
` MS. ERNST: Objection to form. 09:04
` A. Yeah, I -- I don't think I've seen it 09:04
`so I couldn't have responded to it. 09:04
` Q. Okay. So you reviewed Dr. Kalin's 09:04
`declaration in this case? 09:04
` A. I have looked at it, yes. 09:04
` Q. Okay. And when did you review that 09:04
`declaration? 09:04
` A. I don't remember exactly when. 09:04
` Q. Okay. And you relied on that to 09:04
`formulate your opinion here? 09:04
` A. Yes. 09:04
` Q. Okay. In what way did you rely on 09:04
`it? 09:04
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` H. DERENDORF
` A. No, I have not talked to him. 09:06
` Q. Do you disagree with any of the 09:06
`conclusions in Dr. Kalin's declaration? 09:06
` A. Not that I can remember. 09:06
` Q. Have you worked with psychiatrists in 09:06
`the past as part of your research? 09:06
` A. Yes. 09:06
` Q. When? 09:06
` A. Well, I do a lot of collaboration, 09:06
`because we work with many different kinds of 09:06
`drugs. One area is drugs of abuse, and I had 09:06
`collaboration with the chair of psychiatry or 09:06
`previous chair of psychiatry at the University 09:06
`of Florida, Dr. Gold. 09:06
` Q. So when you say "drugs of abuse," can 09:06
`you tell me what that means? 09:06
` A. Well, these are drugs that are taken 09:07
`not for the intended medical purpose but for 09:07
`other intentions. And usually they are 09:07
`addicting, addicting drugs that -- opiates, for 09:07
`example. 09:07
` Q. Things like heroin -- 09:07
` A. Yeah. 09:07
` Q. -- oxycodone? 09:07
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`NEPTUNE GENERICS - Ex. 1037
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` H. DERENDORF
` A. Heroin would not be an approved drug 09:07
`but, you know, these things are -- 09:07
`unfortunately, a lot of approved drugs that are 09:07
`taken for these kinds of purposes, yeah. 09:07
` Q. Okay. Outside of drafting this 09:07
`report do you have any experience working with 09:07
`the pharmacokinetics of mifepristone? 09:07
` A. No. 09:07
` Q. Okay. Outside of drafting this 09:07
`report do you have any experience with the 09:07
`pharmacodynamics of mifepristone? 09:07
` A. No, although in this class of 09:07
`corticosteroids I have vast experience. I have 09:07
`published probably close to 100 papers in the 09:08
`field on glucocorticoids. So not with 09:08
`mifepristone, but with other glucocorticoids. 09:08
` Q. Do you understand what the term 09:08
`"claim construction" means? 09:08
` A. Yes. 09:08
` Q. Okay. Did your attorneys instruct 09:08
`you on how to construe the claims of the '348 09:08
`patent? And I'm just looking for a yes/no 09:08
`answer. I'm not looking to push into any 09:08
`discussions you may have had with your counsel. 09:08
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`Page 20
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` H. DERENDORF
`of the '348 patent? 09:09
` A. It is what I understand the claim 09:09
`constructions reflect. 09:09
` Q. Okay. So you applied these 09:10
`constructions to your analysis of the prior art 09:10
`in the '348 patent? 09:10
` A. Yes. 09:10
` Q. Would mifepristone have the same 09:10
`pharmacodynamics regardless of what disorder it 09:10
`was being used to treat? 09:10
` MS. ERNST: Objection to form, 09:10
` scope. 09:10
` A. The pharmacodynamics would depend on 09:10
`the dose that is used. So if you have a drug 09:10
`that's used for a number of different 09:10
`indications in different doses, then the 09:10
`pharmacodynamics would not be identical because 09:10
`it would be dose dependent. 09:11
` Q. Okay. Assuming that the same dose 09:11
`was being given, the pharmacodynamics would not 09:11
`change depending on the disorder that was being 09:11
`treated? 09:11
` MS. ERNST: Objection to form. 09:11
` A. If you give the same dose, you would 09:11
`
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` H. DERENDORF
` A. Can you repeat the question? 09:08
` Q. Sure. 09:08
` Did your attorneys instruct you on 09:08
`how to construe the claims of the '348 patent 09:08
`in this case? 09:08
` MS. ERNST: And I'll interpose the 09:08
` same caution that counsel has provided 09:08
` you caution you not to disclose any 09:08
` communications that you may have had 09:08
` with your attorneys in connection with 09:08
` the case. 09:09
` A. Well, we discussed the claim 09:09
`construction. 09:09
` Q. If I could direct you to page 7 of 09:09
`your declaration. 09:09
` A. Yes. 09:09
` Q. Okay. So going from paragraph 20 to 09:09
`22, were these the instructions that your 09:09
`attorneys gave you on how to construe the 09:09
`claims of the '348 patent? 09:09
` MS. ERNST: Objection to form. 09:09
` A. What do you mean with instructions? 09:09
` Q. I mean is what's in paragraph 20 to 09:09
`22 the way that you construed the claim terms 09:09
`
`Page 21
`
` H. DERENDORF
`expect the same effects and side-effects 09:11
`independent of the intention that you use it 09:11
`for, yes. 09:11
` (Exhibit No. 1001, previously marked, was 09:11
` referenced and indexed.) 09:11
`BY MR. MAY: 09:11
` Q. Okay. I believe you have 09:11
`Exhibit 1001 in front of you. If not, I can 09:11
`hand it to you. 09:11
` A. What is this, please? 09:11
` Q. This is the '348 patent. 09:11
` A. I don't have that. 09:11
` Q. I can hand it to you. 09:11
` A. Yes, yes, thank you. Yes. 09:11
` Q. And if you could, I'd like to ask you 09:11
`to turn to column 16. 09:11
` A. Yes. 09:11
` Q. And you see Claim 1 there starting at 09:11
`line 26? 09:11
` A. Yes. 09:11
` Q. Is it your understanding that -- and 09:11
`I will -- and I will point you to the first 09:11
`clause. It says "a method for optimizing 09:12
`levels of mifepristone in a patient suffering 09:12
`
`TSG Reporting - Worldwide 877-702-9580
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`6
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`NEPTUNE GENERICS - Ex. 1037
`Page 6
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`

`

`Page 22
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`Page 23
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` H. DERENDORF
`from a disorder amenable to treatment by 09:12
`mifepristone, the method comprising." 09:12
` Is it your understanding that the 09:12
`term "disorder" in Claim 1 is limited to mental 09:12
`disorders? 09:12
` A. This is explained or defined in 09:13
`column 3 of the patent under Definitions. And 09:13
`there, you see the term amenable to treatment 09:13
`by mifepristone refers to a condition that is 09:13
`known to be treated by glucocorticoid 09:13
`antagonists such as mifepristone, conditions 09:13
`such as mental disorders amenable to treatment 09:13
`by mifepristone. 09:13
` Q. Okay. So it's your understanding 09:13
`that that paragraph there limits Claim 1 to 09:13
`disorders -- to mental disorders? 09:13
` MS. ERNST: Objection to form, 09:13
` misstates testimony. 09:13
` Q. You can answer. 09:14
` A. No, that's not what it says. It says 09:14
`that -- it refers to a condition that is known 09:14
`to be treated by glucocorticoid antagonists. 09:14
`Conditions such as mental disorders are 09:14
`amenable to treatment, so "such as is" does not 09:14
`
`Page 24
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` H. DERENDORF
`up. And you will reach that point where the 09:16
`amount that you give with your dose is equal to 09:16
`the amount that you eliminate at the same time, 09:16
`and that is then the situation when for each 09:16
`dose that you give you repeat the same profile, 09:16
`the same pattern over and over, and that's 09:16
`called steady state. 09:16
` Q. Okay. So as a pharmacist, how would 09:16
`you determine when enough of a drug has been 09:16
`given that you've reached steady state? 09:16
` A. The simplest way is you measure the 09:16
`drug concentrations before you give the drug. 09:16
`And at the very end of the dosing interval if 09:16
`they don't differ then that would show you that 09:16
`you're in steady state. 09:16
` Q. You would be taking blood both before 09:16
`the drug is administered and after the drug is 09:16
`administered? 09:16
` A. At the very end of the dosing 09:17
`interval. So it's really the two same -- on 09:17
`two consecutive doses at the end of your dosing 09:17
`interval, which is usually referred to as the 09:17
`trough concentration, so the lowest 09:17
`concentration that you achieve. And you 09:17
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` H. DERENDORF
`exclude others. 09:14
` Q. Okay. So as long as the -- as long 09:14
`as the disorder is amenable to treatment by 09:14
`mifepristone, you would understand that to be a 09:14
`disorder? 09:14
` MS. ERNST: Objection to form. 09:14
` A. That's what it says. 09: