UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SAMSUNG BIOEPIS CO., LTD.,
` Petitioner, Patent No.
` 10,888,601
`vs.
`REGENERON PHARMACEUTICALS, INC.,
` Inter Partes
` Patent Owner. Review No.
` IPR2023-00739
`
`_______________________________
`
` Hampton Inn Ponte Vedra
` 1220 Marsh Landing Parkway
` Jacksonville Beach, FL 32250
` March 29, 2024
` 8:17 a.m. - 12:56 p.m.
`
` VIDEOTAPED DEPOSITION OF MICHAEL W. STEWART, M.D.
`
` Taken on behalf of the Petitioner before
`Alice J. Teslicko, Registered Professional Reporter,
`Registered Merit Reporter, and Notary Public in and
`for the State of Florida at Large, pursuant to a
`Notice of Taking Deposition in the above cause.
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`Veritext Legal Solutions
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`Samsung Bioepis Exhibit 1085
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`1 PETITIONER'S EXHIBITS
`2 EXHIBIT DESCRIPTION PAGE
`
`Exhibit 1 Declaration of Michael W. 7
` Stewart, M.D.
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`Exhibit 2 U.S. Patent No. 10,888,601 7
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`34
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`5
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`6
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`Exhibit 3 Eylea DME Market Assessment 34
`7 Q3 2017
`8 Exhibit 4 Decision granting 84
` institution of U.S. Patent
`9 10,888,601
`10 Exhibit 5 Final written decision 109
` regarding IRP2022-01226
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`1 APPEARANCES:
`2
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` QUINN EMANUEL URQUHART & SULLIVAN, LLP
`3 BY: RAYMOND N. NIMROD, ESQ.
` 51 Madison Avenue, 22nd Floor
`4 New York, NY 10010
` (212) 849-7000
`5 raynimrod@quinnemanuel.com
` Attorneys for the Petitioner
`
`67
`
` MORRISON & FOERSTER, LLP
` BY: ADAM R. BRAUSA, ESQ.
`8 425 Market Street
` San Francisco, CA 94105
`9 (415) 268-6053
` abrausa@mofo.com
`10 Attorneys for the Patent Owner
`11
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` Also Present: Eileen Woo - Regeneron (Via Zoom)
`12 Cameron Hodges - Videographer
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`1 THE VIDEOGRAPHER: Good morning. We are now 08:17:31
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`2 on the record at 8:17 a.m. This is March 29th,
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`3 2024. Please note that this deposition is being
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`4 conducted in person and virtually. Quality of
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`5 recording depends on the quality of camera and 08:17:42
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`6 internet connection of participants. What is
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`7 seen from the witness and heard on screen is what
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`8 will be recorded. Audio and video recording will
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`9 continue to take place unless all parties agree
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`10 to go off the record. 08:17:55
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`11 This begins media unit one of the deposition
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`12 of Michael Stewart, taken in the matter of
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`13 Samsung Bioepis Co. Ltd., et al. vs. Regeneron
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`14 Pharmaceuticals, Incorporated. This deposition
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`15 is happening in person at the Hampton Inn 08:18:09
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`16 Jacksonville in Ponte Vedra and online via Zoom.
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`17 My name is Cameron Hodges. I'm the
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`18 videographer. The court reporter is Alice
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`19 Teslicko. We represent Veritext.
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`20 Will counsel please introduce themselves, 08:18:27
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`21 after which would the court reporter please swear
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`22 in the witness. Thank you.
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`23 MR. NIMROD: Ray Nimrod from Quinn Emanuel
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`24 on behalf of petitioner Samsung Bioepis.
`
`25 MR. BRAUSA: Adam Brausa from Morrison & 08:18:33
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`1 I N D E X
`2 WITNESS PAGE
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`34
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`MICHAEL STEWART, M.D.
`5 Direct Examination by Mr. Nimrod 6
`6 Certificate of Oath 157
`7 Errata Sheet 160
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`89
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`Samsung Bioepis Exhibit 1085
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`1 Foerster on behalf of patent owner Regeneron. 08:18:35
`2 I'm joined by Eileen Woo remotely from Regeneron,
`3 and I'm also here on behalf of the witness.
`4 Thereupon:
`5 MICHAEL STEWART, M.D. 08:18:44
`6 was called as a witness and having been first duly
`7 sworn, was examined and testified as follows:
`8 THE WITNESS: I do.
`9 THE COURT REPORTER: Thank you.
`10 DIRECT EXAMINATION 08:18:55
`11 BY MR. NIMROD:
`12 Q Would you state your name for the record,
`13 please?
`14 A My name is Michael W. Stewart.
`15 Q Dr. Stewart, have you been deposed before? 08:19:01
`16 A I have.
`17 Q About how many times?
`18 A Three or four.
`19 Q Okay. In patent cases?
`20 A No. 08:19:07
`21 Q In what type cases?
`22 A They were medical malpractice cases.
`23 Q So this is your first patent case?
`24 A Correct.
`25 Q I'm going to mark as Stewart Exhibit 1 a 08:19:16
`Page 6
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`1 copy of your declaration from this IPR proceeding. 08:19:18
`2 A Thank you.
`3 Q I'd also like to mark as Stewart Exhibit 2 a
`4 copy of the patent, the 601 patent.
`5 A Thank you. 08:19:50
`6 (Whereupon document/items were marked for
`7 identification as Petitioner's Exhibits 1 and 2.)
`8 BY MR. NIMROD:
`9 Q Dr. Stewart, you recognize Exhibit 1 as your
`10 declaration? 08:20:04
`11 A I do.
`12 Q And you provided opinions regarding the 601
`13 patent, which is Exhibit 2?
`14 A Correct.
`15 Q Okay. Can you turn in Exhibit 2 to the 08:20:12
`16 claim section, which starts at column 22, which is
`17 page 20.
`18 A Okay.
`19 Q You provided opinions regarding claim 10; is
`20 that correct? 08:20:29
`21 A That's correct.
`22 Q And also claims 18 and 26?
`23 A Correct.
`24 Q If you could go to your declaration, please,
`25 to page three. 08:20:44
`
`Page 7
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`1 MR. BRAUSA: Just so we're clear, are we 08:20:52
`2 going with the middle page number or the bottom
`3 right-hand corner page number?
`4 MR. NIMROD: Oh, yes, that's a good point.
`5 Let's go to the middle one, because that's the 08:21:01
`6 page of his expert report.
`7 MR. BRAUSA: Sounds good.
`8 BY MR. NIMROD:
`9 Q Okay. On page three there's a Roman II,
`10 "Summary of Opinions." Do you see that? 08:21:10
`11 A Yes.
`12 Q And the first bullet says: "The plain and
`13 ordinary meaning of the challenged claims requires a
`14 predetermined dosing regimen."
`15 Do you see that? 08:21:22
`16 A Yes.
`17 Q And that would be your opinion with respect
`18 to Claims 10, 18, and 26, correct?
`19 A Correct.
`20 Q All right. Is there a particular phrase 08:21:29
`21 within Claim 10 that you're interpreting to determine
`22 that this requires a predetermined dosing regimen?
`23 MR. BRAUSA: Objection, form.
`24 A So it's not a particular phrase as much as
`25 it is the writing of the entire claim. Because it 08:21:50
`
`Page 8
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`1 states "comprising intravitreal administration to said 08:21:53
`2 patient in an effective amount, which is 2 milligrams,
`3 approximately every four weeks" -- so the first five
`4 weeks -- "followed by 2 milligrams approximately every
`5 eight weeks or once every two months," which to me 08:22:07
`6 means predetermined, a predetermined schedule,
`7 predetermined intervals.
`8 Q Can you turn to the page in Exhibit 2,
`9 page 17 in the bottom corner. In Column 16 --
`10 A Yes. 08:22:41
`11 Q -- there's a reference to -- strike that.
`12 There's an example seven that has a list of
`13 dosing regimens, correct?
`14 A A list of possible dosing regimens, yes.
`15 Q And these are dosing regimens for which 08:22:54
`16 there's no data provided as to any test results from
`17 patients, correct?
`18 MR. BRAUSA: Objection, form.
`19 A There's no data provided within the example.
`20 Q Is there any data provided elsewhere with 08:23:06
`21 respect to the dosing regimens in example seven?
`22 A Under example five, there is some data which
`23 comes out of the phase two trial, some of which is --
`24 well, let me catch myself, please.
`25 So although we have data elsewhere, I don't 08:23:36
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`1 see where that data is the same as what would be 08:23:39
`2 listed in example seven, dosing regimens. So that's
`3 correct, that data does not apply. So there's no data
`4 that I can tell that is associated with example seven.
`5 Q When you say example seven, you mean the 08:23:56
`6 dosing regimens of example seven, there's no data
`7 provided for those regimens?
`8 A Not that I can tell.
`9 Q By "data", we mean test results on patients,
`10 yes? 08:24:06
`11 A Correct.
`12 Q All right. So if we turn to Column 16, the
`13 second one at about line seven refers to VEGFT,
`14 2 milligrams, administered by intravitreal injection
`15 once every four weeks for the first 16 weeks. 08:24:25
`16 So is that a reference to five initial
`17 doses?
`18 A It is, yes -- let me count them up, but I
`19 believe the answer is yes.
`20 16, yes, five doses. 08:24:42
`21 Q We do that the same way.
`22 Okay, and then it says followed by
`23 2 milligrams once every eight weeks, correct?
`24 A Followed by 2 milligrams -- number seven,
`25 yes, 2 milligrams intravitreally once every eight 08:24:55
`Page 10
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`1 patent as to whether these dosing regimens set forth 08:26:11
`2 in example seven would be appropriate for DME?
`3 MR. BRAUSA: Objection, form.
`4 A Can you repeat the question, please?
`5 Q Sure. Do you know, is there any teaching in 08:26:21
`6 the 601 patent that any of the dosing regimens in
`7 example seven would be appropriate for DME?
`8 MR. BRAUSA: Objection, form.
`9 A So the patent gives you the same regimen as
`10 the one you pointed me to in terms of the frequency of 08:26:40
`11 the injections, as well as the follow-ups. So that
`12 those two are the same.
`13 Q Okay. Does the patent teach that the
`14 regimen set forth in Column 16, lines seven to ten, is
`15 appropriate for DME treatment? 08:26:55
`16 MR. BRAUSA: Objection, form.
`17 A Well, the patent describes a method for DME
`18 treatment. I'm not quite sure what you're meaning by
`19 "teaching" that.
`20 Q Where does the patent teach that the dosing 08:27:09
`21 regimen set forth in example seven at Column 16, lines
`22 seven to ten, is appropriate for DME?
`23 MR. BRAUSA: Objection, form.
`24 A So if we look at number 10, then we find
`25 that the patent is a method for treating diabetic 08:27:29
`Page 12
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`1 weeks. 08:25:07
`2 Q Now, the dosing regimen that I just directed
`3 you to in Column 16, lines seven to ten, does not
`4 state whether it's for DME or any other indication,
`5 correct? 08:25:17
`6 A That's correct.
`7 Q And the dosing regimens that are set forth
`8 in example seven are intended to be for what types of
`9 medications, as you understand it?
`10 MR. BRAUSA: Objection, form. 08:25:34
`11 A Well, it is not stated what indication it's
`12 for.
`13 Q So, in your opinion, would all these dosing
`14 regimens that are set forth in example seven be
`15 suitable for DME treatment? 08:25:43
`16 MR. BRAUSA: Objection, form, scope.
`17 A There are a lot of them there and I would
`18 have to go through each individually to determine if
`19 all of them were appropriate for DME.
`20 Q Well, you studied the patent, right? 08:25:59
`21 A I have.
`22 Q And you directed -- I think in your expert
`23 report you referred to example seven, correct?
`24 A Correct.
`25 Q Do you know if there's any teaching in the 08:26:09
`Page 11
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`1 macular edema, five monthly injections followed by 08:27:34
`2 injections every eight weeks, which is the same
`3 regimen as was listed in example seven.
`4 Q Is there any other teaching in the patent
`5 other than -- strike that. Let me start over. 08:27:51
`6 When you said example 10, did you mean
`7 Claim 10?
`8 A I'm sorry, Claim 10. Thank you.
`9 Q So in your view, Claim 10 teaches that the
`10 regimen of example seven in Column 16, lines seven to 08:28:02
`11 ten, is appropriate for DME; is that right?
`12 A Again, I'm hung up on your term of
`13 "teaching." It certainly lists this as a method for
`14 treating, and example seven -- line seven also talks
`15 about a possible dosing regimen. So they're saying 08:28:28
`16 the same thing.
`17 I'm hung up on the "teaching" of this.
`18 Q Other than Claim 10, is there any teaching
`19 in the 601 patent that the dosing regimen in
`20 Column 16, line seven to ten, would be appropriate for 08:28:46
`21 the treatment of DME?
`22 MR. BRAUSA: Objection, form.
`23 A Repeat the question, please.
`24 Q Other than Claim 10, is there any teaching
`25 in the 601 patent that the dosing regimen set forth in 08:29:03
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`1 example seven, Column 16, lines seven to ten, would be 08:29:07
`2 appropriate for treatment of DME?
`3 MR. BRAUSA: Objection, form.
`4 A I'm not aware of anything else in the patent
`5 that speaks to the treatment with this regimen for 08:29:21
`6 DME.
`7 Q And the same would be true for DR; is that
`8 correct?
`9 A "The same" meaning --
`10 Q The same as if there's no teaching in the 08:29:34
`11 patent that the regimen of example seven, Column 16,
`12 line seven to ten, would be appropriate for treatment
`13 of DR?
`14 MR. BRAUSA: Objection, form.
`15 A Well, I would say that Claim 18 gives us the 08:29:57
`16 similar regimen, and so the answer would be the same.
`17 Q Got it, thank you.
`18 By the way, what is -- just so it's for the
`19 record, when I say "DME", what does that refer to?
`20 A Diabetic macular edema. 08:30:16
`21 Q And I'm just going to say "DME" throughout
`22 the deposition.
`23 A Very good.
`24 Q And then just for the record, what is "DR"?
`25 A Diabetic retinopathy. 08:30:23
`
`1 that would be within the scope of Claim 10? 08:32:08
`2 MR. BRAUSA: Objection, form, calls for a
`3 legal conclusion.
`4 A Certainly on its face the schedule -- the
`5 predetermined schedule in 16 is the same as the 08:32:23
`6 predetermined schedule in line 10 -- or in Claim 10.
`7 Q So does that mean that your opinion is that
`8 the dosing regimen of Claim 16, lines seven to ten, if
`9 practiced by a physician, would fall within the scope
`10 of Claim 10? 08:32:46
`11 MR. BRAUSA: Counsel, I think you referred
`12 to Claim 16.
`13 MR. NIMROD: Oh, I'm sorry. Thank you.
`14 BY MR. NIMROD:
`15 Q Start over again. 08:32:56
`16 A Go ahead.
`17 Q Is it your opinion that if a physician
`18 practiced the dosing regimen in Column 16, lines seven
`19 to ten, that would fall within the scope of Claim 10
`20 if it was for the treatment of DME? 08:33:05
`21 MR. BRAUSA: Objection, form, outside the
`22 scope.
`23 A Yes, I would think it was within that scope.
`24 Q It would necessarily be within the scope?
`25 A Yes, I would think it would be. 08:33:28
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`Page 14
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`Page 16
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`1 Q And then Claim 26 refers to DR in a patient 08:30:25
`2 with DME. How should I refer to that?
`3 A That was fine.
`4 Q What is the difference between DR and DME?
`5 A So DR is changes to the retina. So DR is 08:30:41
`6 commonly believed to be a vasculopathy of the retina
`7 where you see microvascular changes related to
`8 diabetes, and it can occur anywhere in the retina, be
`9 it the posterior pole, which is where DME exists, or
`10 it can be the more peripheral parts of the retina. 08:31:04
`11 DME is only confined to the macula; hence
`12 the name diabetic macular edema, and specifically it
`13 is swelling of the retina in the back center of the
`14 eye, the macula.
`15 DME may or may not have associated-- I'm 08:31:24
`16 sorry, DR may or may not have associated DME. The two
`17 can coexist, but they do not necessarily coexist.
`18 Q So DME occurs in the central region of the
`19 eye, in short terms?
`20 A The macula, which is the central region of 08:31:44
`21 the retina.
`22 Q So let's go back to Column 16 of the 601
`23 patent.
`24 In Column 16 at lines seven to ten, the
`25 dosing regimen I referred you to, is that something 08:32:05
`Page 15
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`1 Q Now, there is another dosing regimen right 08:33:29
`2 below the one that we looked at that has five monthly
`3 doses, starting at line 11, right?
`4 A Yes, I see that.
`5 Q So at line 11 through 16 in Column 16 of the 08:33:38
`6 patent, the dosing regimen has five initial doses on a
`7 monthly basis and then speaks to dosing on a less
`8 frequent basis. Do you see that?
`9 A Yes.
`10 Q Under what circumstances would a physician 08:33:57
`11 or other qualified medical professional decide to do
`12 dosing on a less frequent basis?
`13 MR. BRAUSA: Objection, form.
`14 A So there are different treatment strategies
`15 that we employ. There are fixed dosing regimens, and 08:34:10
`16 the fixed dosing is what we see in lines seven through
`17 ten, where it is predetermined an initial number of
`18 injections, followed by a predetermined frequency of
`19 injections to follow, and that's set up and
`20 established right from the beginning and the physician 08:34:30
`21 follows it regularly.
`22 In your second example, beginning at line 11
`23 and going through 16, that's what we call an
`24 individualized reactive schedule, where at some point
`25 during the treatment the physician is making elective 08:34:53
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`1 assessments of the patient and either treating or not 08:34:58
`2 treating based on the way the patient looks.
`3 Some people prefer the first example, which
`4 is the predetermined regimen. Some people prefer the
`5 second, which is more individualized or as needed or 08:35:13
`6 prn, and it's individual preference.
`7 Q So Column 16 at lines 15 to 16 refers to
`8 assessment by a physician or other qualified medical
`9 professional to start doing dosing on a less frequent
`10 basis. 08:35:37
`11 What are the circumstances that would lead a
`12 physician to dose on a less frequent basis than
`13 monthly after five initial monthly doses?
`14 MR. BRAUSA: Objection, form.
`15 A So there are lots of circumstances here to 08:35:50
`16 discuss and I don't even think I can go through all of
`17 them. But there have to be assessments that are done,
`18 and in this case it's after the five monthly doses.
`19 Assessments usually include visual acuity,
`20 both in terms of absolute visual acuity and change 08:36:07
`21 from baseline; the swelling or thickness of the
`22 retina, which is usually done with our OCT
`23 laser-guided machines; the satisfaction of the
`24 patient, where are they in terms of the treatment, are
`25 they happy or not happy; is this stable, meaning have 08:36:29
`Page 18
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`1 suggests one versus the other or guides a physician to 08:37:54
`2 one versus the other.
`3 Q So there's no criteria in the 601 patent as
`4 to when one would apply a predetermined dosing regimen
`5 versus an individualized regimen; is that correct? 08:38:11
`6 A That's my understanding, yes.
`7 Q So let's go back to Column 16, lines 11
`8 to 16, which is one where there's five initial monthly
`9 doses and then there is a less frequent dosing, okay.
`10 A Yes. 08:38:27
`11 Q Now, if a physician using -- strike that.
`12 If a physician followed the dosing regimen
`13 set forth in Column 16, lines 11 through 16, and gave
`14 five initial monthly doses followed by dosing every
`15 eight weeks, would that fall within the scope of 08:38:50
`16 Claim 10, if it was for the treatment of DME?
`17 MR. BRAUSA: Objection, form, calls for a
`18 legal conclusion.
`19 A It is a different strategy and the reason
`20 there's a different strategy is in Claim 10, that's a 08:39:06
`21 predetermined regimen. So the physician is not
`22 required or even advised to go ahead and make
`23 assessments as time goes by. He simply follows the
`24 instruction.
`25 In our example under Column 16, there's an 08:39:21
`Page 20
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`1 you got progressive improvement over the course of 08:36:33
`2 five injections or have you reached a plateau after
`3 two or three.
`4 So there are lots of different factors that
`5 come into play and then are used repeatedly down the 08:36:42
`6 road to assess is the patient stable, are they
`7 worsening, and if worsening based on any of the
`8 factors, including the ones I mentioned, that would
`9 probably suggest to the physician another injection is
`10 needed. 08:37:00
`11 Q What is the criteria that a physician would
`12 apply to determine whether or not to use a
`13 predetermined dosing regimen versus an individualized
`14 regimen?
`15 MR. BRAUSA: Objection, form. 08:37:14
`16 A Again, much of that is an individual
`17 preference for the physician. There's lots of data to
`18 support either one of those and it's a matter of
`19 individual preference, the patient's desire, and some
`20 combination of the two as to which regimen is reached. 08:37:33
`21 Q Does the 601 patent teach under what
`22 circumstances a physician should use a predetermined
`23 dosing regimen versus an individualized regimen?
`24 MR. BRAUSA: Objection, form.
`25 A I'm not aware of anything in the patent that 08:37:52
`Page 19
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`1 assessment that's done at each month or perhaps at 08:39:24
`2 every eight weeks here and then based on the
`3 assessment, the patient either gets or does not get an
`4 injection. But it's the assessment that drives the
`5 injection, not the predetermination. 08:39:38
`6 Q You had said Column 16, just to be clear?
`7 A Yes.
`8 Q Let me ask another question.
`9 The regimen in Column 16, lines 11 through
`10 16, if a professional physician followed that regimen 08:39:51
`11 and gave five monthly doses followed by dosing every
`12 eight weeks for treatment of DME, that would not fall
`13 within the scope of Claim 10, in your opinion?
`14 A In my opinion, that's correct.
`15 Q Similarly, if a physician -- oh, strike 08:40:10
`16 that.
`17 Please read the dosing regimen in Column 16,
`18 lines 17 to 22, just to yourself, please.
`19 A Okay.
`20 Q The dosing regimen in Column 16, lines 17 08:40:39
`21 to 22, refers to a dosing regimen where there is an
`22 injection every -- let me start that over.
`23 The dosing regimen in Column 16, lines 17
`24 to 22, includes five initial doses every four weeks
`25 followed by prn, correct? 08:41:06
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`1 A Correct. 08:41:09
`2 Q And what is "prn", as you understand it?
`3 A So it's short for "pro re nata," which means
`4 as needed.
`5 Q So the dosing regimen in Column 16, lines 17 08:41:17
`6 to 22, would be what you refer to as an individualized
`7 regimen, correct?
`8 A Yes, it would.
`9 Q Similarly, the one right above it in
`10 Column 16, line 11 to 16, would be an individualized 08:41:28
`11 dosing regimen; is that correct?
`12 A Correct.
`13 Q Now, if a physician practiced the dosing
`14 regimen of Column 16, lines 17 to 22, and gave five
`15 initial doses four weeks apart and then went to prn 08:41:44
`16 and decided to do dosing every eight weeks thereafter,
`17 let's say for two years, to treat DME, would that fall
`18 within the scope of Claim 10?
`19 MR. BRAUSA: Objection, form.
`20 A Well, I don't agree with your question, 08:42:04
`21 because he would not agree to do every eight weeks,
`22 because the prn applies that it is individually based
`23 and it's -- it's individually assessed at each visit.
`24 So he would not make that decision up front.
`25 He would make the decision at every visit, to treat or 08:42:23
`Page 22
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`1 MR. NIMROD: I appreciate that, actually. 08:43:57
`2 (Discussion off the record.)
`3 BY MR. NIMROD:
`4 Q You ready?
`5 A Go ahead. 08:44:15
`6 Q So it is your opinion that if a physician
`7 followed the dosing regimen in Column 16, lines 17 to
`8 22, and gave five initial doses every four weeks and
`9 then following prn for the next year and a half gave
`10 doses every eight weeks for the treatment of DME, that 08:44:33
`11 would not fall within the scope of Claim 10, correct?
`12 MR. BRAUSA: Objection, form.
`13 A Correct, I agree.
`14 Q The dosing regimens in example seven -- let
`15 me start over. There appear to be 20 dosing regimens 08:45:12
`16 set forth in example seven; is that right?
`17 A I would have to count them.
`18 Q Please do.
`19 A Please do? Okay, I count 20.
`20 Q Thank you. And there are some dosing 08:45:35
`21 regimens set forth in example seven where there are
`22 three initial monthly doses; is that right?
`23 A That's correct, which leads me back to an
`24 earlier question of yours. If I remember the
`25 question, it is do any of the regimens in example 08:45:53
`Page 24
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`1 not to treat. 08:42:26
`2 Q That's helpful. Let me reframe the question
`3 then. If a physician decided to practice the regimen
`4 of Claim 16, line 17 to 22, and gave five initial
`5 doses every four weeks and then following prn for the 08:42:42
`6 next, let's say, year and a half gave dosing every
`7 eight weeks for treatment of DME, would that fall
`8 within the scope of Claim 10?
`9 MR. BRAUSA: Objection, form.
`10 A For the same reason that I answered 11 08:43:00
`11 through 16, as the assessments are made, the
`12 injections are given based on assessment.
`13 That differs from the claim, which is
`14 predetermined, and the injections are five followed by
`15 every eight weeks regardless of the response of the 08:43:16
`16 patient.
`17 So I would say no, it does not.
`18 Q Okay. So your opinion is that if a
`19 physician followed the dosing regimen of Claim 16,
`20 lines 17 to 22, gave five initial doses every four 08:43:28
`21 weeks and then followed by prn eight-week dosing, that
`22 would not fall within the scope of Claim 10, if it was
`23 for the treatment of DME?
`24 MR. BRAUSA: Objection. You said Claim 16.
`25 I know you meant that. 08:43:57
`
`Page 23
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`1 seven -- are any of them supported by data in the 08:45:57
`2 patent application. I believe that was one of your
`3 original questions.
`4 Q That's correct.
`5 A So the regimens that talk about once every 08:46:07
`6 four weeks for the first eight weeks are three loading
`7 doses, followed by 2 milligrams once every eight
`8 weeks. That is something that we see on page 16,
`9 Column 14, Table 2.
`10 Q You said page 16? 08:46:43
`11 A Yeah, page 16.
`12 Q And then what?
`13 A Column 14.
`14 Q Oh, Table 2?
`15 A Table 2. 08:46:50
`16 Q All right. So there is data for which
`17 dosing regimen of example seven?
`18 A So the example seven, the first one,
`19 2 milligrams intravitreally every four weeks. When
`20 you look at Table 2, that is the third example, laser. 08:47:12
`21 Then 0.5-milligram monthly and 2 milligram monthly.
`22 That is 2 milligrams monthly.
`23 The next one on example seven is one
`24 injection every four weeks for the first eight weeks,
`25 followed by 2 milligrams every eight weeks. That is 08:47:33
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`Veritext Legal Solutions
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`7 (Pages 22 - 25)
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`Samsung Bioepis Exhibit 1085
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`1 the fourth one on Table 2. And then the fourth one 08:47:36
`2 under example seven is the same as the fifth one on
`3 Table 2.
`4 Q Okay, thank you.
`5 Is there any data for any of the dosing 08:48:02
`6 regimens, other than the three that you just mentioned
`7 in example seven?
`8 MR. BRAUSA: Objection, form.
`9 A You're speaking of data within the patent?
`10 Q Yes. 08:48:20
`11 A And you're speaking, of course, of VEGF-Trap
`12 or aflibercept?
`13 Q That's correct.
`14 While you're looking, all of the regimens
`15 set forth in the 601 patent are for aflibercept, as 08:48:34
`16 you understand it, correct?
`17 A That's right, yes.
`18 The one, two, three -- the third one down
`19 under example seven is -- though by different wording,
`20 is essentially a prn protocol as well. So the third 08:48:53
`21 and fourth are both prn that follow the same regimens.
`22 Q Okay. The next one, two, three regimens
`23 speak to an injection once every four weeks for the
`24 first 12 weeks. Which would be four initial loading
`25 doses; is that right? 08:49:17
`
`1 20 weeks. Do you see that? 08:50:36
`2 A Uh-huh, correct.
`3 Q And there's no data -- that would be six
`4 initial loading doses, correct?
`5 A That would be correct. 08:50:45
`6 Q And there's no data in the patent with
`7 respect to dosing regimens where there is six initial
`8 loading doses, correct?
`9 MR. BRAUSA: Objection, form.
`10 A None that I'm aware of. 08:50:59
`11 Q And then the rest of the regimens in example
`12 seven speak to -- well, strike that.
`13 The next six dosing regimens in Column 16,
`14 lines 38 to 67, refer to injections once every four
`15 weeks for the first 24 weeks or once every four weeks 08:51:20
`16 for the first 28 weeks; is that right?
`17 MR. BRAUSA: Objection, form.
`18 A That is correct.
`19 Q And that would be seven or eight initial
`20 monthly loading doses; is that right? 08:51:37
`21 A Correct.
`22 Q And there's no data in the patent with
`23 respect to any regimens where there is six or seven --
`24 excuse me, seven or eight -- yeah, seven or eigh