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`KARL CSAKY, MD, PhD - DIRECT
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`macular edema, and diabetic retinopathy.
`
`Q.
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`For the next bit of your testimony, I want to ask you
`
`just to focus on the AMD indication. Okay?
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`A.
`
`Q.
`
`Uh-huh.
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`So let's take down PTX 3097 and go back -- actually,
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`before we do that let me ask this.
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`Can we check off the box in Claim 6 for the first
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`limitation that Mylan or Biocon recommends the first step of
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`Claim 6?
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`A.
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`Q.
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`Yes, that would be correct.
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`Let's take down PTX 3097, and then let's keep moving.
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`What's the next limitation of Claim 6 that you
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`analyzed to determine whether Mylan's label or Biocon's label
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`recommends infringement?
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`A.
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`So the next limitation is that the treatment, the
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`method, comprises sequentially administering to the patient by
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`intravitreal injection a single initial dose of 2 milligrams of
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`aflibercept.
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`Q.
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`Dr. Csaky, does the proposed Yesafili labeling
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`encourage, recommend, or promote doctors to sequentially
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`administer to the patient by intravitreal injection a single
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`initial dose of 2 milligrams of aflibercept?
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`A.
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`Q.
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`Yes.
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`Let's bring back up the label. That's PTX 3097, and
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`we're looking at page 1 and the "Dosage and Administration"
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 309
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
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`KARL CSAKY, MD, PhD - DIRECT
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` 318
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`macular edema, and diabetic retinopathy.
`
`Q.
`
`For the next bit of your testimony, I want to ask you
`
`just to focus on the AMD indication. Okay?
`
`A.
`
`Q.
`
`Uh-huh.
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`So let's take down PTX 3097 and go back -- actually,
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`before we do that let me ask this.
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`Can we check off the box in Claim 6 for the first
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`limitation that Mylan or Biocon recommends the first step of
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`Claim 6?
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`A.
`
`Q.
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`Yes, that would be correct.
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`Let's take down PTX 3097, and then let's keep moving.
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`What's the next limitation of Claim 6 that you
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`analyzed to determine whether Mylan's label or Biocon's label
`
`recommends infringement?
`
`A.
`
`So the next limitation is that the treatment, the
`
`method, comprises sequentially administering to the patient by
`
`intravitreal injection a single initial dose of 2 milligrams of
`
`aflibercept.
`
`Q.
`
`Dr. Csaky, does the proposed Yesafili labeling
`
`encourage, recommend, or promote doctors to sequentially
`
`administer to the patient by intravitreal injection a single
`
`initial dose of 2 milligrams of aflibercept?
`
`A.
`
`Q.
`
`Yes.
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`Let's bring back up the label. That's PTX 3097, and
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`we're looking at page 1 and the "Dosage and Administration"
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 309
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
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`KARL CSAKY, MD, PhD - DIRECT
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`section for AMD. Excuse me. We're looking at page 2, and
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`that's the "Dosage and Administration" section for AMD.
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`Where does Mylan or Biocon's label recommend that
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`doctors sequentially administer to the patient by intravitreal
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`injection a single initial dose of 2 milligrams of aflibercept?
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`A.
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`Right. So under the, again, "Dosage and
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`Administration," it says the recommended dose for Yesafili,
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`2 milligrams, to be administered intravitreal injection every
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`four weeks, monthly.
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`Q.
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`Okay. And you said every four weeks, monthly. Are
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`any of those monthly doses a single initial dose?
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`A.
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`Q.
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`A.
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`Yes.
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`Which one?
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`Well, it's the first -- first one would be the
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`initial dose.
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`Q.
`
`Fair enough.
`
`We're going to move to the next requirement of
`
`Claim 6 here in just a second, but before we do I want to talk
`
`about a few issues that I think we're going to see over and
`
`over again, and I want to see if we can clear the air on those
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`first to streamline things.
`
`The patent claims on the right, they refer to
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`administering aflibercept. Do you see that?
`
`A.
`
`Q.
`
`Yes.
`
`Yesafili's label on the left -- that's PTX 3097 --
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 310
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
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`KARL CSAKY, MD, PhD - DIRECT
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`refers to administering Yesafili. Do you see that?
`
`A.
`
`Q.
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`A.
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`Q.
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`Yes.
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`What is the active ingredient in Yesafili?
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`Aflibercept.
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`So whenever PTX 3097 recommends administration of
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`Yesafili, is it recommending the use of aflibercept?
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`A.
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`Q.
`
`Yes.
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`The patent claims also all require that the doses of
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`aflibercept be 2 milligram doses.
`
`Do you see that?
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`Yes.
`
`And that will appear in the other claims we look at,
`
`Yes.
`
`Turning back to the "Dosage and Administration"
`
`A.
`
`Q.
`
`right?
`
`A.
`
`Q.
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`section we looked at earlier -- that's again PTX 3097, page
`
`2 -- what dose of aflibercept does Yesafili's label recommend
`
`that doctors administer?
`
`A.
`
`Q.
`
`2 milligrams.
`
`I know we're only looking at AMD on the screen right
`
`now, but have you reviewed PTX 3097 -- that's the proposed
`
`labeling -- in full?
`
`A.
`
`Q.
`
`Yes.
`
`Is there any dose referred to in PTX 3097 that is not
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`a 2-milligram dose?
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
`
`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 311
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
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`KARL CSAKY, MD, PhD - DIRECT
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`A.
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`Q.
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`Not that I could find.
`
`Okay. So whenever PTX 3097 recommends administration
`
`of Yesafili, is it recommending the use of 2 milligrams of
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`aflibercept?
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`A.
`
`Q.
`
`Yes.
`
`All right. Last but not least, the claims are all
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`going to require intravitreal administration, I think an image
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`that is now burned into our brains.
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`How does Mylan or Biocon recommend administering
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`aflibercept in PTX 3097?
`
`A.
`
`Q.
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`Through intravitreal injection.
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`Again, any kind of administration other than
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`intravitreal administration that's described at all in this
`
`label?
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`A.
`
`Q.
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`Not that I could find.
`
`For shorthand, whenever PTX 3097 recommends
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`administering Yesafili, is it, in fact, recommending that
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`doctors administer a 2-milligram intravitreal dose of
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`aflibercept?
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`A.
`
`Q.
`
`Yes.
`
`All right. Then let's keep cruising here. You can
`
`take down PTX 3097 for a moment and turn back to your slides.
`
`Can we check off this box that Yesafili's label
`
`recommends sequentially administering to the patient by
`
`intravitreal injection a single initial dose of 2 milligrams of
`
`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
`
`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 312
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
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`KARL CSAKY, MD, PhD - DIRECT
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`aflibercept?
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`A.
`
`Q.
`
`Yes.
`
`All right. Then let's turn to the next set of
`
`limitations, and I see you've highlighted two.
`
`What are the next limitations of Claim 6 that you'll
`
`address?
`
`A.
`
`So the next limitations are these idea of secondary
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`doses. And the claims are that there should be one or more
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`secondary doses of 2 milligrams of aflibercept and that each of
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`these secondary doses be administered approximately four weeks
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`following the immediate preceding dose.
`
`Q.
`
`Let's bring back up PTX 3097, still looking at
`
`page 2.
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`Does Mylan or Biocon's labels recommend that doctors
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`administer -- excuse me -- does Mylan or Biocon's label
`
`recommend that doctors follow the initial dose with one or more
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`secondary doses of 2 milligrams of aflibercept wherein each
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`secondary dose is administered approximately four weeks
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`following the immediately preceding dose?
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`A.
`
`Q.
`
`A.
`
`Yes.
`
`Where?
`
`So, again, it says under "Dosage and Administration,"
`
`the recommended dose of Yesafili is 2 milligrams to be
`
`administered every four weeks for the first 12 weeks or three
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`months.
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
`
`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 313
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
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`KARL CSAKY, MD, PhD - DIRECT
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`Q.
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`And of those first three injections, which, if any,
`
`of those correspond to the secondary doses of the claim
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`language?
`
`A.
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`So the secondary doses in this case would be the
`
`second and third injections.
`
`Q.
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`A.
`
`Q.
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`Those are the ones after the initial one?
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`Correct.
`
`Does PTX 3097 recommend that doctors administer those
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`secondary doses approximately four weeks following the
`
`immediately preceding dose?
`
`A.
`
`Q.
`
`A.
`
`Yes.
`
`Where does it do that?
`
`It says right here that these injections should be
`
`administered every four weeks, approximately every 28 days or
`
`monthly.
`
`Q.
`
`So then let's turn back to your slides. We're
`
`looking at PDX 4028.
`
`Dr. Csaky, can we check off these boxes? Does the
`
`label recommend -- excuse me -- does PTX 3097 recommend both of
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`these steps of the method of Claim 6?
`
`A.
`
`Q.
`
`Yes.
`
`All right. What's next? What's the next limitation
`
`of Claim 6 you analyzed?
`
`A.
`
`So the next are the "followed by one or more tertiary
`
`doses of 2 milligrams of aflibercept," and this too has another
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
`
`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 314
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
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`KARL CSAKY, MD, PhD - DIRECT
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`limitation in that each tertiary dose be administered
`
`approximately eight weeks following the immediate preceding
`
`dose.
`
`Q.
`
`Okay. After recommending the initial and secondary
`
`doses we just looked at, does PTX 3097 encourage, recommend, or
`
`promote that doctors administer one or more tertiary doses of
`
`2 milligrams aflibercept wherein each tertiary dose is
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`administered approximately eight weeks following the
`
`immediately preceding dose?
`
`A.
`
`Q.
`
`Yes.
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`Let's pull back up the label. That's PTX 3097.
`
`Dr. Csaky, where is that recommendation?
`
`A.
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`So, again, it states here under "Dosage and
`
`Administration" that, after the initial doses, they should be
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`followed by 2 milligrams of the intravitreal injection once
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`every eight weeks or two months.
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`Q.
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`And just in the language of the claims, which of
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`those 2-milligram intravitreal injections once every eight
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`weeks or two months are the tertiary doses of the claim?
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`A.
`
`Q.
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`A.
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`All of them.
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`Any of them that are administered?
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`Any of them that are administered would be considered
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`tertiary doses.
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`Q.
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`And, again, does the label explicitly recommend
`
`administering tertiary doses once every eight weeks?
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
`
`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 315
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
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`KARL CSAKY, MD, PhD - DIRECT
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`A.
`
`Q.
`
`A.
`
`Yes.
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`Where is that?
`
`Again, it says to be -- injection once every eight
`
`weeks under the dosage and administration label.
`
`Q.
`
`All right. So turning to Slide 29, that's PDX 429,
`
`can we check off these boxes? Does Mylan/Biocon's label
`
`recommend that doctors perform the tertiary dose steps of
`
`Claim 6?
`
`A.
`
`Q.
`
`Yes.
`
`All right. Looking at PDX 430, we've now made it to
`
`the crossed-out limitation. Can we skip this one for purposes
`
`of your analysis?
`
`A.
`
`Q.
`
`Yes, I did.
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`Then let's turn to Slide PDX 431. What's the last
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`limitation of Claim 6, Dr. Csaky?
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`A.
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`It says, "wherein the aflibercept is formulated as an
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`isotonic solution."
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`Q.
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`Dr. Csaky, did you evaluate whether the Yesafili
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`aflibercept that Mylan's label recommends doctors administer is
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`formulated as an isotonic solution?
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`A.
`
`Q.
`
`A.
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`Q.
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`A.
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`I did not.
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`Why not?
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`I'm not a formulation expert.
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`Do you know if anyone did address that limitation?
`
`I've been informed that Dr. Trout performed that
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 316
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
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`KARL CSAKY, MD, PhD - DIRECT
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` 326
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`analysis.
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`Q.
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`And just to set expectations, Dr. Trout will testify
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`as to infringement shortly. I expect him to address that
`
`limitation. And so with that in mind, Dr. Csaky, let's turn to
`
`the next slide, PDX 432. And I just want to ask you, for the
`
`rest of your testimony about Claim 6, I need you to assume that
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`Dr. Trout will testify that the aflibercept recommended by
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`Mylan Biocon's label to be administered is formulated in an
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`isotonic solution.
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`Do you understand that?
`
`A.
`
`Yes.
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`THE COURT: While those boxes are checked, Counsel,
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`would it be a good time to take our morning break?
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`MS. KAYALI: Absolutely, Your Honor.
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`THE COURT: We'll do that, then. We'll take
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`15 minutes. If everybody could be ready to resume at ten after
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`11:00, we'll resume the doctor's testimony.
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`Sir, you can take a break if you'd like, and you can
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`step down. I'll give you the same speech. I recognize you're
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`an expert; but for purity of our circumstances, yes, the same
`
`speech you heard me give Dr. Yancopoulos yesterday applies to
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`you. You're a man without a country. No one's being rude or
`
`discourteous, but they're not allowed to talk you midstream.
`
`So we'll go with that.
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`Otherwise, we'll see everyone here in 15 minutes.
`
`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
`
`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 317
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
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`KARL CSAKY, MD, PhD - DIRECT
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`Thank you all.
`
`(A recess was taken from 10:59 a.m. to
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`11:15 a.m.)
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`THE COURT: Counsel, you may proceed.
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`MS. KAYALI: Thank you, Your Honor.
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`BY MS. KAYALI:
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`Q.
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`Dr. Csaky, we're going to hop right back to Slide 32
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`where we left off. But before I ask the next question there,
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`earlier in your testimony, I believe you testified that about
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`1 million patients suffer from AMD. Is that about 1 million in
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`the United States?
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`A.
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`Q.
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`Correct.
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`And DME and DR, you also explained that those
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`diseases are common. Are they common in the United States?
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`A.
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`Q.
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`Correct.
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`So then let's turn back to where we left off. We had
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`just checked off all the boxes. Let me just ask this: Is
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`there anything else in Claim 6 we need to look for in Mylan's
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`label?
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`A.
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`Q.
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`A.
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`Q.
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`No.
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`We got them all. That's all the limitations?
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`Correct.
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`All right. So then let's go to the next slide. And
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`I want to turn back to the question we started with. That's
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`PDX 433.
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 318
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`KARL CSAKY, MD, PhD - DIRECT
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`In view of your testimony, in your opinion, does the
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`Mylan Biocon label, PTX 3097, recommend that doctors perform
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`every step of the method of Claim 6 to treat AMD using
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`Yesafili?
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`A.
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`Q.
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`Yes.
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`Okay. In view of that, does the Mylan Biocon label
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`recommend that doctors perform a method that infringes Claim 6?
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`A.
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`Q.
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`Yes.
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`Let's turn to the next slide, then, and ask -- let's
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`focus now on Question Number 2. Okay?
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`And, actually, I should back myself up.
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`Before we focus on Question Number 2, I want to see
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`if we can do something to help us move just a little faster
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`through the rest of this examination. We've been looking at
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`page 2 of PTX 3097.
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`If we could bring that back up, please. And if we
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`could call out the -- there you go, Section 2.2, the dosing
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`instructions for AMD.
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`Is there anywhere else other than this section on
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`page 2, "Dosage and Administration," that communicates the same
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`information about Mylan or Biocon's label recommends that
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`doctors use Yesafili to treat AMD?
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`A.
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`Q.
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`Not that I can see.
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`Let's take a look at page 1 of the label. And
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`page 1, are they what's called the "Highlights of the
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 319
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`KARL CSAKY, MD, PhD - DIRECT
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`Prescribing Information"?
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`A.
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`Q.
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`Yes.
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`Okay. Do the highlights of the prescribing
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`information say the same thing about how doctors should
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`administer Yesafili to treat AMD as the more -- the longer
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`section on page 2 of the exhibit?
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`A.
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`Q.
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`When I read these, they are identical.
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`Okay. So, really, what I'm asking is, to avoid
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`flipping back and forth, can we stick with the highlights of
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`the prescribing information as we move forward?
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`A.
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`Q.
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`later?
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`A.
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`Q.
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`That would be fine.
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`It says the same thing as the more detailed stuff
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`Yes.
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`All right. Now, let me ask while we have this up, I
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`see three bullet points under -- on the left. This is
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`PTX 3097, page 1, the dosage and administration section and the
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`highlights of the prescribing information. I see three bullet
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`points that look like they correspond to the three sentences in
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`the full Section 2.2 dosage and administration on page 2.
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`Do you see that?
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`Yes.
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`Which of those bullet points have you focused your
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`A.
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`Q.
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`testimony on today?
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`A.
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`The first bullet point.
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 320
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
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`Q.
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`A.
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`Why did you do that?
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`I did that because that's the only place in reviewing
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`this document that I could see that the term "recommended" was
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`used.
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`Q.
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`So how many recommended dosing regimens are there in
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`Mylan or Biocon's label as to how doctors should administer
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`Yesafili in order to treat AMD?
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`A.
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`Q.
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`A.
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`Q.
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`There's only one recommended way.
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`Is that the one you've offered testimony on today?
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`That's the one I've offered testimony on.
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`Now, let's look at this briefly, because we're going
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`to get there, for diabetic macular edema and diabetic
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`retinopathy too.
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`Are there also highlights of the prescribing
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`information for diabetic macular edema and diabetic
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`retinopathy?
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`A.
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`Q.
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`On here all I'm seeing is neovascular wet AMD.
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`Okay. If we go back to page 1 of PTX 3097, could we
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`pull up the highlights of the prescribing information at the
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`bottom for diabetic macular edema and diabetic retinopathy?
`
`Will we also be referring to the highlights of
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`prescribing information -- let me ask a better question.
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`Do the highlights of the prescribing information also
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`instruct doctors about how to use Yesafili to treat DME and DR?
`
`A.
`
`Yes.
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 321
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
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`KARL CSAKY, MD, PhD - DIRECT
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`Q.
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`And we're going to come back to that in a minute. I
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`just wanted to sort of establish where we're headed next.
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`Let's go back. Let's go back to PDX 4/34 and turn
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`back to Question Number 2. We're in a world where you just
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`answered yes to Question Number 1, and now we're asking
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`ourselves -- you're asking yourself -- will any doctor perform
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`infringing methods as a result of Mylan or Biocon marketing
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`Yesafili using the proposed labeling we've just looked at?
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`And so I want to get into the nitty-gritty of your
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`answer in just a second, but let's answer that at a high level
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`first.
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`In your opinion, if Mylan or Biocon sell Yesafili
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`with the proposed labeling we've just looked at, will doctors
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`perform the method of Claim 6 and infringe Claim 6 as a result?
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`A.
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`Q.
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`Yes.
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`Okay. I want to talk a lot more about how and why
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`you know that. Let's ask some prefatory questions first.
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`Do ophthalmologists like yourself read labels?
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`A.
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`Q.
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`A.
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`Yes.
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`Why?
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`Well, there's several reasons. Especially when a
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`drug comes onto the market, it gives us a good synopsis of the
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`important information of that drug, right? It tends to be a
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`synopsis of the data that supported its approval. So there
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`typically is a recommended usage that we now can be understood
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 322
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`KARL CSAKY, MD, PhD - DIRECT
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`should be an approach that we should consider. It outlines
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`again some of the issues, contraindications, reasons why you
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`would not want to use it, what to look for.
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`Other reasons -- for example, we have continuing
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`medical education lectures, right? And those typically require
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`that, if you're going to give a lecture on a drug, that you
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`give it on-label, which means that, as you're talking about the
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`aspects of the drug, that you're talking about it per the
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`label. So that's typically either a requirement or that you
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`have to notify the audience that you're going to be going
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`off-label.
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`And then of course in many cases sometimes insurance
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`carriers, they utilize the label for reimbursement purposes,
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`and so it's something you have to be aware of. So it's
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`something that all of us from time to time will be either
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`exposed to, read, or understand what's in the label.
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`Q.
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`Well, does what the label say influence the way that
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`ophthalmologists use ophthalmic drugs?
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`A.
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`Q.
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`A.
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`Of course.
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`Why?
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`Well, because, again, I mean, we have to understand
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`that there's several reasons that we'd want to look -- you
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`know, as we look at a label, these are the guideposts, right?
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`These are the instructions. And for many people, these are
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`kind of a good way to start. They're going to say, okay,
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 323
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`KARL CSAKY, MD, PhD - DIRECT
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`here's how the agencies like the Food and Drug Administration,
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`who has approved the drug, is -- has recommended that it be
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`used. So, again, it gives us a starting point for how do we
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`utilize the drug.
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`So, again, there's lots of reasons to begin to review
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`that, especially with a new drug as it comes out, that's
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`something that we'll be exposed to and read.
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`Q.
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`So in view of that, Mylan or Biocon sells Yesafili
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`with a label that recommends that doctors infringe Claim 6.
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`Will some doctors actually do what that label says and use
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`Yesafili according to the method of Claim 6?
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`A.
`
`Q.
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`Some doctors will in some patients.
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`So I want to break things down a little bit because
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`you're offering testimony about Yesafili, and I think we've
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`established that drug's not on the market yet, right?
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`A.
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`Q.
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`Yes.
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`So how is it that you can form an opinion about how
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`ophthalmologists will use Yesafili even though it hasn't been
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`sold yet?
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`A.
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`Well, in forming my opinion I looked at how people
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`use Eylea. And I reviewed the Eylea label and I asked myself
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`is there any doctor with any patient that follows the label of
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`Eylea in order to make my decision.
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`Q.
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`And if we bring back up PTX 917 on the left and
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`PTX 3097 on the right, is there any difference between how
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 324
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`KARL CSAKY, MD, PhD - DIRECT
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`Regeneron recommends that doctors use Eylea and how Mylan or
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`Biocon recommends that doctors use Yesafili?
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`A.
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`Q.
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`Not that I can see.
`
`All right. In view of the fact that these labels
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`make the same recommendations and in view of the fact that we
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`just walked through your opinion that Mylan or Biocon's label
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`encourages, recommends that doctors perform every method of
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`claim -- excuse me -- every step of the method of Claim 6, does
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`Eylea's label also recommend that doctors perform every step of
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`the method of Claim 6?
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`A.
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`Q.
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`Yes.
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`Now, we touched on this at a high level before, but
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`let's be a little more granular now. Do some doctors use Eylea
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`in the way that Regeneron's label recommends?
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`A.
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`Q.
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`A.
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`Yes.
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`How do you know?
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`Well, in doing my assessment, I kind of reviewed
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`several aspects. One, of course, is thinking back on how I
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`have used Eylea. And, again, as I said, there are certain
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`circumstances with certain patients, certain situations, where
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`I have followed the label for lots of reasons.
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`I've also -- when we sit on these committees and talk
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`about various approaches, clearly there are lots of
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`alternatives that people use, but there's still people who feel
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`as if these label indications still in many cases they have
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 325
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`KARL CSAKY, MD, PhD - DIRECT
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`that comfort in knowing that this will give them good visual
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`acuity in the patients that they want to treat.
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`So I used several kind of indicators of trying to
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`determine our -- again, are there some doctors in some patients
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`who will utilize this approach? And the conclusion I came to
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`was yes.
`
`Q.
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`I want to take each of those reasons that you just
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`offered in turn and dive in in a little more detail.
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`You said you have used Eylea in the way the label
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`recommends in accordance with the method of Claim 6. When and
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`why?
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`A.
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`So, again, sometimes -- again, if you look -- I mean,
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`the label basically suggests that, you know, I need to be
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`giving three injections, which is again a very common approach
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`for neovascular AMD. And then it instructs me to say, okay,
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`wait eight weeks after that initial injection and do
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`eight-weeks injections.
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`And, again, there's certain circumstances, especially
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`when there is -- I think back specifically to times when, for
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`example, patients had challenges with scheduling, right? They
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`want to know exactly kind of what to expect. They want to be
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`able to figure out, Dr. Csaky, tell me exactly when I'm going
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`to be coming in. I can give them some guideposts and metrics
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`using this kind of approach.
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`So there again, it's lots of reasons to have this
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 326
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`wider range of treatment options for patients as you talk with
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`them and you ask them questions about what specifically --
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`remember, this is a burdensome approach. And if somebody,
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`especially in areas where they have trouble getting back and
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`forth and they have to arrange certain trips, you know, having
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`kind of a known schedule in certain circumstances can be really
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`helpful for the patient. So, again, there have been some cases
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`where I tried to and I have reviewed with the patient and I've
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`used this approach.
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`Q.
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`A.
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`Are there particular circumstances that stand out?
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`Again, I think, you know, when I look back -- again,
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`and this is typically in areas where getting to and from
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`certain regions are challenging -- like, again, sometimes in
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`these rural communities, it can be very challenging. If I'm
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`there once a week and I don't have the luxury of being there
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`often, it's nice to have that comfort to know the patients are
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`coming back and forth.
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`Also sometimes when I'm sharing a clinic with -- in
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`this case in one of my satellite clinics, we can easily share
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`patients because we kind of know what the schedules are going
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`to be like. So, again, there's certain circumstances in which
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`this type of approach can have some benefits.
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`Q.
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`And this type of approach, that's the fixed-dosing
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`approach that's recommended by Eylea's label and covered by
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`Claim 6?
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 327
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
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`A.
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`Correct. So this is a -- an approach where, again,
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`if you look at this label, it suggests that you want to have
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`that patient come in once every month for three months and then
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`start extending it to eight weeks.
`
`Q.
`
`Well, I understand that's your experience, Dr. Csaky.
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`Is the retinal community such that you're familiar with how
`
`other doctors use Eylea?
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`A.
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`Yeah. I mean, I have -- like I said, I'm involved in
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`lots of committees, discussions. Even with some of my fellow
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`colleagues at Texas Retina, we talk about various approaches
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`that people use. So, again, this is -- it's part of our
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`armamentarium. What we want is we want to have different
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`approaches in our armamentarium that we can offer patients and
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`try to meet some of their needs and what they can have in terms
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`of their scheduling and things like that.
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`So that's really kind of a critical aspect to work
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`with patients and fully appreciate what's the best for them in
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`trying to get the best treatments.
`
`Q.
`
`And just to be very clear, in your conversations that
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`you mentioned with other doctors, have you become aware as to
`
`whether other doctors used the fixed-dosage regimen recommended
`
`by Eylea's label and covered by Claim 6?
`
`A.
`
`Yeah, I've had certain -- like I said, discussions.
`
`And also I've seen certain documents where people have talked
`
`about using these kinds of approaches.
`
`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
`
`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2003 Page 328
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
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`KARL CSAKY, MD, PhD - DIRECT
`
` 338
`
`Q.
`
`Okay. During the course of preparing your opinion,
`
`did you come across a document reflecting how any particular
`
`doctor used the fixed-dosing approach?
`
`A.
`
`Yes.
`
`THE COURT: One second, Doctor.
`
`Yes, Counsel?
`
`MS. LESKO: Objection, Your Honor. I believe what --
`
`the document that counsel's about to refer to is the
`
`declaration of Dr. Do, who was an expert on behalf of Regeneron
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`in a separate proceeding. That is hearsay. It should not be
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`admissible. If they wanted to introduce Dr. Do as an expert in
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`this case, they could have done it.
`
`THE COURT: Agreed, but, Counsel, go ahead.
`
`MS. KAYALI: Your Honor, we don't intend to seek
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`admission of this document. Under Rule 703, Dr. Csaky is
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`permitted to rely on such things. And he only intends to
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`testify
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