1
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`IN RE: OZEMPIC (SEMAGLUTIDE)) MDL NO. 22-MD-3038 (CFC)
`PATENT LITIGATION ) ANDA CASE
`
`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
`
` Plaintiffs,
`
`v.
`
`RIO BIOPHARMACEUTICALS
`INC., et al.,
`
` Defendants.
`
`NOVO NORDISK INC. and NOVO
`NOVO NORDISK A/S,
`
` Plaintiffs,
`
`v.
`
`)
`)
` )
`)
` ) C.A. No. 22-294 (CFC)
` )
` )
`)
`)
` )
`)
` )
`)
`)
` )
`)
` ) C.A. No. 22-1040 (CFC)
` )
` )
`MYLAN PHARMACEUTICALS INC., )
` )
`)
`
` Defendant.
`
`Thursday, July 13, 2023
`9:00 a.m.
`Markman Hearing
`
`844 King Street
`Wilmington, Delaware
`
`BEFORE: THE HONORABLE COLM F. CONNOLLY
`United States District Court Judge
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`MPI EXHIBIT 1088 PAGE 1
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 1 of 134
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`IN RE: OZEMPIC (SEMAGLUTIDE)) MDL NO. 22-MD-3038 (CFC)
`PATENT LITIGATION ) ANDA CASE
`
`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
`
` Plaintiffs,
`
`v.
`
`RIO BIOPHARMACEUTICALS
`INC., et al.,
`
` Defendants.
`
`NOVO NORDISK INC. and NOVO
`NOVO NORDISK A/S,
`
` Plaintiffs,
`
`v.
`
`)
`)
` )
`)
` ) C.A. No. 22-294 (CFC)
` )
` )
`)
`)
` )
`)
` )
`)
`)
` )
`)
` ) C.A. No. 22-1040 (CFC)
` )
` )
`MYLAN PHARMACEUTICALS INC., )
` )
`)
`
` Defendant.
`
`Thursday, July 13, 2023
`9:00 a.m.
`Markman Hearing
`
`844 King Street
`Wilmington, Delaware
`
`BEFORE: THE HONORABLE COLM F. CONNOLLY
`United States District Court Judge
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`MPI EXHIBIT 1088 PAGE 1
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 1 of 134
`
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`
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`APPEARANCES:
`
`
` MORRIS NICHOLS ARSHT & TUNNELL
` BY: BRIAN P. EGAN, ESQ.
`
` .
`
` -and-
`
`
` FENWICK & WEST LLP
` BY: JEFFREY J. OELKE, ESQ.
` BY: ROBERT E. COUNIHAN, ESQ
` BY: LAURA T. MORAN, ESQ.
` BY: RYAN JOHNSON, ESQ.
` BY: ERICA SUTTER, ESQ.
`
` Counsel for the Plaintiffs
`
`
`
`
`
` MORRIS JAMES
` BY: CORTLAN S. HITCH, ESQ.
`
`
`-and-
`
`
` TAFT STETTINIUS & HOLLISTER LLP
` BY: PHILIP KOUYOUMDJIAN, ESQ.
`
` Counsel for the Defendants
`Rio Biopharmaceuticals, Inc. and EMS S/A
`
`
`
`
`
` STAMOULIS & WEINBLATT LLC
` BY: STAMATIOS STAMOULIS, ESQ.
`
`-and-
`
`
`
`
`
`
`MPI EXHIBIT 1088 PAGE 2
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 2 of 134
`
`
`
`APPEARANCES:
`
` 3
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`PERKINS COIE LLP
` BY: EMILY J. GREB, ESQ.
` BY: BRANDON M. WHITE, ESQ.
`
` Counsel for the Defendants
`Mylan Pharmaceuticals Inc.
`
` SHAW KELLER
` BY: KAREN E. KELLER, ESQ.
`
`-and-
`
` AXINN, VELTROP & HARKRIDER LLP
` BY: AZIZ BURGY, ESQ.
` Counsel for the Defendant
`Alvogen, Inc.
`
` YOUNG CONAWAY STARGATT & TAYLOR
` BY: ALEXIS STOMBAUG, ESQ.
`
` Counsel for the Defendants
`Zydus Worldwide DMCC, Zydus Pharmaceuticals Inc.
`and Zydus Lifesciences Limited
`
` HEYMAN ENERIO GATTUSO & HIRZEL
` BY: DOMINICK GATTUSO, ESQ.
`
`-and-
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`MPI EXHIBIT 1088 PAGE 3
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 3 of 134
`
`
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`APPEARANCES:
`
` WINSTON & STRAWN
` BY: JOVIAL WONG, ESQ.
` BY: ASHLEY GRAHAM, ESQ.
`
` Counsel for the Defendants
`Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
`Laboratories, Inc.
`
` RICHARDS, LAYTON & FINGER
` BY: KELLY E. FARNAN, ESQ.
` BY: SARA METZLER, ESQ.
`
`-and-
`KATTEN MUCHIN ROSENMAN LLP
`BY: BRIAN SODIKOFF, ESQ.
`BY: CHRISTOPHER W. WEST, ESQ.
`
` Counsel for Defendants
`Sun Pharmaceutical Industries Ltd. and Sun
`Pharmaceutical Industries, Inc.
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`MPI EXHIBIT 1088 PAGE 4
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 4 of 134
`
`
`
` 5
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`P R O C E E D I N G S
`
`(Proceedings commenced in the courtroom beginning at
`
`9:00 a.m.)
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`THE COURT: Good morning. Please be seated.
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`All right. Let's start. We've got a lot of
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`folks here. I guess I'll just do it in the order I have
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`with Mr. Hitch. Oh, Mr. Egan, you're on that side. Go
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`ahead and start.
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`MR. EGAN: Good morning, Your Honor. Brian
`
`Egan from Morris Nichols on behalf of plaintiff Novo
`
`Nordisk. Joining me today from the Fenwick law firm are
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`Jeff Oelke, Robert Counihan.
`
`MR. COUNIHAN: Morning, Your Honor.
`
`MR. EGAN: Ryan Johnson, Erica Sutter, and
`
`Laura Moran.
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`We also have a number of client representatives
`
`here today, Your Honor, from Novo Nordisk: Kathryn Jones,
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`Chloe Jiang, Wesley Nicolas, and Lori Klewin. And just in
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`terms of order of presentation today, Your Honor, the
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`parties have agreed to argue in the order in which they
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`were briefed.
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`THE COURT: Okay.
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`MR. HITCH: Good morning, Your Honor. On
`
`behalf of Rio Pharmaceuticals, it's Cortlan Hitch from
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`MPI EXHIBIT 1088 PAGE 5
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 5 of 134
`
`
`
` 6
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`Morris James. And joining me today is Phil Kouyoumdjian
`
`Taft Stettinius & Hollister.
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`MR. STAMOULIS: Hi, Your Honor. Good morning.
`
`Stam Stamoulis here on behalf of Mylan. With me here at
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`counsel table is Emily Greb and Brandon White from the
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`Perkins Coie firm and Matt Greiner is in-house counsel for
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`Mylan. He's here today. Thank you, Your Honor.
`
`MS. KELLER: Good morning, Your Honor, Karen
`
`Keller from Shaw Keller on behalf of Alvogen. And with me
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`today is Aziz Burgy from Axinn, Veltrop.
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`MS. STOMBAUGH: Good morning, Your Honor.
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`Alexis Stombaugh from Young Conaway, on behalf of
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`defendant Zydus. Thank you.
`
`MR. GATTUSO: Good morning, Your Honor.
`
`Dominick Gattuso from Heyman Eneria Gattuso & Hirzel on
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`behalf of DRL. I also have with me Jovial Wong.
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`MR. WONG: Good morning, Your Honor.
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`MR. GATTUSO: And Ashley Graham, from Winston &
`
`Strawn.
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`THE COURT: Thank you.
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`MR. GATTUSO: Thank you.
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`MS. METZLER: Good morning, Your Honor. Sara
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`Metzler from Richards Layton & Finger, on behalf of
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`defendant Sun. With me today are Kelly Farnan from my
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`office and Brian Sodikoff and Christopher West, from
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`MPI EXHIBIT 1088 PAGE 6
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 6 of 134
`
`
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`Katten Muchin.
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`THE COURT: Good morning.
`
`Okay. So we'll start with the first term is
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`"piston rod rotates," right?
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`MR. OELKE: Your Honor, it's the '462 patent,
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`method of treatment. We're doing it in the order of the
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`briefing.
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`THE COURT: Which is different than the order
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`of the amended claim construction chart, right?
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`MR. OELKE: That's right, Your Honor.
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`THE COURT: Let's do in the order of that.
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`Since that's the last thing you presented to me, that's
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`the thing I went by. Let's start with piston rod rotates.
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`MR. OELKE: Mr. Counihan will be handling the
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`device terms.
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`THE COURT: Why did you do it in a different
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`order?
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`I mean, I have to say that threw me for a loop.
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`It made it much more difficult to prepare.
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`You know, you have a joint brief. You've got
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`all your table of contents. You've got your terms.
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`That's what I look at, and then I get an amended joint
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`claim construction chart, which has a completely different
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`order, and I've got to go match it up to Claim A to
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`Page 89 to 91.
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`MPI EXHIBIT 1088 PAGE 7
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 7 of 134
`
`
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` 8
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`I'm just curious what the thinking is when you
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`put something together like that.
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`MR. OELKE: Your Honor, I think we should have
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`redone the claim chart. The briefing was done in order of
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`the '462 patent first and then the device terms. That's
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`how we did the briefing. We should have just re- -- we
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`should have amended the claim chart to have it in that
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`order as you said.
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`THE COURT: Why? I'm just curious. Seriously,
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`I just want to understand. Because you're advocates.
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`You're presenting things to the Court. You want me to
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`engage.
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`I'm just kind of curious, so how did you come
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`up with this?
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`You have spent all this time briefing it. You
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`have a table of contents. You've got the order of the
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`terms. You give that to me. Then you have this meet and
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`confer. Not the longest meet and confer by the way, but,
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`you know, and you come up with an amended thing, you file
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`it.
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`I'm not even being critical. I'm just trying
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`to understand, since you're trying to persuade me and
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`engage me, how did you come up with let's have a
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`completely different order that we're going to submit this
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`to the Court. Just curious. What was it?
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`MPI EXHIBIT 1088 PAGE 8
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 8 of 134
`
`
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`MR. OELKE: The chart, I think, was in the
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`order in which the defendants presented the terms, and
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`then when we briefed it, we did it with the '462 patent
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`first. That's all, Your Honor.
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`THE COURT: All right. Well, anyway, let's
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`start with the piston rod rotates.
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`MR. OELKE: We're happy to start with the
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`device terms, Your Honor.
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`MR. COUNIHAN: Your Honor, may I approach?
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`THE COURT: Sure.
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`MR. COUNIHAN: Is two copies good for Your
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`Honor or would you like more?
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`THE COURT: Yeah, that would be great. Thank
`
`you. Unless you've got more.
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`MR. COUNIHAN: I have more.
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`THE COURT: All right.
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`MR. COUNIHAN: So, Your Honor I apologize in
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`advance. Our slides are in the order of the briefing, so
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`I will -- what I'm going to do is start at the very
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`beginning and then I'm going to jump to where the piston
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`rod rotates slides are.
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`So I'd like to start at the tab that says
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`device patents, Mr. Watkins, and I'm going to just give a
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`two-, three-minute overview of the issues and then jump
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`into the disputed term, if that works.
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`MPI EXHIBIT 1088 PAGE 9
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 9 of 134
`
`
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` 10
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`THE COURT: That's great.
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`MR. COUNIHAN: Okay. Great.
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`So, Your Honor, Robert Counihan, Fenwick &
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`West, on behalf of the plaintiffs. So the invention of
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`the device patents -- okay. So the invention of the
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`device patents relates to limiters for injection pens. So
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`dose limiters are important in injection pens because they
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`allow users or patients to be confident that the amount of
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`dose that they want to give themselves is, in fact,
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`available in the pen.
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`So if you've ever had a small child and given
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`them medicine from a syringe that you get at the pharmacy,
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`you can visibly see if you happen to pull up some air and
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`there's less than what you intend to give to your child,
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`but the injection pens, you often cannot actually see the
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`amount of dose available. And that's because the pen is
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`designed to be efficient, compact, easy to use, and so
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`what the user requires is some piece of mind that they are
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`actually giving themselves the right dose.
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`So as the patent acknowledges, the general
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`concept of dose limiters was known in the art at the time.
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`But those mechanisms were cumbersome. They were -- if
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`they were internal to the device, they were positioned
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`outside of the driver, a common component found in
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`injection pens, which made the pen unnecessarily large and
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`MPI EXHIBIT 1088 PAGE 10
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 10 of 134
`
`
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` 11
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`unwieldy, or it involved exterior mechanisms that would
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`require user to flip a switch or do something else that
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`could be complicated and add additional issues to the
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`device.
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`What the inventors came up with is a design
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`where they took the limiter and they moved it inside of
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`the driver. So this is one of the figures from the
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`patent. The driver is in green. The piston rod is in
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`blue. Those are two common components in injection pens.
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`The limiter in is in orange.
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`What they did is they took advantage of the
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`inner space within the driver walls. And they increased
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`the space a little bit and they created a limiter that
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`could move within it.
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`This might look like a relatively simple design
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`there's only four or five components, but what needs to be
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`appreciated is that these components are moving with
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`respect to each other. So there's a number of forces
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`going on; there's a number of different aspects of what's
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`happening.
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`And what the inventors created was a
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`streamlined, slimmed-down profile design. Something that
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`was critically robust, that was accurate, that was
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`reliable. And they described their design through three
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`different embodiments. On the screen here are figures 1,
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`MPI EXHIBIT 1088 PAGE 11
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 11 of 134
`
`
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` 12
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`5, and 8, which reference at three embodiments. They
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`describe different arrangements of limiting mechanisms. I
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`don't think today we need to go into the different types
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`of limiting mechanisms described, but we can if Your Honor
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`is interested. But what they say is that each of these
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`limiting mechanisms has three critical components: The
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`piston rod, the limiter, and the driver.
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`THE COURT: What's a limiting mechanism?
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`MR. COUNIHAN: A limiting mechanism, Your
`
`Honor? Well, the claim term is a limiter, but to answer
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`your question of what a limiting mechanism is, if they had
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`used that term, that, to me, would have sounded like the
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`means-plus-function issue that's at dispute. Because,
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`then, they would have used a nonce term like "mechanism"
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`and a functional word like "limiting."
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`They used the word "limiter." Limiter has
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`structural understanding in this field. It's a Component
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`that is used to limit, in this situation, the amount of
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`dose that can be set.
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`And the claim --
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`THE COURT: You say it's in the field. Do I
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`need to go to extrinsic evidence to know that? Because
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`I'm not a -- what's the field?
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`MR. COUNIHAN: The field here is injection
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`pens.
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`MPI EXHIBIT 1088 PAGE 12
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 12 of 134
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`THE COURT: Okay. So I'm not an injection
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`medicine guy, so how do I know that "limiter" is a defined
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`term in the field?
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`MR. COUNIHAN: Well, because in the patent when
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`they talk about limiters, they talk about limiters in a
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`structural sense. They don't use "limiters" as a
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`placeholder for the function of limiting that then has a
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`broad scope. They're talking specifically about different
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`types of limiters, limiters with different designs. All
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`of the limiters have engaging surfaces. Engaging surfaces
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`that engage with the piston rod and the -- let me go back
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`one slide.
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`THE COURT: But how do I know that that's in
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`the field that has that definition as opposed to in the
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`specific patents it has that definition? Don't I have to
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`resort to extrinsic evidence to know that?
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`MR. COUNIHAN: Your Honor, I don't think you
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`need to, but here you can. Because Dr. Cameron did put in
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`a declaration on behalf of the plaintiffs explaining how
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`the term limiter is used in different situations in the
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`field of mechanical engineering and injection pens.
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`THE COURT: Right. And they have a different
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`definition from their expert, right, a different
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`understanding?
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`MR. COUNIHAN: Their expert does not actually
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`MPI EXHIBIT 1088 PAGE 13
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 13 of 134
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`
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` 14
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`opine on whether the term is means-plus-function or not.
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`He offers an opinion about the proper construction if it's
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`not means-plus-function, but I don't --
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`THE COURT: Right. But, I mean, doesn't he
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`have opinions about what's understood in the field by that
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`term.
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`MR. COUNIHAN: He does, but he does not
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`actually take the next step and say that means in this
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`situation, limiter, the claim term, does not have a
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`structural meaning. What he is saying, as I understand
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`it, is limiters in general have these various uses and
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`different applications and -- and then, yeah.
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`It deserves this very unique, very specific
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`construction that is, in essence, taking
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`means-plus-function concepts and injecting it into a
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`nonmeans-plus-function construction.
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`THE COURT: All right.
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`MR. COUNIHAN: So when the patents use --
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`discuss these embodiments, the patents refer to them as
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`general embodiments. They explain even within these
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`embodiments that there are alternative designs, there are
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`options within them, and then they use the figures to
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`illustrate the embodiments.
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`In the present disputes -- I'm not going to go
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`through all of these -- what consistently comes up, Your
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`MPI EXHIBIT 1088 PAGE 14
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 14 of 134
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`
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` 15
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`Honor, is that the defendants are trying to inject
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`specific concepts into the claim terms. You will not,
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`Your Honor, hear today about definitions in the spec.
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`They don't make any of those types of arguments. They
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`make one argument about a prosecution disclaimer, which
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`we'll address.
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`But otherwise, what they are consistently doing
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`is trying to take the embodiments, and specifically the
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`figures, interpret them and say, the figures say you have
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`to have this, therefore, we should inject it into the
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`claims.
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`THE COURT: Let's get to piston rod.
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`MR. COUNIHAN: Okay. So I'm going to start
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`with piston rod rotates relative.
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`So, Mr. Watkins, if you could turn to slide 71,
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`please. There you go.
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`So, Your Honor, as I'm sure you -- over the
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`course of the briefing, the parties continued to negotiate
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`their constructions. So as I'm sure you saw in the
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`briefing, some of the issues briefed at the outset no
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`longer apply at this point. So what we have consistently
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`in our slides is what the final positions are from the
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`parties, and I believe that's reflected in the chart that
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`you received with the exception of one term that the
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`defendants clarified they're arguing from the brief.
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`MPI EXHIBIT 1088 PAGE 15
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 15 of 134
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` 16
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`I believe it's this term, right?
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`MS. GREB: Right.
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`MR. COUNIHAN: Sorry. So, anyway, on this
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`term, as we understand it, the only dispute at this point
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`is what the piston rod must rotate relative to. We say
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`it's to another component; they say it's relative to the
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`housing. Now, of course, the term --
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`THE COURT: Can you tell me, just so I
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`understand, what component other than the housing would it
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`rotate relative to?
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`MR. COUNIHAN: Well, in Claim 1, of the '383,
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`which is where this -- this phrase, that's where this
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`dispute comes up.
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`THE COURT: Right.
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`MR. COUNIHAN: Here we go. Here's the Claim 1
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`one language. It doesn't require it to rotate with
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`respect to the housing in particular. It just must rotate
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`with respect to another component.
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`THE COURT: Right. I get that. So but what --
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`I'm trying to figure out the nature -- well, I kind of
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`want to know. So other than the housing, what else would
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`it rotate relative to?
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`MR. COUNIHAN: So if we look at the figures,
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`Your Honor, it rotates relative to other components such
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`as the limiter and the driver in this embodiment. And
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`MPI EXHIBIT 1088 PAGE 16
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 16 of 134
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`
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` 17
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`that's all that's required. It's requiring rotation. It
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`cannot be static in terms of rotational movement. And so
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`the -- well, you know, a critical point in terms of their
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`construction is that they're trying to say most rotate
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`relative to the housing. The concept of a housing is not
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`presented in Claim 1. The concept of housing comes in, in
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`Claim 2 of this -- of the '383 patent.
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`And so they are trying to read in a limitation
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`about -- that is found explicitly in the dependent claim,
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`and under the law, the Trustees of Columbia University
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`case, that is not allowed. Because the independent claim
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`was drafted without reference to the housing at all.
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`And their central point about why it's
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`appropriate to focus on the housing or to read the housing
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`in, is what they call a "prosecution disclaimer". And
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`that's with respect to this reference called Burroughs.
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`And this is the language that they side from the
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`prosecution history, Your Honor.
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`THE COURT: Actually, don't go there yet.
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`MR. COUNIHAN: Okay.
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`THE COURT: I'm trying to figure out,
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`essentially, what's really at issue. I mean, the -- and
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`why we even need to construe this because -- and the
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`difference, right, is, they want, or rather you want this
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`to rotate relative to another component undefined.
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`MPI EXHIBIT 1088 PAGE 17
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 17 of 134
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`
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` 18
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`MR. COUNIHAN: Correct.
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`THE COURT: Right?
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`MR. COUNIHAN: Yes.
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`THE COURT: They want it to rotate relative to
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`the housing.
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`MR. COUNIHAN: Correct.
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`THE COURT: Do you dispute that -- actually, in
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`all pens, is this going to rotate relative to the housing?
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`MR. COUNIHAN: So one issue with their -- I
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`will come back to your question in a moment. One issue
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`with their construction is that the meaning of "housing"
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`is also disputed. So there's a world where --
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`THE COURT: I'm aware, yeah.
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`MR. COUNIHAN: There's a world where the
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`housing construction actually informs whether there might
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`be agreement on this term. But to come back to your
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`question, which I understand to be: Is there a world
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`where an infringing pen, if you will, rotates -- the
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`piston rod rotates with respect to anything other than --
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`I assume you're referring to the exterior shell, the
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`outermost housing, Your Honor, when you say, "housing" in
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`that question?
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`THE COURT: Yes.
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`MR. COUNIHAN: Yeah, here's where the issues
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`start compiling on top of each other. So --
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`MPI EXHIBIT 1088 PAGE 18
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 18 of 134
`
`
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` 19
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`THE COURT: I mean, should we construe
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`"housing" first? Would that take care of it?
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`MR. COUNIHAN: Yes. Your Honor, yes, I think
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`that would help. So we could go there first. It also
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`might help to construe "piston rod" first, because it's
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`the piston rod that's rotating. So the answer to that
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`question might also inform some of these issues too. So
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`whatever Your Honor would prefer. Here's -- yeah.
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`THE COURT: So if you were trying to be
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`efficient about this, sounds like what you would say is go
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`with "piston rod" first then "housing" and then this first
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`term?
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`MR. COUNIHAN: Yes, Your Honor, because I think
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`we can kind of compartmentalize some of these issues.
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`Like kind of bucket those three, and then the limiter and
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`driver, bucket those together, and then the other two
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`device terms, and then the '462.
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`THE COURT: What do you think?
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`MS. GREB: Your Honor, this is Emily Greb on
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`behalf of defendants.
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`I think it would be fine if we bucketed them as
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`suggested and started with piston rod and housing and then
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`did this last, or if we wanted to start with limiter and
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`driver. But I do agree that it would be more efficient to
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`talk about piston rod and housing before we do that.
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`MPI EXHIBIT 1088 PAGE 19
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 19 of 134
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`
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` 20
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`THE COURT: All right. Let's do that. Let's
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`do "piston rod" first, then.
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`MS. GREB: Okay. Thank you, Your Honor.
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`THE COURT: Okay.
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`Mr. Watkins, you are ahead of me.
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`MR. COUNIHAN: Okay. So, Your Honor, with
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`respect to the piston rod, in general, the parties are
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`pretty close on piston rod. Our view is that it's plain
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`and ordinary meaning, and then we tried to capture what
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`that is. We believe a piston rod is a readily understood
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`term of art in the field and in general parlance.
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`The defendants largely track that -- they
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`obviously use different words, but conceptually it's
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`fairly similar. But they also add in this language that
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`the shaft, that is the rod of the -- the piston rod --
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`must extend into the syringe barrel itself. So the
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`dispute is whether that requirement is required or not.
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`THE COURT: Well, let me start -- let's go back
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`to your construction first.
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`MR. COUNIHAN: Sure.
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`THE COURT: Because, you know, when I read,
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`this strikes me, this is plain and ordinary meaning.
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`MR. COUNIHAN: Yes, we agree.
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`THE COURT: It's a shaft that causes a piston
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`to be moved. What I don't understand about your
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`MPI EXHIBIT 1088 PAGE 20
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 20 of 134
`
`
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` 21
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`construction is the quote "such that the medicament is
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`expelled," unquote. It doesn't make sense to me
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`grammatically that you would have that clause because
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`isn't that covered by a limitation in the claim?
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`MR. COUNIHAN: Yes, Your Honor.
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`THE COURT: So it's redundant. It's like
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`saying I need a piston shaft such that the medicament is
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`expelled and then later on I have to have a medicament
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`that's expelled. So I don't understand why you repeat it.
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`MR. COUNIHAN: Agree. And the reason why we
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`repeat it is during the course of negotiations over the
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`constructions, one of the concerns that was raised by
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`defendants is that our construction of piston rod is
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`untethered to what the piston is dealing with. And so we
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`propose that language as a compromise.
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`We would be happy to have that removed and just
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`stop at "to be moved." Sorry. The constructions are at
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`the top. So we would be more than comfortable with "a
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`shaft that causes the piston to be moved."
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`THE COURT: Okay. Let me hear from them. I
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`mean, because plain and ordinary meaning, the burden is on
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`them to come up and say why it should be different, right?
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`MR. COUNIHAN: Yes, agreed.
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`THE COURT: All right. Let's hear from them.
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`MS. GREB: Good morning, Your Honor. Emily
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`MPI EXHIBIT 1088 PAGE 21
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 21 of 134
`
`
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` 22
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`Greb on behalf of defendants. I'm happy to address piston
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`rod. If you don't mind indulging me with a few comments
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`on what -- what was said about the device patents in
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`general before I get started on piston rod.
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`THE COURT: Sure.
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`MS. GREB: So as was mentioned, you know, these
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`patents have sort of been described as the end-of-content
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`patents. And I'd just like to make it clear that these
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`patents disclose a very --
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`THE COURT: I have no idea, what is
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`end-of-content patent?
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`MS. GREB: We don't have to call it that. It's
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`really just directed towards this dose setting where a
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`user dials in a dose, and you can't --
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`THE COURT: Oh, at the end of content.
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`MS. GREB: Yep. At the end of content, you
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`can't dial something that's not there.
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`THE COURT: Yep.
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`MS. GREB: And the point of these patents is
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`that they describe and claim this really specific
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`mechanism. These patents don't claim an injection device,
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`and they don't even claim all mechanisms that prevent this
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`sort of over-dialing of doses. They claim a very specific
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`mechanical design. And to that end, the bulk of the
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`specification is directed toward two embodiments. Now,
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`MPI EXHIBIT 1088 PAGE 22
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 22 of 134
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`
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` 23
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`you heard counsel say, I think, three embodiments, but the
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`specification pretty clearly only talks about two.
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`Figure 8 that he talked about is the third
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`embodiment. The specification ties in Column 5 actually
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`to the second embodiment. So the specification has two
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`embodiments and a number of figures that provide details
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`about those. So I just want to make that clear.
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`So with respect to the piston rod in
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`particular, as was mentioned, so defendants' proposed
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`construction is a shaft extending into the syringe barrel
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`such that the end of the device shaft drives the plunger
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`in the distal direction to expel medicament from the
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`device.
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`And so I heard your question about expelling
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`medicament from the device, so I'll start there since I
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`know you are thinking about that. The part that's
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`important there and the reason that it's included is
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`because we wanted to make it clear that what the piston
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`rod or shaft is doing is driving this plunger down. And
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`it's true that every single figure and every single
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`embodiment, the way that this worked is the piston rod
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`rotates relative to the housing. And it moves down.
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`There's threading between those two components that causes
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`downward motion and expels the medicament from the device
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`in the distal direction. There's not some sort of other
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`MPI EXHIBIT 1088 PAGE 23
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 23 of 134
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`
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` 24
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`movement in the piston rod where it could move, you know,
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`upwards. And so it was providing clarity about the --
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`THE COURT: When you say "clarity," I mean, the
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`claim says it. The claim says "a piston rod having a
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`threaded outer surface wherein piston rod rotates and
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`translates axially forward during expelling of
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`medication."
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`MS. GREB: Yeah.
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`THE COURT: So it would be during that, right?
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`MS. GREB: Yeah. And your Honor is right with
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`respect to the '383. This terms is also in the '953
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`patent, and I think the claims of the '953 are a little
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`less clear because that rotation term that's in the '383
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`patent is not in the '953 patent in the same way.
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`THE COURT: Hold up. Show me. Where are you
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`now? You're on --
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`MS. GREB: Yes. So this would be the '953
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`patent, Claim 1, and it starts with in Column 9 and then
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`goes to Column 10.
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`THE COURT: Hold on. Can you go back and let
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`me just look at both the competing --
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`MS. GREB: This is Slide 27.
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`THE COURT: All right. So putting all your
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`disagreements aside, so then what you would say is
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`because -- if you agreed with them, if I could get you to
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`MPI EXHIBIT 1088 PAGE 24
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 24 of 134
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`
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` 25
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`agree with them, you'd say: Well, include the "such that
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`the medicament is expelled because it would bring clarity
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`for the '953 patent claims," because you admit it's
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`totally redundant for the first patent.
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`MS. GREB: I would agree with Your Honor that
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`it would be -- if we're just talking about the back end of
`
`the construction. I certainly have a number of
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`disagreements on the front end of the construction.
`
`THE COURT: We will get to those, right.
`
`MS. GREB: But, yeah, on the back end of the
`
`construction, I agree that in the '383 patent, there is
`
`the portion that expels medicament, but the '953 does not
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`have that same term. And I think, frankly, too, the other
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`part that sort of is important --
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`THE COURT: Hold on one second.
`
`MS. GREB: Sure. Of course.
`
`THE COURT: All right. Well, the more I think
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`about it, though, I mean, this patent, the '953, you know,
`
`we're talking a mechanism for an injection device.
`
`I mean, what else does an injection device do
`
`except it expels medicament, right? All right. So maybe
`
`then we have to include that. I don't really get it. But
`
`all right. It certainly would be redundant and confusing
`
`for the first patent if we were to construe it that way to
`
`a jury, I think. But let's deal with then, go back to
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`MPI EXHIBIT 1088 PAGE 25
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1088, p. 25 of 134
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`
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` 26
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`your main arguments then. Go ahead.
`
`MS. GREB: Sure. The other components of the
`
`construction the defendants have put forward talk about a
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`shaft extending in a syringe barrel. So location of the
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`shaft where the piston rod is. And it talks about driving
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`the plunger, which we
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