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`L O C K E L O R D L L P
`B Y : C H R IS T O P H E R J . C A S S E L L A , E S Q U I R E
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`F o r th e D e fe n d a n t s
`A p o t e x a n d Z y d u s
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`R I C H A R D S L A Y T O N & F I N G E R , P .A .
`B Y : S T E V E N J . F I N E M A N , E S Q U I R E
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`A X IN N V E L T R O P & H A R K R ID E R L L P
`B Y : A Z I Z B U R G Y , E S Q U IR E
`B Y : C H R IS T O P H E R G A L L O , E S Q U I R E
`B Y : D A V I D S IL V E R S T E I N , E S Q U I R E
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`F o r th e D e fe n d a n t s
`P a r a n d A n c h e n
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`Y O U N G C O N A W A Y S T A R G A T T & T A Y L O R , L L P
`B Y : A N N E S H E A G A Z A , E S Q U I R E
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`- a n d -
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`W I N S T O N & S T R A W N L L P
`B Y : C L A I R E F U N D A K O W S K I , E S Q U I R E
`B Y : C H A R L E S B . K L E I N , E S Q U I R E
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`F o r th e S u n D e fe n d a n t
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`* * * P R O C E E D IN G S * * *
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`T H E C O U R T : G o o d m o rn in g . T h is is J u d g e
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`A n d r e w s . C a n y o u a ll h e a r m e ?
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` IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`1
`
`In re: Sitagliptin Phosphate )
`('708 & '921) Patent Litigation ) MDL No. 19-2902-RGA
` )
` ) C.A. Nos. 19-311-RGA
` )
`
`19-312-RGA
` )
`19-313-RGA
` )
`19-314-RGA
` )
`19-317-RGA
`
` )
`19-318-RGA
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`19-319-RGA
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`19-347-RGA
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` )
`19-1489-RGA
`- - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
` )
`MERCK, SHARP & DOHME CORP.,
`
` )
` Plaintiff,
` )
`
` ) C.A. No. 20-776-RGA
`
` )
`
`v.
`
` )
`
`LUPIN LIMITED and LUPIN
` )
`PHARMACEUTICALS, INC.,
` )
` )
` Defendants.
` )
`- - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
` )
`LUPIN LIMITED,
` )
` Counter Claimant,
`)
` )
` )
`v.
` )
` )
`MERCK, SHARP & DOHME CORP.,
` )
` Counter Defendant. )
`
`
`
` Tuesday, August 18, 2020
` 9:00 a.m.
` Markman Hearing
`
` Videoconference
`
`BEFORE: THE HONORABLE RICHARD G. ANDREWS, U.S.D.C.J.
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`A P P E A R A N C E S :
`M c C A R T E R & E N G L IS H , L L P
`B Y : D A N I E L M . S I L V E R , E S Q U I R E
`B Y : A L E X A N D R A M . J O Y C E , E S Q U I R E
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`W IL L I A M S & C O N N O L L Y L L P
`B Y : E L IS E M . B A U M G A R T E N , E S Q U I R E
`B Y : S H A U N P . M A H A F F Y , E S Q U I R E
`B Y : A L E X A N D E R Z O L A N , E S Q U IR E
`B Y : B R U C E G E N D E R S O N , E S Q U I R E
`B Y :
`J I N G Y U A N L U O , E S Q U I R E
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`F o r th e P la in tiff
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`H E Y M A N E N E R I O G A T T U S O & H I R Z E L L L P
`B Y : D O M IN I C K T . G A T T U S O , E S Q U I R E
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`G O O D W I N P R O C T E R L L P
`B Y : E M IL Y R A P A L IN O , E S Q U IR E
`B Y : S A R A H F IS C H E R , E S Q U I R E
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`F o r th e D e fe n d a n ts
`S a n d o z , T e v a a n d W a ts o n
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`R IC H A R D S L A Y T O N & C O T T R E L L , P .A .
`B Y : F R E D E R I C K L . C O T T R E L L , I I I , E S Q U I R E
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`- a n d -
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`K N O B B E M A R T E N S
`B Y :
`J O N A T H A N B A C H A N D , E S Q U I R E
`B Y : W IL L IA M Z I M M E R M A N , E S Q U I R E
`B Y : A N D R E A C H E E K , E S Q U I R E
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`F o r th e L u p in D e fe n d a n ts
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`P H I L L I P S G O L D M A N M c L A U G H L I N & H A L L
`B Y :
`J O H N J . P H I L L I P S , J R ., E S Q U I R E
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`M s . R a p a lin o a n d M s . F is c h e r w ill b e p r e s e n tin g o n b e h a lf o f
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`M R . S IL V E R : Y e s , Y o u r H o n o r . G o o d m o r n in g .
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`T H E C O U R T : S o th is is th e M a r k m a n . A n d
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`a c c o r d in g to m y c a le n d a r , a ls o a s ta tu s c o n fe r e n c e in th e
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`c a s e th a t's th e m u lti- d is tric t c a s e w h ic h is 1 9 - 2 9 0 2 . A n d
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`a c c o r d in g to m y c o m p u te r , th e r e 's 3 2 p e o p le o n th e lin e .
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`S o in a n y e v e n t, fo r t h e p la in tiff in th is
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`lit ig a tio n , w h o 's r e p r e s e n tin g th e m ?
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`M R . S IL V E R : G o o d m o r n in g , Y o u r H o n o r. D a n
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`S ilv e r a n d A le x J o y c e fr o m M c C a r te r & E n g lis h o n b e h a lf o f
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`M e rc k . A n d w e 'r e jo in e d b y o u r c o - c o u n s e l fro m W illia m s &
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`C o n n o lly , B r u c e G e n d e r s o n , S ta n le y F is h e r , E lis e B a u m g a r te n ,
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`A le x a n d e r Z o la n , S h a u n M a h a ffy , a n d J in g y u a n L u o .
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`T H E C O U R T : A ll rig h t. A n d w h ic h o f th o s e
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`p e o p le a r e a c tu a lly g o in g to d o a n y s p e a k in g ?
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`M R . S IL V E R : I b e lie v e a ll o f th e m m a y , Y o u r
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`H o n o r .
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`T H E C O U R T : O k a y . A ll r ig h t. C o u ld w e h a v e
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`s o m e in tro d u c tio n s fo r th e d e fe n d a n t ?
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`M R . G A T T U S O : G o o d m o rn in g , Y o u r H o n o r . It's
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`D o m in ic k G a ttu s o o n b e h a lf o f S a n d o z , In c ., T e v a
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`P h a r m a c e u tic a ls , U .S .A ., a n d W a ts o n L a b o r a to r ie s , I n c .
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`I h a v e w ith m e b y v id e o E m ily R a p a lin o a n d S a r a h
`
`F is c h e r fro m G o o d w in P r o c te r. Y o u r H o n o r , b o th
`
`Merck Exhibit 2277, Page 1
`Mylan v. Merck, IPR2020-00040
`
`

`

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`the defendants for several of the terms.
`I also have with me on the phone Shaobo Zhu from
`Goodwin Procter, Joseph Crystal, in-house counsel at Teva,
`and Magdalena Spencer, in-house counsel at Sandoz.
`Thank you.
`THE COURT: All right. Thank you, Mr. Gattuso.
`Mr. Cottrell, I see you.
`MR. COTTRELL: Yes. Good morning, Your Honor.
`Thank you.
`Fred Cottrell from Richards Layton for the Lupin
`defendants. And with me on the line from Knobbe Martens,
`Bill Zimmerman, Jonathan Bachand, and Andrea Cheek. And I
`believe Mr. Bachand will be speaking on behalf of the
`defendants at some point.
`THE COURT: All right. Are there more?
`MR. PHILLIPS: Good morning, Your Honor. It's
`Jack Phillips. With me on the line are Guylaine Hache from
`Katten Muchin representing Apotex, and Chris Cassella from
`Locke Lord representing Zydus. And I don't anticipate
`either of them will be speaking, but they could tell me if
`I'm wrong.
`THE COURT: All right. Thank you, Mr. Phillips.
`Is anybody else out there?
`MS. GAZA: Good morning, Your Honor. Anne Gaza
`from Young Conaway. Are you able to see me okay, Your
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`going first.
`MS. FUNDAKOWSKI: Thank you, Your Honor. This
`is Claire Fundakowski on behalf of Sun Pharmaceutical
`Industries.
`Can you see and hear me okay?
`THE COURT: I can, indeed.
`MS. FUNDAKOWSKI: Excellent. I'll be
`presenting, so I will share my screen. And is this
`appearing on Your Honor's screen?
`THE COURT: Not yet, but sometimes it takes a
`few extra seconds. Now, something is happening.
`MS. FUNDAKOWSKI: Is there a power-point?
`THE COURT: It's getting there. Maybe 32 people
`is clogging up the line or something, I don't know, but --
`well, I don't know. Something is happening because now my
`screen says "Feel free to start sharing," but I don't
`actually see anything other than that.
`MS. FUNDAKOWSKI: Okay. Your Honor, should I
`wait for the slides to load or should I proceed?
`THE COURT: Well, it depends. Does your
`computer show that some loading is going on? Because
`normally when it's loading, I have, you know, the little
`endless circle going around, and I'm not seeing that.
`MS. FUNDAKOWSKI: It indicates I'm presenting.
`MR. PHILLIPS: Judge, would it help if some of
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`Honor?
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`THE COURT: Well, I'm not able to see you, but
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`more importantly, I can hear you. So who do you represent
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`and who's with you?
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`MS. GAZA: Thank you, Your Honor. I represent
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`Sun Pharmaceuticals, and I'm joined today by Charles Klein
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`and Claire Fundakowski of Winston & Strawn. And
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`Ms. Fundakowski will be presenting today.
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`THE COURT: Okay. Are there more?
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`MR. FINEMAN: Good morning, Your Honor. It's
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`Steve Fineman from Richards Layton & Finger on behalf of Par
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`and Anchen. And on the Zoom, on the Skype call with me, I
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`have David Silverstein, Aziz Burgy, and Christopher Gallo
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`from Axinn Veltrop. And Mr. Burgy will be addressing the
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`Court today.
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`I also have Gina Gencarelli from Par on the
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`telephonic line. Thank you, Your Honor.
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`THE COURT: All right. Anybody else? Okay.
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`Let me just check that it's all not for nothing.
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`Is my court reporter on the line?
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`THE REPORTER: Yes, Judge.
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`THE COURT: All right. And I saw that my deputy
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`clerk was on the line.
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`MS. FUNDAKOWSKI: Excellent. All right. The
`All right. So I guess we can begin. And I
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`think the way that I set this up, the defendants should be
`first term I'll be presenting, Your Honor, is the surfactant
`08/21/2020 05:06:06 PM
`Page 5 to 8 of 133
`2 of 55 sheets
`
`us dropped off the Skype and just phoned in?
`THE COURT: You know, I don't know whether it
`would or it wouldn't, but I have no objection to you doing
`that.
`
`All right. Well, Ms. Fundakowski, why don't
`you, since I can't really tell why nothing is happening
`here, why don't you just go ahead. You know, I have read
`the briefing, so I think I should be able to follow whatever
`it is you have to say, even though actually as I'm thinking
`about it, hold on a minute because I also was sent
`separately your slides, and I can pull them up.
`All right. So Ms. Fundakowski, I have something
`that's captioned In Re: Sitagliptin Phosphate Patent
`Litigation, August 18th, 2020, Defendants' Claim
`Construction Presentation. It appears to be 74 pages long.
`Is that what it is that you're trying to bring
`up on the screen?
`MS. FUNDAKOWSKI: Yes, Your Honor.
`THE COURT: Okay. Well, why don't I assume
`probably everyone, well more or less has that, too. Why
`don't you just tell me, you know, particularly when there's
`some text or something -- ah, now it's on the screen. Go
`ahead.
`
`Merck Exhibit 2277, Page 2
`Mylan v. Merck, IPR2020-00040
`
`

`

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`term. Defendants have read Your Honor's order. We
`understand at this time Your Honor is tentatively ruling in
`plaintiff's favor. We understand that the defendants'
`proposed construction is a bit long. Certainly is not the
`plain and ordinary meaning.
`I do have a presentation prepared that explains
`why defendants believe this is the proper construction in
`light of the prosecution history, but I thought it would be
`prudent for me to first ask if Your Honor has any specific
`questions knowing Your Honor has read the briefing and has
`issued the order to make a point.
`THE COURT: No, you should go ahead with your
`presentation. You know, I used the word tentative because
`it's tentative, so you have the opportunity to persuade me,
`but you're swimming uphill. That's all.
`MS. FUNDAKOWSKI: I understand that, Your Honor,
`and I'll begin defendants' proposed construction. And this
`is slide 4 of defendants' presentation. Defendants'
`proposed construction tracks the very arguments that Merck
`made during prosecution in order to obtain its patents.
`Merck argued that in the present invention, a surfactant
`works as a wetting agent.
`Merck further explained exactly what that means.
`A surfactant that works as a wetting agent must work to
`facilitate liquid ingress in the tablet and doing so
`
`11
`enhancer or compression enhancer then, according to Merck,
`it's not a surfactant. Merck did this repeatedly.
`Moving on to slide 6. For an additional prior
`art reference, Merck again argued that sodium lauryl
`sulfate, a surfactant, is not a surfactant. And Merck
`argued this again based on how it was used in the tablet.
`Merck argued that even though in the reference sodium lauryl
`sulfate was disclosed as a wetting agent, or surfactant,
`according to the reference, that that wasn't enough.
`Again, Merck argued that in the prior art it was
`not disclosed as performing a specific function which,
`again, is to increase the dissolution rate of sitagliptin in
`metformin. Where the surfactant instead was used for a
`different function such as uniformly distributing the
`compounds, it didn't satisfy the claim limitation.
`Now, I think it's important to note that Merck
`didn't stop there. Merck went a step further.
`Merck expressly argued on three separate
`occasions in order to distinguish three prior art
`references, that sodium or that the surfactant was very
`narrowly defined based on how it works. Merck expressly
`argued that in the present invention, a surfactant works as
`a wetting agent to facilitate liquid ingress into the tablet
`to either promote or increase rapid tablet dissolution.
`Merck was expressly defining how the claimed
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`surfactant works, and it did so in order to overcome prior
`promotes or increases rapid tablet dissolution.
`2
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`art rejections for all pending claims. Merck must be held
`Merck further bolstered its surfactant argument
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`to the disclaimer. And I think it's important, Your Honor,
`by further defining that tablet. Merck argued that in the
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`to take a step back and think about what it means. What is
`present invention the tablet must contain both sitagliptin
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`a surfactant that works as a wetting agent? And what would
`and metformin in a single granulation.
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`this mean to a person of ordinary skill?
`Defendants' proposed construction is lengthy,
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`And on slide 8, I have extrinsic evidence that
`but it perfectly tracks the arguments that Merck made during
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`is relied on by Merck. Defendants submit that Your Honor
`prosecution. And defendants submit that Merck must be held
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`need not rely on extrinsic evidence to construe the claims,
`to these arguments.
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`but we do believe it provides helpful context to understand
`Moving on to slide 5. During prosecution, Merck
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`what Merck was arguing during prosecution.
`repeatedly distinguished the prior art based on the function
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`THE COURT: So Ms. Fundakowski, the little
`of the surfactant and specifically based on how the
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`excerpts you just showed me, you know, basically what you've
`surfactant is used. And I think this is perfectly
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`been doing is quoting things that the inventors said about
`illustrated by noting that Merck was distinguishing prior
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`how their product worked. What I don't think I saw was
`art that contained sodium lauryl sulfate.
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`something saying sort of contrasting it with the prior art.
`Now, there's no dispute that sodium lauryl
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`You know, you, examiner, you cite this piece of prior art
`sulfate is both claimed and disclosed in the patent as a
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`that, you know, has a wetting agent, and here we're not
`surfactant. But according to Merck, that's not enough to
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`doing a wetting agent or vice versa. You know, something
`satisfy the surfactant limitation. The sodium lauryl
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`that is kind of distinguishing the prior art in a way that
`sulfate can only satisfy the surfactant limitation if it was
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`it's clear. And you know, that's part of the reason why I
`used in a certain way.
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`didn't think that there was prosecution history disclaimer
`Now, according to Merck, sodium lauryl sulfate
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`here because I didn't see anything clear. You know, it's
`is only a surfactant if it's used to increase the
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`more just descriptive stuff. And you know, to the extent
`dissolution of sitagliptin in metformin. If it's used in a
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`different way, such as in a prior art as here an absorption
`it's just descriptive stuff, it's not disclaimer.
`3 of 55 sheets
`Page 9 to 12 of 133
`08/21/2020 05:06:06 PM
`
`Merck Exhibit 2277, Page 3
`Mylan v. Merck, IPR2020-00040
`
`

`

`13
`MS. FUNDAKOWSKI: Understood, Your Honor, but I
`do think it's clear that Merck was very clearly
`distinguishing the prior art. And I have again here slide
`5, and I may have skipped over this portion of the slide,
`but what Merck argued and acknowledged that the prior art
`disclosed, what would typically be deemed a surfactant, it
`described that the surfactant was added in a specific way
`that in the prior art it was added using a specific function
`as a granular absorption enhancer or compression enhancer.
`And then Merck stated expressly that that's not
`how the surfactant is used in its invention. It's not
`that -- that different function disclosed in the prior art
`is not what is claimed by the surfactant in the present
`invention. Instead, Merck argued it has to have a specific
`function, and that is increasing the dissolution of
`sitagliptin metformin.
`And again, on slide 6, looking at another prior
`art reference, and I don't think this is all on the slide,
`either, but in J.A. 14 at 17 to 18, Merck not only argued
`that the claimed invention did not meet the function of
`distributing the compound as a wetting agent, Merck also
`argued that the claimed surfactant did not function as the
`lubricant because that was an additional function disclosed
`by the prior art. Merck was being very specific that while
`the prior art disclosed what would typically be a
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`the tablet. And what that means is that the surfactant that
`works as a wetting agent must be added onto the drug
`particles. And this extrinsic evidence explains that one
`function of a surfactant is to wet drug particles with the
`surfactant and then later when the tablet is disintegrated,
`the surfactant will pull water on to the drug particles and
`aid in the dissolution of the tablet.
`And I provided a picture here on slide 9 that
`depicts this. And in yellow around the active, the API or
`active pharmaceutical ingredient, is a surfactant. So the
`surfactant that works as a wetting agent is mixed with the
`active ingredient, and it coats those active ingredients.
`And later when the tablet is consumed or disintegrated,
`water will form around the surfactant such that this aids in
`the dissolution.
`A person of ordinary skill reading Merck's
`arguments would understand this is exactly what Merck was
`arguing, that a surfactant that works as a wetting agent to
`facilitate liquid ingress and increase dissolution simply
`means that the surfactant must wet the drug particles in
`order to increase the solution of the active ingredient.
`Again, Merck made this perfectly clear. Here on
`slide 10, Merck repeatedly argued that a surfactant that
`works as a wetting agent must increase the dissolution of
`sitagliptin.
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`surfactant, sodium lauryl sulfate, performing certain
`functions such as lubricating the tablet or distributing the
`compound, but that is not what the claims require here, that
`the claims that sodium lauryl sulfate or a surfactant is not
`included in the present invention to perform that function.
`And it's in response to these prior art
`rejections, this is, again, when Merck immediately
`characterized the claimed invention. Merck made it crystal
`clear. Here on slide 7, each of these citations to J.A. 14
`on page 12, 14 and 17, that was in response to three
`different prior art references. Merck said sodium lauryl
`sulfate is used in a certain way in these references, but
`that's not enough, that in the present invention a
`surfactant must perform a very specific function. It must
`be used in a certain way, and that is that it has to work as
`a wetting agent to facilitate liquid ingress into the
`tablet.
`
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`In the remarks, Merck argued that a surfactant
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`that works as a wetting agent increased the dissolution rate
`3
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`of sitagliptin. After the examiner preliminarily rejected
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`the claims, Merck repeated this argument in a declaration
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`that a surfactant that works as a wetting agent
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`significantly increased the dissolution rate of sitagliptin.
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`And again, this is because the surfactant must be added onto
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`the sitagliptin. And by doing so, it allows the sitagliptin
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`to freely dissolve such that the tablet provides greater
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`bioavailability.
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`But Merck didn't stop there. On slide 11, Merck
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`clearly and unmistakably argued that the surfactant that
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`works as a wetting agent must be added to a single
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`granulation. And Merck said this in a number of ways.
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`Merck made clear that sitagliptin must be added as a second
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`ingredient to the core tablet, that sitagliptin must be
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`added to metformin. Merck argued that both sitagliptin and
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`metformin are in a single granulation. And Merck argued
`Now, on slide 8, I included intrinsic evidence
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`that there would be no motivation to add sitagliptin to
`cited by Merck, and I think this very clearly explains
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`metformin in the core.
`exactly what Merck was saying during prosecution. It's
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`Merck made all of these arguments to bolster the
`clear from the record that it must -- that the wetting agent
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`importance of a surfactant. And this is clear from the last
`must facilitate liquid ingress into the tablet to increase
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`sentence. Merck argued that because this is required by the
`the solution.
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`present invention, it would require further work on the
`And a POSA would clearly understand that means
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`that the surfactant has to be added in a certain way into
`formulation to ensure increased stability and
`08/21/2020 05:06:06 PM
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`4 of 55 sheets
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`Merck Exhibit 2277, Page 4
`Mylan v. Merck, IPR2020-00040
`
`

`

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`First, Merck argues that the examiner rejected
`its arguments. Second, Merck argues that it did not repeat
`its arguments about the surfactant after the examiner
`rejected its arguments. And third, Merck argues that the
`doctrine of claim differentiation precludes applying
`disclaimer.
`And I'll begin with Merck's claim that the
`examiner rejected its arguments. After Merck made all of
`these arguments, the examiner did maintain its rejections,
`but the examiner made clear that the reason it was
`maintaining its objections was because Merck had failed to
`present factual evidence. And in fact, the examiner made
`clear that he found the arguments persuasive.
`While addressing Merck's arguments, the examiner
`said as a first point that should applicant submit factual
`evidence supporting the criticality of a surfactant such as
`sodium lauryl sulfate, that the claims would be allowable.
`But instead, at this point, Merck had only provided mere
`argumentive counsel and a presentation. The examiner
`explains that if these arguments, this mere argument of
`counsel was resubmitted in a declaration or other form of
`actual factual evidence, that such evidence would be
`persuasive.
`Second, far from abandoning Merck's arguments,
`Merck repeated them almost verbatim after the examiner's
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`rejection. In response to the examiner's rejection, Merck
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`submitted a declaration. And on the point of 103
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`rejections, Merck did not provide any additional argument.
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`Instead, it provided a declaration that repeated in the
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`claimed invention a surfactant works as a wetting agent to
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`facilitate liquid ingress into the tablet. Merck argued
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`that a key issue that the surfactant solved was the rapid
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`dissolution of sitagliptin and metformin, and Merck again
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`argued that a surfactant that works as a wetting agent aided
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`the stability and the dissolution of the claimed product.
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`Now, again, I'm moving on to slide 18, the
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`examiner did not reject these arguments. He expressly
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`adopted them in spite of Merck's arguments in his notice of
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`allowance. The examiner noted that in light of the
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`declaration, the claims were now allowable. And the
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`examiner allowed the claims a day after Merck filed its
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`declaration. It was quite quick. The examiner found that
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`the declaration shows that sodium lauryl sulfate as a
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`surfactant unexpectedly increased dissolution rate of
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`sitagliptin and also enhanced the robustness and stability
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`of the claimed composition.
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`The examiner expressly relied on Merck's
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`arguments, and it's quite clear the only reason why these
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`claims ever issued was because Merck repeatedly, clearly,
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`and unmistakably argued that the surfactant was very narrow
`Page 17 to 20 of 133
`08/21/2020 05:06:06 PM
`
`bioavailability.
`THE COURT: What do you understand is meant by a
`single granulation?
`MS. FUNDAKOWSKI: What I understand from a
`single granulation, what a POSA would understand is that
`both metformin and sitagliptin simply must be mixed
`together. And this goes to, again, why Merck argued that
`the surfactant was so important. And Merck argued this in
`two ways.
`
`First, it argued that stability and
`bioavailability were concerns with a single granulation.
`And Merck on the very same page of its argument argued that
`a surfactant solved these two concerns, that adding a
`surfactant aided with stability and bioavailability, and
`accordingly helped the concerns with a single granulation.
`THE COURT: And so you said a single granulation
`just means mixed together. Is this mixed together at a, you
`know, molecular level or at a, you know, gross level of, you
`know, take a bunch of sitagliptin and take a bunch of
`metformin, and just throw them together and stir them
`around? I mean, does it matter what quantity we're talking
`about?
`
`MS. FUNDAKOWSKI: I don't think so, Your Honor.
`And I can show you on slide 14, this is one of the examples
`in the '921 patent, and all of the examples describe the
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`same process. The only exception you'll note -- I don't
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`have example 4 cited here, and that's because that
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`embodiment does not include a surfactant. But each example
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`and throughout the specification it describes loading both
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`sitagliptin and metformin and then adding sodium lauryl
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`sulfate or any other surfactant to the active ingredients.
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`So it's simply a matter of mixing everything together, both
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`active ingredients and a surfactant.
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`And Merck made this clear. Again, I'm back on
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`slide 13, that the reason that this was needed is because a
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`large dose of metformin is added to sitagliptin in the
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`claimed compositions. There is -- I won't do the math, but
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`there's much more, many, many more times of metformin than
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`sitagliptin in the claimed compositions. So as a result,
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`Merck argued these products are individually soluble such
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`that a surfactant is not necessary.
`17
`But because such a large quantity of metformin
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`is added to sitagliptin, it makes it necessary that a
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`surfactant is added to aid in the dissolution and help allow
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`the active ingredients to be dissolved from the tablet. And
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`again, this is the example that just kind of explains the
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`surfactant needs to be added to both active ingredients.
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`And I'm on slide 15 now. Merck makes several
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`arguments against disclaimer, but each of these arguments
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`ignore the extrinsic intrinsic record.
`5 of 55 sheets
`
`Merck Exhibit 2277, Page 5
`Mylan v. Merck, IPR2020-00040
`
`

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`MS. BAUMGARTEN: Wonderful. And Ms. Barlow, if
`you could pull up Merck's presentation.
`MS. BARLOW: Sure thing.
`MS. BAUMGARTEN: Thank you.
`So Your Honor, I will attempt to be brief,
`although I shouldn't lead off with such a heavy promise, but
`I think I'd like to kind of emphasize where Ms. Fundakowski
`ended which is with the claims in the patent itself.
`If Ms. Barlow, if you'll pull up slide --
`THE COURT: But Ms. Baumgarten, you do agree
`that, generally speaking, if you disclaim something in
`prosecution, that kind of trumps, so to speak, the arguments
`like claim differentiation. So you know -- right?
`MS. BAUMGARTEN: Yes, I think that's a
`fact-specific inquiry there --
`THE COURT: Right. Right.
`MS. BAUMGARTEN: -- which is --
`THE COURT: Right. But I mean, that's the
`difficulty of arguing. But when the argument of the
`defendant is there was disclaimer during prosecution
`history, the response of, well, claim differentiation or the
`specification says this or that, that may all be true, but
`if it got disclaimed during the prosecution, so what?
`MS. BAUMGARTEN: Understood, Your Honor, and I
`think what we have here is not quite so clear as the
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`and had to perform a very specific function which was
`critical to increasing the dissolution of sitagliptin.
`And --
`THE COURT: So Ms. Fundakowski, do I understand
`your position to be basically, okay, you have a surfactant
`or that the general concept of a surfactant, it can be many
`different things, one of which is a wetting agent? And so
`that even though, for example, the examiner here says you've
`shown us a surfactant, it's a subset of surfactants that are
`wetting agents that you say has been a product of disclaimer
`here; right?
`MS. FUNDAKOWSKI: Yes, I think that's correct,
`Your Honor. And I would say, at a minimum, the examiner
`recognized and adopted Merck's arguments that the surfactant
`is -- the claimed surfactant needs to be added in a certain
`way. And when it's added in a certain way, it performs this
`unexpected result which is when it's added as a wetting
`agent, it increases the dissolution.
`THE COURT: Okay.
`MS. FUNDAKOWSKI: Does that answer your
`question, Your Honor?
`THE COURT: I'm thinking about it.
`MS. FUNDAKOWSKI: Okay.
`THE COURT: Go ahead.
`MS. FUNDAKOWSKI: Okay. And just my final
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`point, Merck has argued that claim differentiation precludes
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`upon disclaimer here, and this is somewhat related to Your
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`Honor's last question. Merck has argued that claim 1
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`recites a surfactant while claim 2 recites a wetting agent.
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`And we can't be saying that wetting agent is the same thing
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`as surfactant.
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`But as a threshold issue, the case law is quite
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`clear that claim differentiation is not a rigid rule and
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`where there are clear, unmistakable arguments during
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`prosecution, those arguments trump the doctrine of claim
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`differentiation.
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`And I think also it's possible that some
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`surfactants are also wetting agents, and perhaps the number
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`of compounds that are solely wetting agents as claimed in
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`claim 2 is narrower. So there simply is not an issue of
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`claim differentiation here. But Merck clearly and
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`unmistakably narrowed the meaning of surfactant during
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`prosecution, and defendants submit it should be held to
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`those arguments today.
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`THE COURT: All right. Thank you,
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`Ms. Fundakowski.
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`Okay. Who's arguing this for the plaintiff?
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`MS. BAUMGARTEN: This is Elise Baumgarten on
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`behalf of Merck. Are you able to hear me?
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`THE COURT: I can hear you and see you.
`08/21/2020 05:06:06 PM
`
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`hypothetical posed there which is if, let's say
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`hypothetically during prosecution someone said, I hereby
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`disclaim all non-wetting agent surfactants. That might
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`overcome claim differentiation.
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`Here, what we have is what I would characterize
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`as an ambiguous disclaimer where -- and we can go through
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`the language where the inventors are characterizing what
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`they invented and importantly the parts of the prosecution
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`history that were not put up on the screen by the defendants
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`often differentiating wetting agents from surfactants. And
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`they also note that sodium lauryl sulfate does not only act
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`as a wetting agent to increase dissolution, but also to
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`increase stability.
`14
`So again, there are multiple statements saying
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`multiple things about the use of a surfactant in the
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`invention. And in light of that, when you're weighing an
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`ambiguous disclaimer against a clear argument of claim
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`differentia