UNITED THERAPEUTICS V.
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`LIQUIDIA TECHNOLOGIES INC.
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`In the Matter Of:
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`MARKMAN HEARING
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`June 04, 2021
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`Liquidia Exhibit No. 1053
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`IPR2020-00770 — Page 001
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`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 001
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`LIQUIDIA TECHNOLOGIES INC.
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`In the Matter Of:
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`MARKMAN HEARING
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`June 04, 2021
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`Liquidia Exhibit No. 1053
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`IPR2020-00770 — Page 001
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`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 001
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`1
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`· · ·UNITED STATES DISTRICT COURT
`· ·IN AND FOR THE STATE OF DELAWARE
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`· · · · · · · · ------
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`UNITED THERAPEUTICS· )
`CORPORATION,· · · · ·)
`· · · · Plaintiff,· ·)
`· · · · · · · · · · ·)
`· · · ·V.· · · · · · ) CIVIL ACTION
`· · · · · · · · · · ·) NO. 20-755
`LIQUIDIA TECHNOLOGIES)
`INC.,· · · · · · · · )
`· · · · Defendant.· ·)
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`· · · · · · · · ------
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`· · · ·Markman Hearing taken pursuant
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`to notice at the J. Caleb Boggs Federal
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`Building, 844 North King Street,
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`Courtroom 6A, Wilmington, DE 19801
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`before the Honorable Richard G.
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`Andrews, on Friday, June 4, 2021,
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`beginning at 9:00 a.m., before Patrick
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`J. O'Hare, RPR, Notary Public.
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`· · · · · LEXITAS REPORTING
`· Registered Professional Reporters
`· · · · ·1330 N. King Street
`· · · · Wilmington, DE· 19801
`· · · · · · (302) 655-0477
`· · · · ·www.lexitaslegal.com
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`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 002
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`2
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`·1· · · APPEARANCES:
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`·2
`· · · · · ·BOIES SCHILLER FLEXNER LLP
`·3· · · · ·BY:· WILLIAM C. JACKSON, ESQ.
`· · · · · ·1401 New york Avenue NW
`·4· · · · ·Washington, DC 20005
`· · · · · ·202-237-2727
`·5· · · · ·wjackson@bsfllp.com
`· · · · · ·Counsel for Plaintiff
`·6
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`·7· · · · ·McDERMOTT WILL EMERY LLP
`· · · · · ·BY:· DOUGLAS H. CARSTEN, ESQ.
`·8· · · · ·18565 Jamboree Road
`· · · · · ·Suite 250
`·9· · · · ·Irvine, CA 92612
`· · · · · ·949-620-6111
`10· · · · ·dcarsten@mwe.com
`· · · · · ·Counsel for Plaintiff
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`12· · · · ·McDERMOTT WILL EMERY LLP
`· · · · · ·BY: JIAXIAO ZHANG, ESQ.
`13· · · · ·18565 Jamboree Road
`· · · · · ·Suite 250
`14· · · · ·Irvine, CA 92612
`· · · · · ·949-757-6398
`15· · · · ·jiazhang@mwe.com
`· · · · · ·Counsel for Plaintiff
`16
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`17· · · · ·McDERMOTT WILL EMERY LLP
`· · · · · ·BY: ADAM BURROWBRIDGE, ESQ.
`18· · · · ·500 North Capitol Street NW
`· · · · · ·Washington, DC 20001
`19· · · · ·202-756-8797
`· · · · · ·aburrowbridge@mwe.com
`20· · · · ·Counsel for Plaintiff
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`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 003
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`·1· · · APPEARANCES:· (Cont'd)
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`·2
`· · · · · ·MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`·3· · · · ·BY: MICHAEL J. FLYNN, ESQ.
`· · · · · ·1201 North Market Street
`·4· · · · ·Wilmington DE 19899
`· · · · · ·302-351-9661
`·5· · · · ·mflynn@mnat.com
`· · · · · ·Counsel for Plaintiff
`·6
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`·7· · · · ·COOLEY LLP
`· · · · · ·BY: JONATHAN R. DAVIES, ESQ.
`·8· · · · ·1299 Pennsylvania Avenue, NW
`· · · · · ·Suite 700
`·9· · · · ·Washington DC 20004-2400
`· · · · · ·202-776-2049
`10· · · · ·jdavies@cooley.com
`· · · · · ·Counsel for Defendant
`11
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`12· · · · ·COOLEY LLP
`· · · · · ·BY:· SANYA SUKDUANG, ESQUIRE
`13· · · · ·1299 Pennsylvania Avenue, NW
`· · · · · ·Suite 700
`14· · · · ·Washington, DC 20004-2400
`· · · · · ·202-776-2982
`15· · · · ·ssukduang@cooley.com
`· · · · · ·Counsel for Defendant
`16
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`17
`· · · · · ·SHAW KELLER LLP
`18· · · · ·BY:· KAREN ELIZABETH KELLER, ESQUIRE
`· · · · · ·1105 North Market Street
`19· · · · ·12th Floor
`· · · · · ·Wilmington, DE 19801
`20· · · · ·302-298-0700
`· · · · · ·kkeller@shawkeller.com
`21· · · · ·Counsel for Defendant
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`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 004
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`·1· · · APPEARANCES: (Cont'd)
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`·2
`· · · · · ·COOLEY LLP
`·3· · · · ·BY:· DOUGLAS W. CHEEK, ESQUIRE
`· · · · · ·1299 Pennsylvania Avenue, NW
`·4· · · · ·Suite 700
`· · · · · ·Washington, DC· 20004-2400
`·5· · · · ·202-776-2108
`· · · · · ·dcheek@cooley.com
`·6· · · · ·Counsel for Defendant
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`·7
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`·8· · · · ·COOLEY LLP
`· · · · · ·BY:· BRITTANY CAZAKOFF, ESQUIRE
`·9· · · · ·3175 Hanover Street
`· · · · · ·Palo Alto, CA· 94304
`10· · · · ·650-843-5522
`· · · · · ·bcazakoff@cooley.com
`11· · · · ·Counsel for Defendant
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`12
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`13
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`14· · · ALSO PRESENT:· Kevin Kessler, Esq.
`· · · · · · · · · · · ·Shaun Snader, UTC
`15· · · · · · · · · · ·Rusty Schundler,
`· · · · · · · · · · · ·Liquidia
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`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 005
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`5
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`·1· · · · · · · · ·ALL COUNSEL:· Good morning,
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`·2· · · Your Honor.
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`·3· · · · · · · · ·THE COURT:· This is the
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`·4· · · Markman hearing in the United
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`·5· · · Therapeutics versus Liquidia, Civil
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`·6· · · Action No. 20-755.
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`·7· · · · · · · · ·Oh, Mr. Shaw -- no, you're
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`·8· · · not Mr. Shaw.· Mr. Flynn?
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`·9· · · · · · · · ·MR. FLYNN:· Yes, sir.
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`10· · · · · · · · ·THE COURT:· Sir, I believe
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`11· · · you're hiding that lovely beard you
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`12· · · have.
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`13· · · · · · · · ·So, are you the plaintiff?
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`14· · · · · · · · ·MR. FLYNN:· Yes, Your Honor.
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`15· · · · · · · · ·THE COURT:· And who have you
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`16· · · got with you here?
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`17· · · · · · · · ·MR. FLYNN:· We have William
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`18· · · Jackson from Boies Schiller & Flexner,
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`19· · · and Doug Carsten, Jiaxiao Zhang, and
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`20· · · Adam Burrowbridge from McDermott Will
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`21· · · Emery, and Shaun Snader from United
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`22· · · Therapeutics.
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`23· · · · · · · · ·MR. SNADER:· Good morning,
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`24· · · Your Honor.
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`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 006
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`6
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`·1· · · · · · · · ·MR. JACKSON:· Good morning,
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`·2· · · Your Honor.
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`·3· · · · · · · · ·MR. CARSTEN:· Good morning,
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`·4· · · Your Honor.
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`·5· · · · · · · · ·MR. BURROWBRIDGE:· Good
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`·6· · · morning, Your Honor.
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`·7· · · · · · · · ·THE COURT:· Thank you,
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`·8· · · Mr. Flynn.
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`·9· · · · · · · · ·Miss Keller, I recognize
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`10· · · you.
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`11· · · · · · · · ·MS. KELLER:· Good morning,
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`12· · · Your Honor, Karen Keller from Shaw
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`13· · · Keller on behalf of Liquidia.· With me
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`14· · · today is Kevin Kessler.
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`15· · · · · · · · ·MR. KESSLER:· Good morning,
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`16· · · Your Honor.
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`17· · · · · · · · ·MS. KELLER:· Jonathan
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`18· · · Davies.
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`19· · · · · · · · ·MR. DAVIES:· Good morning,
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`20· · · Your Honor.
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`21· · · · · · · · ·MS. KELLER:· Doug Cheek and
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`22· · · Brittany Cazanoff all from -- Cazakoff,
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`23· · · my apologies, also from Cooley.
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`24· · · · · · · · ·And with me today also is
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`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 007
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`7
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`·1· · · Rusty Schundler from Liquidia.
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`·2· · · · · · · · ·THE COURT:· Okay.· All
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`·3· · · right.· So, I have read the brief. I
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`·4· · · have ideas about how to resolve each of
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`·5· · · these claims.
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`·6· · · · · · · · ·In terms of presentation,
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`·7· · · when you're speaking, when you're
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`·8· · · presenting, you can take your mask off.
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`·9· · · It kind of helps with the auditability,
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`10· · · but everyone else keep your masks on.
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`11· · · · · · · · ·All right.· So, somebody
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`12· · · from the plaintiff.
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`13· · · · · · · · ·MR. JACKSON:· Good morning,
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`14· · · Your Honor, William Jackson on behalf
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`15· · · of United Therapeutics.
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`16· · · · · · · · ·So, the claim terms there
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`17· · · are five.· We are happy to go in
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`18· · · whatever order Your Honor thinks.· We
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`19· · · just thought numbers one, four, and
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`20· · · five which -- may I approach?
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`21· · · · · · · · ·THE COURT:· Yeah, yeah,
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`22· · · yeah.
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`23· · · · · · · · ·MR. JACKSON:· I've got
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`24· · · PowerPoints.
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`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 008
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`8
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`·1· · · · · · · · ·THE COURT:· No, keep them.
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`·2· · · Presumably you're going to put them up
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`·3· · · on the screen; right?
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`·4· · · · · · · · ·MR. JACKSON:· Yes.
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`·5· · · · · · · · ·THE COURT:· Yeah, yeah.· So,
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`·6· · · I'll talk with my staff later about
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`·7· · · whether they actually want the hard
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`·8· · · copy.
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`·9· · · · · · · · ·Will you want a hard copy?
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`10· · · · · · · · ·LAW CLERK:· No, I don't
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`11· · · think so.
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`12· · · · · · · · ·THE COURT:· Yeah, we don't
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`13· · · need a hard copy.
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`14· · · · · · · · ·MR. JACKSON:· So, one, a
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`15· · · process, four, pharmaceutical batch,
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`16· · · and five, contacting the solution
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`17· · · comprising treprostinil from Step B
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`18· · · with a base to form a salt of
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`19· · · treprostinil.
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`20· · · · · · · · ·You'll see we put those in a
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`21· · · reddish orange color to say I think
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`22· · · those should be argued in consecutive
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`23· · · order because they present similar
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`24· · · issues.
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`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 009
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`·1· · · · · · · · ·THE COURT:· Okay.· So,
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`·2· · · rather than argue about the order, do
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`·3· · · you care what order we do this in?
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`·4· · · · · · · · ·MR. SUKDUANG:· We've already
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`·5· · · agreed, Your Honor.
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`·6· · · · · · · · ·THE COURT:· Go ahead.
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`·7· · · · · · · · ·MR. JACKSON:· And
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`·8· · · Mr. Carsten will be taking those three
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`·9· · · claims.
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`10· · · · · · · · ·MR. SUKDUANG:· Your Honor,
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`11· · · our understanding is that will be a
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`12· · · claim out of time, so it will be
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`13· · · processed, plaintiff processed,
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`14· · · defendant, pharmaceutical batch
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`15· · · plaintiff, pharmaceutical batch
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`16· · · defendant.
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`17· · · · · · · · ·THE COURT:· Okay.
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`18· · · · · · · · ·MR. CARSTEN:· Good morning,
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`19· · · Your Honor, Doug Carsten.
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`20· · · · · · · · ·Let's start off with process
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`21· · · if we might, Your Honor.
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`22· · · · · · · · ·So, the claim terms is
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`23· · · obviously a process.· United
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`24· · · Therapeutics proposes that plain and
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`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 010
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`·1· · · ordinary meaning dispatches of
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`·2· · · insufficient and dispatches of a
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`·3· · · dispute.· Liquidia proposed
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`·4· · · construction and argue, Your Honor, is
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`·5· · · not a construction at all.
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`·6· · · · · · · · ·It simply takes the disputed
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`·7· · · claim term and adds a limitation that
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`·8· · · appears or that they believe appears in
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`·9· · · the specification or has been
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`10· · · disclaimed.
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`11· · · · · · · · ·The process in our view, and
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`12· · · according to the specification as well
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`13· · · as according to Dr. Ruffolo, the only
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`14· · · expert that Your Honor has heard
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`15· · · testimony from in this matter, is a
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`16· · · commonly understood term.
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`17· · · · · · · · ·Moreover, Your Honor, the
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`18· · · claim term itself is by its own terms
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`19· · · open-ended.· It contains comprising,
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`20· · · and we know that for two reasons.
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`21· · · First, we know that from black letter
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`22· · · patent law comprising as an open-ended
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`23· · · transitional phrase, and unless there
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`24· · · be any doubt, the specification itself
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`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 011
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`·1· · · provides an expressed definition to
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`·2· · · meaning including but not limited to.
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`·3· · · · · · · · ·And Liquidia, in fact, here
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`·4· · · even admits that its claim construction
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`·5· · · is wrong.· In the IPR relating to this
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`·6· · · patent that Liquidia filed, it
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`·7· · · identified a process comprising the
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`·8· · · whole term to be construed as a process
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`·9· · · therefore includes but is not limited
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`10· · · to the recited process steps, and may
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`11· · · include without limitation any other
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`12· · · non-recited steps.
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`13· · · · · · · · ·THE COURT:· On the subject
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`14· · · of the IPR, were they instituted?
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`15· · · · · · · · ·MR. CARSTEN:· The one for
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`16· · · the '066 was not instituted, Your
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`17· · · Honor.· The one for the '901 has been
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`18· · · instituted.
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`19· · · · · · · · ·THE COURT:· And so, when is
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`20· · · the PTAB decision due?
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`21· · · · · · · · ·MR. CARSTEN:· Well, I'm
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`22· · · sorry, Your Honor, I believe the oral
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`23· · · hearing is scheduled for June.· I don't
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`24· · · know exactly what the institution date
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`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 012
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`·1· · · was, but that's typically three months
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`·2· · · after that.· So, we should know by
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`·3· · · September I would imagine.
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`·4· · · · · · · · ·THE COURT:· Okay.· Thank
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`·5· · · you.
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`·6· · · · · · · · ·MR. CARSTEN:· I can dig and
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`·7· · · look for the --
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`·8· · · · · · · · ·THE COURT:· No, no, I
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`·9· · · just -- it wasn't -- it's not as really
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`10· · · important, but I was curious about
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`11· · · that.· Okay.· So, September you think
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`12· · · there will be a decision roughly give
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`13· · · or take on the '901?
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`14· · · · · · · · ·MR. CARSTEN:· I believe
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`15· · · that's correct, Your Honor, and I'll
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`16· · · have somebody check that while I'm
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`17· · · talking and perhaps it will give it
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`18· · · more clarity.
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`19· · · · · · · · ·THE COURT:· All right.
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`20· · · · · · · · ·MR. CARSTEN:· So, what we
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`21· · · have here is a shift of position.· In
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`22· · · the IPR, you know, and looking further
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`23· · · at the IPR also, Liquidia has said not
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`24· · · only are these construction --
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`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 013
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`·1· · · · · · · · ·THE COURT:· So, let me just
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`·2· · · say generally speaking, I'm not all
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`·3· · · that interested in rehashing arguments
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`·4· · · people made at different places in the
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`·5· · · past, and particularly Liquidia, you
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`·6· · · know, they're not in the same position
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`·7· · · as you are.· You say something stupid,
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`·8· · · and it could be prosecution disclaimer.
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`·9· · · · · · · · ·It doesn't work the same way
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`10· · · for them, so I don't really care if
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`11· · · they're shifting their positions.
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`12· · · There are other reasons to do that, you
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`13· · · know, PTAB, you can't get it in this
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`14· · · institution if it's indefinite, you
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`15· · · know.
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`16· · · · · · · · ·So, what I'm interested in
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`17· · · and what seems like the issue here is
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`18· · · essentially, I think they're saying,
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`19· · · that you disclaim or you limited
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`20· · · process by what you've said somewhere
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`21· · · along the way, and that seems to be the
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`22· · · only thing that's really in dispute
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`23· · · here; don't you think?
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`24· · · · · · · · ·MR. CARSTEN:· Yes,
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`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 014
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`·1· · · Your Honor, I can skip exactly to that
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`·2· · · point.· Liquidia argues that a
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`·3· · · statement that was made in the '066 IPR
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`·4· · · in our patent owner response disavows
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`·5· · · claims too, and they say -- the
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`·6· · · sentence that they quote is in which;
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`·7· · · e.g., no purification steps appear
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`·8· · · between the alkylation and salt
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`·9· · · formation.· That's a correct statement.
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`10· · · · · · · · ·It's an open-ended claim and
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`11· · · no purification steps specifically
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`12· · · appear between alkylation and salt
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`13· · · formation in the text of the claim, but
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`14· · · the claim is open-ended.· It is a
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`15· · · comprising claim, and there's no clear
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`16· · · and unmistakable disavowal there.
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`17· · · · · · · · ·Moreover, that statement has
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`18· · · to be read consistently with the
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`19· · · specification, and that statement of
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`20· · · disavowal is inconsistent with the
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`21· · · specification itself; i.e., it would
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`22· · · read out the preferred embodiment of
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`23· · · the claim.
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`24· · · · · · · · ·THE COURT:· Well, of course,
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`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 015
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`·1· · · that's what happens when you disclaim
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`·2· · · something during the prosecution;
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`·3· · · right?
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`·4· · · · · · · · ·MR. CARSTEN:· Well, I
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`·5· · · suppose that it's entirely possible to
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`·6· · · do it, but when there's a single
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`·7· · · specific embodiment disclosed, a
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`·8· · · specific embodiment disclosed, it would
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`·9· · · have to be a clear and unmistakable
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`10· · · disavowal to be operational as a
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`11· · · disclaimer at all.
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`12· · · · · · · · ·And when you have a
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`13· · · situation where you got one specific
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`14· · · example, operational example that's
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`15· · · disclosed, I submit that the standard
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`16· · · is even somewhat higher because
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`17· · · you're --
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`18· · · · · · · · ·THE COURT:· So, basically,
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`19· · · your understanding of their argument is
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`20· · · based on this one statement that you
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`21· · · just shown us.· Other than that, they
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`22· · · really only got nothing; right?
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`23· · · · · · · · ·MR. CARSTEN:· In terms of
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`24· · · this claim, the '066?
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`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 016
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`·1· · · · · · · · ·THE COURT:· Yes.· So, that's
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`·2· · · kind of what I understood from the
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`·3· · · briefing.· So, why don't we save a
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`·4· · · little time here, since I tend to think
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`·5· · · they're right, and hear from them so
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`·6· · · that you have something more focused
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`·7· · · you can be addressing.
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`·8· · · · · · · · ·MR. CARSTEN:· Very well,
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`·9· · · Your Honor.
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`10· · · · · · · · ·MR. SUKDUANG:· Thank you,
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`11· · · Your Honor, Sanya Sukduang.· Let me
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`12· · · skip ahead.
`
`13· · · · · · · · ·So, with respect to the
`
`14· · · process, Your Honor, and getting to the
`
`15· · · heart of the issue, the position
`
`16· · · Liquidia takes is not based solely on
`
`17· · · the single statement that Mr. Carsten
`
`18· · · pointed out.· It's consistent with the
`
`19· · · claim.
`
`20· · · · · · · · ·UTC wants to argue that the
`
`21· · · word appear just means, oh, it's not a
`
`22· · · recited step.· That's really not what
`
`23· · · they mean.· It's not that it just
`
`24· · · doesn't appear, but probably someone
`
`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 017
`
`
`
`17
`
`·1· · · would understand that it's there, is
`
`·2· · · that it's excluded, it's eliminated,
`
`·3· · · this process of purification and column
`
`·4· · · chromatography.
`
`·5· · · · · · · · ·And they say that in a
`
`·6· · · number of places.· In the
`
`·7· · · specifications, they say purification
`
`·8· · · of the benzindene nitrile by column
`
`·9· · · chromatography is eliminated.· It's not
`
`10· · · that it doesn't appear, that it's
`
`11· · · eliminated, this is a specification of
`
`12· · · the '066.
`
`13· · · · · · · · ·When you look at example
`
`14· · · six, the former process is actually
`
`15· · · UTC's former commercial process for
`
`16· · · making --
`
`17· · · · · · · · ·THE COURT:· Let's go back.
`
`18· · · Let's take it like this.· When you say
`
`19· · · this step, our invention eliminates the
`
`20· · · step, that doesn't mean that you can
`
`21· · · then practice their invention, just say
`
`22· · · we'll do that step for sport; right?
`
`23· · · · · · · · ·MR. SUKDUANG:· Well, it's
`
`24· · · not for sport, Your Honor, it's
`
`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 018
`
`
`
`18
`
`·1· · · actually an integral part of Liquidia's
`
`·2· · · process.
`
`·3· · · · · · · · ·THE COURT:· Well, even if
`
`·4· · · you do it integrally, if they claim
`
`·5· · · steps one, two, three, and four and say
`
`·6· · · we no longer need to do step five, the
`
`·7· · · fact that you do step five doesn't make
`
`·8· · · it non-infringing.
`
`·9· · · · · · · · ·MR. SUKDUANG:· In a general
`
`10· · · concept, yes, but in the context of
`
`11· · · when they seek to eliminate a step in
`
`12· · · order to gain allowance of the patent,
`
`13· · · then that eliminates it, and let me
`
`14· · · move to here.
`
`15· · · · · · · · ·So, this is the prosecution
`
`16· · · of the '066 itself.· It's not the IPR,
`
`17· · · it's actually the prosecution.· So, the
`
`18· · · prosecution of the '066, and this is
`
`19· · · Exhibit D-13 of our exhibits, there was
`
`20· · · a rejection by the examiner over
`
`21· · · Moriarty and Phares.· So, Moriarty, as
`
`22· · · acknowledged by UTC and Dr. Ruffolo, is
`
`23· · · this former process.· It's example six
`
`24· · · former process.
`
`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 019
`
`
`
`19
`
`·1· · · · · · · · ·And then, the examiner, they
`
`·2· · · rejected it over Moriarty and Phares,
`
`·3· · · and the examiner specifically said that
`
`·4· · · that rejection is withdrawn in view of
`
`·5· · · their arguments.· And the examiner said
`
`·6· · · Moriarty fails to teach the formation
`
`·7· · · of a salt prior to purification.
`
`·8· · · · · · · · ·This is the issue.· This
`
`·9· · · is -- in order to overcome the prior
`
`10· · · art, and the examiner recognized this,
`
`11· · · the elimination of purification before
`
`12· · · salt formation was the basis of
`
`13· · · withdrawing the rejection.· The only
`
`14· · · rejection that remained after this was
`
`15· · · a double patent rejection.
`
`16· · · · · · · · ·So, essentially -- and you
`
`17· · · can follow term disclaimer to get rid
`
`18· · · of that.· So, essentially, the basis to
`
`19· · · get rid of the rejections for the '066
`
`20· · · itself was the elimination of
`
`21· · · purification before salt formation, and
`
`22· · · that is consistent, as we pointed out
`
`23· · · with the specification, because the
`
`24· · · real difference between the claimed
`
`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 020
`
`
`
`20
`
`·1· · · process and the former commercial
`
`·2· · · process is these elimination of certain
`
`·3· · · steps.· And those eliminations of
`
`·4· · · certain steps lead to these advantages
`
`·5· · · that UTC wants to call out in the
`
`·6· · · background section of their brief,
`
`·7· · · faster, greener, more economical,
`
`·8· · · safer.
`
`·9· · · · · · · · ·You don't get those unless
`
`10· · · you eliminate these steps, and
`
`11· · · Dr. Ruffolo actually testified to that.
`
`12· · · He said, and this is at Pages 71 to 76
`
`13· · · and 207 to 208, that under his
`
`14· · · interpretation of the claim, comprising
`
`15· · · open-ended, under UTC's construction,
`
`16· · · all of these steps, steps that can make
`
`17· · · it less clean, less green, less
`
`18· · · economical, less safe are now included
`
`19· · · or read into the claim.· They're
`
`20· · · allowed by the claim.
`
`21· · · · · · · · ·Well, if that's true, then
`
`22· · · all of these advantages, the
`
`23· · · distinguishing feature between the
`
`24· · · claim and the prior art is eliminated.
`
`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 021
`
`
`
`21
`
`·1· · · It ignores -- if you accept that, and
`
`·2· · · Dr. Ruffolo accepts that, it ignores
`
`·3· · · the basis for withdrawing the rejection
`
`·4· · · during prosecution itself.
`
`·5· · · · · · · · ·And this statement is
`
`·6· · · confirmed again in the IPR.· So, UTC
`
`·7· · · argues in the background of their
`
`·8· · · opening brief and claim construction,
`
`·9· · · and for the person of skill in the art,
`
`10· · · that the skilled artisan needs to have
`
`11· · · background in commercial manufacturing,
`
`12· · · okay?
`
`13· · · · · · · · ·Well, none of the claims
`
`14· · · recite that, but they say that because
`
`15· · · in their view, having that perspective
`
`16· · · is critical, and they say it here in
`
`17· · · the IPR.· That having this background
`
`18· · · in the commercial marketing
`
`19· · · manufacturing state is critical in the
`
`20· · · context of the claimed pharmaceutical
`
`21· · · composition.· So, the '066 claim, one,
`
`22· · · is a pharmaceutical composition, and
`
`23· · · it's critical because no purification
`
`24· · · steps appear between alkylation and
`
`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 022
`
`
`
`22
`
`·1· · · salt formation.· That's clear.
`
`·2· · · · · · · · ·And UTC can't have the
`
`·3· · · position that the claim needs to be
`
`·4· · · understood by a skilled artisan with
`
`·5· · · commercial background and have this
`
`·6· · · critical perspective, but then say,
`
`·7· · · well, the claim allows for all these
`
`·8· · · other things disregarding the claim,
`
`·9· · · disregarding the specification,
`
`10· · · disregarding the prosecution history,
`
`11· · · and just disregarding their own
`
`12· · · arguments here that elimination of
`
`13· · · these steps is critical to
`
`14· · · understanding the claim.
`
`15· · · · · · · · ·And it's not just the
`
`16· · · statement here from the IPR that we're
`
`17· · · relying on, as I noted in the
`
`18· · · prosecution history, but in this
`
`19· · · litigation, we served an interrogatory
`
`20· · · asking for objective indicia of
`
`21· · · nonobviousness, and this is Exhibit
`
`22· · · D-29.· And they say in this section --
`
`23· · · · · · · · ·THE COURT:· But aren't there
`
`24· · · responsive interrogatories that are
`
`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 023
`
`
`
`23
`
`·1· · · relevant claimed construction?
`
`·2· · · · · · · · ·MR. SUKDUANG:· No, Your
`
`·3· · · Honor, it's not.· The reason why is
`
`·4· · · because the statements here are
`
`·5· · · consistent with statements made
`
`·6· · · previously and --
`
`·7· · · · · · · · ·THE COURT:· So what? I
`
`·8· · · mean, it's not part of the prosecution
`
`·9· · · history, it's a litigation position.
`
`10· · · · · · · · ·MR. SUKDUANG:· Well, that
`
`11· · · may be true, Your Honor, but the
`
`12· · · litigation position is one where
`
`13· · · they're trying to claim construction to
`
`14· · · have a broad construction to maintain
`
`15· · · infringement, and that's having an
`
`16· · · open-ended term, an open-ended claim,
`
`17· · · but for validity, they're trying to
`
`18· · · read it narrowly to --
`
`19· · · · · · · · ·THE COURT:· Well, that's an
`
`20· · · argument for a different day, it's not
`
`21· · · an argument for today.
`
`22· · · · · · · · ·MR. SUKDUANG:· It does
`
`23· · · relate in our view to claim
`
`24· · · construction to an extent because you
`
`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 024
`
`
`
`24
`
`·1· · · can't construe the claims broadly in
`
`·2· · · one instance and narrowly in the other.
`
`·3· · · · · · · · ·THE COURT:· Right.· I'm only
`
`·4· · · going to construe it one way.· What
`
`·5· · · they do with it is their problem or
`
`·6· · · your problem depending.
`
`·7· · · · · · · · ·MR. SUKDUANG:· Yes.· So,
`
`·8· · · again, based on what we believe the
`
`·9· · · intrinsic evidence shows, and they
`
`10· · · mention Dr. Ruffolo, it's extrinsic
`
`11· · · evidence, but the intrinsic evidence,
`
`12· · · the prosecution history, the claim
`
`13· · · terms, the specification, all wrapped
`
`14· · · up with respect to the statements in
`
`15· · · the IPR lead to the same conclusion
`
`16· · · that in order to gain allowance of the
`
`17· · · claims, purification, and particularly
`
`18· · · purification by column chromatography,
`
`19· · · is eliminated in the process;
`
`20· · · otherwise, there is no distinction
`
`21· · · between the claim and the prior art.
`
`22· · · · · · · · ·And the patent examiner at
`
`23· · · the PTO for the '066 made that
`
`24· · · recognition explicit in the withdrawal
`
`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 025
`
`
`
`25
`
`·1· · · of the rejection.· That covers the
`
`·2· · · issue.
`
`·3· · · · · · · · ·There's one other issue that
`
`·4· · · Mr. Carsten didn't raise, and I can
`
`·5· · · bring it up if they bring it up, but
`
`·6· · · it's the issue of reprocessing
`
`·7· · · treprostinil API.· In their briefing
`
`·8· · · UTC argued that our construction
`
`·9· · · eliminates common pharmaceutical
`
`10· · · practices, as testified to by
`
`11· · · Dr. Ruffolo, and that once you make the
`
`12· · · API you might need to purify it further
`
`13· · · so that you can meet your release
`
`14· · · specifications, okay?· That's true.
`
`15· · · · · · · · ·Our construction does not
`
`16· · · eliminate that.· The treprostinil API
`
`17· · · in the claims is the treprostinil salt
`
`18· · · that's made after the alkylation and
`
`19· · · hydrolysis in the claim of the '066
`
`20· · · patent.· So, our construction allows
`
`21· · · for what Dr. Ruffolo wants to do,
`
`22· · · reprocess the salt.· What our
`
`23· · · construction does is just adopt what
`
`24· · · UTC is already arguing what the
`
`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 026
`
`
`
`26
`
`·1· · · examiner understood is eliminate it,
`
`·2· · · and that's the purification and
`
`·3· · · purification by column chromatography
`
`·4· · · before you make the salt.
`
`·5· · · · · · · · ·And so, this issue of
`
`·6· · · reprocessing is permitted by both
`
`·7· · · constructions, and we understand that a
`
`·8· · · skilled artisan might do that after
`
`·9· · · they already make the salt.
`
`10· · · · · · · · ·THE COURT:· All right.· So,
`
`11· · · for the '066 patent in this term of
`
`12· · · process I am going to give it its plain
`
`13· · · and ordinary meaning.· I think the
`
`14· · · statements that Liquidia is relying on
`
`15· · · they don't constitute clear and
`
`16· · · unmistakable disclaimer.· I think what
`
`17· · · they were saying is, or an
`
`18· · · interpretation of what they were
`
`19· · · saying, is that the invention doesn't
`
`20· · · require that you do this step that
`
`21· · · Liquidia wants to add in, and so,
`
`22· · · therefore, I'm not going to add it in
`
`23· · · and the process will just be a process.
`
`24· · · · · · · · ·All right.· Let's go on to
`
`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 027
`
`
`
`27
`
`·1· · · the second one of this series.
`
`·2· · · · · · · · ·MR. CARSTEN:· Your Honor, I
`
`·3· · · need to approach the podium to switch.
`
`·4· · · · · · · · ·THE COURT:· Sure.· I think
`
`·5· · · the next one is a pharmaceutical batch?
`
`·6· · · · · · · · ·MR. CARSTEN:· Yes,
`
`·7· · · Your Honor.
`
`·8· · · · · · · · ·So, here it's slide 29 of
`
`·9· · · our presentation, the disputed claim
`
`10· · · term is pharmaceutical batch.· UTC has
`
`11· · · offered a proposed construction. I
`
`12· · · know you don't want to hear about the
`
`13· · · IPR, but this is, in fact, the proposed
`
`14· · · construction that we submitted in
`
`15· · · connection with the '901 IPR and that
`
`16· · · the patent office adopted provisionally
`
`17· · · in the institution decision.
`
`18· · · · · · · · ·THE COURT:· Yeah, I'm not
`
`19· · · sure -- I mean, you know decisions of
`
`20· · · PTAB under the same standards that we
`
`21· · · use, you know, I consider them, but
`
`22· · · what you propose and what PTAB adopted,
`
`23· · · you know, to the extent that that's
`
`24· · · supposed to add something to the plain
`
`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 028
`
`
`
`28
`
`·1· · · meaning of pharmaceutical batch, I'm
`
`·2· · · not going to do that.
`
`·3· · · · · · · · ·You know, I've done a lot of
`
`·4· · · these cases, I've never seen before
`
`·5· · · where somebody tried to put FDA
`
`·6· · · definition of something in as -- you
`
`·7· · · know, for a patent, you know, and if it
`
`·8· · · helps, I mean -- to me it seems like
`
`·9· · · the issue boils down to here as to
`
`10· · · whether I should give it its plain
`
`11· · · meaning, which after all is what the
`
`12· · · defendants proposed that they add in
`
`13· · · the same step that we're talking about.
`
`14· · · And this is in the '901 patent rather
`
`15· · · than the other patent.
`
`16· · · · · · · · ·MR. CARSTEN:· I think that's
`
`17· · · exactly right, Your Honor, and if it's
`
`18· · · easier for the Court -- what we tried
`
`19· · · to do here is to put words around the
`
`20· · · plain -- what we think is the plain and
`
`21· · · ordinary meaning.· If Your Honor is
`
`22· · · more comfortable just going with plain
`
`23· · · and ordinary meaning, we obviously
`
`24· · · would be fine with that.
`
`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 029
`
`
`
`29
`
`·1· · · · · · · · ·THE COURT:· Well, you know,
`
`·2· · · because -- and the reason why I say
`
`·3· · · this the defendants they do have the
`
`·4· · · plain and ordinary meaning, because
`
`·5· · · their definition is pharmaceutical
`
`·6· · · batch, blah, blah, blah.· And I really
`
`·7· · · don't think pharmaceutical is going to
`
`·8· · · be too difficult, and I understand
`
`·9· · · batch to be, you know, essentially
`
`10· · · something that's made at one time.
`
`11· · · · · · · · ·And because of the other
`
`12· · · limitations, it appears that it's going
`
`13· · · to have at least 2.9 grams of
`
`14· · · treprostinil in it, but that's
`
`15· · · obviously a different limitation.· So,
`
`16· · · why don't you hold your fire and let me
`
`17· · · hear what the defendant has to say
`
`18· · · about this one.
`
`19· · · · · · · · ·MR. SUKDUANG:· Thank you,
`
`20· · · Your Honor.· Again, so I'm Sanya
`
`21· · · Sukduang.· So, I'm going to jump ahead.
`
`22· · · · · · · · ·Again, similar to the
`
`23· · · '066 --
`
`24· · · · · · · · ·THE COURT:· So, actually
`
`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 030
`
`
`
`30
`
`·1· · · just as -- do you kind of as a starting
`
`·2· · · point agree that really this is just a
`
`·3· · · plain meaning of pharmaceutical batch
`
`·4· · · with the limitation about what you want
`
`·5· · · to add in?
`
`·6· · · · · · · · ·MR. SUKDUANG:· Yes.· So, the
`
`·7· · · term pharmaceutical we understand is
`
`·8· · · defined in the spec as just something
`
`·9· · · that's going to be safe and nontoxic.
`
`10· · · A batch is what quantity of drug, 2.9
`
`11· · · grams, for instance.· The issue --
`
`12· · · you're right, Your Honor, the issue is
`
`13· · · what are the steps used to make this,
`
`14· · · and I go to here in the '901 IPR.
`
`15· · · · · · · · ·And, again --
`
`16· · · · · · · · ·THE COURT:· So, let me just
`
`17· · · interrupt you for a second, because
`
`18· · · when I was reading this, you know, I
`
`19· · · did note at least something about a
`
`20· · · similarity between the argument term
`
`21· · · four and term five which contain the
`
`22· · · '901 patent, and yet -- and when I was
`
`23· · · reading it, I thought there was sort of
`
`24· · · different evidence offered for one than
`
`Liquidia Exhibit No. 1053
`IPR2020-00770 - Page 031
`
`
`
`31
`
`·1· · · there is for the other.
`
`·2· · · · · · · · ·And now that I'm sitting
`
`·3· · · here I'm wondering if you could just
`
`·4· · · explain to me why that makes sense.
`
`·5· · · Maybe -- I'm not saying it doesn't, but
`
`·6· · · I'm just curious is it because we're
`
`·7· · · basically -- that we're trying it in
`
`·8· · · one place, add it into the
`
`·9· · · pharmaceutical batch term, and
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