·1· · · · · · UNITED STATES PATENT AND TRADEMARK OFFICE
`·2· · · · · · BEFORE THE PATENT TRIAL AND APPEAL BOARD
`·3
`·4
`·5
`·6· ·GENERICO, LLC, FLAT LINE
`· · ·CAPITAL, LLC, MYLAN
`·7· ·PHARMACEUTICALS, INC., FOXFILL
`· · ·CAPITAL PARTNERS, MYCONOVO,
`·8· ·INC.,
`·9· · · · · · · ·Petitioner,
`· · · · · · · · · · · · · · · · · · · · ·No. IPR2016-00297
`10· · · · · · · · · · · · · · · · · · · ·Patent 8,865,688
`· · · · · · -vs-
`11
`12· ·DR. FALK PHARMA GmbH,
`13
`· · · · · · · · ·Patent Owner,
`14· ·_____________________________/
`15
`16
`17· · · · · · ·DEPOSITION OF LORIN JOHNSON, Ph.D.
`18
`19
`· · ·Date and Time:· ·Friday, December 16, 2016
`20· · · · · · · · · · 9:43 a.m.
`21
`· · ·Location:· · · · 2479 East Bayshore Road
`22· · · · · · · · · · Suite 290
`· · · · · · · · · · · Palo Alto, California
`23
`24
`25· ·Reported By:· · ·Martha Ruble, CSR-5145
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`Page 2
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`·1· ·A P P E A R A N C E S:
`·2
`·3· · For the Petitioner· ·KROUB, SILBERSHER & KOLMYKOV,
`·4· · Generico, LLC,· · · ·PLLC
`·5· · Flat Line Capital,· ·305 Broadway
`·6· · LLC:· · · · · · · · ·7th Floor
`·7· · · · · · · · · · · · ·New York, New York 10007
`·8· · · · · · · · · · · · ·BY:· ZACHARY SILBERSHER, Esq.
`·9· · · · · · · · · · · · ·zsilbersher@kskiplaw.com
`10· · · · · · · · · · · · · · · ***
`11· · For the Petitioner· ·PARKER POE
`12· · Mylan· · · · · · · · 1180 Peachtree Street NE
`13· · Pharaceuticals,· · · Suite 1800
`14· · Inc.:· · · · · · · · Atlanta, Georgia 30309
`15· · · · · · · · · · · · ·BY:· ROBERT L. FLORENCE, Esq.
`16· · · · · · · · · · · · ·robertflorence@parkerpoe.com
`17· · · · · · · · · · · · ·and
`18· · · · · · · · · · · · ·BY:· MICHAEL L. BINNS, Esq.
`19· · · · · · · · · · · · ·michaelbinns@parkerpoe.com
`20· · · · · · · · · · · · · · · ***
`21
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`·1· · · · · · · · · · A P P E A R A N C E S
`·2
`·3· ·For the Patent· · · ·WOMBLE CARLYLE SANDRIDGE & RICE,
`·4· ·Owner, Dr. Falk· · · LLP
`·5· ·Pharma, and the· · · 222 Delaware Avenue
`·6· ·witness:· · · · · · ·Suite 1501
`·7· · · · · · · · · · · · Wilmington, Delaware 19801
`·8· · · · · · · · · · · · BY:· MARY BOURKE, Esq.
`·9· · · · · · · · · · · · mbourke@wcsr.com
`10· · · · · · · · · · · · and
`11· · · · · · · · · · · · KRISTEN H. CRAMER, Esq.
`12· · · · · · · · · · · · kcramer@wcsr.com
`13· · · · · · · · · · · · · · ·***
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`Page 4
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`·1· · · · · · · · · · · ·I N D E X
`·2· ·Examinations· · · · · · · · · · · · · · · · · · · ·Page
`·3
`· · · · MR. SILBERSHER· · · · · · · · · · · · · · · · · · ·6
`·4
`·5· · · MS. BOURKE· · · · · · · · · · · · · · · · · · · · 89
`·6
`·7
`·8· · · · · · · · · · · · E X H I B I T S
`·9
`10· ·Petitioner's· · · · · ·Description· · · · · · · · ·Page
`11· ·Exhibit
`12
`13· ·Exhibit· 1060· ·United States Patent Application· · ·82
`· · · · · · · · · · ·Publication
`14· · · · · · · · · ·Pub. No.: US 2013/0164384 A1
`· · · · · · · · · · ·Johnson et al.
`15
`16· ·Exhibit· 1061· ·Press Release, dated 5-29-01,· · · · 85
`· · · · · · · · · · ·Salix Pharmaceuticals Reports
`17· · · · · · · · · ·Results of Second Phase III
`· · · · · · · · · · ·trial of Rifaximin
`18
`19
`20· ·Patent Owner· · · · · ·Description· · · · · · · · ·Page
`· · ·Exhibit
`21
`22· ·Exhibit· 2051· ·United States Patent Application· · ·89
`· · · · · · · · · · ·Publication
`23· · · · · · · · · ·Pub. No.: Us 2007/0167416 A1
`· · · · · · · · · · ·Johnson et al
`24
`25
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`GeneriCo, Flat Line Capital
`Exhibit 1067 Page 1
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`·1
`·2· ·PREVIOUS EXHIBITS REFERRED TO
`·3· · · · Exhibit No.· Page No.
`·4
`· · · · · · · ·1001· · · · ·92
`·5
`· · · · · · · ·2026· · · · ·66
`·6
`· · · · · · · ·2029· · · · ·68
`·7
`· · · · · · · ·2036· · · · ·17
`·8
`· · · · · · · ·2042· · · · ·34
`·9
`· · · · · · · ·2043· · · · ·51
`10
`· · · · · · · ·2048· · · · ·73
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`·1· · · · · · · · · · LORIN JOHNSON, Ph.D.,
`·2· ·having been first duly affirmed to tell the truth, the
`·3· ·whole truth, and nothing but the truth, testified as
`·4· ·follows:
`·5· · · · · ·MR. SILBERSHER:· Should we state our
`·6· ·appearances?
`·7· · · · · ·THE REPORTER:· Sure.
`·8· · · · · ·MR. SILBERSHER:· Zack Silbersher on behalf of
`·9· ·the petitioners.
`10· · · · · ·MR. FLORENCE:· Robert Florence and Michael Binns
`11· ·on behalf of Mylan.
`12· · · · · ·MS. BOURKE:· Mary Bourke and Kristen Cramer from
`13· ·Womble Carlyle on behalf of Dr. Falk Pharma and the
`14· ·witness.
`15· · · · · ·THE WITNESS:· Lorin Johnson, witness.· I guess
`16· ·that's right.
`17· · · · · · · · ·EXAMINATION BY MR. SILBERSHER
`18· · · ·Q.· That's right.
`19· · · · · ·Okay.· Good morning, Dr. Johnson.· My name is
`20· ·Zack Silbersher.· I represent the petitioners in this
`21· ·action.
`22· · · · · ·How are you?
`23· · · ·A.· Fine, thank you.
`24· · · ·Q.· I'm going to quickly go over some ground rules.
`25· ·I'm going to ask you a series of questions today.· If at
`
`Page 7
`·1· ·any time you don't understand my question or you would
`·2· ·like me to repeat my question, you'll let me know.· Okay?
`·3· · · · · ·And just to be clear, all your answers need to
`·4· ·be verbal for the purpose of the court reporter.
`·5· · · ·A.· Yes.
`·6· · · ·Q.· Is there any reason that you cannot give
`·7· ·accurate testimony today?
`·8· · · ·A.· No.
`·9· · · ·Q.· You're not on any medication that you believe
`10· ·might impair your testimony?
`11· · · ·A.· No.
`12· · · ·Q.· Have you been deposed before?
`13· · · ·A.· Yes.
`14· · · ·Q.· And when were you deposed before?
`15· · · ·A.· September 2015, I believe.
`16· · · ·Q.· And was that in connection with a -- with what
`17· ·kind case was that in connection with?
`18· · · ·A.· Same patent, different issue.
`19· · · ·Q.· Okay.· So was it in connection with a district
`20· ·court litigation involving Apriso?
`21· · · ·A.· Yes.
`22· · · ·Q.· Was that case pending in Delaware?
`23· · · ·A.· Yes.
`24· · · ·Q.· And were you deposed more than once?
`25· · · ·A.· No.
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`Page 8
`·1· · · ·Q.· And were there any other times that you were
`·2· ·deposed?
`·3· · · ·A.· No.
`·4· · · ·Q.· Okay.· So beginning with your -- after your high
`·5· ·school education, could you briefly describe your
`·6· ·educational background.
`·7· · · ·A.· Yes.· I was an undergraduate at the University
`·8· ·of Southern California, majoring in biological sciences.
`·9· ·I completed graduate school at the University of Southern
`10· ·California, molecular biology.· I then moved to the
`11· ·University of California San Francisco, where I spent a
`12· ·post-doctoral period of four years.· That brings us up to
`13· ·1980.
`14· · · · · ·I then became assistant professor of pathology
`15· ·at Stanford University between 1980 and 1983.· And in
`16· ·1983 I moved to California Biotechnology Incorporated,
`17· ·also in the Bay Area, where I was ultimately chief
`18· ·scientist and head of an inflammation research program.
`19· · · · · ·In 1989 I became the founder of Salix
`20· ·Pharmaceuticals, and I held various positions within the
`21· ·company until its sale 26 years later to Valeant.
`22· · · ·Q.· Okay.· So going back to your -- you received a
`23· ·Ph.D. in molecular biology from USC?
`24· · · ·A.· Correct.
`25· · · ·Q.· And did you write a dissertation?
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`·1· · · ·A.· Correct.
`·2· · · ·Q.· Can you tell me briefly the topic of your
`·3· ·dissertation.
`·4· · · ·A.· The topic was on transcription of genes,
`·5· ·regulation of transcription by hormones, and it was all
`·6· ·molecular-biology based, mainly on the enzyme RNA
`·7· ·polymerase.
`·8· · · ·Q.· And during your post-doctoral work at UCSF,
`·9· ·could you briefly describe the work that you worked on.
`10· · · ·A.· I worked on the molecular biology of
`11· ·corticosteroid action, so anti-inflammatory steroids.
`12· ·That started my interest in inflammation research, which
`13· ·I have continued throughout the rest of my career.· It's
`14· ·also what lead Salix to initially become involved in
`15· ·inflammatory bowel disease.
`16· · · ·Q.· So could you explain that a little bit more, how
`17· ·your interest in inflammation research led to --
`18· · · ·A.· Well, corticosteroids are the prime
`19· ·anti-inflammatory drug that is used for serious
`20· ·inflammation.· So we -- originally we wanted to
`21· ·understand how they work.· Later on, we wanted to
`22· ·understand if we could provide therapeutic agents that
`23· ·could replace them so it could have the same mechanism of
`24· ·action but not have the side effects of corticosteroids.
`25· · · · · ·And in researching all that area, of course, we
`Page 10
`·1· ·then learned a lot about inflammation and about the
`·2· ·various meditators in inflammation.· We also learned that
`·3· ·anti-inflammatory compounds can be used, not just
`·4· ·systemically, but to treat the site of inflammation
`·5· ·directly at the site of inflammation, which then led to
`·6· ·specific drugs that can be used in the GI tract to treat
`·7· ·inflammation of the GI tract.
`·8· · · ·Q.· Okay.· And then you mention that after your
`·9· ·post-doc work you were on the faculty of Stanford's
`10· ·Medical School.
`11· · · ·A.· Correct.
`12· · · ·Q.· And you said you were chief scientist.· No, I'm
`13· ·sorry.
`14· · · · · ·Could you remind me what your position was?
`15· · · ·A.· Assistant professor of pathology.
`16· · · ·Q.· And what -- can you briefly describe what you
`17· ·worked on in that position.
`18· · · ·A.· We were working on the link between inflammation
`19· ·of the blood vessels and coronary artery disease.· So
`20· ·coronary artery disease has an inflammation component.
`21· · · ·Q.· Right.
`22· · · ·A.· And we -- there was data showing that, in fact,
`23· ·corticosteroids would worsen the disease.· So that was
`24· ·kind of an inroad for us into insights in coronary artery
`25· ·disease.
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`Page 11
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`·1· · · · · ·And we had a model where we were growing
`·2· ·vascular endothelial cells, the cells that line the blood
`·3· ·vessels.· They are very important in the initial stages
`·4· ·of coronary artery disease.· So we used models, cell
`·5· ·models, of endothelial cells and smooth-muscle cells,
`·6· ·which are the layer just below the endothelial cells, to
`·7· ·look at how corticosteroids interacted with them and
`·8· ·changed their physiology and the various inflammatory
`·9· ·mediators that they produced.
`10· · · ·Q.· So correct me if I'm wrong, but that was mostly
`11· ·around the heart?
`12· · · ·A.· No.· It was individual cells.· And when you
`13· ·think about endothelial cells, they are in all the blood
`14· ·vessels including the capillaries.· They are the main
`15· ·target for cytokines like TNF-alpha.
`16· · · ·Q.· Right.
`17· · · ·A.· Because the first thing that has to happen in
`18· ·inflammation is white blood cells have to bind to those
`19· ·endothelial cells and then get out of the blood.
`20· · · ·Q.· Right.
`21· · · ·A.· So everything that activates those cells or
`22· ·changes their physiology is very important in all
`23· ·inflammatory diseases.
`24· · · ·Q.· So did this work relate to ulcerative colitis?
`25· · · ·A.· Eventually it did, yes.
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`Page 12
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`·1· · · ·Q.· Could you briefly explain how.
`·2· · · ·A.· So I moved my laboratory from Stanford to
`·3· ·California Biotechnology.· And at Cal Bio -- which I'll
`·4· ·just mention later became Scios and was purchased by
`·5· ·J & J in 2002 or maybe '04.· I can't remember.
`·6· · · ·Q.· And, briefly, can you -- what is Cal
`·7· ·Biotechnology?
`·8· · · ·A.· It was a biotechnology company.
`·9· · · ·Q.· Okay.
`10· · · ·A.· Nasdaq-listed.· We had a variety of programs,
`11· ·and I led the one in inflammatory disease research.
`12· · · ·Q.· Okay.
`13· · · ·A.· So with my background in inflammation, that's
`14· ·where we started a program to look for mediators, natural
`15· ·mediators that were involved in corticosteroid action,
`16· ·hoping that -- well, there was information at the time
`17· ·that corticosteroids produced a key protein which was an
`18· ·inhibitor of inflammation and an inhibitor of the key
`19· ·enzyme phospholipase A2, which is in the membrane of
`20· ·endothelial cells or other the inflammatory cells.
`21· · · · · ·So our goal was to discover that protein
`22· ·mediator, inhibitor of phospholipase A2.· So that's where
`23· ·our journey was on.
`24· · · · · ·At the same time, we discovered all of the --
`25· ·the first human genes that encoded phospholipase A2.· So
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`Page 13
`·1· ·it was very focused on that one step in corticosteroid
`·2· ·action.
`·3· · · · · ·So we actually looked at various disease models:
`·4· ·arthritis, even asthma.· Inflammatory bowel disease was a
`·5· ·niche market.· We, in fact, designed a first-generation
`·6· ·product for inflammatory bowel disease that was a locally
`·7· ·delivered steroid.
`·8· · · ·Q.· By "locally" you mean --
`·9· · · ·A.· Right to the colon.
`10· · · ·Q.· Okay.
`11· · · ·A.· So we were doing all this other research on
`12· ·proteins to ultimately have a product.· Shorter term, we
`13· ·also started on a derivative of a corticosteroid that
`14· ·could be delivered directly to the colon.
`15· · · · · ·That's kind of how I started getting involved in
`16· ·inflammatory bowel disease.· There was a big need at the
`17· ·time because the only treatment was sulfasalazine.
`18· · · ·Q.· And roughly when was this?
`19· · · ·A.· It would have been 1986.
`20· · · · · ·So by the time Salix started, our goal was to
`21· ·take what I knew about inflammation and start an
`22· ·inflammation company but at the same time have a product
`23· ·that we could get approved very quickly to help fund the
`24· ·research.· And we identified inflammatory bowel disease.
`25· · · · · ·Ulcerative colitis has a very nice niche area
`Page 14
`·1· ·that we could address with 30 salespeople.· And we
`·2· ·actually went out and looked for a product that was well
`·3· ·advanced.· We found that in the UK from a company Biorex
`·4· ·Laboratories, and that molecule was balsalazide.
`·5· · · ·Q.· Okay.
`·6· · · ·A.· So that was the first product we in-licensed.
`·7· ·And I was responsible for all the clinical activity to
`·8· ·get that drug approved in the U.S.
`·9· · · ·Q.· So let's talk about Salix.
`10· · · ·A.· Yes.
`11· · · ·Q.· You founded Salix with someone else, correct?
`12· · · ·A.· Randy Hamilton.
`13· · · ·Q.· And can you briefly describe the positions you
`14· ·held in Salix.· I know it's a long time.· But during your
`15· ·tenure there.
`16· · · ·A.· Well, in a startup company with two people, you
`17· ·do everything, right?· I was the first bookkeeper.
`18· · · ·Q.· So you were doing everything?
`19· · · ·A.· We worked out of his house for two years.
`20· ·Officially, I was vice president of research, and he was
`21· ·CEO, and we were the only employees.
`22· · · ·Q.· Was he a scientist?
`23· · · ·A.· No.· He was a business person, and he had been
`24· ·at California Biotechnology in the business development
`25· ·side.· And we had traveled a lot to Japan to out-license
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`Page 15
`·1· ·our technology.· So we had worked a lot together, and
`·2· ·that's how we formed this partnership.
`·3· · · · · ·So I was officially founder, vice president of
`·4· ·research, member of the board of directors.· As we
`·5· ·started hiring more people in, I think as we got other
`·6· ·vice presidents, I took the title of senior vice
`·7· ·president and chief scientist, so I was always on the
`·8· ·science side.
`·9· · · · · ·I was essentially VP of research -- of
`10· ·development -- research and development five times
`11· ·because we went through several people that came in and
`12· ·then left until Bill Forbes was hired.
`13· · · ·Q.· Okay.
`14· · · ·A.· And he came on board in January 2005 and
`15· ·remained until the end in 2015.
`16· · · ·Q.· So he was hired as a chief scientist?
`17· · · ·A.· No, he was hired as VP of R & D.
`18· · · ·Q.· Okay.
`19· · · ·A.· And I was always chief scientist, or we called
`20· ·it chief scientific liaison because I did a lot of
`21· ·liaison with the medical community.· And like the MSLs,
`22· ·or medical science liaison, we used that title.
`23· · · ·Q.· So -- and when you say liaison with the medical
`24· ·community, can you describe that?
`25· · · ·A.· Well, for balsalazide, we got balsalazide
`Page 16
`·1· ·approved in 2000.· And we -- the only thing we had to
`·2· ·promote it with was the package insert.· So we had
`·3· ·doctor dinner meetings, maybe a hundred of them over a
`·4· ·two-year period, and I gave all the science.· So that was
`·5· ·the liaison component.· I wasn't selling the drug.· I was
`·6· ·providing information.
`·7· · · ·Q.· Okay.· And do you recall when Salix went public?
`·8· · · ·A.· We went public on the Toronto Stock Exchange
`·9· ·first in 1996, May of 1996.
`10· · · ·Q.· And then you eventually went public in the U.S.,
`11· ·as well?
`12· · · ·A.· We moved to Nasdaq in November of 2000.
`13· · · ·Q.· Okay.· And do you still work at Salix?
`14· · · ·A.· No.
`15· · · ·Q.· And when did you stop working at Salix?
`16· · · ·A.· April 1st, 2015.
`17· · · ·Q.· And was -- did you leave Salix as part of
`18· ·Valeant's acquisition?
`19· · · ·A.· Yes.
`20· · · ·Q.· And when you left, could you remind me what your
`21· ·position was at the time that you left?
`22· · · ·A.· Chief scientific liaison and founder.
`23· · · ·Q.· Did you ever attend medical school?
`24· · · ·A.· No.
`25· · · ·Q.· You're not a medical doctor?
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`·1· · · ·A.· No.
`·2· · · ·Q.· Did you ever treat patients?
`·3· · · ·A.· No.
`·4· · · ·Q.· When you were on the faculty at the medical
`·5· ·school at Stanford, just to confirm, you never treated
`·6· ·patients there?
`·7· · · ·A.· No.
`·8· · · ·Q.· Okay.· I'm going to briefly show you what's been
`·9· ·premarked Exhibit 2036.
`10· · · · · ·(Exhibit 2036, a prior exhibit, was identified.)
`11· ·BY MR. SILBERSHER:
`12· · · ·Q.· Do you recognize this document?
`13· · · ·A.· Yes, I do.
`14· · · ·Q.· Can you tell me what this document is?
`15· · · ·A.· This is a declaration that I gave.
`16· · · ·Q.· In this action, correct?
`17· · · ·A.· In this action, correct.
`18· · · ·Q.· Did you prepare this document?
`19· · · ·A.· I didn't type it physically.· I prepared the
`20· ·scientific contents, yes.
`21· · · ·Q.· You prepared it in connection with your counsel?
`22· · · ·A.· Right.
`23· · · · · ·MS. BOURKE:· Counsel, is this the official
`24· ·Exhibit 2036?· I notice there is highlighting in here.
`25· ·It was on the witness' copy and my copy.
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`Page 18
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`·1· · · · · ·MR. SILBERSHER:· This is not.· So the
`·2· ·highlighting, unfortunately, is my own, and I just
`·3· ·printed it out by accident.· But I'll represent to you
`·4· ·that absent the highlighting, this is the official 2036.
`·5· · · · · ·MS. BOURKE:· Thank you.
`·6· ·BY MR. SILBERSHER:
`·7· · · ·Q.· I'm going to ask you to turn to page 2,
`·8· ·paragraph 2.
`·9· · · ·A.· Uh-huh.
`10· · · ·Q.· You mention that -- and I'm quoting in the first
`11· ·sentence, "I'm the founder and chief scientist of" --
`12· · · ·A.· Glycyx.
`13· · · ·Q.· -- "Glycyx Pharma Ventures."
`14· · · · · ·Could you describe what that is.
`15· · · ·A.· That's my own company for -- I put together for
`16· ·the acquisition of technology that will be further
`17· ·developed and commercialized.· It's headquartered on the
`18· ·Isle of Man.
`19· · · ·Q.· And do you have any products yet?
`20· · · ·A.· Only patents.
`21· · · ·Q.· And is there a general area that you're focusing
`22· ·on?
`23· · · ·A.· No.· Several areas.
`24· · · ·Q.· Do they include ulcerative colitis?
`25· · · ·A.· Not right now.
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`Page 19
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`·1· · · ·Q.· Do they include other anti-inflammatory
`·2· ·conditions?
`·3· · · ·A.· I'm just going through everything.
`·4· · · · · ·Not right now.
`·5· · · ·Q.· Okay.· In the second sentence you mention that
`·6· ·you're on the board of directors of Atlantic Healthcare.
`·7· · · ·A.· Yes.
`·8· · · ·Q.· Could you describe what that is.
`·9· · · ·A.· Atlantic Healthcare has acquired an
`10· ·anti-inflammatory product.· Remember I talked about how
`11· ·the white blood cells adhere to endothelial cells to
`12· ·start the process?· They do so through a cell adhesion
`13· ·molecule called ICAM 1.· And Atlantic licensed in an
`14· ·antisense all of the nucleotide directed at ICAM 1 from
`15· ·Ionis Pharmaceuticals, previously Isis Pharmaceuticals.
`16· · · ·Q.· Right.
`17· · · ·A.· So they have -- they've licensed in that
`18· ·technology for the treatment of inflammatory bowel
`19· ·disease.· And they are in a Phase III study for the
`20· ·treatment of pouchitis, which is essentially after the
`21· ·patient -- the ulcerative colitis patient has a colectomy
`22· ·and they remove the colon, they create an artifical colon
`23· ·out of the end of the terminal ileum, and that's called a
`24· ·J-pouch.· That J-pouch gets re-inflamed.· The disease
`25· ·comes back.· And this drug is used to treat that
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`Page 20
`·1· ·inflammation.· It's also used to treat ulcerative
`·2· ·colitis, but the most advanced indication is pouchitis.
`·3· · · ·Q.· Okay.· Now, can we turn to the same page which
`·4· ·is paragraph 4.
`·5· · · ·A.· Uh-huh.
`·6· · · ·Q.· And in this paragraph I believe you describe the
`·7· ·formation of Salix.
`·8· · · ·A.· Uh-huh.
`·9· · · ·Q.· Now, on the last sentence on the page you said,
`10· ·quote, "Over time, as we acquired more technology, we
`11· ·hired people to perform," and so forth.
`12· · · ·A.· Uh-huh.
`13· · · ·Q.· Could you briefly explain what you mean by
`14· ·"acquired more technology"?
`15· · · ·A.· So our -- the way we acquired products was to
`16· ·in-license products.
`17· · · ·Q.· Right.
`18· · · ·A.· So that was the technology that we acquired
`19· ·through in-licensing.
`20· · · ·Q.· Okay.· And the examples would be?
`21· · · ·A.· Balsalazide; Xifaxin or rifaximin; the Falk
`22· ·product, the Apriso, and on and on and on, up to 22
`23· ·products.
`24· · · ·Q.· Now, turning to the next page.· At the end of
`25· ·paragraph 4 you indicate that some of your duties are
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`Page 21
`·1· ·also, quote, "Life-cycle management of our products."
`·2· · · ·A.· Uh-huh.
`·3· · · ·Q.· Could you describe what that is.
`·4· · · ·A.· So life-cycle management is a general term to
`·5· ·look at how the product can be improved over time.· So it
`·6· ·may -- we may decide to develop additional indications.
`·7· ·We might decide to produce new dosage forms.
`·8· · · ·Q.· Right.
`·9· · · ·A.· We might under certain conditions file new
`10· ·patents based on some of this.
`11· · · ·Q.· Why would you file new patents?
`12· · · ·A.· To have further protection for the product.
`13· · · ·Q.· Okay.
`14· · · ·A.· So composition of matter might lapse.
`15· ·Additional patents can still protect the product. I
`16· ·think rifaximin is a very good example.· Composition of
`17· ·matter patent expired the same year that we got our first
`18· ·approval.· There are now 22 patents covering that
`19· ·molecule.· That's life-cycle management.
`20· · · ·Q.· Were you involved in the life-cycle management
`21· ·of Apriso?
`22· · · ·A.· There really hasn't been any since we acquired
`23· ·it.
`24· · · ·Q.· Since you acquired it?
`25· · · ·A.· Yeah.
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`Page 22
`·1· · · ·Q.· So would the filing of the patents on Apriso
`·2· ·have been -- fall into life-cycle management?
`·3· · · ·A.· I would say that would fall into the initial use
`·4· ·of the product for us in the U.S.· So life-cycle
`·5· ·management would come after that.
`·6· · · ·Q.· Okay.· So turning to paragraph 6 -- well, sorry.
`·7· ·Let's turn to paragraph 7.· In this paragraph you state
`·8· ·that both you and William Forbes are inventors on the
`·9· ·'688 patent.
`10· · · ·A.· Uh-huh, yes.
`11· · · ·Q.· And William Forbes joined the company in 2005?
`12· · · ·A.· Correct.
`13· · · ·Q.· And did you work directly with Mr. Forbes?
`14· · · ·A.· Yes.
`15· · · ·Q.· Did you work with him a lot?
`16· · · ·A.· Yes.
`17· · · ·Q.· And Mr. Forbes --
`18· · · ·A.· Dr. Forbes.
`19· · · ·Q.· I'm sorry.· Is Dr. Forbes a medical doctor?
`20· · · ·A.· He is a Pharm.D.
`21· · · ·Q.· So he's not a medical doctor?
`22· · · ·A.· No.
`23· · · ·Q.· Do you know if Dr. Forbes ever treated patients?
`24· · · ·A.· No.
`25· · · ·Q.· You don't know?· Or he never treated?
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`Page 23
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`·1· · · ·A.· I doubt that he treated patients.· As a
`·2· ·Pharm.D., he could prescribe -- or he could fill
`·3· ·prescriptions for patients.· So is that treatment?
`·4· · · ·Q.· I guess we will leave it at that.
`·5· · · · · ·Now, both you and Dr. Forbes worked at Salix,
`·6· ·and you were the inventors of the '688 patent.· Could you
`·7· ·explain why the patent was nevertheless assigned to
`·8· ·Dr. Falk?
`·9· · · ·A.· Under the terms of our license agreement with
`10· ·Dr. Falk, any new patents, improvements that we generated
`11· ·during the time of the license would be assigned to
`12· ·Dr. Falk.
`13· · · ·Q.· Okay.· Now, in paragraph 7 you mentioned that a
`14· ·petition to correct the inventorship was filed on
`15· ·July 31st, 2015, correct?
`16· · · ·A.· Uh-huh, yes.
`17· · · ·Q.· And that was to add you as an inventor?
`18· · · ·A.· Yes.
`19· · · ·Q.· So could you explain why you were not originally
`20· ·identified as an inventor?
`21· · · · · ·MS. BOURKE:· I'm going to caution the witness at
`22· ·this point in time.· To the extent that your knowledge of
`23· ·why you were not originally named an inventor on the
`24· ·patent came from legal advice that you received from
`25· ·counsel, whether it be outside counsel or inside counsel
`Page 24
`·1· ·at Salix, I would instruct you not to answer.· If you
`·2· ·have independent knowledge of that that did not come from
`·3· ·an attorney, you can answer.
`·4· · · · · ·THE WITNESS:· No.· All that knowledge came from
`·5· ·my attorney.
`·6· ·BY MR. SILBERSHER:
`·7· · · ·Q.· Okay.· So were you aware that a patent --
`·8· ·Dr. Forbes had -- a patent had been filed where
`·9· ·Dr. Forbes was the inventor?
`10· · · ·A.· Yes, I was.
`11· · · ·Q.· Were you aware of the subject matter of that
`12· ·patent when it was filed?
`13· · · ·A.· Yes, I was.
`14· · · ·Q.· And can you describe your collaboration with
`15· ·Dr. Forbes in connection with what became the subject
`16· ·matter of the '688 patent.
`17· · · ·A.· Well, the collaboration started in 2004 when
`18· ·Dr. Forbes was being interviewed by me to become vice
`19· ·president of research and development.· And we talked
`20· ·about upcoming studies that we envisioned, and we
`21· ·discussed various approaches that could be taken where
`22· ·improvements in the technology would be applicable and
`23· ·desirable.
`24· · · · · ·Those discussions led over a couple of months to
`25· ·a final protocol -- well, I don't know if it's the final
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`·1· ·protocol -- but a protocol that was signed by me in
`·2· ·October 2004 and was reviewed by FDA as a protocol for
`·3· ·the first study that Salix was going to perform on the
`·4· ·Falk product, which became Apriso.
`·5· · · · · ·So in anticipation of Dr. Forbes taking over
`·6· ·this program when he arrived in January, he and I had
`·7· ·extensive discussions about the protocol and the
`·8· ·direction the study should take.
`·9· · · ·Q.· Okay.· And how did those studies relate to what
`10· ·eventually became the patent?
`11· · · ·A.· The protocol that was developed for those
`12· ·studies envisioned a certain low-dose, once-a-day
`13· ·treatment and the possibility that the product could be
`14· ·used without regard to food.
`15· · · ·Q.· Okay.· And you and Dr. Forbes jointly designed
`16· ·those studies?
`17· · · ·A.· Yes.
`18· · · ·Q.· And do you recall -- as an inventor of the '688
`19· ·patent, do you recall how many hours you spent as part of
`20· ·your work as an inventor of that patent?
`21· · · · · ·MS. BOURKE:· Objection to form.
`22· · · · · ·THE WITNESS:· That was a long time ago.· That
`23· ·was 12 years ago.
`24· ·BY MR. SILBERSHER:
`25· · · ·Q.· It was.
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`·1· · · ·A.· It was 12 years ago.· So I don't recall.
`·2· · · · · ·But I do recall that Apriso was the third
`·3· ·product that Salix in-licensed.· I had led the
`·4· ·development on the first two.· And this was the first one
`·5· ·that I was hopefully going to have some help with.
`·6· · · ·Q.· Right.
`·7· · · ·A.· So I had control -- well, I had responsibility
`·8· ·for that product until Dr. Forbes arrived.· So it was
`·9· ·during that transition that we collaborated on the
`10· ·protocol development and what turned out to be the
`11· ·subject of the patent.
`12· · · ·Q.· Okay.· Did you have lab notebooks that you used
`13· ·in the course of your contribution?
`14· · · ·A.· They wouldn't have been lab notebooks, no.· They
`15· ·would be draft protocols.
`16· · · ·Q.· Did you participate in drafting the protocols?
`17· · · ·A.· Yes.
`18· · · ·Q.· In conjunction with Dr. Forbes?
`19· · · ·A.· Yes.
`20· · · ·Q.· And you don't recall how many hours you spent.
`21· · · · · ·Would you say that at the time you were working
`22· ·considerably on this project?
`23· · · ·A.· Yes.
`24· · · ·Q.· And after Dr. Forbes joined, did you work a
`25· ·little bit less and he took over more of a role?
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`Page 27
`·1· · · ·A.· I did because he was then responsible for the
`·2· ·execution of the study.
`·3· · · ·Q.· Okay.
`·4· · · ·A.· And I no longer had to worry about the execution
`·5· ·of studies.
`·6· · · ·Q.· Right, which was nice probably.
`·7· · · ·A.· Yes, which was great.
`·8· · · ·Q.· So at the time did you think you should have
`·9· ·been an inventor on the patent?
`10· · · · · ·MS. BOURKE:· Objection.· Form.
`11· · · · · ·THE WITNESS:· Well, obviously, at the time we
`12· ·had no idea there was an invention.
`13· ·BY MR. SILBERSHER:
`14· · · ·Q.· Well, you knew about the patent application that
`15· ·was being filed, correct?
`16· · · ·A.· That was filed in 2007.
`17· · · ·Q.· Right.
`18· · · ·A.· So I'm talking about 2004.
`19· · · ·Q.· Okay.· So when the patent application was filed
`20· ·in 2007, did you think that you should have been an
`21· ·inventor on that patent?
`22· · · ·A.· That's a decision by my legal counsel.
`23· · · ·Q.· Okay.· So -- and was the legal counsel in-house
`24· ·counsel or outside counsel?
`25· · · ·A.· We used both.
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`·1· · · ·Q.· Did you have -- did Salix have in-house patent
`·2· ·prosecution counsel?
`·3· · · ·A.· We did, but that's right at the transition.· Our
`·4· ·in-house counsel came in September of 2007.
`·5· · · ·Q.· Your in-house patent prosecution counsel?· Or
`·6· ·just general counsel?
`·7· · · ·A.· She did both.
`·8· · · ·Q.· She did both.· You said she came in --
`·9· · · ·A.· In September of 2007 from the outside patent
`10· ·firm that we used.
`11· · · ·Q.· And what was that firm?· Do you recall?
`12· · · ·A.· Edwards and Ankle -- Angell?· Is that what it
`13· ·was?· Sorry.· You knew.
`14· · · ·Q.· Right.
`15· · · ·A.· You know.· In Boston.
`16· · · ·Q.· In Boston, right.
`17· · · ·A.· Right.
`18· · · ·Q.· And when you were -- when the patent was being
`19· ·filed, were you involved -- strike that.
`20· · · · · ·When you were at Salix around 2007, did you have
`21· ·a relationship with outside patent counsel?
`22· · · ·A.· On several patents, yes.
`23· · · ·Q.· So you knew who they were, and you spoke with
`24· ·them?
`25· · · ·A.· Uh-huh, yes.
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`·1· · · ·Q.· Were you involved in hiring the in-house counsel
`·2· ·that you mentioned came on board in September?
`·3· · · ·A.· I did interview her, yes, and I had previously
`·4· ·worked with her on several projects.
`·5· · · ·Q.· And what was her name?
`·6· · · ·A.· Stephana Patton, P-a-t-t-o-n.
`·7· · · ·Q.· And she was a lawyer, correct?
`·8· · · ·A.· Yes, and a Ph.D.
`·9· · · ·Q.· And Ph.D.· Okay.· Okay.· So turn back to the
`10· ·declaration which is Exhibit 2036.
`11· · · · · ·Could you please look at page 4, paragraph 9.
`12· ·So I would like to direct you to the first sentence in
`13· ·paragraph 9 which states, quote:
`14· · · · · ·"Although it was known at the time of the
`15· ·in-license and even up to the time the '688 patent
`16· ·application was filed in October of 2008 that a
`17· ·simplified dosing regimen could facilitate greater
`18· ·compliance in patients" --
`19· · · · · ·Now, I'm going to stop there, and I would like
`20· ·to ask you:· On what basis did you say that?
`21· · · ·A.· Well, there had actually been studies of patient
`22· ·compliance from a variety of studies.· A variety of
`23· ·clinical studies were looked at, and patient compliance
`24· ·was looked at, those that had once-a-day dosing,
`25· ·twice-a-day dosing, and three-times-a-day dosing.
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`·1· · · ·Q.· Was this for specific drugs?· Or just drugs in
`·2· ·general?
`·3· · · ·A.· It was a whole variety of drugs.
`·4· · · ·Q.· And so --
`·5· · · ·A.· Three-times-a-day dosing was the worst.
`·6· · · ·Q.· With respect to compliance?
`·7· · · ·A.· With respect to compliance.· And twice-a-day
`·8· ·dosing was between.· And once-a-day dosing was the best.
`·9· · · ·Q.· Do you recall the names of any of these studies?
`10· · · ·A.· I don't.· It was a general -- I don't remember.
`11· · · · · ·I mean, we certainly were