UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`V.
`
`UNITED THERAPEUTICS, INC.
`
`Patent Owner
`
`Trial N0. IPR2017—01621
`
`Patent No. 9,358,240
`
`DECLARATION OF MS. PILAR WYMAN
`
`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017-01622
`
`UNITED THERAPEUTTCS, EX. 2093
`
`Page 1 of 13
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`V.
`
`UNITED THERAPEUTICS, INC.
`
`Patent Owner
`
`Trial N0. IPR2017—01621
`
`Patent No. 9,358,240
`
`DECLARATION OF MS. PILAR WYMAN
`
`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017-01622
`
`UNITED THERAPEUTTCS, EX. 2093
`
`Page 1 of 13
`
`
`
`IPR2017-01621
`
`I, Pilar Wyman, hereby declare:
`
`INTRODUCTION
`
`1.
`
`I am a paid consultant for United Therapeutics Corporation in
`
`connection with two patent proceedings, IPR2017-01621 and IPR20l7-01622. My
`
`compensation does not depend on the content of this declaration, the substance of
`
`any other testimony that I may offer in connection with this proceeding, or the
`
`disposition of this proceeding.
`
`2.
`
`I am a professional freelance medical indexer and indexing consultant.
`
`My Curriculum Vitae describing my background and experience is provided as Ex.
`
`2094.
`
`I have personal knowledge of the facts and opinions set forth in this
`
`declaration, which I believe to be true, and if called upon to do so, I would testify
`
`competently to them.
`
`In particular, as shown in my Curriculum Vitae, I have been
`
`involved in indexing medical publications for many years, as well as employed as
`
`a librarian.
`
`I was also lead consultant for the American Medical Association’s
`
`AMA Manual ofStyle, 10'}l edition chapter 13, “Medical Indexes.”
`
`3.
`
`I am informed by counsel that a reference is considered “prior art” in
`
`these proceedings if it is publicly accessible and can be located prior to a certain
`
`date using reasonable diligence by a hypothetical person referred to as the person
`
`of ordinary skill in the “art” (which I will often refer to as a “POSA”) or field to
`
`UNITED THERAPEUTICS, EX. 2093
`2
`WATSON LABORATORIES v- UNITED THERAPEUTICS, IPR2017-01622
`
`Page 2 of 13
`
`
`
`IPR2017-01621
`
`which the patent pertains.
`
`I am further informed that, for these proceedings, the
`
`patties have offered two alternative definitions for a POSA:
`
`(a) a POSA at the time of invention would have been a person with a post-
`
`graduate degree in medicine or drug development (such as the
`
`pharmaceutical sciences) with at least two years of experience in the
`
`investigation or treatment of pulmonary hypertension. A POSA may also
`
`have had additional experience in the study, development, or use of
`
`dosage forms that had been used to treat pulmonary hypertension, such as
`
`solid oral dosage forms (e.g., tablets and capsules), injectables, and
`
`inhaled therapies. A POSA may have had a lower level of formal
`
`education if such a person had more years of experience in the
`
`investigation or treatment of pulmonary hypertension; and
`
`(b) according to Dr- Bennett (Ex. 1013,1H] 12-13), a POSA holds a Ph.D.
`
`degree in pharmaceutical science or a related discipline like chemistry or
`
`medicinal chemistry, as well as at least two years of practical experience
`
`in the development of potential drug candidates, specifically in the
`
`delivery of drug by inhalation.
`
`I understand that this person according to
`
`his definition could have had a lower level of formal education than a
`
`PhD- degree if such a person had more years of experience in the
`
`UNITED THERAPEUTICS, EX. 2093
`3
`WATSON LABORATORIES v- UNITED THERAPEUTICS, IPR2017-01622
`
`Page 3 of 13
`
`
`
`IPR2017-01621
`
`development of inhalable drugs. Also, according to Dr. Bennett’s
`
`definition, this person would regularly review literature about
`
`pharmaceutical sciences and drug delivery and would know how to carry
`
`out library research using library resources to find out more information
`
`about areas being researched. In addition, this POSA would know how to
`
`evaluate potential drugs for their in vitro and in vivo activity and toxicity
`
`using tests disclosed in the relevant literature. Furthermore, because drug
`
`development involves a multidisciplinary approach, I understand that a
`
`POSA according to Dr. Bennett may interface or consult with individuals
`
`having specialized expertise, for example, a pharmacologist and/or
`
`physician with experience in the administration, dosing and efficacy of
`
`drugs for the treatment of a particular disease state.
`
`These definitions of a POSA are interchangeable for purposes of my analysis.
`
`4.
`
`I have reviewed the Declaration of Scott Bennett along with all of its
`
`attachments (Ex. 1013).
`
`1 have also conducted some searches of PubMed (NLM)
`
`and American Heart Association Scientific Sessions in connection with preparing
`
`this Declaration and reviewed certain other exhibits identified below.
`
`UNITED THERAPEUTICS, EX. 2093
`4
`WATSON LABORATORIES v- UNITED THERAPEUTICS, IPR2017-01622
`
`Page 4 of 13
`
`
`
`lPR2017-0162l
`
`Document 1. Robert Voswinckel, et al. "Inhaled trepostinil sodium for the
`
`treatment of pulmonary hypertension" Abstract #1414, Circulation, 110, 17,
`
`Supplement (October 2004): 111-295.
`
`5.
`
`The first reference discussed in the Bennett Declaration is
`
`Voswinckel, an abstract that is contained in a 1102—page supplement to the journal
`
`Circulation in 2004 — specifically to vol. 1 10, issue 17 (Ex. 1013, 27-32). The
`
`Supplement, dated October 26, 2004, contains 1 102 pages (Ex. 1013, 29), with the
`
`Voswinckel abstract appearing on page 295 (Ex. 1013, 32). According to Ex-
`
`1013, the abstract was also presented at a meeting of the American Heart
`
`Association in New Orleans in Nov. 2004 (Ex. 1013, 27).
`
`6.
`
`The Bennett Declaration asserts that this abstract would have been
`
`available by December 2004. Ex. 1013, 13-14.
`
`I do not agree with this conclusion
`
`for the following reasons. What is shown in the Bennett Declaration is an online
`
`entry from the British Library (Ex. 1013, 33):
`
`UNITED THERAPEUTICS, EX. 2093
`5
`WATSON LABORATORIES v- UNITED THERAPEUTICS, IPR2017-01622
`
`Page 5 of 13
`
`
`
`IPR2017-0162l
`
`aunt
`
`Lh- 'dr-1';r.r- WWII“
`
`BRITISH*HVHH!
`
`':‘t'9||.lh -
`
`tT-dlufionl
`
`-
`
`] Llicw -
`
`I
`
`Sen-41:“
`
`-
`
`I- vI'
`
`-
`
`ills-ml
`
`-
`
`lnl'vIII-dloll lad.
`
`-
`
`Explore the British Library
`hum-- l-i‘fl'r
`F--m:..a.t.
`I:».--.
`r\...-.-.r:
`rim-qdw.‘
`
`‘.:'r--—: n.-.-.--‘
`
`I
`
`.. K
`
`22=f4
`
`ABSTRACTS FROM SCIENTIFIC SESSIONS 2004
`'_-ICulilI(-1 '.-I.IL 1'.
`I‘-.L'I'.‘L- 1r
`b|_'»1—‘ 41:4 ,'~LL AMERICAN HEAR] ASSOCIAIICNILI.
`
`p991];
`
`-( u'
`
`'-u-
`
`w --
`
`JI
`
`.m-
`
`|'\ I
`'I'
`'1
`
`a
`--
`-
`-.-r\-7 '- =:
`
`1
`_-r.--.
`
`-.-'-.
`
`Lu»)
`'-—..
`
`.n.--..
`
`u-
`
`..
`
`I
`
`lulo mfiTqmfls-I-
`Fourdln
`'.
`.-L1'.-
`-.
`JOLI'I'IJI "II!
`Sumac-ta
`'- by.
`
`in
`
`”-1-.
`
`'-
`
`--
`
`.1 ..
`
`. m
`
`Wblitfllof Dtulls was-mu 49R? mongol-or: ._-
`Larguaga
`r
`immune!
`, -'.-.'
`Nunuhnr Dam.
`---I.
`Mcrual Inhmuon:
`human} .-.:'. _. J.'L'.
`LIIH
`-|-II
`‘."
`E'
`--
`
`
`
`o This is a catalogue record for the entire 1102-page Supplement. This record
`
`provides no meaningfill way to find or search for individual abstracts
`
`published in it (it does not list individual authors, titles, or specific key
`
`words).
`
`0
`
`It does not indicate any date when the catalogue record was created, nor is
`
`there any reason provided by Dr. Bennett to believe it existed by December
`
`2004.
`
`UNITED THERAPEUTICS, EX. 2093
`6
`WATSON LABORATORIES v- UNITED THERAPEUTICS, IPR2017-01622
`
`Page 6 of 13
`
`
`
`IPR2017-01621
`
`- The catalogue record reveals in the “subjects” field that the entire 1102—page
`
`Supplement was catalogued broadly, under the general terms: “Medicine,”
`
`“Biotechnology,” and “Pharmaceutical Chemistry.”
`
`7.
`
`In addition, the cover of the Supplement in which the Voswinckel
`
`abstract appears contains a “LOAN BAN” sticker, indicating that its circulation
`
`was restricted until May 22, 2005. See Ex. 1013, 27. In my experience as a
`
`librarian, this indicates that this bound issue was not available for review outside of
`
`the premises of the British Library during this time period. Not only that, per an
`
`email response dated April 20, 2018 from the British Library provided to me by
`
`counsel (Ex. 2092), visitors must request individual items in the collection to be
`
`brought to them for review in the Reading Room. Thus, the Supplement
`
`containing Voswinckel would not have been simply sitting out for anyone to view,
`
`and a member of the public would have had to know it existed in order to request
`
`it. As noted above, there is no indication of when the Supplement was catalogued.
`
`8.
`
`It is also worth mentioning that even today this Supplement is difficult
`
`to access, whereas other articles from the same period have since been digitized or
`
`uploaded. This Supplement’s contents are not indexed in PubMed (a common
`
`database for clinical research and POSAs), nor is this Supplement listed in the
`
`online listing of ('ircuiation Supplements from the American Heart Association
`
`UNITED THERAPEUTICS, EX. 2093
`7
`WATSON LABORATORIES v- UNITED THERAPEUTICS, IPR2017-01622
`
`Page 7 of 13
`
`
`
`lPR2017-01621
`
`and the Scientific Sessions. Indeed, I could not locate the Voswinckel abstract by
`
`searching for it in PubMed; whereas other articles published by Circulation such as
`
`Nagaya et al., “Plasma Brain Natriuretic peptide as a prognostic indicator in
`
`patients with primary pulmonary hypertension”, (2000) Circulation, 102(8): pp-
`
`865-870 (Endnote 71 of the Sulica and Poon reference in the Bennett Declaration
`
`at Ex. 1013, 47) can easily be located in PubMed.
`
`9.
`
`Even if it had been shown that the Supplement was catalogued by a
`
`library by a certain date that is relevant to these proceedings, a POSA exercising
`
`reasonable diligence still would not have been able to find the Voswinckel abstract
`
`because the Supplement lacks a meaningful table of contents and key word index
`
`for finding it.
`
`10.
`
`First, the table of contents for the Supplement provided by Dr.
`
`Bennett’s excerpts gives a single heading of “Abstracts From Scientific Sessions
`
`2004” which identifies pages “Ill-1 — 111-1 102”, the entire 1 102-page section
`
`containing the Voswinckel abstract (Ex. 1013, 29). This would not allow a POSA
`
`exercising reasonable diligence to locate it because it would require reviewing the
`
`thousands of abstracts contained within the 1102 pages.
`
`11.
`
`Second, the 262—page author and subject index obtained from the
`
`British Library for this Supplement, a copy of which was provided to me by
`
`UNITED THERAPEUTICS, EX. 2093
`8
`WATSON LABORATORIES v- UNITED THERAPEUTICS, IPR2017-01622
`
`Page 8 of 13
`
`
`
`IPR2017-01621
`
`counsel (Ex. 2096,59—262), would not allow a POSA exercising reasonable
`
`diligence to locate the Voswinckel abstract. While the Voswinckel abstract is
`
`listed in the author portion of the index (Ex. 2096, 54), it is only listed twice in the
`
`subject index under the categories “Prostaglandins” (Ex. 2096, 219) and
`
`“Pulmonary Circulation” (Ex. 2096, 221). However, it is not listed under the more
`
`descriptive categories “Hypertension” (Ex. 2096, 165—166), “Hypertension,
`
`Pulmonary” (Ex. 2096, 166—167), “Prostacyclin” (Ex. 2096, 218), “Pulmonary
`
`Heart Disease” (Ex. 2096, 221) or “Vasodilation” (Ex. 2096, 255).
`
`In particular,
`
`each of the categories “Hypertension, Pulmonary”, “Prostacyclin”, and
`
`“Pulmonary Heart Disease” cite to abstracts with the term “pulmonary
`
`hypertension” in the title.
`
`In my opinion, a POSA would be more likely to search
`
`for a pulmonary hypertension abstract like the Voswinckel abstract in one of these
`
`more descriptive categories than in the two general ones where it is cited.
`
`Document 2. R. Sulica and M. Poon, “Medical therapeutics for pulmonary
`
`arterial hypertension: from basic science and clinical trial design to evidence-
`
`based medicine,” Expert Review of Cardiovascular Therapy, 3, 3 (March
`
`2005): 347-360
`
`12.
`
`The second reference in the Bennett Declaration discussed in par. 33
`
`is an article by Sulica and Poon, provided as Ex. 1047, that cites the Voswinckel
`
`UNITED THERAPEUTICS, EX. 2093
`9
`WATSON LABORATORIES v- UNITED THERAPEUTICS, IPR2017-01622
`
`Page 9 of 13
`
`
`
`IPR2017-01621
`
`abstract. The Bennett Declaration also provides a Scopus record for the Sulica and
`
`Poon publication (Ex. 1013, 39-48). The Bennett Declaration uses the Sulica and
`
`Poon reference to assert that the Voswinckel abstract was able to be located by
`
`these authors at least by March 2005 when they published their own article citing
`
`to it. However, it is possible that these authors learned about the Voswinckel
`
`abstract through methods other than searching at a library that would not be
`
`available to a POSA exercising reasonable diligence to find it.
`
`13.
`
`First, the Scopus record provided by the Bennett Declaration shows
`
`that the Voswinckel abstract has not been cited by any other medical publications
`
`as of the 2017 date of the Scopus record. Ex. 1013, 39-48. Endnote 1 of the
`
`Scopus record (Ex. 1013, 40), for example, shows a reference by Simmoneau et al-
`
`that was cited by other authors and researchers 1321 times:
`
`Elm I, 1|...r.ll..|l|r|r|ul|n. "ulrl.rl\' lwpI-t'I-‘rl‘ I'l.‘
`I
`5-1
`.'
`'
`'I ."‘.'".'..‘.v.:- ': ‘
`.‘.'.'.y.; "I
`:1“ ""h'
`;-|
`_
`ll
`ll 1'-
`
`.lll
`
`"‘
`
`‘ .'
`
`I'd-1|
`
`"|"-.a"
`
`..m'.r—'i|\ i.
`
`By contrast, the Voswinckel abstract, in endnote 51 (Ex. 1013, 45), lists no
`
`citations by anyone else:
`
`UNITED THERAPEUTICS, EX. 2093
`10
`WATSON LABORATORIES v- UNITED THERAPEUTICS, IPR2017-01622
`
`Page 10 of 13
`
`
`
`IPR2017-0162l
`
`14.
`
`In view of the fact that the Voswinckel abstract has never been cited
`
`by others besides Drs. Sulica and Poon according to the Scopus record, it is
`
`possible that they learned about the Voswinckel abstract while attending the New
`
`Orleans meeting in 2004 for which the Supplement was published. As seen in
`
`endnote 70 (Ex. 1013, 47), Dr. Sulica did in fact present on pulmonary
`
`hypertension at the very same meeting and published an abstract in the same
`
`supplement:
`
`Thus, Dr. Sulica might have obtained a copy of the Meeting Abstracts by virtue of
`
`her participation at the meeting, or herself being an author of an abstract in the
`
`same Supplement. However, learning about it these ways would not indicate that it
`
`could be located by a POSA exercising reasonable diligence attempting to find it
`
`through indexing records who had no advance knowledge of its existence.
`
`15.
`
`Second, I have been informed by counsel that Dr. Sulica (the lead
`
`author) was one of the clinical principal investigators working on the subject
`
`matter underlying the Voswinckel abstract around the time she published her
`
`article with Dr. Poon. Ex. 2095. The documents do not show exactly when Dr.
`
`Sulica’s work began on the clinical trial, but it is possible that Dr. Sulica learned
`
`UNITED THERAPEUTICS, EX. 2093
`11
`WATSON LABORATORIES v- UNITED THERAPEUTICS, IPR2017-01622
`
`Page 11 of 13
`
`
`
`IPR2017-01621
`
`about the Voswinckel abstract fiom interactions with the other investigators in this
`
`study.
`
`16.
`
`Third, as mentioned above regarding the Supplement, the Voswinckel
`
`abstract is one of thousands of abstracts in a bound llO2—page supplement, which
`
`was not widely available nor carried by many libraries, and which, when it was
`
`carried, was catalogued only generally in the one instance identified in the Bennett
`
`Declaration. And while other libraries do also carry the parent journal Circulation,
`
`it is not clear that their cataloguing for supplements would be any more detailed
`
`than that of the British Library. Dr. Bennett has provided no records indicating
`
`that the particular supplement containing the Voswinckel abstract has been
`
`catalogued at any other library and, if so, when it was catalogued.
`
`17.
`
`If a POSA or other researcher did not already know about the abstract
`
`from the AHA Scientific Sessions meeting or otherwise, the abstract could have
`
`been found only by searching the Subject Index in the hard copy of the Supplement
`
`or by flipping through it page by page. For this reason and the reasons cited above,
`
`I do not believe that a POSA exercising reasonable diligence could have easily
`
`accessed the Voswinckel abstract based on the materials identified in the Bennett
`
`Declaration.
`
`UNITED THERAPEUTICS, EX. 2093
`12
`WATSON LABORATORIES v- UNITED THERAPEUTICS, IPR2017-01622
`
`Page 12 of 13
`
`
`
`IPR2017-01621
`
`18.
`
`I hereby declare that all statements made herein of my knowledge are
`
`true and that all statements made on information and belief are believed to be true;
`
`and further that these statements were made with the knowledge that willful false
`
`statements and the like so made are punishable by fine or imprisonment, or both
`
`under Section 1001 of Title 18 of the United States Code.
`
`Date:
`
`April 25: 2018
`
`‘
`J5 /
`
`/
`. £0 hflE-a’Z—a.
`
`Pilar Wyman
`
`UNITED THERAPEUTICS, EX. 2093
`13
`WATSON LABORATORIES v- UNITED THERAPEUTICS, IPR2017-01622
`
`Page 13 of 13
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
