`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`V.
`
`UNITED THERAPEUTICS CORP.
`Patent Owner
`
`Patent No. 9,339,507
`Issue Date: May 17, 2016
`Title: TREPROSTINIL ADMINISTRATION BY INHALATION
`
`Inter Partes Review No. 2017-01622
`
`
`DECLARATION OF AARON TRIPPE
`
`UNITED THERAPEUTICS, EX. 2106
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 1 of 19
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`Declaration of Aaron Trippe
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`I, Aaron Trippe, hereby declare as follows:
`
`L.
`
`I graduated with an A.B. in Computer Science anda certificate in
`
`Neuroscience from Princeton University in 2012. Upon graduation I was elected as
`
`a memberof Sigma Xi, the Scientific Research Society. While attending Princeton,
`
`I worked in the lab of Dr. Naomi Leonard developing a multi-camera motion
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`tracking system and conducted research onartificial neural networks under Dr.
`
`Ken Norman. From 2012 to 2015, I was employed by Elysium Digital, LLC, a
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`technicallitigation consulting companyspecializing in providing computer science
`
`and electrical engineering expertise in legal disputes involving intellectual
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`property, computer forensics, and other high-tech subject matter. In 2015, Elysium
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`Digital was acquired by the risk management company Stroz Friedberg, LLC. I am
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`currently employed as a Managerin the Intellectual Property division of Stroz
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`Friedberg, LLC. During my time at Elysium Digital and Stroz Friedberg, I have
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`worked on over 100 technical matters involving computer forensics, computer
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`networks, mobile applications, microprocessor technology, and other diverse fields
`
`within computer science. My CV and Biography are provided as Ex. 2107.
`
`a
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`I am a paid consultant for United Therapeutics Corporation (“United
`
`Therapeutics”), the assignee of U.S. Patent No. 9,339,507 (“the ’507 patent”), in
`
`connection with IPR2017-01622. My compensation does not depend on the
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`content of my opinionsor the disposition of this proceeding.
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`3.
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`At the request of United Therapeutics, I reviewed various archived
`
`Internet web pages available through the Wayback Machine, a tool provided by the
`
`Internet Archive. The statements in this declaration are made based on my review
`
`of those archived pages, my training and experience, and other materials I
`
`reviewedin connection with this matter. Specifically, I reviewed the Ex. 1014
`
`(“Butler Affidavit’), Ex. 1009 (“Ventavis label”), Ex. 1042 (“Commission
`
`Decision”), Ex. 1043 (“EU Community Register”), Ex. 1044 (“Summary of
`
`Decisions”), Ex. 1051 (“European Commission — Homepage’’), Ex. 1053
`
`(“European Commission Exhibit”), and paragraphs 105 and 106 of Ex. 1002
`
`(“Donovan Declaration’’), all submitted in this matter by Watson Laboratories, Inc.
`
`(“Watson”). In addition, I reviewed public materials on the Internet Archive (such
`
`as the Internet Archive FAQpageathttp://archive.org/about/faqs.php), Alexa
`
`Internet, and other relevant topics.
`
`I. BACKGROUND: CRAWLING, INDEXING, AND SEARCH
`
`4.
`
`The following paragraphs regarding crawling, indexing, and searching
`
`on the internet are applicable to the 2002-2006 timeframe, which I am advised is
`
`the relevant timeframe for the documents and webpages Watsonhasidentified for
`
`this proceeding, even though some information maybepresented in the present
`
`tense.
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`5.
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`The Internet consists of a vast amount of unstructured data. Unlike a
`
`library, where documents are centrally sorted and indexedto facilitate searching,
`
`web pagesare hosted by a widevariety ofthird parties and there is no universal
`
`way of organizing them. Search engines, such as Google, have attempted to solve
`
`this problem by locating Internet content and structuring it to allow for retrieval in
`
`response to user queries. Sinceat least the early 2000s, keyword search engines
`
`have been one of the main waysusers locate information on the Internet, so much
`
`so that the verb “Google” has entered the English lexicon.
`
`6.
`
`At a high level, most keyword search engines use a crawler-indexer
`
`architecture. A web crawler navigates from website to website by following
`
`hyperlinks, a process called crawling or spidering. It feeds information(e.g. textual
`
`content) about each identified site to an indexer, which builds an index. The index
`
`is an organized representation of the crawled content (or a subset of the crawled
`
`content) that facilitates fast identification of websites for keyword queries. Search
`
`engines also employ ranking algorithms, which rank the responses to a query based
`
`on various indicators, such as number of keywordhits, indicators of website
`
`popularity (such as the numberof incoming links), word relevance rankings,etc.
`
`a
`
`Webcrawlers can be operated independently of indexers, and thus
`
`used for other purposes than user-facing search engines. One example ofthis is the
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`crawler operated by the Internet Archive’s Wayback Machine, which usesit for
`
`locating and saving website content in order to create an archive of websites as
`
`they existed at a particular point in time. Alexa Internet operated a crawlerstarting
`
`in the 1990s that performed a similar function as the Wayback Machine crawler,
`
`and in someinstances the information archived by AlexaInternet is providedto the
`
`Internet Archive for storage in its archive of website content.'* The archiving of a
`
`web page does not require or imply the indexing of a page for search by a search
`
`engine. Archived pages can simply be maintained in connection with a given URL
`
`and any relevant metadata, such as the date the page was archived, such as in the
`
`case of the Wayback Machineof the Internet Archive. As a result, while words or
`
`phrases maybepresent throughout a website that has been crawled by the Internet
`
`Archive or Alexa Internet, that does not mean such words or phrases are searchable
`
`' Ex. 2118 is a true andcorrect copy of Kalev Leetaru, “The Internet Archive
`
`Turns 20: A Behind The Scenes Look At Archiving The Web,”retrieved from
`
`https://www.forbes.com/sites/kalevleetaru/2016/01/18/the-internet-archive-turns-
`
`20-a-behind-the-scenes-look-at-archiving-the-web/#1a67d0fc82e0, accessed on
`
`June 19. 2018.
`
`* Ex. 2119 is a true and correct copy of the webpage “Alexa Crawls,” retrieved
`
`from https://archive.org/details/alexacrawls, accessed on June 19, 2018.
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`through any public, contemporary search engineas related to the website or even
`
`that links on the parent website would lead a person to individual archived content.
`
`Theresult is that the website and any ofits individual webpages would not
`
`necessarily be searchable and thusidentifiable using a public, contemporary search
`
`engine.
`
`8.
`
`Furthermore, while a given party mightoperate several crawling
`
`programsin parallel to speed up their collection of information, web crawlers from
`
`different parties typically operate independently of each other. The set of web
`
`pages crawled and indexedbysearch provider A typically differs from the set
`
`crawled and indexedby search provider B (though the sets may overlap). This also
`
`means that pages may be crawled bythird parties such as the Internet Archive or
`
`Alexa Internet, yet still not crawled or indexed by one or more search providers
`
`and thus not readily available through a keyword search.
`
`Il.
`
`REVIEW OF ARCHIVED PAGES
`
`a.
`
`OptiNeb-ir Manual
`
`9.
`
`I wasasked to navigate to the URL
`
`https://web.archive.org/web/20040718112852/http://www.nebu-
`
`tec.de:80/PDFE/GA_B de.pdf and provide my opinion regarding the manner in
`
`whichit was archived.
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`10.
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`After navigating to said URL, I then clicked “About this capture”in
`
`the lower right-hand cornerof the top bar. This displays information about the
`
`archived page, including which organization captured it, the collection to whichit
`
`belongs, and the timestamps of any sub-resources (such as external images or
`
`scripts). I noted that the organization that captured the pageis called “Alexa
`
`Crawls,” and the crawl is in the collection “Alexa Crawl DX.” The descriptions
`
`underneath the organization and collection indicate both “Alexa Crawls” and
`
`“Alexa Crawl DX” are connected to Alexa Internet, and that Alexa Internet
`
`donates their crawl data to the Internet Archive. An imageof the “Aboutthis
`
`capture” information forthis particular .pdf is provided in Ex. 2120.*
`
`b.
`
`European Community Register website
`
`11.
`
`I was asked to navigate to a series of identified URLs on the
`
`“ec.europa.eu” domain and provide my opinion regarding the earliest available
`
`archived version of those websites through the Internet Archive’s Wayback
`
`Machine.
`
`* Ex. 2120 is a true and correct copy ofthe “Aboutthis capture”information for
`
`the .pdf located at https://web.archive.org/web/20040718112852/http://www.nebu-
`
`tec.de:80/PDF/GA_B_de.pdf.
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`12.
`
`I navigated to the Internet Archive’s Wayback Machine, whichis
`
`available at the URL https://web.archive.org. I entered the URL
`
`http://ec.europa.eu/health/documents/community-register/ into the search bar,
`
`which resulted in a display of the dates of all archived versionsof this page
`
`available through the Wayback Machine.* Accordingto the results page, the
`
`earliest available archived version of the website at this URL is dated October12,
`
`2013.°
`
`13.
`
`I then entered the URL
`
`http://ec.europa.eu/health/documents/community-register/html/h255.htm into the
`
`Wayback Machine. Accordingto the results page, the earliest available archived
`
`‘Ex. 2121 is a true and correct copy of the webpageat
`
`https://web.archive.org/web/20130801000000*/http://ec.europa.eu/health/documen
`
`ts/community-register/.
`
`> Ex. 2122 is a true andcorrect copy ofthe webpageat
`
`https://web.archive.org/web/20131012140925/http://ec.europa.eu/health/document
`
`s/community-register/.
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`version is dated August 18, 2010.° ’ I navigated to the earliest archived version of
`
`this page, which lists a procedure with the EMEA number EMEA/H/C/474/II/5
`
`and a “close date procedure” of 8/09/2005. Forthis procedure, I attempted to locate
`
`the associated documents via the “summary publ,” “decision docs,” and “annex”
`
`dropdown menus.
`
`14.
`
`I noted that upon selection of each “summary publ” languageoption, a
`
`popup window appearedindicating the request could notbe processed.* I then
`
`entered the URL of each popup window into the Wayback Machinethat resulted
`
`‘Ex. 2123 is a true and correct copy of the webpageat
`
`https://web.archive.org/web/20100815000000*/http://ec.europa.eu/health/documen
`
`ts/community-register/html/h255 htm.
`
`7 Ex. 2124is a true and correct copy of the webpage at
`
`https://web.archive.org/web/20100818181435/http://ec.europa.eu/health/document
`
`s/community-register/html/h255.htm.
`
`‘Ex. 2125 is a true and correct copy of the popup windowresulting from the
`
`selection of the “EN” option in the “summary publ” menu
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`from each selected language option. None of the URLs had available archived
`
`Ba
`versions.
`
`ntll
`
`15.
`
`Upon selection of each “decision docs” and “annex”option, a popup
`
`window appeared, attempting to show an archived version of the associated PDF
`
`file. I observed that for each language option, the URL for the PDF was alwaysof
`
`the same format, namely the sub-URL
`
`http://ec.europa.eu/health/documents/community-register/2005/20050905 10259/
`
`followed by the name of the PDFfile (e.g. dec_10259en.pdf or
`
`anx_10259en.pdf). I found that for each language option, the popup window
`
`indicated there wasno available archived versionof the associated PDFfile.’ I
`
`then checked whether any archived pages existed under aforementioned sub-URL
`
`by navigating to
`
`° Ex. 2126 is a true and correct copy of the Wayback Machineresults for the
`
`webpage at the popup windowresulting from the selection of the “EN” option in
`
`the “summary publ” menu.
`
`' Ex. 2127 is a true and correct copy of the popup windowresulting from the
`
`selection of the “EN”option in the “decision docs” menu,and a true and correct
`
`copy of the popup windowresulting from selection of the “EN”option in the
`
`“annex” menu.
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`register/2005/2005090510259/*. No URLs werearchived underthis sub-URL."!
`
`16.
`
`Finally, I navigated to the current hosted version of the page at the
`
`URLhttp://ec.europa.eu/health/documents/community-register/html/h255.htm,
`
`whichalsolists a procedure with the EMEA number EMEA/H/C/474/II/5, a “close
`
`date procedure” of 8/09/2005, and three drop down menus(“summary publ,”
`
`“decision docs,” and “annex”) with different language options.'” Upon selection,
`
`the “decision docs”and “annex”options(all languages) each open a new tab with
`
`a PDFfile located under the sub-URL
`
`http://ec.europa.eu/health/documents/community-register/2005/2005090510259/
`
`(the same sub-URLtriggered by selection of the analogous menus in the archived
`
`'' Ex, 2128 is a true and correct copy of the webpageat
`
`https://web.archive.org/web/*/http://ec.europa.eu/health/documents/community-
`
`register/2005/2005090510259/*.
`
`? Ex, 2129 is a true and correct copy of the webpageat
`
`http://ec.europa.eu/health/documents/community-register/html/h255.htm as
`
`accessed on June 29, 2018.
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`page version mentioned abovein paragraph 15).'° Upon selection of each
`
`“summary publ” menuoption(i.e., all languages), a new tab opened showing
`
`content from a different URL than that triggered by selection of the analogous
`
`menu option in the archived page(i.e. the URLs of the popup windowsdiscussed
`
`in paragraph 14).'* I entered each of the URLstriggered by selection ofthe
`
`“summary publ” menu options into the Wayback Machineand observed that none
`
`of them had available archived versions."
`
`c.
`
`European Commission: Document Search Page
`
`17.
`
`I navigated to the Internet Archive’s Wayback Machine, whichis
`
`available at the URL https://web.archive.org. I entered the URL
`
`https://ec.europa.eu/transparency/regdoc/index.cfm?fuseaction=homeinto the
`
`'S Ex, 2130 is a true and correct copy of the new tab resulting from the selection of
`
`the “ENG”option in the “decision docs” menu anda true and correct copy of the
`
`newtab resulting from selection of the “ENG” option in the “annex” menu.
`
`Ex. 2131 is a true and correct copy of the new tab resulting from the selection of
`
`the “ENG”option in the “summary publ” menu.
`
`'S Ex, 2132 is a true and correct copy of the Wayback Machineresults for the
`
`webpageat new tab resulting from the selection of the “ENG”option in the
`
`“summary publ” menu.
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`search bar, which resulted in a display of the dates of all archived versionsofthis
`
`page available through the Wayback Machine. Accordingto the results page, the
`
`earliest available archived version of the website at this URL is dated January 1,
`
`2014.!° 17
`
`18.
`
`I then entered the top level domain of the website
`
`(https://ec.europa.eu) into the Wayback Machine and navigated to the earliest
`
`archived version.'* I clicked “Welcometo the European Commission!”, which
`
`loaded an archivedversion of the European Commission’s English language main
`
`'S Ex, 2133 is a true and correct copy of the webpage available at
`
`https://web.archive.org/web/20140115000000*/https://ec.europa.eu/transparency/r
`
`egdoc/index.cfm?fuseaction=home.
`
`'7 Ex. 2134 is a true and correct copy of the webpageavailableat
`
`
`
`doc/index.cfm?fuseaction=home.
`
`'S Ex. 2135 is a true and correct copy of the webpageavailableat
`
`https://web.archive.org/web/200605 13232957/http://ec.europa.eu/ (dated May 13,
`
`2006).
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`page. |” *’ I clicked “Documents”in the Quick Links on the bottom right of the
`
`page.” From here I clicked “Register of COM, SEC and C documents” which
`
`
`
`' Ex. 2136 is a true and correct copy ofthe webpage availableat
`
`https://web.archive.org/web/20060514064044/https://ec.europa.eu/index_en.htm
`
`(dated May14, 2006).
`
`*° Tn somecases, clicking on said link navigated to the URL
`
`https://web.archive.org/web/200605 13232957/https://index_en.htm, which has not
`
`been archived. I was able to navigate to the archived version of the European
`
`Commission’s English language main pagein these cases by entering
`
`https://ec.europa.eu/index_en.htm into the Wayback Machine
`
`*! Ex. 2137 is a true and correct copy of the webpage available at
`
`https://web.archive.org/web/20060613114419/http://europa.eu:80/documents/com
`
`m/index_en.htm (dated June 13, 2006).
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`redirected me to a French language page.” After selecting the option for English,”
`
`I observed that this was an archived version of the top level page for the European
`
`Commission documentregister, and that it is intended to provide access to COM,
`
`C, and SEC documentsas well as “other categories such as the agendas and
`
`minutes of Commission meetings.” Based on the content, the page is an early
`
`version of the web page shownin the “European Commission — Homepage”
`
`exhibit (Exhibit 1051).
`
`19.
`
`Ithen clicked “Document Search.” This took meto an archive of the
`
`URL http://ec.europa.eu/comm/secretariat_general/regdoc/recherche.cfm?CL=en.
`
`According to the top bar of Wayback Machine information, the earliest archived
`
`*? Ex. 2138 is a true and correct copy of the webpage available at
`
`https://web.archive.org/web/20060615094022/http://ec.europa.eu:80/comm/secreta
`
`riat_general/regdoc/registre.cfm (dated June 15, 2006).
`
`*3 Ex. 2139 is a true and correct copy of the webpage available at
`
`https://web.archive.org/web/200609201 11254/http://ec.europa.eu/comm/secretariat
`
`general/regdoc/registre.cfm?CL=en (dated September 20, 2006).
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`version ofthis page is dated June 15, 2006.The page provides an interface for
`
`searching documents.
`
`20.
`
`I entered “ventavis” in the “Word(s) in the title or subject” field and
`
`clicked search. This resulted in a page indicating the Wayback Machine did not
`
`have the resulting URL archived.”I also reviewed the archived materials underthe
`
`URL http://ec.europa.eu:80/comm/secretariat general/regdoc/.”° In this set, there
`
`* Ex. 2140is a true and correct copy of the webpagelocatedat
`
`https://web.archive.org/web/20060615002523/http://ec.europa.eu/comm/secretariat
`
`general/regdoc/recherche.cfm?CL=en.
`
`> Ex. 2141 is a true and correct copy of the webpage locatedat
`
`https://web.archive.org/web/20060615002523/http://ec.europa.eu:80/comm/secreta
`
`riat_general/regdoc/liste.cfm?CL=enresulting from a search for “ventavis.”
`
`°° Ex. 2142is a true andcorrect copy of the webpagelocatedat
`
`https://web.archive.org/web/*/http://ec.europa.eu:80/comm/secretariat_general/reg
`
`doc/*
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`wasone item with the MIMEtypeapplication/pdf, with a single archived version
`
`dated September 20, 2006, which is not Ex. 1009.7’
`
`21.
`
`Finally, I selected each of the different language options from the
`
`menu in the top right of the documentsearch page and,if any archived versions
`
`were available, observed the date of the earliest archived version as provided by
`
`the Internet Archive. I attempted to search “ventavis” from the earliest archived
`
`version and recorded the result. This information is shown in the table below.
`
`Date ofEarliest Archived
`eaneuaee codes
`Version
`28
`fr June17, 20067
`
`jen June 15, 2006
`
`Result of Search
`
`*7 Ex. 2143is a true andcorrect copyofthe .pdf located at
`
`https://web.archive.org/web/20060920103705/http://ec.europa.eu/comm/secretariat
`
`general/regdoc/rep/2/2006/EN/2-2006-737-EN-1-0.Pdf
`
`> Ex. 2144 is a true and correct copy of the webpage locatedat
`
`https://web.archive.org/web/20060617112044/http://ec.europa.eu:80/comm/secreta
`
`riat_general/regdoc/recherche.cfm?CL=fr
`
`» Ex. 2145 is a true and correct copy of the webpage locatedat
`
`https://web.archive.org/web/20060615002523/http://ec.europa.eu:80/comm/secreta
`
`riat_general/regdoc/liste.cfm?CL=en
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`,|Date of Earliest Archived Result of Search
`
`
`Language Code
`Vers;ersion
`de
`N/A (not archived)
`N/A
`N/A (not archived)
`N/A
`cs
`
`da
`August 27, 2006
`Page not archived
`
`el
`N/A (not archived
`N/A
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`es N/A (redirects to different|N/A
`
`page
`N/A (not archived
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`N/A
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` a August 27, 2006 Page not archived
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`eo N/A(not archived
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`mt
`N/A (not archived)
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`Ipl=sSNA (oot archived N/A
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`* Ex. 2146 is a true and correct copy of the webpage locatedat
`
`
`
`general/regdoc/recherche.cfm?CL=da
`
`1 Ex. 2147 is a true and correct copy of the webpage locatedat
`
`https://web.archive.org/web/20060827112249/http://ec.europa.eu/comm/secretariat
`
`general/regdoc/recherche.cfm?CL=it
`
`UNITED THERAPEUTICS, EX. 2106
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 18 of 19
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`
`
`IPR2017-01622
`
`Declaration of Aaron Trippe
`
`
`
`Result of Search
`
`oe
`
`Date of Earliest Archived
`Version
`N/A (notarchived
`N/A (not archived
`
`* The URL for
`
`the listed page is
`
`the language code appended to
`
`http://ec.europa.eu:80/comm/secretariat_general/regdoc/recherche.cfm?CL=
`
`22.
`
` Ihereby 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 knowledgethat willful false
`
`statements and the like so madeare punishable by fine or imprisonment, or both
`
`under Section 1001 of Title 18 of the United States Code.
`
`Date: July 11, 2018
`
`
`
`Aaron Trippe
`
`UNITED THERAPEUTICS, EX. 2106
`WATSON LABORATORIES v. UNITED THERAPEUTICS,IPR2017-01622
`Page 19 of 19
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`9
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`