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`BEFORE THE PA TENT TRIAL AND APPEAL BOARD
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`BRECKENRIDGE PHARMACEUTICAL, INC.
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`Petitioner
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`v.
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`NOV ARTIS PHARMACEUTICALS CORPORATION
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`Patent Owner
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`Case IPR2017-01592
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`U.S. Patent No. 8,410,131
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`DECLARATION OF DANIEL R. EVANS
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`I, Daniel R. Evans, declare as follows:
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`1.
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`I am a partner at Merchant & Gould, P.C.
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`I am lead counsel for
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`Breckenridge Pharmaceutical, Inc.
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`in the above-styled Inter Partes Review
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`(IPR2017-01592).
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`2.
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`As part of the preparation of the petition for inter partes review, I
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`researched and located certain prior art references identified in the petition, including
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`an abstract entitled "Sirolimus Prevents Tumor Progression: mTOR Targeting For
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`The Inhibition Of Neoplastic Progression," which was authored by Fulung Luan and
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`other authors (the "Luan Abstract").
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`3.
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`I identified the Luan Abstract and its date of publication from a review
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`of other prior art references. One of those references was an article entitled
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`"Inhibitors of mTOR and FTY 720" by D. Morel (hereinafter referred to as "Morel").
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`Morel, which was originally published in French in the September 1, 2001 issue of
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`La Press Medicale. I commissioned an English translation of Morel as part of my
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`prior art search in preparation of Breckenridge's IPR petition. A copy of both the
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`French version and English translation of Morel is attached hereto as Exhibit 1113.
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`Therein, Morel includes reports of a meeting referred as "Transplant 2001" that took
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`place in Chicago, Illinois on May 11-16, 2001. It can be seen that Morel was publicly
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`available at least as early as October 29, 2001. (See Ex. 1113, p. 9.)
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`4.
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`I noticed that Morel summarizes several sessions of the Transplant
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`2001 meeting with citations to the Supplement 1 issue of the 2001 American Journal
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`1
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`of Transplantation ("AJT") publication. (See Ex. 1113, p. 2.) As explained below,
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`the AJT publication is the official journal of the American Society of Transplantation
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`("AST") and the American Society of Transplant Surgeons ("ASTS"). I also noticed
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`that Morel summarizes an "exciting abstract" that relates to "the ability of sirolimus
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`to inhibit tumor proliferation and metastatic diffusion of a renal adenocarcinoma in
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`the mouse, as compared to a control, unlike the highly stimulative effect of
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`cyclosporine on tumor diffusion." (See Ex. 1113, p. 2.) I considered the "exciting
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`abstract" relevant to Breckenridge's petition.
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`5.
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`I decided to research the materials that were presented at Transplant
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`2001. From online research, I located a "Program Book" for the Transplant 2001
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`conference. My experience attending conferences such as these is that these Program
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`Books are compilations of information to be presented at conferences such as
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`Transplant 2001. The Program Books are provided to conference attendees at the
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`conference. A copy of the "Transplant 2001 Program Book" available online is
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`attached as Exhibit 1114 to this declaration.
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`6.
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`The Transplant 2001 Program Book states that the Transplant 2001
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`conference was organized by the AST and the ASTS, and was held in Chicago,
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`Illinois on May 11-16, 2001. (See Ex. 1114, pp. 6, 15.) The Transplant 2001 Program
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`Book included, among other things, copies of abstracts presented in "plenary,
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`concurrent and poster sessions" that took place at Transplant 2001. (See Ex. 1114,
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`2
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`p. 7.) As pages 6-7 of the Transplant 2001 Program Book state under the heading
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`Abstracts:
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`All oral abstract presentations listed in the program section have
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`been assigned a chronological program number. This number
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`corresponds with the number of the abstract printed in this
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`supplement. Poster presentations will be held in the River
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`Exhibition Hall. All poster presentations have been assigned a
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`chronological program number for reference when locating your
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`printed abstract. Board numbers for poster presentations are
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`identified with a P before the number. Please refer to the program
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`for the appropriate board number when locating a poster for
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`v1ewmg.
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`* * *
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`All accepted abstracts
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`are published m
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`this official
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`TRANSPLANT 2001 program book, a supplement to the new
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`joint AST/ASTS journal, American Journal of Transplantation
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`(AJT). All abstracts selected for presentation and the final
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`program are available on-line through the TRANSPLANT 2001
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`website, www.transplant200 l .org.
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`(See Ex. 1114, pp. 6, 7.)
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`3
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`7.
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`I reviewed the Transplant 2001 Program Book after I located it. As part
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`of that review, I discovered the Luan Abstract (Abstract# 428) on page 243 of the
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`Transplant 2001 Program Book. (See Ex. 1114, p. 243.) It is this copy of the Luan
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`Abstract from the Transplant 2001 Program Book that was submitted as page 001 in
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`Ex. 1005 to Breckenridge's IPR petition. I also discovered that pages 75-77 of the
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`Transplant 2001 Program Book show the schedule for the presentations at a plenary
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`session of Transplant 2001 on Monday, May 14, 2001. (See Ex. 1114, pp. 75-77.)
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`Page 77 of the Transplant 2001 Program Book states that the Luan Abstract was
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`presented at a Joint Plenary Session in the Sheraton Chicago Ballroom at 10:30am
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`on May 14, 2001. (See Ex. 1114, p. 071; see also Ex. 1010, p. 96 (i1190).) Copies of
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`pages 7 5-77 of the Transplant 2001 Program Book were submitted as pages 007-009
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`in Ex. 1005 to Breckenridge's IPR petition.
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`8.
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`After it was determined that Luan would be submitted as part of the
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`grounds in Breckenridge's IPR petition, I contacted Mr. Terrence L. Stokke ofE.L.F.
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`Research Services LLC ("ELF") in St. Paul, Minnesota. ELF provides document
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`research services. I asked Mr. Stokke to help confirm that the Transplant 2001
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`Program Book was a publication that was publicly available in May 2001.
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`9.
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`Mr. Stokke originally provided me with a copy of the Luan Abstract
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`with a date stamp ofNovember 7, 2001. (See Ex. 1115.) Therein, it can be seen that
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`the AJT publication is the official journal of the AST and ASTS. (See Ex. 1115, p.
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`1.) Subsequently, I conducted an online search to determine if the Luan Abstract had
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`4
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`been published earlier than November 2001. I reviewed the online library of
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`publications maintained by John Wiley & Sons, Inc. (the "Wiley Online Library")
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`for the AJT publication. The Wiley Online Library indicated that the Transplant
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`2001 Program Book, which included the Luan Abstract, was published in May 2001.
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`A copy of the results from my search of the Wiley Online Library are included as
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`pages 002-004 in Exhibit 1005 to Breckenridge's IPR petition.
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`10.
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`I note that the search results from the Wiley Online Library show that
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`the Transplant 2001 Program Book was assigned a Digital Object Indicator ("DOI")
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`of 10.ll 11/j.1600-6143.2001.tb00014.x. I am familiar with the use of DOis and
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`have attached hereto the International Organization for Standardization ("ISO")
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`publication (ISO 263 24: 12, attached as Exhibit 1116) that provides additional details
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`concerning DOis. In essence, a DOI is a unique alphanumeric string assigned by the
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`International DOI Foundation to identify a publication and provide its location on
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`the Internet. A DOI number typed into a web browser obtains the appropriate
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`webpage that hosts the electronic content. (See Ex. 1116 at 11, 1 Sect. 4.2.2 URI
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`presentation.) For example, a search conducted on the website of the International
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`DOI Foundation using the DOI number assigned to the Transplant 2001 Program
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`Book directs a user to the Wiley Online Library that states the Transplant 2001
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`Program Book was published in May 2001. (See Exhibit 1117 attached hereto, p. 1;
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`1 The citation of page 11 is to the added page number-the native number is page 5.
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`5
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`cf Ex. 1005 at 002-004.) Inclusion of the above-mentioned DOI for the Transplant
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`2001 Program Book into a web browser produces the above-mentioned Wiley
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`Online Library webpage.
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`11. After reviewing the results from the Wiley Online Library, I asked Mr.
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`Stokke to contact Wiley to see if they could confirm the publication date for the
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`Luan Abstract. Mr. Stol<l<.e and I worked together through a couple revisions of an
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`email to be sent to Wiley. Mr. Stokke ultimately sent the "final revision" of the email
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`to Wiley on June 5, 2017. The email from Mr. Stokke to the Journal Customer
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`Services department of Wiley was attached as page 006 in Exhibit 1005.
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`12. On June 6, 2017, Christine Goff of Wiley's Journal Customer Services
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`responded by email to Mr. Stold<.e. Ms. Goff stated that the Transplant 2001 Program
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`Book was published as the American Journal of Transplantation, Supplement 1,
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`Volume 1 (2001) in May 2001. Ms. Goffs email response is shown on page 005 of
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`Ex. 1005.
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`I declare under penalty of perjury under the laws of the United States of
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`America that the foregoing is true and correct.
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`Dated: January 18, 2018
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`6
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