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`Filed on behalf of: CSL Behring GmbH and CSL Behring LLC
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`__________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
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`CSL BEHRING GMBH and CSL BEHRING LLC,
`Petitioners,
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`v.
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`SHIRE VIROPHARMA INC.,
`Patent Owner.
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`__________________
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`U.S. Patent No. 9,616,111
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`__________________
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`DECLARATION OF THOMAS MACHNIG & HANNO WALDHAUSER
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`Page 1 of 6
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`CSL EXHIBIT 1084
`CSL v. Shire
`IPR2017-01512
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`ECLARATION __________________________ , ,
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`We. Thomas Machnig, MD. and Hanno Waldhauser. declare:
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`1. We are both permanent and full-time employees of CSL Behring.
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`a.
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`I. Thomas Machnig, am a trained physician for internal medicine
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`and hold the position of Director Medical Afl'airs at CSL Behring
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`since Sept. 2010.
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`b. I. Hanno Waldhauser, am a trained commercial clerk and
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`marketing / communication specialist and hold currently the
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`position of Director Marketing at CSL Behring and was acting as
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`Senior Global Product Manager in March 2012 at time of the 2012
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`AAAAI Annual Meeting (March 2—6, 2012).
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`2. We both attended the 2012 American Academy of Allergy, Asthma &
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`Immunology (AAAAI) annual meeting that was held from March 2 to March 6 in
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`Orlando, Florida. The meeting was attended by nearly 5,000 delegates from over
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`60 countries and featured 960 abstracts, 370 educational sessions, and 144
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`exhibitors.
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`See meeting summary provided at http://enewsaaaai.org/april-
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`2012/news-briefs/thousands-assemble-in-orlando-for-the-2012-annual-meeting.
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`Attendees
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`included an international audience of primarily physicians and
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`specialists in the area of allergy and immunology. as well as academics and
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`Page 2 of 6
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`industry representatives of companies who operate in the same field, most of them
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`having exhibitor booths during the conference.
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`3.
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`The attached Exhibit A is a true and accurate reproduction (scanned
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`copy) of a hardcopy handout of a poster titled “Safety, Pharmacokinetics (PK), and
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`Pharmacodynamics (PD) of Subcutaneous (SC) CINRYZE® (C1 Esterase Inhibitor
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`[Human]) with Recombinant Human Hyaluronidase (rHuPH20) in Subjects with
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`Hereditary Angioedema (HAE)” by J. Schranz et al. that was displayed during the
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`2012 AAAAI annual meeting (“Schranz poster”). The METHODS section of the
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`poster (enlarged as Exhibit B) includes “Figure 1. Study Design,” which provides
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`a simple graphical representation of a “Prior 200 Study” and a “Current 204
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`Study.” The Figure discloses that CINRYZE® was subcutaneously administered to
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`participants in the “Prior 200 Study” at concentrations of 333.3U/mL (1,000U in 2
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`separate injections of 1.5mL or 2,000U in 4 separate injections of 1.5mL).
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`4.
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`The Schranz poster was displayed as a late breaker abstract on
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`Tuesday, March 6th, at 9:45AM ET) in the poster viewing area / hall close to the
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`industry exhibition area of the conference and accessible to all registered delegates
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`and exhibitors of the conference. As discussed in paragraph 2, there were
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`approximately 5,000 people in attendance at the conference, all of whom were
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`permitted to view the poster. In our recollection, the poster was presented by one
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`of the authors on-site (as mandated by the conference) and discussed with relevant
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`2
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`physicians who are actively treating patients with Hereditary Angioedema as well
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`as other industry representatives of other manufacturers of HAE therapies
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`(including CSL Behring) while it was on display.
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`5.
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`Presenting authors as well as representatives of ViroPharma (at that
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`time ViroPharma was sponsoring the research of the study which results were
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`presented in the Schranz poster) were present on-site i.e. near the poster and
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`provided answers to viewers. Handouts of the poster were freely available and
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`picked-up by us as well as by other poster viewers.1 The abstract of the poster was
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`published as L21 in the abstracts section of the Journal of Allergy and Clinical
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`Immunology, Vol.129, Issue 2, AB369, Feb. 2012 (see attached Exhibit C). In
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`addition, ViroPharma and Halozyme issued a press release through the PR
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`Newswire service on March 6, 2012 titled “ViroPharma and Halozyme Announce
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`Positive Data of Subcutaneous Cinryze® (C1 esterase inhibitor [human]) with
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`Recombinant Human Hyaluronidase (rHuPH20)” (see attached Exhibit D)
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`confirming the presentation of a poster by Jennifer Schranz entitled “Safety,
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`Phrmacokinetics (PK), and Pharmacodynamics (PD) of Subctuaneous (SC)
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`Cinryze® (C1 inhibitor (C1 INH) with Recombinant Human Hyaluronidase
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`(rHuPH20) in Subjects with Hereditary Angioedema (HAE) at the 2012 annual
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`1 While we do not know how many copies of the Schranz poster were taken by
`viewers during the meeting, we note that we have typically distributed between 50-
`100 copies of the posters we have presented at similar conferences.
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`3
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`Page 4 of 6
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`AAAAI meeting held March 2-6 in Orlando, Florida. Finally, a Biotechnology –
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`Company Report of ViroPharma Incorporated by JMP Securities (attached as
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`Exhibit E) mentions on the day thereafter that the presentation of the Schranz
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`poster took place at the 2012 AAAAI Annual Meeting, and discloses a summary of
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`the poster together with a Figure of the mean plasma C1-INH Functional
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`Concentration (Figure 2 of the Schranz poster).
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`We further declare that all statements made herein of our own knowledge
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`are true and that all statements made on information and belief are believed to be
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`true. We further declare under penalty of perjury that the foregoing is true and
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`correct.
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`Dated:
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`Dated:
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`By:
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`By:
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`4
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`Page 5 of 6
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`Dated: ______________
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`Dated: ______________
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`By:
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`By:
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`5
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`Page 6 of 6
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