`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`CSL BEHRING GMBH and CSL BEHRING LLC,
`Petitioners,
`
`
`v.
`
`
`SHIRE VIROPHARMA INC.,
`Patent Owner.
`
`_________________
`
`U.S. Patent No. 10,080,788
`Case No. IPR2019-00459
`_________________
`
`
`
`
`DECLARATION OF HANNO WALDHAUSER
`
`Page 1 of 9
`
`CSL EXHIBIT 1013
`
`
`
`DECLARATION
`
`I, Hanno Waldhauser, declare:
`
`I am a permanent and full—time employee of CSL Behring. I am a
`
`trained commercial clerk and marketing / communication specialist and currently
`
`hold the position of Therapy Area Director EU.
`
`I was acting as Senior Global
`
`Product Manager in March 2012.
`
`Each year, academic and clinical leaders, as well as marketing directors
`
`and product managers attend the American Academy of Allergy, Asthma &
`
`Immunology (“AAAAI”) Annual Meeting, which showcases new research and
`
`developments in the areas of allergy, asthma, and immunology. See Ex. 1084 [2012
`
`Exhibitor Prospectus], p. 2.
`
`In 2012 the AAAAI annual meeting was held from
`
`March 2 to March 6 in Orlando, Florida. Ex. 1084 [2012 Exhibitor Prospectus, p. l],
`
`I attended that meeting, and a photograph of my access badge is provided as
`
`Exhibit 1085. The meeting was attended by nearly 5,000 delegates from over 60
`
`countries and featured 960 abstracts, 370 educational sessions, and 144 exhibitors.
`
`See Ex. 1086 [eNews Meeting Summary, p. 1],
`
`l. Attendees included an
`
`international audience of primarily physicians and specialists in the area of allergy
`
`and immunology, as well as academics and industry representatives of companies
`
`who operate in the same field, most of them having exhibitor booths during the
`
`conference. See Ex. 1087 [2012 AAAAI Meeting Program].
`
`Page 2 of 9
`
`
`
`3.
`
`Exhibit 1004 is a true and accurate reproduction (scanned copy) of a
`
`hardcopy handout of a poster
`
`titled “Safety, Pharmacokinetics
`
`(PK), and
`
`Phannacodynamics (PD) of Subcutaneous (SC) CINRYZE® (Cl Esterase Inhibitor
`
`[Human]) with Recombinant Human Hyaluronidase (rHuPH20) in Subjects with
`
`Hereditary Angioedema (HAE)” by J. Schranz et al. that was displayed during the
`
`2012 AAAAI annual meeting (“Schranz poster”). The METHODS section of the
`
`poster (enlarged as Ex. 1088 [Enlarged Schranz Figure 1]) includes “Figure 1. Study
`
`Design,” which provides a simple graphical representation of a “Prior 200 Study”
`
`and a “Current 204 Study.”
`
`The Figure discloses that CINRYZE® was
`
`subcutaneously administered to participants in the “Prior 200 Study” at a
`
`concentration of 333.3U/mL (1,000U in 2 separate injections of 1.5mL or 2,000U in
`
`4 separate injections of 1.5mL).
`
`The Schranz poster was displayed during the poster session held on
`
`Tuesday, March 6th, at 9:45 AM ET in the poster viewing area / hall close to the
`
`industry exhibition area of the conference and was accessible to all registered
`
`delegates and exhibitors of the conference. See Ex. 1087 [2012 AAAAI Meeting
`
`Program, p. 123—29], 125—31. Exhibit 1089 is a photograph of the poster in the
`
`poster viewing hall taken by me during the AAAAI annual meeting poster session.
`
`Id. As discussed in paragraph 2,
`
`there were approximately 5,000 people in
`
`attendance at the conference, all of whom were permitted to View the poster, take
`
`copies of the poster that were made available to the attendees, and also photograph
`
`Page 3 of 9
`
`
`
`the poster, as I did.1 In my recollection, the poster was presented by one of the
`
`authors on-site, as requested by the conference.
`
`See Exhibit 1090 [Poster
`
`Presentation Instructions, p. 1], 1. In my recollection, the poster was discussed with
`
`physicians who were actively treating patients
`
`suffering from Hereditary
`
`Angioedema (“HAE”), and with industry representatives of manufacturers of HAE
`
`therapies (including CSL Behring) while it was on display.
`
`Presenting authors, as well as representatives of ViroPharma (at that
`
`time ViroPharma was sponsoring the research of the study which results were
`
`presented in the Schranz poster) were present on-site (i.e., near the poster) and
`
`provided answers to viewers. Handouts of the poster were freely available to those
`
`attending the annual meeting.2 A copy of the handout was brought back to CSL
`
`Behring, and copies were then distributed within the company.
`
`I personally
`
`distributed copies of the handout to my medical and marketing colleagues within
`
`CSL Behring a few days after the 2012 AAAAI annual meeting.
`
`1 My colleague, Dr. Thomas Machnig, who is a trained physician and medical
`
`doctor (MD) for internal medicine and holds the position of Director Medical
`
`Affairs at CSL Behring, was also in attendance and viewed the Schranz poster.
`
`2 While I do not know how many copies of the Schranz poster were taken by viewers
`
`during the meeting, I note that my colleagues at CSL Behring typically distribute
`
`between 50—100 copies of the posters we have presented at similar conferences.
`
`Page 4 of 9
`
`
`
`6.
`
`On February 9, 2012, the Journal of Allergy and Clinical Immunology
`
`published the abstract of the Schranz poster online. See Ex. 1091 [Schranz Poster
`
`Abstract, p. AB3 69 (L21)], 3. The same day that the Schranz poster was presented,
`
`ViroPharma and Halozyme issued a press release through the PR Newswire service
`
`titled “ViroPharma and Halozyme Announce Positive Data of Subcutaneous
`
`Cinryze® (C1 esterase inhibitor [human]) with Recombinant Human Hyaluronidase
`
`(rHuPHZO)” (confirming the presentation of a poster by Jennifer Schranz entitled
`
`“Safety, Phrmacokinetics (PK), and Pharmacodynamics (PD) of Subctuaneous (SC)
`
`Cinryze® (C1 inhibitor
`
`(C1 INH) with Recombinant Human Hyaluronidase
`
`(rHuPH20) in Subjects with Hereditary Angioedema (HAE) at the 2012 annual
`
`AAAAI meeting held March 2—6 in Orlando, Florida. See Exhibit 1092 [Halozyme
`
`Press Release, p. 1—3], 1—3. In addition, IMP Securities published a “Biotechnology
`
`— Company Report” of ViroPharma Inc. the day after the poster was presented
`
`(March 7, 2012). See Ex. 1093 [IMP Company Report, p. 1—2],
`
`l—2. The report
`
`mentions that the presentation of the Schranz poster took place at the 2012 AAAAI
`
`Annual Meeting and includes a summary of the poster together with Figure 2 of the
`
`Schranz poster (presented as Figure l in the report), which presented data regarding
`
`the mean plasma Cl-INH Functional Concentration. Id. This further confirms the
`
`public availability of the Schranz poster.
`
`I declare that all statements made herein of my own knowledge are true
`
`and the statements made herein on information and belief are believed to be true.
`
`I
`
`Page 5 of 9
`
`
`
`further declare that all statements made herein were made with the knowledge that
`
`willful false statements and the like are punishable by fine or imprisonment or both
`
`pursuant to 18 U.S.C. § 1001.
`
`In signing this declaration, I understand that the declaration will be filed
`
`as evidence in a contested case before the Patent Trial and Appeal Board of the
`
`United States Patent and Trademark Office. I acknowledge that I may be subject to
`
`cross examination in the case and that cross examination will take place within the
`
`United States.
`
`If cross examination is required of me, I Will appear for cross
`
`examination within the United States during the time allotted for cross examination.
`
`I [Illi/ZZ/g
`
`Page 6 of 9
`
`
`
`
`
`Appendix A
`Appendix A
`
`
`
`
`
`
`
`
`
`Page 7 of 9
`
`Page 7 of 9
`
`
`
`APPENDIX A
`
`List of Materials Cited
`
`DESCRIPTION
`
`Jennifer Schranz et al., Safety, Pharmacokinetics (PK), and
`Pharmacodynamics (PD) ofSubcutaneous (SC) CINR YZE® (CI
`Esterase Inhibitor [Human]) with Recombinant Human
`Hyaluronia'ase (rHuPH20) in Subjects with Hereditary
`Angioedema (HAE), VIROPHARMA INC., Mar. 2—5, 2012
`American Academy of Allergy, Asthma, & Immunology Annual
`Meetin Poster L21 “Schranz” .
`
`
`
`
`
`
`
`
`
`
`
`Exhibitor Prospectus from 2012 American Academy of Allergy,
`
`Asthma & Immunology (AAAAI) Annual Meeting in Orlando,
`Florida (March 2—6, 2012),
`
`h - ://annua1meetin.aaaai.or- de/2012-exhibitora . df.
`
`Delegate badge of Hanno Waldhauser from AAAAI 2012 Annual
`Meetin .
`
`
`Thousands Assemble in Orlandofor the 2012 Annual Meeting,
`ENEWS NOW (June 2018), http://enews.aaaai.org/april-
`
`
`20 12/news=briefs/thousands-assemble-in-orlando-for-the—2012-
`
`
`
`annual-meetin ; downloaded on Nov. 9, 2018 .
`
`Final Program from AAAAI 2012 Annual Meeting,
`
`
`http://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Docu
`
`ments/VAM/AAAAI AM-12-Final-Pro- am EDU-Content. df.
`
`
`
`
`
`
`Enlared exce ts from Ex.1004.
`Photograph of Ex. 1004 taken at the 2012 AAAAI Annual
`Meetin; on Mar. 6,2012.
`Poster Presentation Information & Set-up Instructions,
`2018 AAAAI/WAO JOINT CONGRESS,
`http://annualmeeting.aaaai.org/UserFiles/AbstractPresenterInstru
`
`ctions. .df.
`
`XHEIBIT
`
`Ex. 1004
`
`Ex. 1084
`
`Ex. 1085
`
`Ex. 1086
`
`Ex. 1087
`
`Ex. 1088
`Ex. 1089
`
`EX. 1090
`
`Ex. 1091
`
`
`
`
`
`
`
`J. Schranz et al., Safety, Pharmacokinetics (PK), and
`
`Pharmacodynamics (PD) ofSubcutaneous (SC) CINRYZE® (CI
`
`
`Esterase Inhibitor [Human])with Recombinant Human
`
` Hyaluronidase (rHuPH20) in Subjects with Hereditary
`
`Angioedema (HAE), ViroPharma Incorporated, 129(2)
`
`
`J. ALLERGY & CLIN. IMMUNOL. AB369 (Abstract L21) (2012),
`WWW.sciencedirect.com/science/article/pii/SOO91674912000280
`
`
`(downloaded Sept. 25 2018 .
`
`Press Release from Halozyme Therapeutics, ViroPharma and
`
`Halo me Announce Positive Data 0 Subcutaneous Cin ze®
`
`
`
`
`
`Ex. 1092
`
`
`
`
`
`EXHIBIT
`
`
`
`
`
`
`
`
`
`Ex. 1093
`
`(CI esterase inhibitor [human]) with Recombinant Human
`Hyaluronidase (rHuPHZO) (Mar. 6, 2012),
`http://Www.halozyme.com/investors/news-re1eases/news—release-
`details/2012/ downloaded on Ar. 13, 2016 .
`Liisa A. Bayko et al., ViroPharma Incorporated Company
`Reort IMP SECURITIES Mar. 7 2012 .
`
`DESCRIPTION
`
`
`
`
`
`
`
`
`