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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`PHIGENIX, INC.
`Petitioner
`v.
`IMMUNOGEN, INC.
`Patent Owner
`
`_____________________
`
`CASE IPR2014-00676
`U.S. Patent No. 8,337,856
`_____________________
`
`
`
`DECLARATION OF JOSEPH MORRIS
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`
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`IMMUNOGEN 2110, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
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`CASE IPR2014-00676
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` Declaration of Joseph Morris (Exhibit 2110)
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`I, Joseph Morris, declare as follows:
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`1. My name is Joseph Morris. I reside in San Francisco, California.
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`2.
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`I am employed by Genentech, Inc. (“Genentech”), located at 1 DNA
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`Way, South San Francisco, CA 94080. I am over 18 years of age, and I make this
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`declaration based on my own knowledge, personal experience, and my duties
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`within the ordinary course of business at Genentech. If called upon, I can
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`competently testify to the facts stated in this declaration.
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`3.
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`I am currently employed by Genentech as a Senior Litigation
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`Analyst. I have been employed by Genentech since May 2012. In my position, I
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`am knowledgeable as to Genentech’s regular business practices concerning
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`recordkeeping for Genentech’s promotional and marketing materials. Genentech’s
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`regular business practice
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`is and was
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`to retain copies of its literature,
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`documentation, press releases, marketing materials, product packaging, and media
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`for its pharmaceutical products, including Kadcyla®.
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`4.
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`I am also knowledgeable as to Genentech’s regular business practices
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`concerning recordkeeping for Genentech’s financial documents and information,
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`and Genentech’s contracts with third parties. Genentech maintains financial
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`documents and information in a financial database. Genentech maintains copies of
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`contracts in a contracts database.
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`- 2 -
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`IMMUNOGEN 2110, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
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`5.
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`CASE IPR2014-00676
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` Declaration of Joseph Morris (Exhibit 2110)
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`I searched Genentech’s Kadcyla® files, and confirmed that the
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`below-discussed exhibits are true and correct copies of documents and reports
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`from Genentech’s files. These documents have been kept in the normal course of
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`Genentech’s business, in accordance with Genentech’s policies. Based on my
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`personal knowledge and experience as a Genentech employee, as well as my
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`knowledge of Genentech’s document-retention policies and procedures, I can
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`testify competently as to the authenticity of these documents.
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`Promotional Materials
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`6.
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`Exhibits 2127, 2204, 2226-2238, 2318, 2325, 2334-2335, and 2340-
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`2341 are all promotional materials related to the drug Kadcyla® that I found and
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`collected from Genentech’s Global Product Regulatory System, a database that
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`Genentech uses routinely to store materials relating to its products, including
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`marketing materials.
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`7.
`
`Exhibit 2204 [HPK0001792100] is a true and correct copy of
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`Genentech presentation titled “Treatment Options for HER2+ Metastatic Breast
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`Cancer: A Back-to-Back Presentation of PERJETA and KADCYLA” with a
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`copyright date of 2013.
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`8.
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`Exhibit 2226 [TDM0002117400] is a true and correct copy of a
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`mobile advertisement regarding Kadcyla®’s important safety information for
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`healthcare professionals with a copyright date of 2013.
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`- 3 -
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`IMMUNOGEN 2110, pg. 3
`Phigenix v. Immunogen
`IPR2014-00676
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`9.
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`CASE IPR2014-00676
`
` Declaration of Joseph Morris (Exhibit 2110)
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`Exhibit 2227 [TDM0002117402] is a true and correct copy of a
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`mobile advertisement titled “Multiple antitumor activities from a single agent”
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`with a copyright date of 2013.
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`10. Exhibit 2228 [TDM0002264501] is a true and correct copy of
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`Kadcyla®’s website titled “The first antibody-drug conjugate for the treatment of
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`HER2-positive [HER2+] metastatic breast cancer [MBC]” with a copyright date of
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`2014.
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`11. Exhibit 2127 [TDM0001493600] is a true and correct copy of
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`marketing material titled “EMILIA: A Phase III trial establishing the efficacy and
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`safety of KADCYLA for the treatment of HER2+ metastatic breast cancer in
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`patients who have previously received trastuzumab and a taxane” with a copyright
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`date of 2013.
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`12. Exhibit 2234 [TDM0001957100] is a true and correct copy of a brand
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`alert titled “KADCYLA® (ado-trastuzumab emtansine) was designed to maintain
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`the HER2 suppression and anticancer activities of trastuzumab and to provide the
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`cytoxic strength of DM1” with a copyright date of 2013.
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`13. Exhibit 2229 [TDM0002134300] is a true and correct copy of a
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`Kadcyla® flyer titled “The first antibody-drug conjugate for HER2-positive
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`metastatic breast cancer” with a copyright date of 2013.
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`
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`- 4 -
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`IMMUNOGEN 2110, pg. 4
`Phigenix v. Immunogen
`IPR2014-00676
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`
`
`
`
`
`
`CASE IPR2014-00676
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` Declaration of Joseph Morris (Exhibit 2110)
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`14. Exhibit 2230 [TDM0002133900] is a true and correct copy of a
`
`Kadcyla® flyer titled “The first antibody-drug conjugate for HER2-positive
`
`metastatic breast cancer” with a copyright date of 2013.
`
`15. Exhibit 2231 [TDM0002153400] is a true and correct copy of a
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`Kadcyla® presentation titled “Hybrid in Motion” with a copyright date of 2013.
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`16. Exhibit 2232 [TDM0002652600] is a true and correct copy of a
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`brochure titled “KADCYLA: A different kind of treatment for HER2-positive
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`metastatic breast cancer has emerged” with a copyright date of 2014.
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`17. Exhibit 2238 [TDM0001464301] is a true and correct copy of a
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`Kadcyla® FAQ script for inbound calls for Kadcyla®’s support line.
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`18. Exhibit 2325 [TDM0001305700] is a true and correct copy of a
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`Kadcyla® promotional material titled “KADCYLA is the first FDA-approved
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`antibody drug conjugate (ADC) for HER2-posiitive metastatic breast cancer” with
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`a copyright date of 2013.
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`19. Exhibit 2233 [TDM0002154500] is a true and correct copy of a
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`Kadcyla® website banner.
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`20. Exhibit 2340 [TDM0002373400] is a true and correct copy of a
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`Kadcyla® script email titled “Survival data in HER2+ MBC by ER/PR status,”
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`which is dated March 10, 2014. The material accompanying the email has a
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`copyright date of 2014.
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`- 5 -
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`IMMUNOGEN 2110, pg. 5
`Phigenix v. Immunogen
`IPR2014-00676
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`CASE IPR2014-00676
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` Declaration of Joseph Morris (Exhibit 2110)
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`21. Exhibit 2341 [TDM0002481700] is a true and correct copy of a
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`Genentech-sponsored message titled “Genentech Shares Trial Results by Hormone
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`Receptor Status in HER2+ MBC” with a copyright date of 2014.
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`22. Exhibit 2318 [TDM0001940100] is a true and correct copy of a
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`marketing document titled “The next era of treatment: KADCYLA: The first
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`antibody-drug conjugate for HER2-positive metastatic breast cancer.”
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`23. Exhibit 2237 [TDM0001393200] is a true and correct copy of a
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`Genentech presentation titled “KADCYLATM (ado-trastuzumab emtansine) for the
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`Treatment of HER2-Positive Metastatic Breast Cancer in Patients Previously
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`Treated With Trastuzumab and a Taxane” with a copyright date of 2013.
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`24. Exhibit 2235 [TDM0002192700] is a true and correct copy of a
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`Kadcyla® script email titled “Proven survival benefit for your HER2+ MBC
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`patients,” which is dated November 11, 2013. The material accompanying the
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`email has a copyright date of 2013.
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`25. Exhibit 2236 [TDM0002192701] is a true and correct copy of a
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`Kadcyla® script email titled “Proven survival benefit for your HER2+ MBC
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`patients,” with an alternate title “Significant clinical benefit for your HER2+ MBC
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`patients.” The material accompanying the email has a copyright date of 2014.
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`26. Exhibit 2334 [HPK0002464300] is a true and correct copy of a
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`Kadcyla® banner titled “Improve survival in HER2+ MBC.”
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`- 6 -
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`IMMUNOGEN 2110, pg. 6
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
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`
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`CASE IPR2014-00676
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` Declaration of Joseph Morris (Exhibit 2110)
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`27. Exhibit 2335 [HPK0002464200] is a true and correct copy of a
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`Kadcyla® banner titled “Can you improve survival.”
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`License Agreement and Amendments
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`28. Exhibits 2262 through 2265 are redacted forms of a licensing
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`agreement between Genentech and ImmunoGen, Inc. (“ImmunoGen”), and three
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`amendments to the license agreement. These documents are stored in Genentech’s
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`contract database. In addition, I am informed and believe that they have been filed
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`with the U.S. Securities and Exchange Commission (“SEC”) and are publicly
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`available on the SEC website.
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`29. Exhibit 2262 is a true and correct redacted copy of a license
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`agreement between Genentech and ImmunoGen dated May 2, 2000.
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`30. Exhibit 2263 is a true and correct redacted copy of the first
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`amendment to the May 2, 2000 license agreement between Genentech and
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`ImmunoGen dated May 3, 2006.
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`31. Exhibit 2264 is a true and correct redacted copy of the second
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`amendment to the May 2, 2000 license agreement between Genentech and
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`ImmunoGen dated April 11, 2009.
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`32. Exhibit 2265 is a true and correct redacted copy of the third
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`amendment to the May 2, 2000 license agreement between Genentech and
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`ImmunoGen dated December 18, 2012.
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`
`
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`- 7 -
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`IMMUNOGEN 2110, pg. 7
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`Declaration ofJoseph Morris (Exhibit 2110)
`
`CASE IPR201 4-006 76
`
`33.
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`I hereby declare that all statements made herein of my own
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`knowledge are true and that all statements made on information and belief are
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`believed to be true; and further that
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`these statements were made with the
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`knowledge that willful false statements and the like so made are punishable by
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`fine or imprisonment, or both, under section 1001 of Title 18 of the United States
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`Code.
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`Executed January 22, 2015.
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`
`
`Joseph Morris
`
`IMMUNOGEN 2110, pg. 8
`Phigenix v. Immunogen
`|PR2014—00676
`
`IMMUNOGEN 2110, pg. 8
`Phigenix v. Immunogen
`IPR2014-00676
`
`
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