UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________
`APOTEX INC., APOTEX CORP., APOTEX PHARMACEUTICALS
`HOLDINGS INC., AND APOTEX HOLDINGS, INC.,
`Petitioners,
`v.
`OSI PHARMACEUTICALS, INC.,
`Patent Owner.
`____________________________________________
`Case IPR2016-01284
`U.S. Patent No. 6,900,221
`____________________________________________
`
`DECLARATION OF MR. MARK L. REISENAUER
`
`OSI 2023
`APOTEX V. OSI
`IPR2016-01284
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`APOTEX EX. 1038-001
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`IPR Trial No. 2016-01284
`Declaration of Mr. Mark L. Reisenauer
`I, Mr. Mark L. Reisenauer, declare as follows:
`1.
`My name is Mark L. Reisenauer.
`
`I.
`
`BACKGROUND
`
`2.
`
`I joined Astellas Pharma, the ultimate parent of patent owner, OSI
`
`Pharmaceuticals, in 2011 as Vice President, Sales and Marketing, Oncology. As
`
`part of my responsibilities, I led commercial activities supporting Tarceva®. In
`
`order to fulfill my responsibilities with respect to the Tarceva brand, I became
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`familiar with the historical commercial performance of the product, the market
`
`segments in which it competes and has competed, and the products it has competed
`
`with over time. I held that position until 2016, when I was promoted to my current
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`position as Senior Vice President, Oncology Business Unit. In my current
`
`position, I continue to have responsibility for commercial activities related to
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`Tarceva.
`
`3.
`
`Prior to joining Astellas, I held a variety of positions in innovator
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`pharmaceutical companies. I served as Senior Vice President and Chief
`
`Commercial Officer of Micromet Inc. (now part of Amgen), where I led investor
`
`and public relations, new product planning, and commercial launch planning.
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`Prior to that position, I held various sales and marketing leadership roles at Abbott,
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`Pharmacia, Bristol-Myers Squibb, and AstraZeneca.
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`IPR Trial No. 2016-01284
`Declaration of Mr. Mark L. Reisenauer
`My complete curriculum vitae is attached hereto as Appendix 1.
`
`4.
`
`II.
`
`TARCEVA, ITS USE, AND ITS COMMERCIAL SUCCESS
`5.
`OSI Pharmaceuticals, LLC (“OSI”) is a pharmaceutical company that
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`specializes in the development of molecular targeted therapies. OSI developed
`
`erlotinib and markets it under the brand name Tarceva. Tarceva is an oral, once-a-
`
`day tablet, classified as an inhibitor of epidermal growth factor (“EGFR”) tyrosine
`
`kinase. Tarceva is marketed jointly in the United States by OSI and Genentech,
`
`Inc.
`
`6.
`
`Tarceva was approved by the United States Food and Drug
`
`Administration (“FDA”) on November 18, 2004. Initially, the approved indication
`
`on the label for Tarceva was for treatment of patients with locally advanced or
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`metastatic non-small cell lung cancer (“NSCLC”) after failure of at least one prior
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`chemotherapy regimen. That was the only approved indication on the label for the
`
`first year Tarceva was on the market in the United States. A second indication for
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`first-line treatment of patients with locally advanced, unresectable or metastatic
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`pancreatic cancer, in combination with gemcitabine, was added to the label in
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`November 2005.
`
`7.
`
`Other NSCLC indications were added to the Tarceva label over time.
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`In 2010, an indication for maintenance treatment of patients with locally advanced
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`IPR Trial No. 2016-01284
`Declaration of Mr. Mark L. Reisenauer
`or metastatic NSCLC whose disease has not progressed after four cycles of
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`platinum-based first-line chemotherapy was added to the label, and in 2013, an
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`indication for first-line treatment of patients with metastatic NSCLC whose tumors
`
`have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21
`
`(L858R) substitution mutations as detected by an FDA-approved test. From
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`October 2016 to present, the sole NSCLC-related indication on the Tarceva label is
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`for first-line treatment of patients with metastatic NSCLC whose tumors have
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`epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R)
`
`substitution mutations as detected by an FDA-approved test receiving first-line,
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`maintenance, or second or greater line treatment after progression following at
`
`least one prior chemotherapy regimen.
`
`8.
`
`Tarceva has been a very commercially successful product since its
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`launch and throughout the time period it has been on the market in the United
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`States. As stated in OSI’s Form 10-K for 2005, Tarceva was the most successful
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`oncology drug launch in the United States in terms of number of patients treated
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`during the first 12 months of launch, and was the fourth most successful oncology
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`drug launch in terms of sales in the United States, at that time. OSI 2005 10-K at
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`4 (Exhibit 2033). Total U.S. net sales for Tarceva for the 2005 calendar year were
`
`approximately $275 million. Id.
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`IPR Trial No. 2016-01284
`Declaration of Mr. Mark L. Reisenauer
`By 2006, yearly net U.S. sales of Tarceva reached $400 million and
`
`9.
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`continued to rise, exceeding $500 million in OSI’s 2010 fiscal year. Exhibit 2034
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`(U.S. net sales 2004-2016).1 In OSI’s 2011 fiscal year, Tarceva net sales in the
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`U.S. were $567 million, $629 million in the 2012 fiscal year, $641 million in the
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`2013 fiscal year, $704 million in the 2014 fiscal year, $638 million in the 2015
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`fiscal year, and $540 million in the 2016 fiscal year. Exhibit 2034.
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`10.
`
`The revenue figures cited in paragraph 9 and contained in Exhibit
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`2034 are financial data based on records of Tarceva revenue that OSI tracks and
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`maintains in the course of its regularly conducted business activities, and that are
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`generated from OSI’s accounting records. The tracking and maintaining of these
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`revenues was a regular practice in the course of OSI’s business activities, and the
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`1 Exhibit 2034 provides net sales data on a yearly basis for Tarceva according to
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`OSI fiscal years, which currently run from April 1-March 31. OSI’s fiscal year
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`prior to 2010 (i.e., before OSI was acquired by Astellas), was based on the
`
`calendar year. To facilitate comparison of Tarceva revenues over time, however,
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`the data have been presented on an annual basis according to the fiscal year time
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`period currently employed by OSI and which has been used by OSI since its 2010
`
`acquisition.
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`IPR Trial No. 2016-01284
`Declaration of Mr. Mark L. Reisenauer
`records were created at the time the revenues were accrued by persons with
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`knowledge of, and whose responsibility was to record, sales information. In
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`addition, I routinely use, analyze, and rely upon these data in the regular course of
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`business in connection with my responsibilities at Astellas and with respect to
`
`Tarceva.
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`11. Much of the commercial success that Tarceva has enjoyed is directly
`
`traceable to its use in the treatment of NSCLC. As noted above, since launch in
`
`2004, the Tarceva label has always contained one or more indications related to
`
`treatment of NSCLC. Indeed, an NSCLC related indication was the only approved
`
`indication on the label for the first year Tarceva was on the market in the United
`
`States.
`
`12. OSI, in the regular course of its business activities, including for
`
`forecasting, market positioning, and assessment of performance reasons, among
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`others, tracks what portion of its net sales of Tarceva are related to treatment of
`
`NSCLC.
`
`13.
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`For OSI’s fiscal year 2010, for example, OSI estimated that at least
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`$347 million of its $513 million in U.S. net sales – approximately 68% – were
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`related to the use of Tarceva to treat NSCLC patients. Exhibit 2035 (U.S. NSCLC-
`
`related sales 2010-2016). In fiscal year 2011, the estimated percentage of revenues
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`Declaration of Mr. Mark L. Reisenauer
`related to NSCLC use rose to approximately 75%, approximately 81% in fiscal
`
`year 2012, approximately 85% in fiscal years 2013, 2014 and 2015, and was
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`approximately 82% in fiscal year 2016. Exhibit 2035.
`
`14.
`
`These estimates were based on analysis of a variety of data and/or
`
`market research collected and tracked by OSI in the regular course of its business
`
`activities. The estimates of Tarceva revenues associated with NSCLC treatment
`
`cited in paragraph 13 and contained in Exhibit 2035 are generated, tracked and
`
`relied upon in the course of OSI’s regularly conducted business activities. The
`
`estimation of NSCLC-related revenues was a regular practice in the course of
`
`OSI’s business activities, and these estimates were prepared on a routine and
`
`ongoing basis by knowledgeable personnel at OSI whose responsibility was to
`
`analyze the amount of revenue associated with Tarceva used to treat NSCLC.
`
`15.
`
`I am familiar with the methodology employed by OSI to estimate the
`
`magnitude of sales related to the use of Tarceva to treat NCSLC described in
`
`paragraphs 13 and 14 and Exhibit 2035, and have used, analyzed and relied on
`
`such data in the regular course of business in connection with my responsibilities at
`
`Astellas with respect to Tarceva.
`
`16.
`
`Through my role with the Tarceva brand, and my analysis of the
`
`historical commercial performance of the brand, the markets in which it competes,
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`IPR Trial No. 2016-01284
`Declaration of Mr. Mark L. Reisenauer
`and the products with which it competes, I have an understanding that the
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`proportion of NSCLC-related Tarceva revenues vis-à-vis total revenues before I
`
`came to Astellas in 2011 are in line with those set forth in paragraph 13 above,
`
`namely, that NSCLC-related revenues represent the majority of revenues generated
`
`by the Tarceva brand. However, because Astellas acquired OSI in 2010, the data
`
`on which those estimates were based are no longer available and/or easily
`
`accessible to OSI.
`
`17. As demonstrated in paragraphs 9 and 13 above and Exhibits 2034 and
`
`2035, sales of Tarceva, including those associated with NSCLC use, were steady
`
`and strong over time, and continue to be substantial, notwithstanding the
`
`introduction of other competing drugs indicated for the treatment of NSCLC,
`
`including Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo in 2015. Based
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`on Tarceva’s revenue stream over time, it is clear that physicians have prescribed
`
`and continue to prescribe Tarceva for their NSCLC patients in significant numbers.
`
`III. AVAILABILITY FOR CROSS EXAMINATION
`18.
`In signing this declaration, I recognize that the declaration will be
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`filed as evidence in a contested case before the Patent Trial and Appeal Board of
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`the United States Patent and Trademark Office. I also recognize that I may be
`
`subject to cross examination in the case and that cross examination will take place
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`IPR Trial No. 2016-01284
`Declaration of Mr. Mark L. Reisenauer
`within the United States. Ifcross examination is required ofme,I will appear for
`cross examination within the United States during the timeallotted for cross
`examination.
`
`IV. RIGHT TO SUPPLEMENT
`
`T reserve the right to supplement mydeclarationin the future to
`19.
`respond to any arguments that Petitioners raise and to take into account new
`information as it becomes available to me.
`
`Vv.
`
`JURAT
`
`I declare thatall statements made herein ofmy own knowledgeare
`20.
`true and thatall statements made on informationand beliefare believed to be true;
`and further that these statements were made with the knowledgethat willful false
`statements and the like so made are punishable byfine or imprisonment,or both,
`under Section 1001 of Title 18 ofthe United States Code.
`Dated: Ag d/ dov" )
`
`Jd A lar
`
`Mark L. Reisenauer
`
`
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`IPR2016-01284
`Declaration of Mark L. Reisenauer
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`APPENDIX 1 TO
`DECLARATION OF MARK L. REISENAUER
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`Canadian Citizen on Middle East Technology Engagements Returning to North America
`MARK L. REISENAUER
`Lindenhurst, IL 60046 (cid:120) marklreisenauer@yahoo.com (cid:120) 847-970-0825
`
`BOARD OF DIRECTORS | BIOTECH COMMERCIAL EXECUTIVE
`
`Senior Pharmaceutical Executive offering Board direction and perspective from deep experience in Big
`Pharma, Biotech, and Life Sciences partnerships. Strong commercial and strategic leader with background
`covering medical affairs, investor relations, product launch, and rapid market growth initiatives.
`Strategic Thinking | Commercial Strategy & Launch | Negotiations | Consensus Building | Goal Alignment
`Team Building & Empowerment | Cross-Business Collaboration | Leadership Development | Integrity
`
`BOARD EXPERIENCE
`
`Y-ME National Breast Cancer Organization
`Board of Directors Member
`(cid:131) Set direction in strategic role to drive organization to achieve next-level growth.
`Provided governance and oversight.
`(cid:131)
`
`2003–2009
`
`LUNGevity Foundation
`Board of Directors Member
`(cid:131) Guided executive team in strategy design, fundraising, governance, and tactical execution.
`(cid:131) Helped position for transition from regional to national organization.
`
`2003–2006
`
`PROFESSIONAL EXPERIENCE
`
`2011–Present
`
`Astellas Pharmaceuticals, Inc.
`Senior Vice President (SVP), US Oncology Business Unit (2016-Present)
`Vice President (VP), Oncology Sales and Marketing (2011-2016)
`Named as member of 3-person senior executive team directing all US commercial operations for Oncology.
`As VP, directed sales and P&L management with 138-person team. Designed matrix organizational structure
`to optimize customer experience and service delivery. Built out Oncology Commercial Franchise after
`acquisition of OSI.
`(cid:131) Significantly beat 5-year targets to grow Oncology to 50% of all US sales and positioned franchise as
`key business growth driver into the future.
`(cid:131) Directed launch of Tivozanib and Xtandi; grew Xtandi to Blockbuster Status of >$1B in 2015.
`Ignited sales of Tarceva to break 4-year trend of stagnant growth.
`(cid:131)
`Established corporate governance model and Senior Steering Committee for Oncology that expanded
`(cid:131)
`to other BUs. Served on Joint Governance Committees with Genentech, Medivation, and Aveo.
`Infused high-performance talent and cultivated internal up-and-comers into cross-pollinated roles.
`
`(cid:131)
`
`Micromet, Inc.
`Senior Vice President (SVP), Chief Commercial Officer
`Named to Executive Management Committee, leading strategy development and commercial operations.
`Drove commercial insights to prepare products for US launch with leadership team in Germany. Attended
`Board meetings and presented regularly. Supported investor relations, business development, and PR.
`(cid:131) Set new direction for registration to take new compounds through trials.
`Established value for target indication and presented to shareholders.
`(cid:131)
`(cid:131) Created launch plans encompassing sales, marketing, PR, medical affairs, patient advocacy, regulatory,
`and manufacturing.
`
`2007–2011
`
`Continued…
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`MARK L. REISENAUER
`Page Two (cid:120) marklreisenauer@yahoo.com (cid:120) 847-970-0825
`
`Abbott Laboratories
`Division Vice President / General Manager (VP/GM), Neuroscience (2006-2007)
`Directed 500-person franchise commercial operations, sales, marketing, business development, and clinical
`science management. Drove R&D strategy and commercial development.
`(cid:131) Grew P&L to encompass 30% of Abbott’s pharmaceutical division profits.
`(cid:131) Served on the Neuroscience Therapeutic Executive Committee.
`
`2002–2007
`
`General Manager (GM), Oncology Franchise (2002-2006)
`Launched/developed Oncology franchise. Built/led team of 12 Marketers and 12 Medical Science Liaisons.
`(cid:131) Created innovative regulatory strategy to achieve FDA filing and secure ODAC meeting despite trials
`missing primary endpoint.
`(cid:131) Directed Xinlay launch team and executed fully integrated marketing, PR, advocacy, manufacturing,
`and development program.
`Established Cooperative Group Strategy that led to 4 trials aimed at evaluating oncology compounds.
`
`(cid:131)
`
`Pharmacia Corp.
`Director Marketing, Breast Cancer & Portfolio Lead (2001-2002)
`Director, Breast Cancer Products (1999-2001)
`Oversaw Senior Product Manager plus product management team in design and execution of global
`marketing strategies for compounds to treat breast cancer. Coordinated market research studies; managed
`patient assistance and reimbursement program development.
`(cid:131) Managed commercial products: Ellence, Aromasin, Zinecard, and Trelstar.
`Introduced Ellence as first Breast Cancer Franchise product; drove 7-fold sales increase in 2001.
`(cid:131)
`(cid:131) Guided products through the compound development pipeline: Celebrex, Camptosar, and tyrosine
`kinase inhibitors. Launched Aromasin in 2000.
`
`1999–2002
`
`Bristol-Myers Squibb
`Associate Director, Oncology Global Marketing
`Facilitated design and delivery of global marketing strategies for Oncology products used to treat breast
`cancer, ovarian cancer, and non-small cell lung cancer. Coordinated key opinion leader (KOL) recruitment.
`(cid:131) Captured 20% year-over-year sales increase for TAXOL by introducing Regional Investigator
`Workshops in Asia, the Middle East, and Latin America.
`
`1997–1999
`
`1988–1997
`
`Zeneca Pharmaceuticals
`Product Manager (1997)
`Product Promotions Manager | Associate Promotions Manager (1994-1997)
`Marketing Research Manager | Marketing Research Analyst (1991-1994)
`Medical Sales Representative (1988-1991)
`Earned promotions through sales, marketing, and product management roles of increasing accountability.
`(cid:131) Delivered 56% increase in sales for Zoladex from 1996 to 1997 as Product Manager.
`Increased new prescription share for Casodex by 50% just 14 months after market introduction.
`(cid:131)
`Established first national program to bring together all patient support groups for prostate cancer.
`(cid:131)
`(cid:131) Generated 50% annual growth of Zoladex in 1995; launched breast cancer indication for Zoladex.
`(cid:131) Recognized with the President’s Circle of Excellence Award for sales achievement.
`EDUCATION & CREDENTIALS
`Bachelor of Arts (BA) in Political Science - University of Wisconsin (1987)
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