UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`EXPERT DECLARATION OF MICHAEL E. TATE
`
`Aventis Exhibit 2149
`Mylan v. Aventis, IPR2016-00712
`
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`EXPERT DECLARATION OF MICHAEL E. TATE
`
`Aventis Exhibit 2149
`Mylan v. Aventis, IPR2016-00712
`
`
`
`I.
`
`INTRODUCTION
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`1.
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`My name is Michael E. Tate. I have been retained as an expert in this
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`case by Aventis Pharma S.A. (“Aventis”) and counsel for Aventis. I understand
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`that the commercial success of a product can be used as a secondary consideration
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`in demonstrating the non-obviousness of the underlying patented invention. The
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`following declaration contains my expert testimony regarding certain aspects of
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`secondary considerations relating to the obviousness of the subject matter claimed
`
`in U.S. Patent No. 8,927,592 (“the ’592 patent”).
`
`2.
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`This declaration is based upon information currently known to me. I
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`reserve the right to rely upon any additional information that becomes available to
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`me after the date of this declaration as well as to amend or modify this declaration
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`to reflect such information or if further research or analysis warrants. I also
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`reserve the right to offer rebuttal testimony to any evidence or argument advanced
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`by Mylan Laboratories Limited (“Mylan”) regarding issues of commercial success.
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`Attached to this declaration are schedules summarizing and supporting my
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`opinions.
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`PUBLIC VERSION
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`– 1 –
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`II.
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`PROFESSIONAL AND EDUCATIONAL BACKGROUND
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`3.
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`I am a Vice President of Charles River Associates (“CRA”) in its
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`Chicago office. CRA is an international business consulting firm focusing on,
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`among other things, intellectual property matters in the context of strategy,
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`licensing, valuation and litigation consulting. CRA is a leading provider of expert
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`damage analysis and testimony for complex intellectual property litigation matters.
`
`4.
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`I obtained a Bachelor of Business Administration degree, with a
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`concentration in finance, from the University of Houston in Houston, Texas.
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`Thereafter, I obtained a Master of Science degree in Industrial Administration from
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`Purdue University in West Lafayette, Indiana.
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`5.
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`I have served as a consultant to a wide variety of business and
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`industrial clients on matters involving financial analysis and modeling for the
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`purpose of interpreting and projecting data and evaluating the economic impact of
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`business decisions, transactions and economic events. I have served as an expert
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`witness or consultant in a wide range of litigation matters, including patent,
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`copyright, trademark and trade secret infringement litigation. My work on patent
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`litigation matters has involved the quantification of economic damages and an
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`evaluation of commercial success. I have also advised clients on strategic and
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`valuation issues relating to intellectual property and license negotiations.
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`6.
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`My curriculum vitae is attached hereto at Schedule 1.
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`PUBLIC VERSION
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`– 2 –
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`7.
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`CRA is being compensated on a rate times hours basis for the work
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`my staff and I perform. My current rate is $615 per hour. CRA’s compensation
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`does not depend in any way on the outcome of this litigation.
`
`III.
`
`INFORMATION RELIED UPON
`
`8.
`
`In performing the analysis and developing the opinions reflected in
`
`this report, I relied upon certain documents provided to me by counsel for Aventis,
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`along with certain publicly available information. A list of the information I have
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`cited to is attached hereto in Schedule 2.
`
`IV. BACKGROUND
`
`9.
`
`I understand from counsel that Mylan has filed a petition for inter
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`partes review alleging that the ’592 patent is invalid for obviousness.
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`I further
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`understand that the ’592 patent covers cabazitaxel injections sold under the brand
`
`name Jevtana®.1 Jevtana® is approved for the treatment of hormone-refractory
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`metastatic prostate cancer previously treated with a docetaxel-containing treatment
`
`regimen.2 Jevtana® was launched in the U.S. in July 2010.3
`
`1 Expert Declaration of Dr. Alton Oliver Sartor (Exh. 2176) at ¶ 192-195, 240.
`2 September 2016 Jevtana® Label (Exh. 2150) at 3.
`3 Sanofi-Aventis SEC Form 20-F (2010) (Exh. 2128) at 89/355; FDA News
`Release, FDA Approves New Treatment for Advanced Prostate Cancer (June 17,
`2010) (Exh. 2059) at 1.
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`PUBLIC VERSION
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`A.
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`10.
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`The ’592 Patent4
`The ’592 patent, titled “Antitumoral Use of Cabazitaxel,” issued
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`January 6, 2015. The ’592 patent claims methods of treating patients with prostate
`
`cancer that has progressed during or after treatment with docetaxel by
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`administering 20-25 mg/m2 of cabazitaxel in combination with a corticoid.5
`
`B.
`
`11.
`
`Prostate Cancer Overview
`
`Prostate cancer is the second most common cancer among American
`
`men, with 1 in 7 men expected to be diagnosed with the disease during their
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`lifetime.6 Cancerous cells in the prostate gland may form a tumor, and the tumor
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`may spread from the prostate to other areas of the body, such as the bones, the
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`blood, the lymph nodes, or other organs.7 Prostate cancer that has spread outside
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`of the prostate is described as advanced or metastatic.8 Some of the symptoms that
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`can be caused by advanced prostate cancer include pain in the hips, back, and other
`
`4 The discussion in this section is based on the ’592 patent and the Expert
`Declaration of Dr. Sartor.
`5 Exh. 2176 at ¶ 28.
`6 What is Prostate Cancer?, Jevtana.com, http://www.jevtana.com/what-is-
`prostate-cancer (Exh. 2151).
`7 Exh. 2151 at 1.
`8 Exh. 2151 at 1.
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`PUBLIC VERSION
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`areas from metastases to the bone, weakness or numbness in the extremities, and
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`loss of bladder and bowel control.9
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`C.
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`12.
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`Treatment Options
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`Prostate cancer can be treated in a number of ways depending on
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`whether the disease has spread beyond the prostate including surgery, radiation,
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`cellular immunotherapy, hormone therapy, and chemotherapy.10 Patients with
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`metastatic prostate cancer are frequently treated with hormone therapy that targets
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`testosterone.11 Hormone therapy does not cure metastatic prostate cancer, but for
`
`some men it can stop the disease from getting worse.12
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`13. Metastatic prostate cancer that continues to grow despite testosterone
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`levels that are as low as would be expected if the testicles were removed is
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`described as metastatic castrate-resistant prostate cancer (“mCRPC”) or metastatic
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`hormone-refractory prostate cancer (“mHRPC”).13 The terms mCRPC and
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`mHRPC have been used interchangeably.14
`
`9 Signs and Symptoms of Prostate Cancer, American Cancer Society®,
`http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-signs-
`symptoms (Exh. 2152) at 1.
`10 Prostate Cancer Treatment, Jevtana.com, http://www.jevtana.com/treatment
`(Exh. 2153) at 1.
`11 Exh. 2153 at 2.
`12 Exh. 2153 at 2.
`13 Exh. 2176 at ¶ 34.
`14 Exh. 2176 at ¶ 34.
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`PUBLIC VERSION
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`14. Chemotherapy is often used to treat metastatic prostate cancer if the
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`hormone therapy is no longer working.15 Mitoxantrone in combination with
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`corticosteroids was the first chemotherapy approved by the United States Food and
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`Drug Administration (“FDA”) for mCRPC in 1996.16 Mitoxantrone therapy was
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`shown to reduce pain, but not to increase survival.17 In 2004 the FDA approved
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`Taxotere® (docetaxel) chemotherapy in combination with prednisone for the
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`treatment of mCRPC based on a statistically significant increase in overall survival
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`as compared to mitoxantrone therapy.18
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`15.
`
`In April 2010 the FDA approved Provenge® (Sipuleucel-T) for the
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`treatment of asymptomatic or minimally symptomatic mCRPC.19 Provenge® is a
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`15 Exh. 2153 at 2.
`16 Novantrone Gets FDA Nod for Use in Advanced Prostate Cancer, Cancer
`Network (Dec. 1, 1996), http://www.cancernetwork.com/articles/novantrone-gets-
`fda-nod-use-advanced-prostate-cancer (Exh. 2154) at 1.
`17 Exh. 2176 at ¶ 36.
`18 FDA Approves New Indication for Taxotere – Prostate Cancer, FDA News
`Release (May 19, 2004),
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2004/ucm1083
`01.htm (Exh. 2155) at 1.
`19 Provenge FDA Approval Letter, Center for Biologics Evaluation and Research
`(April 29, 2010),
`http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/Appro
`vedProducts/ucm210215.htm (Exh. 2156) at 1.
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`personalized immunotherapy that uses a patient’s immune cells.20 A clinical study
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`of Provenge® demonstrated an overall survival benefit.21
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`16.
`
`In June 2010 the FDA approved Jevtana® (cabazitaxel) chemotherapy
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`in combination with prednisone for the treatment of mCRPC previously treated
`
`with docetaxel.22 Jevtana® therapy was shown to statistically significantly
`
`increase overall survival as compared to mitoxantrone therapy.23
`
`17.
`
`In April 2011 the FDA approved Zytiga® (abiraterone acetate) in
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`combination with prednisone for the treatment of mCRPC previously treated with
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`docetaxel.24 Zytiga® is an oral medication that inhibits androgen production.25 A
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`clinical study of Zytiga® with prednisone demonstrated an overall survival benefit
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`as compared to prednisone alone.26 In December 2012 the FDA approved Zytiga®
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`20 What Is Provenge Immunotherapy?, Provenge.com,
`http://www.provenge.com/advanced-prostate-cancer-immunotherapy.aspx (Exh.
`2157) at 1.
`21 Exh. 2157 at 1.
`22 Exh. 2059 at 1.
`23 Exh. 2059 at 1.
`24 Zytiga® FDA Approval Letter, Center for Drug Evaluation and Research (Apr.
`28, 2011),
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202379s000ltr.pdf
`(Exh. 2158) at 1, 7.
`25 How Zytiga® Works, Zytiga.com, https://www.zytiga.com/about-zytiga/how-
`zytiga-works (Exh. 2159) at 1.
`26 Why Zytiga®?, Zytiga® website, https://www.zytiga.com/about-zytiga/why-
`zytiga (Exh. 2160).
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`PUBLIC VERSION
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`in combination with prednisone for mCRPC not previously treated with
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`docetaxel.27
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`18.
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`In August 2012 the FDA approved Xtandi® (enzalutamide) for the
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`treatment of mCRPC previously treated with docetaxel.28 Xtandi® is an oral
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`medication that interferes with the connection between androgens and androgen
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`receptors.29 A clinical study of Xtandi® demonstrated an overall survival
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`improvement.30 In September 2014 the FDA approved Xtandi® for the treatment
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`of mCRPC not previously treated with docetaxel.31
`
`19.
`
`In May 2013 the FDA approved Xofigo® (Radium RA 223
`
`dichloride) to treat men with CRPC, symptomatic bone metastases and no known
`
`27 Zytiga® Supplemental FDA Approval Letter, Center for Drug Evaluation and
`Research (Dec. 10, 2012),
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202379Orig1s005lt
`r.pdf (Exh. 2161) at 1, 4.
`28 Xtandi® FDA Approval Letter, Center for Drug Evaluation and Research (Aug.
`31, 2012),
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203415Orig1s000lt
`r.pdf (Exh. 2162) at 1, 7.
`29 How Xtandi® Works, Xtandi.com, https://www.xtandi.com/how-xtandi-works
`(Exh. 2163) at 1-2.
`30 How Xtandi® May Help, Xtandi.com, https://www.xtandi.com/xtandi-clinical-
`trials (Exh. 2164) at 1.
`31 Xtandi® Supplemental FDA Approval Letter, Center for Drug Evaluation and
`Research (Sept. 10, 2014),
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203415Orig1s003lt
`r.pdf (Exh. 2165) at 1, 4.
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`visceral metastatic disease.32 Xofigo® is an intravenous injection of radioactive
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`radium 223.33 A clinical study of Xofigo® demonstrated an increase in overall
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`survival as compared to placebo plus the best standard of care.34
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`20.
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`Prostate cancer can be diagnosed and treated by urologists and
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`oncologists.35 Urologists are doctors that specialize in treating diseases of the
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`urinary system and male reproductive system.36 Urologists generally do not
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`administer chemotherapy.37 Oncologists are doctors that specialize in the
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`treatment of cancers.38 Oncologists treat prostate cancer with the full range of
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`therapies, including chemotherapy.39
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`32 Xofigo® FDA Approval Letter, Center for Drug Evaluation and Research (May
`15, 2013),
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203971Orig1s000lt
`r.pdf (Exh. 2166) at 1, 8.
`33 What Is Xofigo® Used For?, Xofigo.com, https://www.xofigo-
`us.com/patient/about-xofigo (Exh. 2167) at 1.
`34 FDA Approves New Drug for Advanced Prostate Cancer, FDA News Release
`(May 15, 2013),
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352363.ht
`m (Exh. 2168) at 1-2.
`35 Exh. 2153 at 2.
`36 Exh. 2153 at 2.
`37 Exh. 2176 at n.21.
`38 Exh. 2153 at 2.
`39 Exh. 2153 at 1; Exh. 2176 at ¶ 222, n.21.
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`1.
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`Relevant Market
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`21.
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`Jevtana® was approved in the U.S. by FDA on June 17, 2010 for use
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`in combination with prednisone for the treatment of patients with mCRPC
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`previously treated with a docetaxel-containing treatment regimen.40 Therefore, the
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`relevant market for Jevtana® is mCRPC patients who have progressed after being
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`treated with docetaxel. Current competitors in the post-docetaxel mCRPC market
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`include the chemotherapy Jevtana®, the advanced hormone therapies41 Zytiga®
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`and Xtandi®, and the radiopharmaceutical Xofigo®, Provenge®, mitoxantrone,
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`and retreatment with docetaxel.
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`22.
`
`Zytiga®, Xtandi®, and Xofigo®, Provenge®, and mitoxantrone may
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`be prescribed regardless of whether docetaxel has already been administered to the
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`patient. Jevtana®, in contrast, is specifically indicated for use after docetaxel has
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`been administered.42
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`40 Exh. 2059 at 1.
`41 I understand that doctors distinguish Zytiga® and Xtandi® from the traditional
`hormone therapies that were in use to lower hormone levels prior to the approval
`of Taxotere®. Exh. 2176 at ¶ 222.
`42 Exh. 2059 at 1.
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`PUBLIC VERSION
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`23. As noted by the American Cancer Society, docetaxel is favored as a
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`first-line chemotherapy treatment for mCRPC patients.43 At the time of
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`Jevtana®’s launch in July 2010, mitoxantrone was the standard chemotherapy
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`treatment for patients who had already received docetaxel.44 Jevtana® has since
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`become the favored chemotherapy in the post-docetaxel mCRPC market.45
`
`D.
`
`24.
`
`Benefits of Jevtana®
`
`The approval of Jevtana® was prioritized by the FDA and completed
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`in 11 weeks.46 I understand that this expedited approval came as a result of the
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`effectiveness of the drug in significantly extending survival of men suffering from
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`mCRPC and the fact that no other drug was available to extend life of this patient
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`group.47
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`25.
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`It is my understanding that Jevtana® injections are the commercial
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`embodiment of the ’592 patent.48 I also understand that the clinical benefits
`
`43 Chemotherapy for Prostate Cancer, American Cancer Society®,
`http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-
`treating-chemotherapy (Exh. 2169).
`44 Exh. 2176 at ¶ 39, 192-195, 240.
`45 Exh. 2169.
`46 Exh. 2059 at 1.
`47 Exh. 2059 at 1.
`48 Exh. 2176 at ¶ 192-195, 240.
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`PUBLIC VERSION
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`offered by Jevtana® are directly attributable to the patented features.49 I
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`understand that the ’592 patent has provided the following benefit:
`
`Jevtana® is the only chemotherapy that has demonstrated
`a statistically significant overall survival benefit post-
`docetaxel.50 Jevtana® reduced the risk of death by 28%
`with an improvement in median overall survival of 12.7
`months versus 15.1 months when compared to
`mitoxantrone.51
`
`Jevtana® has also been shown to provide a statistically
`significant improvement in progression-free survival and
`tumor response rate as compared to mitoxantrone.52
`Jevtana® is reported to produce less peripheral
`neuropathy, hair loss, nail changes, and taste alterations
`as compared to docetaxel chemotherapy.53
`COMMERCIAL SUCCESS ANALYSIS
`
`V.
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`26.
`
`I understand that the commercial success of a product can be used as a
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`secondary consideration in demonstrating the non-obviousness of the underlying
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`patented invention. The commercial success of Jevtana® can be measured in
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`terms of the sales and market share. Accordingly, I have prepared the following
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`analyses:
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`49 Exh. 2176 at ¶ 221. I have not been asked to opine on the nexus between the
`commercial success of Jevtana® and the ’592 patent.
`50 Exh. 2176 at ¶ 186, 223.
`51 Exh. 2128 at 28/335.
`52 Exh. 2176 at ¶ 186.
`53 Exh. 2176 at ¶ 213-214.
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`A.
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`Sales of Jevtana®
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`1.
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`Revenues
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`27.
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`The revenues generated from sales of Jevtana® are one indicator of
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`the product’s commercial success under the patents-in-suit. In just over six years
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`on the market (i.e., July 2010 through September 2016), Jevtana®’s total U.S. sales
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`exceeded $934 million.54 Jevtana®’s U.S. sales reached $182 million in 2011, the
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`drug’s first full year on the market.55 Sales of Jevtana® decreased in 2012 and
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`2013, around the time that Zytiga® and Xtandi® were introduced.56 Jevtana®’s
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`U.S. net sales have increased year-over-year beginning in 2013, despite the
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`increased competition in the post-docetaxel mCRPC therapy market, growing from
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`$114 million in 2013 to $141 million in 2015.57 The average annual growth rate
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`for U.S. net sales of Jevtana® was 11.1% from 2013 to 2015.58
`
`54 Schedule 3.
`55 Schedule 3.
`56 Schedule 3.
`57 Schedule 3.
`58 Schedule 3.
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`Figure 1 – U.S. Net Sales of Jevtana®59
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`
`
`
`
`April 2011: Zytiga® ApprovedApril 2011: Zytiga® ApprovedApril 2011: Zytiga® Approved
`
`
`
`
`
`Aug. 2012: Xtandi® ApprovedAug. 2012: Xtandi® ApprovedAug. 2012: Xtandi® Approved
`
`Q1 - Q3
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`$200
`
`$180
`
`$160
`
`$140
`
`$120
`
`$100
`
`$80
`
`$60
`
`$40
`
`$20
`
`$0
`
`2. Market Share
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`28. As discussed above, I understand that the relevant market for
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`Jevtana® is mCRPC patients who have progressed during or after using docetaxel.
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`Considering the drug used in this indication and market share data provided to me
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`by Aventis, the primary products in the post-docetaxel market that compete with
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`Jevtana® include Zytiga®, Xtandi®, Xofigo®, Provenge®, mitoxantrone, and
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`retreatment with docetaxel.
`
`29.
`
`I determined Jevtana®’s annualized share of a market consisting of
`
`Jevtana®, Zytiga®, Xtandi®, Xofigo®, Provenge®, mitoxantrone, hormone
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`59 Schedule 3.
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`therapy, and retreatment with docetaxel.60 Mitoxantrone is included in the All
`
`Other category, along with other cytotoxic agents and miscellaneous products.61
`
`62
`
`63
`
`64
`
`65
`
`60 Schedule 4.
`61 Monthly Jevtana Prostate Cancer Treatment Report: August 2014 Results,
`BrandImpact by AlphaImpact Rx and Symphony Health Solutions (September
`2014) (Exh. 2171) at 37. The Hormone Therapy category includes GnRH agonists
`(e.g., Lupron® and Zoladex®) and antagonists (e.g., degaralix), and oral anti-
`androgens (e.g., Casodex®). The All Other category includes other cytotoxic
`agents (e.g., mitoxantrone) and miscellaneous products (e.g., estramustine and
`ketoconazole), and excludes bisphosphonates and other products used to manage
`bone metastases (e.g., Xgeva® and Zometa®). Exh. 2171 at 37.
`62 Schedule 4.1.
`63 Schedule 4.
`64 Schedule 4.
`65 Schedule 4.
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`30.
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`The market share of Jevtana is especially significant, given that
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`Zytiga® and Xtandi are taken orally, which is more convenient for patients, and
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`are generally associated with fewer side effects than chemotherapy.66 The fact that
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`Jevtana® is able to command a sizable portion of the post-docetaxel mCRPC
`
`therapy market despite some patients’ aversion to the relatively harsh side effects
`
`of chemotherapy demonstrates that physicians recognize the benefits of Jevtana®.
`
`3. Marketing and Advertising
`
`31.
`
`I am not aware of any advertising efforts that would drive the sales
`
`and market share of Jevtana®.
`
`4.
`
`Pricing
`
`32.
`
`It does not appear that pricing has played a role in Jevtana®’s
`
`commercial success. The current wholesale acquisition cost (WAC) for Xtandi® is
`
`$9,370.01/month67, for Zytiga® is $8,628.03/month68, for Xofigo® is
`
`$22,051/month69, and for Jevtana® is $9,739.80/cycle70.71 These prices make clear
`
`66 Exh. 2176 at ¶ 222.
`67 Xtandi® is taken at four 40 mg capsules per day, and is sold as a bottle of 120
`capsules (a one-month supply). Aug. 2012 Xtandi® Label (Exh. 2173) at 2, 12.
`68 Zytiga® is taken at four 250 mg tablets per day, and is sold as a bottle of 120
`tablets (a one-month supply). Apr. 2011 Zytiga® Label (Exh. 2174) at 2, 17.
`69 Xofigo® is given as 6 intravenous injections over four-week intervals, and is
`sold as a vial of 162 µCi/6 mL. May 2013 Xofigo® Label (Exh. 2175) at 1, 13.
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`that Jevtana®’s commercial success cannot be attributed to low prices rather than
`
`the clinical benefits of the drug.
`
`5.
`
`New Chemical Entity Exclusivity
`
`33. New Chemical Entity (NCE) exclusivity that was granted by FDA for
`
`Jevtana® did not prevent Mylan or another party from entering the market. The
`
`’592 patent was filed on April 26, 2012 and issued on January 6, 2015. I
`
`understand that when FDA approval was obtained for Jevtana® in June 2010, five
`
`years of NCE exclusivity from the FDA were granted, which expired on June 17,
`
`2015.
`
`34.
`
`It is my understanding that there was no regulatory or legal reason that
`
`a market participant could not have developed a competing product during the
`
`NCE exclusivity period, with the intent of launching that product once the
`
`exclusivity expired.
`
`70 Jevtana® is given intravenously at 20-25 mg/m2 every three weeks (one cycle),
`and is sold as a vial of 60 mg per 1.5 mL (plus a vial of 5.7 mL of diluent). Exh.
`2150 at 3-4, 6.
`71 Red Book Data of Xtandi®, Zytiga®, Xofigo®, and Jevtana® (Exh. 2172). The
`Red Book is a reference on the pricing and product information of available
`pharmaceuticals. It is considered a reliable and commonly referenced resource in
`the pharmaceutical industry. The Red Book data in Exh. 2172 was accessed and
`exported on December 14, 2016 from http://micromedex.com/products/product-
`suites/clinical-knowledge/redbook.
`
`PUBLIC VERSION
`
`– 17 –
`
`
`
`VI. CONCLUSION
`
`35.
`
`In summary, it is my opinion that the sales and market share that
`
`Jevtana® has generated in the post-docetaxel mCRPC market are evidence of
`
`commercial success.
`
`_______________________________
`Michael E. Tate
`Vice President
`Charles River Associates
`December 23, 2016
`
`PUBLIC VERSION
`
`– 18 –
`
`
`
`Schedule 1
`
`Schedule 1
`
`
`
`
`
`
`
`
`
`
`
`MICHAEL E. TATE
`Vice President
`
`M.S. Industrial Administration,
` Purdue University
`
`B.B.A. Finance,
` University of Houston
`
`Mr. Tate has served as a consultant and expert witness in a wide range of litigation matters including
`commercial success, antitrust, patent and copyright infringement, breach of contract, bid rigging, trade
`secrets, lost profits, securities fraud, construction disputes, lender liability, personal injury, wrongful death,
`wrongful termination and a nuclear power plant prudence review.
`
`This experience includes testifying as an expert witness and consulting on accounting and economic issues
`involved in the determination of damages. This experience also includes revenue, cost and pricing
`determinations, the determination or evaluation of claims for economic loss, valuation of intellectual property
`rights, as well as the determination of incremental costs, cost allocations, cost of capital and lost profits, and
`reasonable royalties.
`
`Other experiences in the litigation process include assisting counsel in discovery, fact-finding and information
`management, as well as providing assistance to counsel at deposition and trial.
`
`EXPERIENCE
`
`1999–Present Vice President, Charles River Associates
`
`1994–1999
`
`Principal, Economic Consulting Group, A.T. Kearney, Inc.
`
`Manager, Dispute Analysis & Corporate Recovery Services Group
`1992–1994
`Price Waterhouse
`
`1987–1992
`
`Executive Consultant, Peterson Consulting
`
`PROFESSIONAL AFFILIATIONS
`
` Member, Licensing Executives Society
`
`
`
`
`
`
`
`
`
`Schedule 2
`
`Schedule 2
`
`
`
`Exhibit
`No.
`
`Exh. 2059
`
`Exh. 2128
`
`Exh. 2129
`
`Exh. 2130
`
`Exh. 2131
`
`Exh. 2132
`
`Exh. 2133
`Exh. 2150
`
`Exh. 2151
`
`Exh. 2152
`
`Exh. 2153
`
`Exh. 2154
`
`Exh. 2155
`
`Materials Cited
`
`Description
`FDA News Release, FDA Approves New Treatment for Advanced
`Prostate Cancer (June 17, 2010).
`Sanofi-Aventis SEC Form 20-F (2010), available at
`https://www.sec.gov/Archives/edgar/data/1121404/00011931251105
`0947/d20f.htm.
`Sanofi-Aventis SEC Form 20-F (2011), available at
`https://www.sec.gov/Archives/edgar/data/1121404/00011931251209
`8598/d279567d20f.htm.
`Sanofi-Aventis SEC Form 20-F (2012),
`https://www.sec.gov/Archives/edgar/data/1121404/00010474691300
`2333/a2212980z20-f.htm.
`Sanofi-Aventis SEC Form 20-F (2013),
`https://www.sec.gov/Archives/edgar/data/1121404/00010474691400
`1951/a2217900z20-f.htm.
`Sanofi-Aventis SEC Form 20-F (2014),
`https://www.sec.gov/Archives/edgar/data/1121404/00010474691500
`1974/a2222977z20-f.htm.
`Sanofi-Aventis SEC Form 20-F (2015),
`https://www.sec.gov/Archives/edgar/data/1121404/00011931251649
`3072/d246196d20f.htm.
`September 2016 Jevtana® Label.
`What is Prostate Cancer?, Jevtana.com,
`http://www.jevtana.com/what-is-prostate-cancer.
`Signs and Symptoms of Prostate Cancer, American Cancer
`Society®,
`http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-
`cancer-signs-symptoms.
`Prostate Cancer Treatment, Jevtana.com,
`http://www.jevtana.com/treatment.
`Novantrone Gets FDA Nod for Use in Advanced Prostate Cancer,
`Cancer Network (Dec. 1, 1996),
`http://www.cancernetwork.com/articles/novantrone-gets-fda-nod-
`use-advanced-prostate-cancer.
`FDA Approves New Indication for Taxotere – Prostate Cancer, FDA
`News Release (May 19, 2004),
`
`1
`
`
`
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2
`004/ucm108301.htm.
`Provenge FDA Approval Letter, Center for Biologics Evaluation and
`Research (April 29, 2010),
`http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyP
`roducts/ApprovedProducts/ucm210215.
`What Is Provenge Immunotherapy?, Provenge.com,
`http://www.provenge.com/advanced-prostate-cancer-
`immunotherapy.aspx.
`Zytiga® FDA Approval Letter, Center for Drug Evaluation and
`Research (Apr. 28, 2011),
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/2023
`79s000ltr.pdf.
`How Zytiga® Works, Zytiga.com, https://www.zytiga.com/about-
`zytiga/how-zytiga-works.
`Why Zytiga®?, Zytiga.com, https://www.zytiga.com/about-
`zytiga/why-zytiga (SA_JEV_2177918-23).
`Zytiga® Supplemental FDA Approval Letter, Center for Drug
`Evaluation and Research (Dec. 10, 2012),
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/2023
`79Orig1s005ltr.pdf.
`Xtandi® FDA Approval Letter, Center for Drug Evaluation and
`Research (Aug. 31, 2012),
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/2034
`15Orig1s000ltr.pdf.
`How Xtandi® Works, Xtandi.com, https://www.xtandi.com/how-
`xtandi-works.
`How Xtandi® May Help, Xtandi.com,
`https://www.xtandi.com/xtandi-clinical-trials.
`Xtandi® Supplemental FDA Approval Letter, Center for Drug
`Evaluation and Research (Sept. 10, 2014),
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/2034
`15Orig1s003ltr.pdf.
`Xofigo® FDA Approval Letter, Center for Drug Evaluation and
`Research (May 15, 2013),
`http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/2039
`71Orig1s000ltr.pdf.
`What Is Xofigo® Used For?, Xofigo.com, https://www.xofigo-
`us.com/patient/about-xofigo.
`
`2
`
`Exh. 2156
`
`Exh. 2157
`
`Exh. 2158
`
`Exh. 2159
`
`Exh. 2160
`
`Exh. 2161
`
`Exh. 2162
`
`Exh. 2163
`
`Exh. 2164
`
`Exh. 2165
`
`Exh. 2166
`
`Exh. 2167
`
`
`
`Exh. 2168
`
`Exh. 2169
`
`FDA Approves New Drug for Advanced Prostate Cancer, FDA
`News Release (May 15, 2013),
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/u
`cm352363.htm.
`Chemotherapy for Prostate Cancer, American Cancer Society®,
`http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-
`cancer-treating-chemotherapy.
`Market Share with Docetaxel in Prior Treatment, BrandImpact by
`AlphaImpact Rx (June 2016). PROTECTIVE ORDER MATERIAL.
`Monthly Jevtana Prostate Cancer Treatment Report: August 2014
`Results, BrandImpact by AlphaImpact Rx and Symphony Health
`Solutions (September 2014). PROTECTIVE ORDER MATERIAL.
`Exh. 2171
`Exh. 2172 Red Book Data of Xtandi®, Zytiga®, Xofigo®, and Jevtana®.
`Exh. 2173 August 2012 Xtandi® Label.
`Exh. 2174 April 2011 Zytiga® Label.
`Exh. 2175 May 2013 Xofigo® Label.
`Exh. 2176 December 23, 2016 Expert Declaration of Dr. Alton Oliver Sartor.
`Exh. 2178
`Sanofi Q3 2016 Results
`Underlying data for Market Share with Docetaxel in Prior
`Treatment, BrandImpact by AlphaImpact Rx (June 2016).
`PROTECTIVE ORDER MATERIAL.
`
`Exh. 2170
`
`Exh. 2179
`
`3
`
`
`
`Schedule 3
`
`Schedule 3
`
`
`
`Schedule 3
`Jevtana® U.S. Net Sales
`
`( €/$ in millions)
`
`2010 (2)
`2011 (3)
`2012 (4)
`2013 (5)
`2014 (6)
`2015 (7)
`Q1-Q3 2016 (8)
`Total
`
`CAGR
`(2013 - 2015)
`
`EUR
`
`Exchange Rate (1)
`
`USD
`
`€ 82
`131
`109
`86
`91
`127
`113
`€ 739
`
`1.3254
`1.3931
`1.2859
`1.3281
`1.3297
`1.1096
`1.1166
`
`$109
`182
`140
`114
`121
`141
`126
`$934
`
`11.1%
`
`Notes:
`(1) U.S. Dollars to One Euro, Annual, Not Seasonally Adjusted, Federal Reserve Economic Data.
`(2) Exh. 2129 at 128/335.
`(3) Exh. 2130 at 147/458.
`(4) Exh. 2131 at 124/304.
`(5) Exh. 2132 at 141/413.
`(6) Exh. 2133 at 120/233.
`(7) Exh. 2133 at 100/233.
`(8) Exh. 2178 at 15.
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`Schedule 4
`
`Schedule 4
`
`
`
`Schedule 4
`Post-Docetaxel mCRPC Market Shares (1)
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`Total
`
`Number of Patients
`All Other
`Xtandi
`Zytiga
`Provenge
`Jevtana
`Xofigo
`Docetaxel
`Hormone Therapy
`Total
`
`Market Share
`All Other
`Xtandi
`Zytiga
`Provenge
`Jevtana
`Xofigo
`Docetaxel
`Hormone Therapy
`
`Note:
`(1) Schedule 4.1 through Schedule 4.7.
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`Schedule 4.1
`Post-Docetaxel mCRPC Market Shares (1) (2)
`
`June
`
`July
`
`August
`
`2010
`September
`
`October
`
`November
`
`December
`
`Total
`
`Number of Patients
`All Other
`Xtandi
`Zytiga
`Provenge
`Jevtana
`Xofigo
`Docetaxel
`Hormone Therapy
`Total
`
`Market Share
`All Other
`Xtandi
`Zytiga
`Provenge
`Jevtana
`Xofigo
`Docetaxel
`Hormone Therapy
`
`Notes:
`(1) Exh. 2179 at 1.
`(2) Exh. 2170 at 2-3.
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`Schedule 4.2
`Post-Docetaxel mCRPC Market Shares (1) (2)
`
`January
`
`February
`
`March
`
`April
`
`May
`
`June
`
`2011
`July
`
`August
`
`September
`
`October
`
`November
`
`December
`
`Total
`
`Number of Patients
`All Other
`Xtandi
`Zytiga
`Provenge
`Jevtana
`Xofigo
`Docetaxel
`Hormone Therapy
`Total
`
`Market Share
`All Other
`Xtandi
`Zytiga
`Provenge
`Jevtana
`Xofigo
`Docetaxel
`Hormone Therapy
`
`Notes:
`(1) Exh. 2179 at 2-3.
`(2) Exh. 2170 at 2-3.
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`Schedule 4.3
`Post-Docetaxel mCRPC Market Shares (1) (2)
`
`January
`
`February
`
`March
`
`April
`
`May
`
`June
`
`2012
`July
`
`August
`
`September
`
`October
`
`November
`
`December
`
`Total
`
`Number of Patients
`All Other
`Xtandi
`Zytiga
`Provenge
`Jevtana
`Xofigo
`Docetaxel
`Hormone Therapy
`Total
`
`Market Share
`All Other
`Xtandi
`Zytiga
`Provenge
`Jevtana
`Xofigo
`Docetaxel
`Hormone Therapy
`
`Notes:
`(1) Exh. 2179 at 3-5.
`(2) Exh. 2170 at 2-4.
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`Schedule 4.4
`Post-Docetaxel mCRPC Market Shares (1) (2)
`
`January
`
`February
`
`March
`
`April
`
`May
`
`June
`
`2013
`July
`
`August
`
`September
`
`October
`
`November
`
`December
`
`Total
`
`Number of Patients
`All Other
`Xtandi
`Zytiga
`Provenge
`Jevtana
`Xofigo
`Docetaxel
`Hormone Therapy
`Total
`
`Market Share
`All Other
`Xtandi
`Zytiga
`Provenge
`Jevtana
`Xofigo
`Docetaxel
`Hormone Therapy
`
`Notes:
`(1) Exh. 2179 at 5-7.
`(2) Exh. 2170 at 2, 4.
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`Schedule 4.5
`Post-Docetaxel mCRPC Market Shares (1) (2)
`
`January
`
`February
`
`March
`
`April
`
`May
`
`June
`
`2014
`July
`
`August
`
`September
`
`October
`
`November
`
`December
`
`Total
`
`Number of Patients
`All Other
`Xtandi
`Zytiga
`Provenge
`Jevtana
`Xofigo
`Docetaxel
`Hormone Therapy
`Total
`
`Market Share
`All Other
`Xtandi
`Zytiga
`Provenge
`Jevtana
`Xofigo
`Docetaxel
`Hormone Therapy
`
`Notes:
`(1) Exh. 2179 at 7-8.
`(2) Exh. 2170 at 2, 4.
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`Schedule 4.6
`Post-Docetaxel mCRPC Market Shares (1) (2)
`
`January
`
`February
`
`March
`
`April
`
`May
`
`June
`
`2015
`July
`
`August
`
`September
`
`October
`
`November
`
`December
`
`Total
`
`Number of Patients
`All Other
`Xtandi
`Zytiga
`Provenge
`Jevtana
`Xofigo
`Docetaxel
`Hormone Therapy
`Total
`
`Market Share
`All Other
`Xtandi
`Zytiga
`Provenge
`Jevtana
`Xofigo
`Docetaxel
`Hormone Therapy
`
`Notes:
`(1) Exh. 2179 at 8-10.
`(2) Exh. 2170 at 2, 4.
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`Schedule 4.7
`Post-Docetaxel mCRPC Market Shares (1) (2)
`
`January
`
`February
`
`March
`
`April
`
`May
`
`Total
`
`2016
`
`Number of Patients
`All Other
`Xtandi
`Zytiga
`Provenge
`Jevtana
`Xofigo
`Docetaxel
`Hormone Therapy
`Total
`
`Market Share
`All Other
`Xtandi
`Zytiga
`Provenge
`Jevtana
`Xofigo
`Docetaxel
`Hormone Therapy
`
`Notes:
`(1) Exh. 2179 at 10-11.
`(2) Exh. 2170 at 2, 4.
`
`PROTECTIVE ORDER MATERIAL
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