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`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`In the Inter Partes Review (IPR) of
`U.S. Patent No. 8,822,438
`
`DECLARATION OF DEFOREST MCDUFF, Ph.D.
`
`I, DeForest McDuff, Ph.D., declare as follows:
`
`I.
`
`Introduction
` Qualifications
`A.
`
`1.
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`I am a Vice President of Intensity Corporation and an expert in
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`applied business economics, with more than ten years of experience in consulting,
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`finance, and economic research. I provide expert witness testimony and consulting
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`in a variety of areas, including lost profits, reasonable royalties, unjust enrichment,
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`commercial success, finance, statistics, valuation, and business optimization.
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`2. My expertise and experience span a variety of topics, including
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`intellectual property, competition, antitrust, finance, labor, employment, and class
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`action. My work in intellectual property spans the life sciences (including
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`pharmaceuticals, biotechnology, diagnostics, and medical devices), electronics
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`Declaration of DeForest McDuff, Ph.D.
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`1
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`Application No. 13/034,340
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`(including
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`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY
`consumer
`electronics,
`semiconductors,
`computers,
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`and
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`telecommunications), and has included projects on a diverse range of other
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`industries (such as scuba diving equipment, golf clubs, and contact lenses). I
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`frequently provide expertise and analysis in evaluating commercial success in the
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`pharmaceutical industry.
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`3.
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`I earned my Ph.D. in economics from Princeton University. At
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`Princeton, I received a National Science Foundation Graduate Research Fellowship
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`for academic research studying economic and statistical properties of housing
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`markets and financial derivatives. I have published research in several peer-
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`reviewed academic journals. I graduated summa cum laude with undergraduate
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`degrees in economics and mathematics from the University of Maryland.
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`4. My curriculum vitae, provided in Attachment A-1, contains more
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`details on my background, experience, publications, and prior expert testimony.
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`B.
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`Scope of Work
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`5.
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`Intensity Corporation has been retained by McNeely, Hare & War,
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`LLP on behalf of Amerigen Pharmaceuticals Limited in connection with my work
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`in this matter. Intensity Corporation is being compensated at a rate of $700 per
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`hour for my work and at lower rates for time spent by others on my team. The
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`Declaration of DeForest McDuff, Ph.D.
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`Application No. 13/034,340
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`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY
`compensation of Intensity Corporation is not dependent on the substance of my
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`testimony or the outcome of this matter.
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`6.
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`For this declaration, I was asked to evaluate aspects of commercial
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`success, from an economic perspective, as it pertains to Zytiga (abiraterone
`
`acetate) and U.S. Patent No. 8,822,438. This declaration is a statement of my
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`opinions in this matter and the basis and reasons for those opinions. In forming the
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`opinions expressed in this declaration, I have relied upon my education,
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`experience, and knowledge of the subjects discussed. I have also reviewed,
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`considered, or relied upon documents and other materials, which are cited herein
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`and/or listed in Attachment A-2.
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`7.
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`This declaration summarizes only my current opinions, which are
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`subject to change depending upon additional information and/or analysis. The
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`entirety of my declaration, including attachments and referenced materials,
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`supplies the basis for my analysis and conclusions. The organizational structure of
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`the declaration is for convenience. To the extent that facts, economic analysis, and
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`other considerations overlap, I generally discuss such issues only once for the sake
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`of brevity. Neither the specific order in which each issue is addressed nor the
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`organization of my declaration or attachments affects the ultimate outcome of my
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`analysis.
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`Declaration of DeForest McDuff, Ph.D.
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`3
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`Application No. 13/034,340
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`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY
`II. Background
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` Prostate cancer A.
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`8.
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`Prostate cancer occurs in the male prostate, a small gland that
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`produces the seminal fluid that nourishes and transports sperm.1 Prostate cancer is
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`one of the most common types of cancer in men,2 with a one-in-seven lifetime risk
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`
`1
`AMERIGEN 1051: Mayo Clinic Website, Prostate cancer,
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`http://www.mayoclinic.org/diseases-conditions/prostate-
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`cancer/basics/definition/con-20029597?p=1 (accessed 7/24/2015).
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`2
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`AMERIGEN 1051: Mayo Clinic Website, Prostate cancer,
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`http://www.mayoclinic.org/diseases-conditions/prostate-
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`cancer/basics/definition/con-20029597?p=1 (accessed 7/24/2015).
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`Declaration of DeForest McDuff, Ph.D.
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`of being diagnosed.3 In recent years, estimates for prostate cancer indicate over
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`220,000 new cases and more than 27,000 deaths annually in the US alone.4
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`9.
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`Patients diagnosed with prostate cancer may undergo a variety of
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`treatments options, including: (1) active surveillance (i.e., no action taken until
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`disease progresses);5 (2) radiation therapy (i.e., using high-powered energy to kill
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`3
`AMERIGEN 1041: Cancer.org (ACS), “What are the key statistics about
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`prostate cancer?”
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`http://www.cancer.org/cancer/prostatecancer/detailedguide/prostatecancerke
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`ystatistics (accessed 8/20/2015).
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`4
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`AMERIGEN 1041: Cancer.org (ACS), “What are the key statistics about
`
`prostate cancer?”
`
`http://www.cancer.org/cancer/prostatecancer/detailedguide/prostatecancerke
`
`ystatistics (accessed 8/20/2015).
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`5
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`AMERIGEN 1051: Mayo Clinic Website, Prostate cancer,
`
`http://www.mayoclinic.org/diseases-conditions/prostate-
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`cancer/basics/definition/con-20029597?p=1 (accessed 7/24/2015).
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`Declaration of DeForest McDuff, Ph.D.
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`cancer cells) and surgical removal of the prostate;6 (3) chemotherapy (i.e., using
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`
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`drugs to kill cancer cells);7 (4) hormone therapy (e.g., interrupting production of
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`testosterone to kill or slow growth of cancer cells);8 and (5) other treatments such
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`as cryosurgery (e.g., freezing tissue to kill cancer cells) and immunotherapy (e.g.,
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`genetically engineering immune cells to kill cancer cells).9
`
`
`6
`AMERIGEN 1051: Mayo Clinic Website, Prostate cancer,
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`http://www.mayoclinic.org/diseases-conditions/prostate-
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`cancer/basics/definition/con-20029597?p=1 (accessed 7/24/2015).
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`7
`
`AMERIGEN 1051: Mayo Clinic Website, Prostate cancer,
`
`http://www.mayoclinic.org/diseases-conditions/prostate-
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`cancer/basics/definition/con-20029597?p=1 (accessed 7/24/2015).
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`8
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`AMERIGEN 1051: Mayo Clinic Website, Prostate cancer,
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`http://www.mayoclinic.org/diseases-conditions/prostate-
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`cancer/basics/definition/con-20029597?p=1 (accessed 7/24/2015).
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`9
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`AMERIGEN 1051: Mayo Clinic Website, Prostate cancer,
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`http://www.mayoclinic.org/diseases-conditions/prostate-
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`cancer/basics/definition/con-20029597?p=1 (accessed 7/24/2015).
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`Declaration of DeForest McDuff, Ph.D.
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`6
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`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY
`10. Castrate-resistant prostate cancer (“CRPC”) refers to prostate cancer
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`that is able to grow despite usage of treatments lowering androgen production.10
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`Metastatic castrate-resistant prostate cancer (“mCRPC”) refers to CRPC that has
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`metastasized beyond the prostate into other parts of the body.11 Studies have found
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`that approximately 10% to 20% of patients with prostate cancer develop CRPC
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`within 5 years of follow-up.12 Among these patients, at the time of CRPC
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`10 AMERIGEN 1040: Cancer.net (ASCO Patient Website), Treatment of
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`Metastatic Castration-Resistant Prostate Cancer,
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`http://www.cancer.net/research-and-advocacy/asco-care-and-treatment-
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`recommendations-patients/treatment-metastatic-castration-resistant-prostate-
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`cancer (accessed 7/24/2015).
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`11 AMERIGEN 1040: Cancer.net (ASCO Patient Website), Treatment of
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`Metastatic Castration-Resistant Prostate Cancer,
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`http://www.cancer.net/research-and-advocacy/asco-care-and-treatment-
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`recommendations-patients/treatment-metastatic-castration-resistant-prostate-
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`cancer (accessed 7/24/2015).
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`12 AMERIGEN 1050: Kirby, M., C. Hirst, and E.D. Crawford (2011),
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`“Characterising the Castration-Resistant Prostate Cancer Population: A
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`Declaration of DeForest McDuff, Ph.D.
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`Application No. 13/034,340
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`diagnosis, at least 84% would already have mCRPC, and of the remaining non-
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`metastatic patients at the time of diagnosis, 33% would develop mCRPC within
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`two years.13
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`B.
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`Zytiga (abiraterone acetate)
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`11. Zytiga (abiraterone acetate) is a CYP17 inhibitor indicated in
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`combination with prednisone for the treatment of mCRPC.14 Zytiga works by
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`Systematic Review,” International Journal of Clinical Practice 65(11):
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`1180–1192, at 1180.
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`13 AMERIGEN 1050: Kirby, M., C. Hirst, and E.D. Crawford (2011),
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`“Characterising the Castration-Resistant Prostate Cancer Population: A
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`Systematic Review,” International Journal of Clinical Practice 65(11):
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`1180–1192, at 1180.
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`14 AMERIGEN 1065: Zytiga Label, 5/20/2015, at 1.
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`
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`AMERIGEN 1066: Zytiga Website, How Zytiga® (abiraterone acetate)
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`Works, https://www.zytiga.com/print/about-zytiga/how-zytiga-works
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`(accessed 7/23/2015).
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`Declaration of DeForest McDuff, Ph.D.
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`8
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`interrupting androgen production (including, for example, testosterone) in the
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`
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`testes, adrenal glands, and tumor.15 Zytiga is a type of hormone therapy.16
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`12. Zytiga’s label indicates a recommend dose of 1,000 mg (via four 250
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`mg tablets) administered orally once daily in combination with prednisone 5 mg
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`administered orally twice daily.17 FDA initially approved Zytiga in April 2011
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`with an indication limited to patients whose prostate cancer progressed after
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`15 AMERIGEN 1066: Zytiga Website, How Zytiga® (abiraterone acetate)
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`Works, https://www.zytiga.com/print/about-zytiga/how-zytiga-works
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`(accessed 7/23/2015).
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`16 AMERIGEN 1051: Mayo Clinic Website, Prostate cancer,
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`http://www.mayoclinic.org/diseases-conditions/prostate-
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`cancer/basics/definition/con-20029597?p=1 (accessed 7/24/2015).
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`
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`AMERIGEN 1066: Zytiga Website, How Zytiga® (abiraterone acetate)
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`Works, https://www.zytiga.com/print/about-zytiga/how-zytiga-works
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`(accessed 7/23/2015).
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`17 AMERIGEN 1065: Zytiga Label, 5/20/2015, at 1.
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`Declaration of DeForest McDuff, Ph.D.
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`Application No. 13/034,340
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`treatment with docetaxel, a chemotherapy drug.18 In December 2012, FDA
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`approved Zytiga for treatment of patients with or without prior chemotherapy
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`treatment.19
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` The ’438 patent
`C.
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`13. U.S. Patent No. 8,822,438 (“the ’438 patent”), entitled “Methods and
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`Compositions for Treating Cancer,” was filed on February 24, 2011 and issued on
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`18 AMERIGEN 1046: FDA Website, Drugs@FDA – Zytiga,
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`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction
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`=Search.DrugDetails (accessed 7/23/2015).
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`
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`AMERIGEN 1045: FDA News Release, “FDA expands Zytiga’s use for
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`late-stage prostate cancer,” 12/10/2012,
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`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm3314
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`92.htm.
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`19 AMERIGEN 1065: Zytiga Label, 5/20/2015, at 1.
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`AMERIGEN 1045: FDA News Release, “FDA expands Zytiga’s use for
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`late-stage prostate cancer,” 12/10/2012,
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`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm3314
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`92.htm.
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`Declaration of DeForest McDuff, Ph.D.
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`Application No. 13/034,340
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`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY
`September 2, 2014.20 The ’438 patent lists Alan H. Auerbach and Arie S.
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`Belldegrum as inventors and Janssen Oncology, Inc. as assignee.21 The abstract
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`reads as follows:22
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`Methods and compositions for treating cancer are described herein.
`More particularly,
`the methods for
`treating cancer comprise
`administering a 17α-hydroxyalse/C17,20-lyase
`inhibitor, such as
`abiraterone acetate
`(i.e., 3β-acetoxy-17-(3-pyridyl)androsa-5,16-
`diene), in combination with at least one additional therapeutic agent
`such as an anti-cancer agent or a steroid. Furthermore, disclosed are
`compositions comprising a 17α-hydroxyalse/C17,20-layse inhibitor, and
`at least one additional therapeutic agent, such as an anti-cancer agent
`or a steroid.
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`14.
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`Independent claim 1, the only independent claim, reads as follows: “A
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`method for the treatment of prostate cancer in a human comprising administering
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`20 AMERIGEN 1001: Methods and Compositions for Treating Cancer, U.S.
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`Patent No. 8,822,438 (filed 2/24/2011, issued 9/2/2014).
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`21 AMERIGEN 1001: Methods and Compositions for Treating Cancer, U.S.
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`Patent No. 8,822,438 (filed 2/24/2011, issued 9/2/2014).
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`22 AMERIGEN 1001: Methods and Compositions for Treating Cancer, U.S.
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`Patent No. 8,822,438 (filed 2/24/2011, issued 9/2/2014).
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`Declaration of DeForest McDuff, Ph.D.
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`to said human a therapeutically effective amount of abiraterone acetate or a
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`pharmaceutically acceptable salt thereof and a therapeutically effective amount of
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`prednisone.”23
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`D.
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`Prosecution of the ’438 patent
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`15.
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`I understand that the ’438 patent was filed in February 2011 and
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`issued in September 2014.24 During that period, I understand that Johnson &
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`Johnson (“J&J”) and related parties corresponded with the USPTO regarding the
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`patentability of the presented claims.25 In particular, I understand that the USPTO
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`rejected the presented claims several times due to obviousness and double
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`patenting, but ultimately allowed 20 claims based on “unexpected commercial
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`23 AMERIGEN 1001: Methods and Compositions for Treating Cancer, U.S.
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`Patent No. 8,822,438 (filed 2/24/2011, issued 9/2/2014).
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`24 AMERIGEN 1001: Methods and Compositions for Treating Cancer, U.S.
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`Patent No. 8,822,438 (filed 2/24/2011, issued 9/2/2014).
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`25
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`For brevity, I refer to these entities collectively as Johnson & Johnson or
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`J&J throughout, as appropriate.
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`Declaration of DeForest McDuff, Ph.D.
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`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY
`success of the launch of the drug” and withdrawal of a co-pending patent
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`application.26 See Attachment B-1 for an overview of the prosecution timeline.
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`III. Analysis of Commercial Success
` Economic relevance of commercial success
`A.
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`16. Commercial success is a secondary consideration that a patent owner
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`may use to argue that its patent is not obvious based on the alleged commercial
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`success of an invention embodying that patent. I understand that commercial
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`success is relevant to the determination of a patent’s obviousness since the law
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`presumes that an idea would have been brought to market sooner in response to
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`market forces had it been obvious to persons skilled in the art. I further understand
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`that evidence of commercial success is only relevant if there is a nexus between the
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`alleged commercial success and the patentable features of the asserted claims. In
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`other words, the patent owner must show that the commercial success is
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`26 AMERIGEN 1013: ’438 Patent Prosecution Documents, USPTO Action,
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`7/3/2013, at “Detailed Action,” pp. 2–3.
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`AMERIGEN 1039: ’438 Patent Prosecution Documents, USPTO Action,
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`9/11/2012, at pp. 1–6.
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`Declaration of DeForest McDuff, Ph.D.
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`13
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`attributable to the novel parts of a patent claim, and not on factors that are
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`unrelated or were already known.
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`17. From an economic perspective, commercial success presumes that if
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`an idea were obvious to market participants, then others would have brought that
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`idea to market sooner had there been material economic incentives to do so. A
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`finding of commercial success can, in some circumstances, support the notion that
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`a patent was not obvious to those skilled in the art if those incentives for
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`development existed. Accordingly, analysis of commercial success frequently
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`includes evaluation of sales, profits, market shares, prices, and other metrics to
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`draw inferences on economic incentives for development. Importantly, since
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`analysis of commercial success provides potential indirect inferences relating to
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`obviousness, its informative value depends on the case-specific circumstances and
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`whether
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`those circumstances provided material economic
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`incentives
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`for
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`development at the time of the alleged invention.
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`B.
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`J&J’s ’213 patent limits the economic relevance of commercial
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`success
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`18.
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`J&J’s U.S. Patent No. 5,604,213 (“the ’213 patent”) is a blocking
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`patent covering Zytiga and thus limits the relevance of analysis of commercial
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`Declaration of DeForest McDuff, Ph.D.
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`14
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`Application No. 13/034,340
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`success for the ’438 patent. A blocking patent is one that effectively blocks others
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`
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`from making, selling, or using a product without use of that patent.27 From an
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`economic perspective, the existence of a blocking patent that prevented others
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`from making, selling, or using abiraterone would have limited economic incentives
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`to develop the invention claimed in the ’438 patent.
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`19. The ’213 patent, entitled “17-Substituted Steroids Useful in Cancer
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`Treatment,” describes the abiraterone compound and methods for treating an
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`androgen-dependent or estrogen-dependent disorder using that compound.28
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`According the FDA’s Orange Book, a publication where companies list patents
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`27
`See, for example: AMERIGEN 1054: Murphy et al. (2012), Patent
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`Valuation: Improving Decision Making through Analysis, Wiley, at 102.
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`(“A blocking patent is a patent that blocks a rights holder on a different
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`patent from exploiting the different patented invention without a license to
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`the blocking patent.”).
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`28 AMERIGEN 1005: 17-Substituted Steroids Useful in Cancer Treatment,
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`U.S. Patent No. 5,604,213 (filed 9/30/1994, issued 2/18/1997).
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`
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`AMERIGEN 1036: ’438 Patent Prosecution Documents, Initial Application,
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`2/24/2011, at pp. 7, 10.
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`Declaration of DeForest McDuff, Ph.D.
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`that are asserted to cover pharmaceutical products, the ’213 patent has been alleged
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`to cover the Zytiga product.29 The ’213 patent was filed in 1994 and issued in
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`1997, long before the’438 patent appears to have priority back to its provisional
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`patent application in 2006.30 According to FDA, the ’213 patent is expected to
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`expire in December 2016.31
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`20. From an economic perspective, the existence of the ’213 patent would
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`have significantly reduced economic incentives for development of the technology
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`claimed in the ’438 patent. Because Johnson & Johnson could have effectively
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`prevented market participants from supplying an abiraterone product, typical
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`incentives associated with drug development would not have existed. Courts have
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`29 AMERIGEN 1047: FDA Website, Orange Book, Zytiga (NDA 202379),
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`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_
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`No=202379&Product_No=001&table1=OB_Rx (accessed 7/24/2015).
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`30 AMERIGEN 1001: Methods and Compositions for Treating Cancer, U.S.
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`Patent No. 8,822,438 (filed 2/24/2011, issued 9/2/2014).
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`31 AMERIGEN 1047: FDA Website, Orange Book, Zytiga (NDA 202379),
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`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_
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`No=202379&Product_No=001&table1=OB_Rx (accessed 7/24/2015).
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`Declaration of DeForest McDuff, Ph.D.
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`16
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`found that, in the presence of blocking rights, existence of commercial success
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`provides little probative value on whether a claimed technology is obvious.32
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`32 AMERIGEN 1053: Merck & Co., Inc. v. Teva Pharmaceuticals USA, Inc.,
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`395 F.3d 1364, 1376–77 (Fed. Cir. 2005) (“Commercial success is relevant
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`because the law presumes an idea would successfully have been brought to
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`market sooner, in response to market forces, had the idea been obvious to
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`persons skilled in the art… In this case Merck had a right to exclude others
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`from practicing the weekly-dosing of alendronate specified in claims 23 and
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`37, given (1) another patent covering the administration of alendronate
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`sodium to treat osteoporosis, U.S. Pat. No. 4,621,077 (issued Nov. 4, 1986);
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`and (2) its exclusive statutory right, in conjunction with FDA marketing
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`approvals, to offer Fosamax at any dosage for the next five years. Because
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`market entry by others was precluded on those bases, the inference of non-
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`obviousness of weekly-dosing, from evidence of commercial success, is
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`weak.”).
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`AMERIGEN 1057: Syntex (U.S.A.) LLC and Allergan v. Apotex, Inc. et al.,
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`407 F.3d 1371, 1383 (Fed. Cir. 2005) (““[A] high degree of commercial
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`success permits the inference that other have tried and failed to reach a
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`Declaration of DeForest McDuff, Ph.D.
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`Thus, in the case of abiraterone, analysis of commercial success is of limited value
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`for whether material economic incentives would have been in place for
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`development of the technology claimed in the ’438 patent.
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`solution. In Merck, we held that evidence of commercial success resulted in
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`a particularly weak inference because prior art patents prevented others from
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`competing to reach the solution embodied in the claims at issue.”).
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`AMERIGEN 1048: Galderma Laboratories, L.P. et al. v. Tolmar, Inc., 737
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`F.3d 731, 740–41 (Fed. Cir. 2013) (“Where ‘market entry by others was
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`precluded [due to blocking patents], the inference of non-obviousness of [the
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`asserted claims], from evidence of commercial success, is weak.’ This
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`principle applies forcefully to the present case. The now expired Shroot
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`patents blocked the market entry of 0.3% adapalene products until their
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`expiration in 2010, long after Galderma invented 0.3% adapalene
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`compositions of the asserted claims. As such, no entity other than Galderma
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`could have successfully brought to 0.3% to market prior to 2010. Like the
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`commercial success described in Merck & Co., the commercial success of
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`Differin® Gel, 0.3% is of ‘minimal probative value.’”).
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`Declaration of DeForest McDuff, Ph.D.
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` Unexpected commercial success is not economically relevant C.
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`21.
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`In granting the ’438 patent, the USPTO referenced the “unexpected
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`commercial success” of Zytiga as the primary factor reversing earlier rejections of
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`the patent due to obviousness.33 However, “unexpected” commercial success, if
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`any, is not relevant for an evaluation of whether material economic incentives for
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`development existed at the time of the alleged invention, as any unexpected
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`success would not have provided market participants with incentives for
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`development. I am not aware of J&J providing the USPTO with any expectations
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`or perceptions of expected commercial success of Zytiga by the broader market
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`prior to launch. Instead, J&J relied exclusively on measures of actual Zytiga sales,
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`including arguments based on early sales as of 2012 that were rejected by the
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`USPTO34 and arguments based on sales to date through June 2013.35
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`33 AMERIGEN 1013: ’438 Patent Prosecution Documents, USPTO Action,
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`7/3/2013, at “Detailed Action,” pp. 2–3.
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`AMERIGEN 1039: ’438 Patent Prosecution Documents, USPTO Action,
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`9/11/2012, at pp. 1–6.
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`34 AMERIGEN 1008: ’438 Patent Prosecution Documents, Applicant
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`Response, 7/3/2012, at pp. 1–4.
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`22. From an economic perspective, sales that were unexpected are not
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`relevant for
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`the secondary consideration of commercial success because
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`unexpected sales would not have incentivized market participants to develop the
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`claimed technology at the time of the alleged invention. Rather, whether market
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`participants would have had incentives to develop the claimed technology depends
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`on market incentives existing prior to drug launch. Thus, the notion of
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`“unexpected” success is not economically relevant for an evaluation of commercial
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`success.
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` Zytiga sales are more modest in appropriate context
`D.
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`23.
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`In its correspondence with the USPTO, J&J provided selected patient
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`share information for Zytiga for pre- and post-chemo patients, notably focusing on
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`Zytiga’s “almost 70% market share”, Zytiga’s “market lead[ing]” position for post-
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`AMERIGEN 1039: ’438 Patent Prosecution Documents, USPTO Action,
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`9/11/2012, at pp. 1–6.
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`35 AMERIGEN 1012: ’438 Patent Prosecution Documents, Applicant
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`Response, 6/4/2013, at pp. 6–9 of 9.
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`chemo patients,36 and Zytiga being “the most successful oral oncology launch in
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`history.”37 However, these claims are misleading and unrepresentative of Zytiga’s
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`actual performance due to: (1) Zytiga’s lower share of the overall relevant markets,
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`(2) J&J’s exclusive focus on patient shares instead of market shares, and (3) other
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`cancer drugs outperforming Zytiga.
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`24. First, J&J improperly focused on the significantly smaller post-chemo
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`patient population rather than providing Zytiga’s share of the broader relevant
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`markets. Because the pre-chemo patient population is roughly three times the post-
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`chemo population,38 J&J’s references to each patient population individuals masks
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`Zytiga’s overall patient share among all mCRPC patients. Based on the ratio of
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`post-chemo to pre-chemo patients, J&J’s reported shares of 57% within post-
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`36 AMERIGEN 1012: ’438 Patent Prosecution Documents, Applicant
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`Response, 6/4/2013, at pp. 7–8 of 9.
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`37 AMERIGEN 1012: ’438 Patent Prosecution Documents, Applicant
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`Response, 6/4/2013, at pp. 7–8 of 9.
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`38 AMERIGEN 1036: ’438 Patent Prosecution Documents, Initial Application,
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`2/24/2011, at “Zytiga®: Most Successful Oral Oncology Launch in
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`History,” in Pharmaceuticals Commercial Overview PowerPoint, pp. 11.
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`Declaration of DeForest McDuff, Ph.D.
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`chemo and 20% within pre-chemo as of April 201339 provide an overall patient
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`share of 29% within all mCRPC patients.40 Furthermore, since only about 10% to
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`20% of all prostate cancer patients develop CRPC (and many of these patients will
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`have or will develop mCRPC),41 a reasonable estimate of Zytiga’s share amongst
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`prostate cancer patients is approximately 3% to 6%.42 In other words, putting
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`Zytiga use within the broader context indicates a significantly lower patient share
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`than the ones proffered by J&J to the USPTO.
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`39 AMERIGEN 1012: ’438 Patent Prosecution Documents, Applicant
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`Response, 6/4/2013, at pp. 7–8 of 9.
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`40
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`57% × (1/4) + 20% × (3/4) = 29.25%.
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`41 AMERIGEN 1050: Kirby, M., C. Hirst, and E.D. Crawford (2011),
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`“Characterising the Castration-Resistant Prostate Cancer Population: A
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`Systematic Review,” International Journal of Clinical Practice 65(11):
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`42
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`1180-1192, at 1180.
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`29% × 10% = 2.9% and 29% × 20% = 5.8%.
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`Additionally, Zytiga’s share could be reasonably lower because not all
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`CRPC patients have or will develop mCRPC.
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`Declaration of DeForest McDuff, Ph.D.
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`25. Second, J&J’s evidence exclusively consists of patient shares that do
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`not sum to 100% rather than typical market shares considered in commercial
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`success. In cancer treatment, patient shares (i.e., the share of patients taking a
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`certain medication) overstate market shares (i.e., the share of revenues for any
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`particular treatment), since patients often take more than one medication.43
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`Accordingly, J&J’s patient shares are overstated and misleading relative to market
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`shares more commonly evaluated in commercial success.
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`26. Third, J&J’s claim that Zytiga is the “the most successful oral
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`oncology launch in history” is misleading in light of non-oral cancer drugs with
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`even greater sales. For example, there are at least nine non-oral cancer drugs with
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`annual sales substantially exceeding Zytiga (abiraterone, $2.2 billion), such as
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`43 AMERIGEN 1036: ’438 Patent Prosecution Documents, Initial Application,
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`2/24/2011, at “Overall US Patient Share Continues to Grow,” in
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`Pharmaceuticals Commercial Overview PowerPoint, pp. 12.
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`For example, the chemo refractory chart shows Zytiga, Jevtana, and Xtandi
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`representing approximately nearly 100% of patient shares in April 2013, but
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`only about 85% in July 2012.
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`Declaration of DeForest McDuff, Ph.D.
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`Rituxan (rituximab, $7.4 billion), Avastin (bevacizumab, $6.8 billion), and
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`
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`Herceptin (trastuzumab, $6.7 billion). See Attachment B-2.
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`E.
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`Zytiga has been losing market share due to competition from
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`Xtandi
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`27.
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`In addition to more modest shares than those reported by J&J,
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`competition from Xtandi (enzalutamide) has resulted in: (1) Zytiga losing market
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`share, (2) lower pricing of Zytiga relative to Xtandi, and (3) industry expectations
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`of Xtandi becoming the premier treatment option.
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`28. First, recent data demonstrate a decline in Zytiga’s market share and
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`concurrent growth in Xtandi. In August 2012, FDA initially approved Xtandi for
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`mCRPC patients who previously received docetaxel,44 and expanded Xtandi’s
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`approved indication to include patients who have not previously received do