`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`APOTEX CORP.
`APOTEX, INC.
`Petitioner
`
`v.
`
`ALLERGAN, INC.
`Patent Owner
`
`U.S. Patent No. 8,629,111
`_____________________
`
`Case To be assigned
`_____________________
`
`
`Declaration of Harry C. Boghigian
`
`
`
`APOTEX 1010
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`
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`
`
`I.
`
`II.
`
`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
`
`TABLE OF CONTENTS
`Introduction ...................................................................................................... 2
`
`Summary of opinions ....................................................................................... 3
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`III. My Background and Qualifications ................................................................. 4
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`IV. Documents Reviewed .................................................................................... 10
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`V. My understanding of commercial success ..................................................... 15
`
`VI. Background .................................................................................................... 16
`VII. RESTASIS®'s performance does not provide evidence of commercial
`success for the claims of the '111 patent ....................................................... 19
`RESTASIS®'s sales are driven by commercial factors rather than
`novel features of the '111 patent's claims ............................................ 21
`
`A.
`
`B.
`
`1.
`
`2.
`
`3.
`
`4.
`
`Allergan's market analysis is faulty ..................................................... 26
`
`Allergan's analysis of sales performance improperly focuses on
`net revenue .......................................................................................... 26
`
`Allergan's unduly narrow definition of the U.S. market results
`in a significantly overstated share of the market ................................. 26
`
`Allergan overlooks a blocking patent ................................................. 31
`
`Allergan's analysis fails to establish a nexus between U.S. sales
`and any alleged novel aspect of the '111 patent's claims .................... 34
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`APOTEX 1010
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`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
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`I, Harry C. Boghigian, hereby declare as follows.
`
`I.
`
`Introduction
`1.
`
`I am over the age of eighteen and competent to make this declaration.
`
`2.
`
`I have been retained as an expert witness on behalf of APOTEX CORP.
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`and APOTEX, INC. for the above-captioned inter partes review (IPR). I am being
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`compensated for my time in connection with this IPR at my standard consulting
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`rate, which is $695 per hour. No part of my compensation is affected by the
`
`outcome of this matter or the nature of my opinions in this declaration. I
`
`understand that the petition for inter partes review involves U.S. Patent No.
`
`8,629,111 ("the '111 patent"), Exhibit APO1001, which resulted from U.S.
`
`Application No. 13/967,163 ("the '163 application"), filed on August 14, 2013,
`
`naming Andrew Acheampong, Diane D. Tang-Liu, James N. Chang, and David F.
`
`Power as inventors. The '111 patent issued on January 14, 2014, from the '163
`
`application. The '111 patent claims the benefit of a provisional application that was
`
`filed September 15, 2003. I further understand that, according to the USPTO
`
`records, the '111 patent is currently assigned to Allergan, Inc.
`
`3.
`
`I understand that the claims of the '111 patent recite a topical
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`ophthalmic emulsion comprising 0.05% by weight cyclosporin A and 1.25% by
`
`weight castor oil. I understand that the claims of the '111 patent recite topical
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`APOTEX 1010
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`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
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`ophthalmic emulsions that are therapeutically effective for treating dry eye,
`
`treating keratoconjunctivitis sicca (KCS), or increasing tear production.
`
`II.
`
`Summary of opinions
`4.
`
`I have been asked to assess whether there is any commercial success
`
`attributable to the '111 patent. My declaration focuses on the alleged commercial
`
`success of RESTASIS®, which I understand Allergan has asserted is a commercial
`
`embodiment of claims of the '111 patent. APO1019, 291:¶2.
`
`5.
`
`Briefly, for at least the reasons set forth below, it is my opinion that
`
`the marketplace performance of RESTASIS® does not evince commercial success of
`
`the '111 patent's claims:
`
` RESTASIS®'s world-wide sales revenue, of which its U.S. sales revenue
`
`makes up the majority, does not establish commercial success for the '111
`
`patent's claims because it is driven by extrinsic, commercial factors that are
`
`unrelated to the '111 patent, such as Allergan's established position in the
`
`market, its effective marketing of RESTASIS®, and the growing market for
`
`treating dry eye/KCS.
`
` Allergan's analysis of RESTASIS®'s sales performance is misleading. Allergan
`
`provides evidence of net revenue rather than unit and prescription sales, and
`
`it does not attempt to establish market share for global sales. Its analysis of
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`RESTASIS®'s U.S. market share is overstated because Allergan's definition of
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`APOTEX 1010
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`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
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`the relevant market is unduly narrow. Allergan stated: "As there is no other
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`FDA-approved therapeutic treatment for dry eye available on the US market,
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`Restasis® owns 100% of the market share." And even if Allergan's
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`definition of the market was not flawed, a blocking patent prevented
`
`meaningful competition. Further, Allergan's analysis ignores the existence of
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`four unexpired U.S. patents that also encompass RESTASIS®. Allergan also
`
`failed to establish a nexus with any alleged novel features of the '111 patent's
`
`claims that account for RESTASIS®'s sales.
`
`III. My Background and Qualifications
`6.
`In formulating my opinions, I have relied upon my training,
`
`knowledge, and experience in the area of product commercialization and market
`
`analysis as it relates to intellectual property matters.
`
`7.
`
`I am a pharmaceutical executive with more than 40 years' experience
`
`in the commercialization and marketing of prescription pharmaceutical products.
`
`In 2001, I founded Pharma Consultants LLC, a New Jersey-based consulting firm
`
`serving start-up, small- to medium-size healthcare companies, and advertising
`
`agencies, in all areas of pharmaceutical sales and marketing. Companies I have
`
`consulted for include entrepreneurs, small-medium size companies and start-ups
`
`like EyeGene Bioscience USA, CJ Pharma, CSP Technologies Inc., Dendrite
`
`International, and Morphonics LLC. In 2003, I co-founded PBN PHARMA LLC, a
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`APOTEX 1010
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`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
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`Chicago-based research and development healthcare company, which owns
`
`numerous patents in several therapeutic areas and is currently focused on the
`
`development, licensing and commercialization of prescription and over-the-counter
`
`products for skin care, pain management, and wound care. I do business
`
`development, licensing, and strategy for PBN PHARMA LLC. I am currently
`
`President of both Pharma Consultants LLC and PBN PHARMA LLC.
`
`8.
`
`I earned a Bachelor of Science degree in Business Administration
`
`from the University of New Hampshire Whittemore School of Business in 1971
`
`and have attended eight executive business programs and advanced educational
`
`seminars at leading European and U.S. business and medical schools: INSEAD
`
`Institute of Business Administration in Fontainebleau Cedex, France (1998), IMD
`
`Business School in Lausanne, Switzerland (1995), Harvard Medical School (1997),
`
`Baylor College of Medicine (1987), and University of Rochester Medical School
`
`(1985). The advanced seminars include: Pharmacology and Pharmacodynamics of
`
`CNS Acting Drugs, and Pharmaceutical Marketing.
`
`9. My career in the pharmaceutical industry began in 1971 at Hoffmann-
`
`La Roche, one of the top ten global pharmaceutical research and development
`
`companies, which I joined as a sales representative. During my 30-year career at
`
`Hoffmann-La Roche, I held numerous positions of increasing responsibility, both
`
`in the U.S. and internationally, involving business development, market research,
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`APOTEX 1010
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`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
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`marketing, brand management, sales, sales management, strategic planning,
`
`portfolio management and product commercialization. Through 1989, these
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`positions included Manager of Market Research, Regional Sales Director, and
`
`Product Director with responsibility for marketed and developmental products in
`
`the therapeutic areas of gastroenterology, cardiology, infectious disease and CNS.
`
`10.
`
`In 1989, I was named the Group Director & Global Business
`
`Representative of Hoffmann-La Roche, Switzerland. In this capacity, I coordinated
`
`the marketing for both new product introductions and already on-market products,
`
`including the metabolic therapeutic area and the therapeutic areas in ¶9 above, in
`
`the U.S., France, Germany, Italy, the UK and Japan.
`
`11.
`
`In 1991, I served as the Senior Vice President & General Manager of
`
`Roche Pharmaceuticals, Canada, which I restructured and grew three-fold. As part
`
`of this endeavor, I launched three new products and increased sales of currently-
`
`marketed products.
`
`12.
`
`I was requested in 1993 to return to the U.S. headquarters and asked
`
`to work with the President of the U.S. operations and two other executives to
`
`create twenty business units and decentralize the U.S. pharmaceutical operations.
`
`Successfully decentralizing those operations, I was asked in 1996 to head-up all of
`
`U.S. marketing and serve on the U.S. Operating Committee for the U.S. Division.
`
`Assuming that role, I served as the Vice President of U.S. Marketing until 1999
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`APOTEX 1010
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`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
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`and was responsible for a $2.3 billion portfolio of products and a product
`
`marketing budget in excess of $343 million. During this time, I led a team of
`
`marketing professionals that increased revenue 20% annually. From 1999 until
`
`June of 2001, I served as Vice President of Business Operations and was
`
`responsible for the day-to-day operation and long-term growth of the company, as
`
`well as product licensing and development.
`
`13. While at Hoffmann-La Roche,
`
`I was
`
`responsible
`
`for
`
`the
`
`commercialization, sales and marketing of more than 40 drug products. One of
`
`those products was ZANTAC®, which became one of the world’s most widely-
`
`prescribed products for the treatment of ulcers and reflux. As discussed below, this
`
`was the first co-promotion in the history of the pharmaceutical industry and was
`
`seen as an innovation in the marketing and promotion of pharmaceutical products
`
`(discussed further in paragraph 15, below).
`
`14.
`
` The products I commercialized and marketed fall within numerous
`
`therapeutic areas such as CNS, muscle relaxants, sedative hypnotic, antianxiety,
`
`antidepressants, HIV, antibiotics (oral and injectable), Hepatitis C, antimalarial,
`
`gastroenterology,
`
`cardiovascular
`
`neurology,
`
`immunosuppressants,
`
`anti-
`
`inflammatory, antipsychotic, dermatology, antihypertensive, oncology, anesthesia,
`
`intranasal steroids, and vitamins. I also sold one of the first of a new class of drugs
`
`for the treatment of bacterial infections of the eye. GANTRISIN® (sulfisoxazole) was
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`APOTEX 1010
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`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
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`found to be an improvement over many of the sulfonamides. As a result,
`
`GANTRISIN® Ophthalmic was created for bacterial infections of the eyes as well as
`
`a suspension for the treatment of infections in children. GANTRISIN®, GANTRISIN®
`
`Ophthalmic, GANTRISIN® Pediatric Suspension and AZO–GANTRISIN® have been
`
`prescribed by physicians for decades. To the best of my knowledge GANTRISIN®
`
`Ophthalmic was the first ophthalmic preparation of a sulfonamide and was sold for
`
`decades in the U.S.
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`15.
`
` Because of my experience in commercialization, sales and marketing,
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`I have expertise in the methods used to expand and maximize market share and
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`sales revenue of brand pharmaceutical products. For example, I established the first
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`direct-to-consumer program at Hoffmann-La Roche and directed revitalization of
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`the first and most successful co-promotion arrangement in the pharmaceutical
`
`industry: the Roche/Glaxo co-promotion of ZANTAC® and CEFTIN®. Due to this
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`expertise, most of the 40 products I marketed became number one sellers in their
`
`respective classes.
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`16. Starting in 2003, I have been retained and deposed as an expert on the
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`subject of commercial success in 44 U.S. patent-related litigations, 26 of which
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`settled out of court. I have been qualified as an expert witness and testified during
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`trial in U.S. federal courts on the subject of commercial success in 18 of these
`
`litigations. These 44 cases involved patents directed to pharmaceutical products
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`APOTEX 1010
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`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
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`such as intranasal steroids, gastrointestinal drugs, anxiety and depression
`
`treatments, narcolepsy, antipsychotics, neurological drugs, Alzheimer's treatment,
`
`urinary incontinence, antibiotics, anti-arthritics, and ophthalmic formulations. A
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`list of cases from the last four years is attached as an appendix to my resume
`
`(APO1011).
`
`17.
`
`In the course of my work in the pharmaceutical industry and in
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`providing consulting and expert services, I have frequently analyzed market
`
`information, including gross and net revenue, unit sales, new and total
`
`prescriptions, persistency data, market share, marketing, promotion, direct-to-
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`consumer advertising expenses and diagnosis data that provides insight in
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`physician prescribing habits. In these roles, I regularly rely upon, analyze, and
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`review data for the pharmaceutical industry, including from IMS Health Services,
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`Inc., Wolters Kluwer, Nielsen, U.S. Security and Exchange Commission filings,
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`and company annual reports, as well as information published by the U.S. Food
`
`and Drug Administration (e.g., approved drug listings in the Approved Drug
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`Products with Therapeutic Equivalence Evaluations, or Orange Book, and product
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`monographs and approved labels for over-the-counter and prescription drugs),
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`National Institutes of Health, and other national and state health regulatory
`
`agencies. In addition, I regularly review pharmaceutical publications and trade
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`journals,
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`such as Medical Letter, DTC Perspectives, Fierce Biotech,
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`APOTEX 1010
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`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
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`Pharmaceutical Executive, Medical Marketing and Media, Pharma Voice, and
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`others industry related publications. These sources are reliable authorities and are
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`generally relied on by experts in my field.
`
`18.
`
`I have marketed, consulted, or testified as an expert on five
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`ophthalmic
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`products,
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`including LUMIGAN®
`
`(bimatoprost),
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`PATADAY®
`
`(olopatadine), and TRAVATAN-Z® (travoprost). A copy of my current curriculum
`
`vitae is provided as APO1011. It provides a comprehensive description of my
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`academic and employment history, including the litigations in which I have
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`testified as an expert on commercial success for the last four years (see APO1011,
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`6-11 (Appendix)).
`
`IV. Documents Reviewed
`19.
`In formulating my opinion, I have considered all of the documents
`
`cited herein, including the following documents:
`
`Document
`
`Apotex
`Exhibit
`No.
`1001 US Patent No. 8,629,111 to Acheampong et al. (issued January 14, 2014)
`1003 US Patent No. 5,474,979
`1005 Declaration of Erning Xia, Ph.D.
`Ophthalmic Drug Products for Over-the-Counter Human Use; Final
`Monograph, Federal Register 53 (43):7076-93 (1988), downloaded from
`http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentRe
`sources/Over-the-
`CounterOTCDrugs/StatusofOTCRulemakings/ucm071941.htm, last
`accessed March 24, 2014
`
`1012
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`APOTEX 1010
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`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
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`1019
`
`10201
`
`10252
`
`File History of U.S. Patent No. 8,629,111
`Murphy, R., "The Once and Future Treatment of Dry Eye," Review of
`Optometry (January 2000), available from
`http://legacy.revoptom.com/archive/FEATURES/ro0200f6.htm, last
`accessed October 21, 2014
`Allergan Dry Eye Product Portfolio Fact Sheet, downloaded from
`http://www.allergan.com/assets/pdf/dry_eye_product_portfolio_fact_sheet
`.pdf, last accessed January 26, 2015
`1026 Certain Steroid Preparations for Ophthalmic and/or Otic Use, Federal
`Register 41 (158):34340-42 (1976)
`Albietz, J.M., "Dry eye: an update on clinical diagnosis,
`management and promising new treatments," Clin. & Exp. Optometry
`84:4-18 (2001)
`Certain Ophthalmic Combination Drugs Containing a Steroid and Anti-
`Infectives for Human Use; Drug Efficacy Study Implementation;
`Amendment, Federal Register 47 (96):21296-21301 (1982)
`Lemp, M.A., "Report of the National Eye Institute/Industry Workshop on
`1036
`Clinical Trials in Dry Eyes," CLAO 21(4):221-232 (1995)
`1037 Gilbard, J.P., "Dry Eye, Blepharitis, and Chronic Eye Irritation: Divide
`and Conquer," J. Ophthalmic Nurs. Technol. 18(3):109-115 (1999)
`1038 Napper, G. et al., "Ocular therapeutics," Clin. & Exp. Optometry 86:414-
`
`1 Exhibit APO1020 is a true and correct copy of a document titled "The Once and
`
`1029
`
`1034
`
`Future
`
`Treatment
`
`of Dry
`
`Eye," which
`
`I
`
`downloaded
`
`from
`
`http://legacy.revoptom.com/archive/FEATURES/ro0200f6.htm.
`
`2 Exhibit APO1025 is a true and correct copy of a document titled "Allergan Dry
`
`Eye Product Portfolio Fact Sheet," which I downloaded from Allergan's website
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`http://www.allergan.com/assets/pdf/dry_eye_product_portfolio_fact_sheet.pdf.
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`APOTEX 1010
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`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
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`1043
`
`10443
`
`415 (2003)
`RESTASIS® Approved Label, downloaded from the Allergan website
`https://www.restasisprofessional.com/RestasisProfessional/FullPrescribin
`gInformation, last accessed January 28, 2015
`American Academy of Ophthalmology Cornea/External Disease Panel.
`Preferred Practice Pattern® Guidelines. Dry Eye Syndrome. San
`Francisco, CA: American Academy of Ophthalmology; 2013. Available
`at: www.aao.org/ppp, downloaded from http://one.aao.org/preferred-
`practice-pattern/dry-eye-syndrome-ppp--2013, last accessed December
`31, 2014
`De Paiva, C.S. and Pflugfelder, S.C., "Rationale for anti-inflammatory
`therapy in dry eye syndrome," Arq. Bras. Oftalmol. 71(6 Supl):89-95
`(2008)
`1046 Autry, J.C., "Mix It Up: When to Call a Compounding Pharmacist,"
`Review of Optometry 149(7):30-37 (July 15, 2012)
`Mann, E., "Drugs used in the treatment of dry eye syndrome, anti-
`inflammatory drugs and topical anti-allergy drugs," Continuing Education
`& Training, Nov. 30, 2007, pp. 30-40
`Allergan, Inc. 2001 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January 1,
`2015
`
`1045
`
`1047
`
`10484
`
`
`3 Exhibit APO1044 is a true and correct copy of a document titled as shown in the
`
`table, which I downloaded from the American Academy of Ophthalmology's
`
`website http://one.aao.org/preferred-practice-pattern/dry-eye-syndrome-ppp--2013.
`
`4 Exhibits APO1048 to APO1057 are true and correct copies of documents titled as
`
`shown
`
`in
`
`the
`
`table, which
`
`I downloaded
`
`from Allergan's website
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`http://agn.client.shareholder.com/financials.cfm.
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`
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`APOTEX 1010
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`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
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`Allergan, Inc. 2003 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January 1,
`2015
`Allergan, Inc. 2004 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January 1,
`2015
`Allergan, Inc. 2005 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January 1,
`2015
`Allergan, Inc. 2006 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January 1,
`2015
`Allergan, Inc. 2009 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January 1,
`2015
`Allergan, Inc. 2010 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January 1,
`2015
`Allergan, Inc. 2011 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January 1,
`2015
`Allergan, Inc. 2012 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January 1,
`2015
`Allergan, Inc. 2013 Annual Report, downloaded from
`http://agn.client.shareholder.com/financials.cfm, last accessed January 1,
`2015
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations, patent and exclusivity data for RESTASIS®, downloaded from
`FDA website
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl
`_No=050790&Product_No=001&table1=OB_Rx, last accessed January
`12, 2015
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`1049
`
`1050
`
`1051
`
`1052
`
`1053
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`1054
`
`1055
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`1056
`
`1057
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`1058
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`
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`
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`APOTEX 1010
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`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
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`10605
`
`Systane Lubricant Eye Drops information at Systane.com, Systane
`Products, Systane Balance Lubricant Eye Drops, downloaded from Alcon
`website http://www.systane.com/Systane-Balance-Lubricant-Eye-
`Drops.aspx, last visited April 21, 2015
`Learn more about Systane Gel Drops at Systane.com, Systane Products,,
`Systane Gel Drops, downloaded from Alcon website
`http://www.systane.com/Gel-Drops.aspx, last visited April 21, 2015
`Systane® Lubricant Eye Gel, Systane Products, Systane Lubricant Eye
`Gel, downloaded from Alcon website http://www.systane.com/Systane-
`Lubricant-Eye-Gel.aspx, last visited April 21, 2015
`Dry Eye Drop Symptom relief product information at Systane.com,
`Systane Products, Systane Ultra Lubricant Eye Drops, downloaded from
`Alcon website http://www.systane.com/Dry-Eye-Drop.aspx, last visited
`April 21, 2015
`LACRISERT® (hydroxypropyl cellulose ophthalmic insert) Approved Label,
`downloaded from the FDA website
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018771s017lb
`l.pdf, last accessed April 14, 2015
`Bausch and Lomb "Dry Eye Products," downloaded from Bausch and
`Lomb website http://www.bausch.com/our-products/dry-eye-
`products/dry-eye-products, last accessed April 14, 2015
`1066 Drugs@FDA: FDA Approved Drug Products, LACRISERT®, downloaded
`
`5 Exhibits APO1060 to APO1063 are true and correct copies of documents titled as
`
`1061
`
`1062
`
`1063
`
`1064
`
`10656
`
`shown in the table, which I downloaded from the respective Alcon websites
`
`indicated in the table.
`
`6 Exhibits APO1065 is a true and correct copy of a document titled "Dry Eye
`
`Products," which
`
`I downloaded
`
`from Bausch
`
`and Lomb's website
`
`http://www.bausch.com/our-products/dry-eye-products/dry-eye-products.
`
`
`
`
`
`- 14 -
`
`APOTEX 1010
`
`
`
`
`
`
`1067
`
`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
`
`from the FDA website
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseacti
`on=Search.DrugDetails, last accessed April 16, 2015
`Drugs@FDA: FDA Approved Drug Products, RESTASIS®, downloaded
`from the FDA website
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/temptn.cfm, last
`accessed April 14, 2015
`
`
`V. My understanding of commercial success
`20.
`It is my understanding that an analysis of commercial success is
`
`premised on the concept that if a product is economically successful, it may
`
`provide objective evidence of nonobviousness. I understand that objective
`
`evidence of nonobviousness is also known as a secondary consideration.
`
`21.
`
`I understand that, to establish commercial success of a product, one
`
`must show evidence of significant market share in the relevant market, based on
`
`unit sales or prescription volume. I understand that the relevant market for a
`
`pharmaceutical product is defined by its therapeutic uses.
`
`22.
`
`I further understand that the commercial success of the product must
`
`be attributable to the purported novel features of the claims at issue. I understand
`
`this to mean that, to support a finding of nonobviousness, the alleged sales success
`
`must be attributable to the purported novel features of the claims, and not by other,
`
`unrelated factors. Such other unrelated factors may include economic and
`
`commercial factors unrelated to the claims. For example, a company's dominant
`
`
`
`
`
`- 15 -
`
`APOTEX 1010
`
`
`
`
`
`
`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
`
`market position, its extensive advertising for the product, and an increase in overall
`
`market size weighs against a finding of commercial success. I also understand that
`
`the existence of a blocking patent also weigh against a finding of commercial
`
`success. In other words, there must be a causal correlation, or "nexus," between the
`
`unique characteristics of the claimed invention and the success of the product.
`
`Finally, I understand that the existence of additional patents encompassing the
`
`commercial product negates any presumption that the sales data has a nexus with
`
`the claims of the patent at issue.
`
`VI. Background
`I understand that Allergan has asserted that RESTASIS® is a
`23.
`
`commercial embodiment of claims of the '111 patent. During prosecution of the
`
`'111 patent, Allergan's Vice President for Marketing Aziz Mottiwala stated "the
`
`pending claims cover the specific formulation of RESTASIS® that has been sold
`
`since 2003." APO1019, 291:¶2, see also 241:¶1.7 It is my understanding from this
`
`and other statements by Allergan that RESTASIS® launched in 2003. APO1019,
`
`291:¶2, see also, e.g., 241:¶1. I also understand from the '111 patent's file history
`
`7 Page numbering for all documents starts at 1 according to the numbers
`
`added at the bottom right, and may include column and paragraph numbers.
`
`Paragraph numbering includes partial paragraphs.
`
`
`
`
`
`- 16 -
`
`APOTEX 1010
`
`
`
`
`
`
`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
`
`that Allergan asserted that RESTASIS® showed sales success (in net sales revenue)
`
`during the period of quarter 1, 2003 to quarter 2, 2013. APO1019, 291:¶¶2-5, 297.
`
`24.
`
` I also understand from the RESTASIS® label, a fact sheet concerning
`
`Allergan dry eye treatments (on Allergan's website), and Allergan's annual reports
`
`that Allergan promotes RESTASIS® for "increas[ing] tear production in patients
`
`whose tear production is presumed to be suppressed due to ocular inflammation
`
`associated with keratoconjunctivitis sicca" and for treating dry eye. APO1043, 1:1
`
`(under Indications and Usage); APO1025, 1 (title), 3 (under RESTASIS®…); see
`
`also, e.g., APO1049, 38:2:¶3; APO1052, 14:2 (under Dry Eye); APO1057, 9:¶2.
`
`Allergan also purports, in its promotional material and annual reports, that
`
`RESTASIS® is effective in treating dry eye because it inhibits inflammation:
`
`"RESTASIS® is the only therapeutic option … for people with dry eye disease that
`
`goes beyond providing temporary relief for the dryness and also treats the
`
`underlying cause of the condition – ocular inflammation." APO1049, 38:2:¶3;
`
`APO1052, 14:2 (under Dry Eye); APO1025, 3 (RESTASIS® … section).
`
`25.
`
` Allergan excluded sales of many products from its definition of the
`
`U.S. market for RESTASIS®. As discussed in detail below (see paragraph 43), I
`
`understand that practitioners and researchers have authored publications that
`
`recommend many pharmaceutical drug products for treating dry eye disease/KCS.
`
`Such authors include subcommittee members of the International Dry Eye
`- 17 -
`
`
`
`
`APOTEX 1010
`
`
`
`
`
`
`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
`
`Workshop (APO1019, 330:title, 330:1 (bottom of column))8; the members of the
`
`American Academy of Ophthalmology’s Corneal/External Disease Preferred
`
`Practice Pattern Panel (2012-2013) (APO1044, 1-3); Drs. Genevieve Napper, Ian
`
`Douglas, and Julie Albietz (APO1038, 1), and others. Recommendations such as
`
`theirs have resulted in actual sales of the products listed and discussed in paragraph
`
`43, below, during the period of quarter 1, 2003 to quarter 2, 2013 (which Allergan
`
`focused on during prosecution). APO1019, 291:¶¶2-4, 297, 315:title, 318, 393:2:¶5
`
`to 394:1:¶3; APO1049, 23:¶¶1-2; APO1054, 26:¶4, 41:¶5 (under Chronic Dry
`
`Eye). For example, in January 2013, Eric D. Donnenfeld, MD noted that "we have
`
`been adding topical corticosteroids such as loteprednol when we initiate therapy."
`
`APO1019, 393:1:¶1, 393:2:¶8 to 393:3:¶1, 393:3:¶4.
`
`26. Allergan did not include any sales of these products for dry eye/KCS
`
`treatment in its discussion of RESTASIS®'s sales performance. APO1019, 291:¶4.
`
`Instead, Allergan's definition of the relevant market included only RESTASIS®. Id.
`
`
`8 Exhibit APO1019 is the '111 patent's file history. During prosecution, Allergan
`
`submitted articles in support of a Declaration of Dr. Rhett M. Schiffman, including
`
`several that I have cited here. See APO1019, e.g., 315, 321 (referring to dry eye as
`
`dysfunctional tear syndrome), 330, 388, 393.
`
`
`
`
`
`- 18 -
`
`APOTEX 1010
`
`
`
`
`
`
`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
`
`Specifically, during prosecution of the '111 patent, Allergan's Vice President of
`
`Marketing stated "[a]s there is no other FDA-approved therapeutic treatment for
`
`dry eye available on the US market, Restasis® owns 100% of the market share."
`
`APO1019, 291:¶4. This definition is unduly narrow because it excludes all other
`
`products used to treat dry eye/KCS. See VII.B.2, below.
`
`27.
`
`I understand that, to analyze commercial success of a pharmaceutical
`
`drug product, the relevant market is defined by the product's uses. RESTASIS® is a
`
`drug product used for treating dry eye/KCS. APO1043, 1:1 (under Indications and
`
`Usage); APO1025, 1 (title), 3 (under RESTASIS®…); see also, e.g., APO1049,
`
`38:2:¶3; APO1052, 14:2 (under Dry Eye); APO1057, 9:¶2. Thus, the relevant
`
`market includes all sales of drug products for the use of treating dry eye/KCS.
`
`VII. RESTASIS®'s performance does not provide evidence of commercial
`success for the claims of the '111 patent
`28. The market performance of RESTASIS® does not provide evidence of
`
`commercial success that is attributable to the claims of the '111 patent, as I discuss
`
`in detail below.9
`
`
`9 I am aware of no commercial product besides RESTASIS® that falls within the
`
`scope of the '111 patent's claims.
`
`
`
`
`
`- 19 -
`
`APOTEX 1010
`
`
`
`
`
`
`Inter Partes Review of USPN 8,629,111
`Declaration of Harry C. Boghigian (Exhibit 1010)
`
`29. The '111 patent file history includes information regarding the alleged
`
`commercial success of RESTASIS®, which I have concluded is significantly
`
`overstated and not attributable to the '111 patent's claims for the reasons discussed
`
`below.
`
`30. Allergan provided sales information to the USPTO concerning the
`
`market performance of RESTASIS® in an attempt to assert that it has experienced
`
`commercial success. APO1019, 291-299. Allergan asserted that (i) RESTASIS®'s
`
`world-wide sales revenue has steadily increased since its launch, (ii) the U.S.
`
`market is defined by products that are "FDA-approved [for] therapeutic treatment
`
`for dry eye," and (iii) "As there is no other FDA-approved therapeutic treatment for
`
`dry eye available on the US market, RESTASIS® owns 100% of the market share."
`
`APO1019, 291:¶2-5.
`
`31. Based on my analysis to date, the performance of RESTASIS® does not
`
`provid
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