Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov
`ESTTA383212
`ESTTA Tracking number:
`12/11/2010
`
`Filing date:
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`91193303
`Plaintiff
`Allergan, Inc.
`Kenneth L. Wilton
`Seyfarth Shaw LLP
`2029 Century Park East, Suite 3500
`Los Angeles, CA 90067-3021
`UNITED STATES
`kwilton@seyfarth.com, kelko@seyfarth.com, hinchey_susan@allergan.com
`Plaintiff's Notice of Reliance
`Kenneth L. Wilton
`kwilton@seyfarth.com, kelko@seyfarth.com
`/Kenneth L. Wilton/
`12/11/2010
`Fourth_Notice_of_Reliance.pdf ( 162 pages )(1518716 bytes )
`
`Proceeding
`Party
`
`Correspondence
`Address
`
`Submission
`Filer's Name
`Filer's e-mail
`Signature
`Date
`Attachments
`
`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`In the Matter of Application Serial No. 79/061,765
`Published in the Official Gazette of September 8, 2009
`
`ALLERGAN, INC.,
`
`Opposer,
`
`Opposition No. 91193303
`
`v.
`
`BOOT OX PTY LTD,
`
`Applicant.
`
`OPPOSER’S FOURTH NOTICE OF RELIANCE, PURSUANT TO RULE 2.122(e), ON
`OPPOSER’S 2003 FORM 10-K
`
`Pursuant to Rule 2.122(e) of the Trademark Rules of Practice, Opposer Allergan, Inc.
`
`(“Opposer) hereby gives notice of its reliance at trial on the Form 10-K (Annual Report) it filed
`
`with the United States Securities and Exchange Commission on March 2, 2004 for the period
`
`ending December 31, 2003. A true and correct copy of the referenced Form 10-K is attached
`
`hereto as Exhibit 4. The Form 10-K was obtained from the Internet, and the printed version
`
`attached as Exhibit 4 identifies the date it was accessed and printed, and the URL from where it
`
`was obtained. See Safer, Inc. v. OMS Invs., Inc., 94 USPQ2d 1031, 1039 (TTAB 2010).
`
`The Form 10-K is relevant to the issue of the fame of the BOTOX® mark, in that it
`
`reflects revenue received by Opposer for sales of goods under the BOTOX® mark for the years
`
`ended 2003, 2002 and 2001. In addition, the Form 10-K discusses Opposer’s direct-to-consumer
`
`

`
`advertising of goods sold under the BOTOX® mark, and provides other information relevant to
`
`the fame of the mark.
`
`Date: December 10, 2010
`
`SEYFARTH SHAW LLP
`
`By:
`
`/Kenneth L. Wilton/
`Kenneth L. Wilton
`Attorneys for Opposer
`ALLERGAN, INC.
`
`2029 Century Park East, Suite 3500
`Los Angeles, CA 90067-3021
`Telephone: (310) 277-7200
`Facsimile: (310) 201-5219
`
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`EXHIBIT 4
`EXHIBIT 4
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`Table of Contents
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`SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
`
`Form 10-K
`
`ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
`OF THE SECURITIES EXCHANGE ACT OF 1934
`
`For The Fiscal Year Ended December 31, 2003
`
`Commission File No. 1-10269
`
`Allergan, Inc.
`
`(Exact name of Registrant as Specified in its Charter)
`
`Delaware
`(State of Incorporation)
`2525 Dupont Drive
`Irvine, California
`(Address of principal executive offices)
`
`(714) 246-4500
`(Registrant’s telephone number)
`
`95-1622442
`(I.R.S. Employer Identification No.)
`92612
`(Zip Code)
`
`Securities registered pursuant to Section 12(b) of the Act:
`
`Title of each class
`
`Common Stock, $0.01 par value
`Preferred Share Purchase Rights
`
`Name of each exchange on
`which each class registered
`
`New York Stock Exchange
`
`Securities registered pursuant to Section 12(g) of the Act: None
`
`Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities
`Exchange Act of 1934 during the preceding 12 months, and (2) has been subject to such filing requirements for the past 90 days. Yes 
`No .
`
`Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be
`contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this
`Form 10-K or any amendment to this Form 10-K. 
`
`Indicate by check mark whether the registrant is an accelerated filer (as defined in Exchange Act Rule 12b-2).
`Yes 
`No .
`
`The aggregate market value of the registrant’s common equity held by non-affiliates was approximately $10,081 million on June 27, 2003,
`based upon the closing price on the New York Stock Exchange on such date.
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`Common Stock outstanding as of February 27, 2004 — 134,254,772 shares (including 3,033,468 shares held in treasury).
`
`DOCUMENTS INCORPORATED BY REFERENCE
`
`Part III incorporates certain information by reference from the registrant’s proxy statement for the annual meeting of stockholders to be
`held on April 28, 2004, which proxy statement will be filed no later than 120 days after the close of the registrant’s fiscal year ended
`December 31, 2003.
`
`TABLE OF CONTENTS
`
`PART I
`Item 1. Business
`Item 2. Properties
`Item 3. Legal Proceedings
`Item 4. Submission of Matters to a Vote of Security Holders
`
`Page
`
`1
`1
`16
`16
`17
`
`18
`PART II
`Item 5. Market For Registrant’s Common Equity and Related Stockholder Matters and Issuer Purchases of Equity Securities 18
`Item 6. Selected Financial Data
`19
`Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
`20
`Quantitative and Qualitative Disclosures About Market Risk
`Item 7A.
`Item 8. Financial Statements and Supplementary Data
`Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
`Controls and Procedures
`Item 9A.
`
`37
`44
`44
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`44
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`PART III
`
`Item 10.
`
`Item 11.
`
`Item 12.
`
`Item 13.
`
`Item 14.
`
`PART IV
`
`Item 15.
`
`Directors and Executive Officers of Allergan, Inc.
`
`Executive Compensation
`
`Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
`
`Certain Relationships and Related Transactions
`
`Principal Accountant Fees and Services
`
`Exhibits, Financial Statement Schedules And Reports On Form 8-K
`
`SIGNATURES
`
`EXHIBIT 3.6
`EXHIBIT 10.9
`EXHIBIT 10.12
`EXHIBIT 10.27
`EXHIBIT 10.29
`EXHIBIT 21
`EXHIBIT 23
`EXHIBIT 31.1
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`45
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`45
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`46
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`46
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`46
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`46
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`47
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`47
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`EXHIBIT 31.2
`EXHIBIT 32
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`i
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`Table of Contents
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`Item 1.
`
`Business
`
`General Development of Our Business
`
`PART I
`
`Allergan, Inc. is a technology-driven, global health care company that develops and commercializes specialty pharmaceutical products for
`the ophthalmic, neurological, dermatological and other specialty markets. We are a pioneer in specialty pharmaceutical research, targeting
`products and technologies related to specific disease areas such as glaucoma, retinal disease, dry eye, psoriasis, acne and movement disorders.
`Additionally, we develop and market aesthetic-related pharmaceuticals and over-the-counter products. Within these areas, we are an innovative
`leader in therapeutic and other prescription products, and to a limited degree, over-the-counter products that are sold in more than 100 countries
`around the world. We are also focusing research and development efforts on new therapeutic areas, including gastroenterology, neuropathic
`pain and various types of cancer.
`
`We were originally incorporated in California in 1948 and became known as Allergan Corporation in 1950. In 1977, we reincorporated in
`Delaware. In 1980, we were acquired by SmithKline Beecham plc (then known as SmithKline Corporation). From 1980 through 1989, we
`operated as a wholly-owned subsidiary of SmithKline and in 1989 we again became a stand-alone public company through a spin-off
`distribution by SmithKline.
`
`Our Internet website address is www.allergan.com . We make our periodic and current reports, together with amendments to these reports,
`available on our Internet website, free of charge, as soon as reasonably practicable after such material is electronically filed with, or furnished
`to, the Securities and Exchange Commission. The information on our Internet website is not incorporated by reference in this Annual Report on
`Form 10-K.
`
`On June 29, 2002, we completed the spin-off of our optical medical device business to our stockholders. The optical medical device
`business consisted of two businesses: our ophthalmic surgical products business, which developed, manufactured and marketed products that
`included artificial lenses for the eye, called intraocular lenses, and equipment for cataract and refractive eye surgery; and our contact lens care
`products business, which developed, manufactured and marketed a broad range of products for use with every available type of contact lens.
`The spin-off was effected by contributing our optical medical device business to a newly formed subsidiary, Advanced Medical Optics, Inc.,
`and issuing a dividend of Advanced Medical Optics’ common stock to our stockholders. The Internal Revenue Service ruled that the
`transaction qualified as tax-free for Allergan and our stockholders for U.S. federal income tax purposes, with the exception of cash received for
`fractional shares. The common stock of Advanced Medical Optics began trading publicly on the New York Stock Exchange on July 1, 2002
`under the symbol “AVO.” Following the spin-off, we continue to own and operate our specialty pharmaceutical business and Advanced
`Medical Optics owns and operates what was formerly our optical medical device business. We have no ownership interest in Advanced
`Medical Optics. Our consolidated financial statements and related notes reflect the financial position, results of operations and cash flows of the
`optical medical device business as a discontinued operation.
`
`Acquisitions in 2003
`
`On May 16, 2003, we completed the acquisition of all of the outstanding equity interests in Bardeen Sciences Company, LLC from
`Farallon Pharma Investors, LLC for an aggregate purchase price of approximately $264.6 million, including transaction costs of $1.1 million
`and $12.8 million in certain intangible contract-based product marketing and other rights, net of cash acquired. The Bardeen acquisition
`occurred through our exercise of a previously granted equity purchase option that became exercisable on April 7, 2003. The option purchase
`price was determined pursuant to a formula established at the time of the grant of the equity purchase option in 2001. As a result of the Bardeen
`acquisition, we acquired all of Bardeen’s assets, which consisted of the rights to certain pharmaceutical compounds and research projects.
`
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`On November 20, 2003, we completed the acquisition of Oculex Pharmaceuticals, Inc., a company engaged in developing treatments for
`sight-threatening diseases of the eye. We acquired the Oculex business for an aggregate purchase price of approximately $223.8 million, net of
`cash acquired, including transaction costs of $1.6 million and $6.1 million in other assets, comprised principally of notes receivable, an equity
`investment and certain deferred tax assets related to Oculex. The primary focus of the transaction was our acquisition of a bioerodable,
`extended release drug delivery technology to deliver drug to the back of the eye, including Posurdex ®, which is intended to deliver
`dexamethasone for the treatment of edema. We currently intend to enroll study subjects in Phase 3 clinical trials for Posurdex® during the first
`half of 2004. The Phase 3 clinical trials will focus on macular edema associated with diabetes and other conditions. If these Phase 3 clinical
`trials are successful, we anticipate potential FDA approval of Posurdex® in the late 2006 or early 2007 timeframe.
`
`Our Business
`
`The following table sets forth, for the periods indicated, net sales from continuing operations for each of our specialty pharmaceutical
`product lines, earnings (loss) from continuing operations, domestic and international sales as a percentage of total net sales and domestic and
`international long-lived assets:
`
`Net Sales by Product Line
`Eye Care Pharmaceuticals
`Botox ®/ Neuromodulator
`Skin Care Products
`Other(1)
`
`Total
`
`Year Ended December 31
`
`2003
`
`2002
`
`2001
`
`$ 999.5
`563.9
`109.3
`82.7
`
`(in millions)
`
`$ 827.3
`439.7
`90.2
`27.8
`
`$ 753.7
`309.5
`78.9
`—
`
`$1,755.4
`
`$1,385.0
`
`$1,142.1
`
`Earnings (loss) from continuing operations
`
`$ (52.5)
`
`$
`
`64.0
`
`$ 171.2
`
`Sales
`Domestic
`International
`Long-Lived Assets (in millions)
`Domestic
`International
`
`70.4%
`29.6%
`
`70.6%
`29.4%
`
`67.0%
`33.0%
`
`$ 573.8
`$ 252.9
`
`$ 381.2
`$ 225.2
`
`$ 354.6
`$ 199.3
`
`(1) Other sales primarily consist of sales to Advanced Medical Optics pursuant to the manufacturing and supply agreement entered into as
`part of the spin-off of Advanced Medical Optics.
`
`See Note 15, “Business Segment Information,” in the notes to the consolidated financial statements listed under Item 15(a) of Part IV of
`this report for further information concerning our foreign and domestic operations.
`
`Eye Care Pharmaceutical Product Line
`
`We develop, manufacture and market a broad range of prescription and non-prescription products designed to treat diseases and disorders
`of the eye, including glaucoma, dry eye, inflammation, infection and allergy.
`
`Glaucoma. The largest segment of the market for ophthalmic prescription drugs is for the treatment of glaucoma, a sight-threatening
`disease typically characterized by elevated intraocular pressure leading to optic nerve damage. Glaucoma is currently the world’s second
`leading cause of blindness, and we estimate that over 60 million people worldwide have glaucoma. According to IMS Health Inc., an
`independent research firm, our
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`products for the treatment of glaucoma, including Alphagan ®, Alphagan ® P and Lumigan ®, captured approximately 18% of the worldwide
`glaucoma market in 2003.
`
`Our largest selling eye care pharmaceutical products are the ophthalmic solutions Alphagan ® (brimonidine tartrate ophthalmic solution)
`0.2% and Alphagan ® P (brimonidine tartrate ophthalmic solution) 0.15%, preserved with Purite ®. Alphagan ® and Alphagan ® P lower
`intraocular pressure by reducing aqueous humor production and increasing uveoscleral outflow. Alphagan ® P is an improved reformulation
`of Alphagan ® containing brimonidine, Alphagan ®’s active ingredient, preserved with Purite ®. We currently market Alphagan ® and
`Alphagan ® P in over 70 countries worldwide.
`
`Alphagan ® and Alphagan ® P combined are the second best selling glaucoma products in the world, as measured by 2003 revenue,
`according to IMS Health Inc. Combined sales of Alphagan ®and Alphagan ® P represented 16% of our total consolidated sales in 2003, 18%
`of our total consolidated sales in 2002 and 22% of our total consolidated sales in 2001. In July 2002, based on the overwhelming acceptance of
`Alphagan ® P, we discontinued the U.S. distribution of Alphagan ®. The marketing exclusivity period for Alphagan ® P expires in September
`2004, although we have a number of patents covering the Alphagan ® P technology that extend to 2021 in the U.S. and 2009 in Europe, with
`corresponding patents pending in Europe. In May 2003, the first generic form of Alphagan ® was approved by the FDA. Additionally, a
`generic form of Alphagan ® is sold in a limited number of other countries, including Canada, Mexico, India, Brazil and Argentina. See Item 3
`of Part I of this report, “Legal Proceedings” and Note 13, “Commitments and Contingencies,” in the notes to the consolidated financial
`statements listed under Item 15(a) of Part IV of this report for further information regarding litigation involving Alphagan ®. We believe that
`Falcon Pharmaceuticals, a company affiliated with Alcon Laboratories, Inc., will attempt to obtain FDA approval for and launch a brimonidine
`product to compete with our Alphagan ® P product in 2005.
`
`In March 2001, the FDA approved Lumigan ® (bimatoprost ophthalmic solution) 0.03%, a topical treatment indicated for the reduction of
`elevated intraocular pressure in patients with glaucoma or ocular hypertension who are either intolerant or insufficiently responsive when
`treated with other intraocular pressure-lowering medications. In March 2002, the European Commission approved Lumigan ® through its
`centralized procedure. In January 2004, the European Union’s Committee for Proprietary Medicinal Products approved Lumigan ® as a first-
`line therapy for the reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension. We currently sell
`Lumigan ® in over 40 countries worldwide. We have also initiated a process to out-license Lumigan ® in Japan.
`
`In September 2001, we filed a New Drug Application with the FDA for a brimonidine and timolol combination designed to treat glaucoma.
`This New Drug Application remains pending. During the fourth quarter of 2003, we received approval from Health Canada for our brimonidine
`and timolol combination, which is marketed as Combigan TM . In November 2003, we filed a New Drug Application with the FDA for a
`Lumigan ® and timolol combination designed to treat glaucoma or ocular hypertension. This New Drug Application remains pending.
`
`Ocular Surface Disease. In December 2002, the FDA approved Restasis® (cyclosporine ophthalmic emulsion) 0.05%, the first and
`currently the only prescription therapy for the treatment of chronic dry eye disease. We launched Restasis® in the United States in April 2003.
`Dry eye disease is a painful and irritating condition involving abnormalities and deficiencies in the tear film initiated by a variety of causes.
`The incidence of dry eye disease increases markedly with age, after menopause in women and in people with systemic diseases such as
`Sjogren’s syndrome and rheumatoid arthritis. Until the approval of Restasis® , physicians used lubricating tears as a temporary measure to
`provide palliative relief of the debilitating symptoms of dry eye disease. In June 2001, we entered into a licensing, development and marketing
`agreement with Inspire Pharmaceuticals, Inc. under which we obtained an exclusive license to develop and commercialize Inspire’s INS365
`Ophthalmic in exchange for royalty payments to Inspire on sales of both Restasis® and, ultimately, INS365. INS365 has completed Phase III
`clinical trials investigating its ability to relieve the signs and symptoms of dry eye disease by rehydrating conjunctival mucosa and increasing
`non-lacrimal tear component production. In December 2003, the FDA issued an approvable letter for INS365, although Inspire has reported
`that the FDA has also requested additional clinical data. We believe that if INS365 is approved, it will be complementary to Restasis ® in the
`market.
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`Ophthalmic Inflammation. Our leading ophthalmic anti-inflammatory product is Acular ® (ketorolac ophthalmic solution) 0.5%. Acular ®
`is a registered trademark of and is licensed from its developer, Syntex (U.S.A.) Inc., a business unit of F. Hoffmann-LaRoche Inc. Acular ® is
`indicated for the temporary relief of itch associated with seasonal allergic conjunctivitis, the inflammation of the mucus membrane that lines
`the inner surface of the eyelids, and for the treatment of post-operative inflammation in patients who have undergone cataract extraction.
`Acular PF ® is the first, and currently remains the only unit-dose, preservative-free topical non-steroidal anti-inflammatory drug in the United
`States. Acular PF ® is indicated for the reduction of ocular pain and photophobia following incisional refractive surgery. Acular ® is the
`number one prescribed non-steroidal anti-inflammatory in the United States. See Item 3 of Part I of this report, “Legal Proceedings” and
`Note 13, “Commitments and Contingencies,” in the notes to the consolidated financial statements listed under Item 15(a) of Part IV of this
`report for information regarding our successful patent infringement lawsuit against Apotex, Inc., et al. confirming the validity and
`enforceability of our intellectual property covering Acular ®.
`
`In June 2003, we received FDA approval of Acular LS TM , a reformulated ketorolac 0.4% concentration, for the reduction of ocular pain,
`burning and stinging following corneal refractive surgery. We launched Acular LS TM in the United States in August 2003.
`
`Our product Pred Forte® remains a leading topical steroid worldwide based on 2003 sales. Pred Forte® has no patent protection or
`marketing exclusivity and faces generic competition.
`
`Ophthalmic Infection. A leading product in the ophthalmic anti-infective market is our Ocuflox ® / Oflox ® / Exocin ® ophthalmic
`solution. According to Verispan, an independent research firm, this ophthalmic solution was the number one ocular anti-infective prescribed by
`ophthalmologists in the United States in 2003. The U.S. compound and ophthalmic use patents covering Ocuflox ® expire in March 2004 and
`May 2004, respectively.
`
`In March 2003, we received FDA approval of Zymar (gatifloxacin ophthalmic solution) 0.3%. Zymar is the first fourth-generation
`fluoroquinilone to enter the market for the treatment of bacterial conjunctivitis. Laboratory studies have shown that Zymar kills the most
`common bacteria that cause eye infections as well as specific resistant bacteria. We launched Zymar in the United States in April 2003.
`
`Allergy. The allergy market is, by its nature, a seasonal market, peaking during the spring months. We market Alocril® ophthalmic
`solution for the treatment of itch associated with allergic conjunctivitis. Additionally, in October 2003, we received FDA approval of Elestat
`(epinastine ophthalmic solution) 0.05%, for the prevention of itching associated with allergic conjunctivitis. In December 2003, we announced
`the execution of an agreement with Inspire Pharmaceuticals for the co-promotion of Elestat in the United States within the ophthalmic
`specialty area and to allergists. Under the terms of the agreement, Inspire provided us with an up-front payment and we will pay royalties to
`Inspire on Elestat net sales. In addition, the agreement reduces our existing royalty payment to Inspire for Restasis ®. Inspire will have
`primary responsibility for selling and marketing activities in the United States related to Elestat. We have retained all international marketing
`and selling rights. We plan to launch Elestat in Europe under the brand names Relestat ® and Purivist ® during the first quarter of 2004, and
`we anticipate that Inspire will also launch Elestat TM in the United States during the first quarter of 2004.
`
`Neuromodulator
`
`Our neuromodulator product, Botox ® (Botulinum Toxin Type A), is used in a wide variety of treatments which continue to expand. Botox
`® is accepted in many global regions as the standard therapy for indications ranging from therapeutic neuromuscular disorders and related pain
`to cosmetic facial aesthetics. There are currently in excess of 100 therapeutic and cosmetic indications for Botox ® based on its localized
`treatment effect and approximately 20 years of safety experience in large patient groups. Marketed as Botox ®, Botox ® Cosmetic or Vistabel
`®, depending on the indication and country of approval, the product is approved in over 70 countries for a broad range of indications. Sales of
`Botox ® represented approximately 32%, 32% and 27% of our total consolidated sales in 2003, 2002 and 2001, respectively.
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`Botox ® . Botox® is used therapeutically in the treatment of certain neuromuscular disorders which are characterized by involuntary
`muscle contractions or spasms. The approved therapeutic indications for Botox ® in the United States are as follows:
`
`• blepharospasm, the uncontrollable contraction of the eyelid muscles which can force the eye closed and result in functional blindness;
`
`• strabismus, or misalignment of the eyes, in people 12 years of age and over; and
`
`• cervical dystonia, or sustained contractions or spasms of muscles in the shoulders or neck in adults, along with the associated pain.
`
`In certain countries outside of the United States, Botox ® is also approved for treating blepharospasm, strabismus, cervical dystonia,
`hemifacial spasm, pediatric cerebral palsy, hyperhidrosis (excessive sweating) and upper limb spasticity associated with debilities occurring
`after a stroke. We are pursuing new approved indications for Botox ® in the United States, Japan and Europe, including hyperhidrosis
`(excessive sweating), headache, back spasm and spasticity. In July 2003, we achieved two Botox ® milestones. We filed with the FDA the
`Biologics License Application (BLA) supplement for the use of Botox ® for hyperhidrosis in the United States, and we received a positive
`opinion in the Mutual Recognition Process (MRP) for Vistabel ® for seven additional European countries.
`
`The European Commission has granted Botox ® a positive opinion for focal spasticity of the wrist and hand in adult post-stroke patients.
`Health Canada has also approved Botox ® for the management of focal spasticity, including the treatment of upper limb spasticity associated
`with adult post-stroke patients. In addition, Botox ® has been granted approval for hyperhidrosis in Canada, Australia, New Zealand and
`several European countries. To date, the European countries that have approved Botox ® for hyperhidrosis are Austria, Belgium, Denmark,
`Finland, France, Germany, Iceland, Luxembourg, the Netherlands, Portugal, Sweden, Switzerland and the United Kingdom.
`
`Botox ® Cosmetic. The FDA approved Botox ® in April 2002 for the temporary improvement in the appearance of moderate to severe
`glabellar lines in adult men and women age 65 or younger. Referred to as Botox ® , Botox ® Cosmetic or Vistabel ®, depending on the country
`of approval, this product is designed to relax wrinkle-causing muscles to smooth the deep, persistent, glabellar lines between the brow that
`often develop during the aging process. Health Canada approved Botox ® Cosmetic for similar use in Canada in April 2001. In 2003, we
`continued our previously launched direct-to-consumer marketing campaigns in Canada and the United States. These campaigns included
`television commercials, radio advertising and print advertising aimed at consumers and aesthetic specialty physicians. Since its FDA approval
`in the United States, approximately 25 other countries have approved the glabellar line indication for Botox ®, Botox ® Cosmetic or Vistabel
`®, depending on the country of approval, including Australia, Brazil, Canada, Denmark, France, Israel, Mexico, Norway, Poland, Portugal,
`Spain, Sweden, and Switzerland. We now sponsor training of aesthetic-oriented physicians in approved countries to further expand the base of
`qualified physicians using Botox ® , Botox ® Cosmetic or Vistabel ®.
`
`Skin Care Product Line
`
`Our skin care product line focuses on the high growth, high margin segments of the acne and psoriasis markets, particularly in the United
`States and Canada.
`
`Tazarotene Products. Since 1997, we have marketed Tazorac ® gel in the United States for the treatment of plaque psoriasis, a chronic
`skin disease characterized by dry red patches, and acne. We have marketed the cream formulation of Tazorac ® for the treatment of psoriasis
`since its FDA approval in October 2000. In September 2001, we received FDA approval to market Tazorac ® cream for the topical treatment
`of acne. Under a co-promotion agreement for Tazorac ® in the United States, Procter & Gamble Pharmaceuticals Inc. markets Tazorac ®
`primarily to the general practitioner market and we market Tazorac ® to dermatologists currently covered by our in-house sales force. We have
`also engaged Pierre Fabre Dermatologie as our promotion partner for Zorac ® in certain parts of Europe, the Middle East and Africa.
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`Allergan - Annual Report
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`Page 11 of 158
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`Table of Contents
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`In October 2002, we received FDA approval of Avage TM . Avage TM is a tazarotene cream indicated for the treatment of facial fine
`wrinkling, mottled hypo- and hyperpigmentation (blotchy skin discoloration) and benign facial lentigines (flat patches of skin discoloration) in
`patients using a comprehensive skin care and sunlight avoidance program. We launched Avage TM in the United States in January 2003.
`
`In November 2003, we filed a New Drug Application with the FDA for oral tazarotene for the treatment of moderate to very severe
`psoriasis. This New Drug Application remains pending. We also announced our intention to initiate a process to out-license the tazarotene
`molecule for indications in both psoriasis and acne outside North America. In North America, we currently intend to seek a development
`partner for our oral tazarotene acne Phase 3 clinical trials.
`
`Azelex®. Azelex ® cream is approved for the topical treatment of mild to moderate inflammatory acne vulgaris. We launched Azelex ®
`cream in the United States in December 1995.
`
`M.D. Forte ® . We also develop and market glycolic acid-based skin care products. Our M.D. Forte® line of alpha hydroxy acid products
`are marketed to and dispensed by physicians.
`
`Finacea ® . In 2003 we entered into a collaboration with Berlex, Inc. to jointly promote Berlex’s topical rosacea treatment, Finacea ®
`(azelaic acid gel 15%). Finacea ® is the first new therapeutic class option to be approved for the treatment of rosacea in more than a decade
`and has rapidly gained a leading position in the market.
`
`Employee Relations
`
`At December 31, 2003, we employed approximately 4,930 persons throughout the world, including approximately 2,430 in the United
`States. None of our U.S.-based employees are represented by unions. We believe that our relations with our employees are generally very good.
`
`International Operations
`
`Our international sales of specialty pharmaceutical products have represented 29.6%, 29.4% and 33.0% of total sales for the years ended
`December 31, 2003, 2002 and 2001, respectively. Our products are sold in over 100 countries. Marketing activities are coordinated on a
`worldwide basis, and resident management teams provide leadership and infrastructure for customer-focused, rapid introduction of new
`products in the local markets.
`
`Sales and Marketing
`
`We maintain a global marketing team, as well as regional sales and marketing organizations. We also engage contract sales organizations
`to promote certain products. Our sales efforts and promotional activities are primarily aimed at eye care professionals, neurologists, plastic
`surgeons and dermatologists who use, prescribe and recommend our products. We advertise in professional journals and have an extensive
`direct mail program of descriptive product literature and scientific information that we provide to specialists in the ophthalmic, dermatological
`and movement disorder fields. We have developed training modules and seminars to update physicians regarding evolving technology in our
`products. We have also utilized direct-to-consumer advertising for our Botox ® Cosmetic and Refresh ® products.
`
`Our products are sold to drug wholesalers, independent and chain drug stores, pharmacies, commercial optical chains, opticians, mass
`merchandisers, food stores, hospitals, ambulatory surgery centers and medical practitioners, including ophthalmologists, neurologists,
`dermatologists, pediatricians and plastic surgeons. As of December 31, 2003, we employed approximately 1,300 sales representatives
`throughout the world. In 2003, for the sixth year in a row, an independent survey of U.S. ophthalmologists ranked our sales force No. 1 in
`terms of product knowledge and service. We also utilize distributors for our products in smaller international markets.
`
`Sales to Cardinal Healthcare for the years ended December 31, 2003, 2002 and 2001 were 14.0%, 14.8% and 15.1%, respectively, of our
`total consolidated product net sales