Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov
`ESTTA383214
`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
`Second Notice of Reliance - 1.pdf ( 253 pages )(1766781 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 SECOND NOTICE OF RELIANCE, PURSUANT TO RULE 2.122(e), ON
`OPPOSER’S 2009 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 February 26, 2010 for the period
`
`ending December 31, 2009. A true and correct copy of the referenced Form 10-K is attached
`
`hereto as Exhibit 2. The Form 10-K was obtained from the Internet, and the printed version
`
`attached as Exhibit 2 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 2009, 2008 and 2007. 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
`
`2
`
`

`
`EXHIBIT 2
`EXHIBIT 2
`
`

`
`Allergan - Annual Report
`
`Page 1 of 249
`
`Table of Contents
`
`UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
`
`(Mark One)
`; ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
`SECURITIES EXCHANGE ACT OF 1934
`
`FORM 10-K
`
`For the Fiscal Year Ended December 31, 2009
`
`or
`
`… TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
`SECURITIES EXCHANGE ACT OF 1934
`
`Commission File Number 1-10269
`
`Allergan, Inc.
`
`(Exact Name of Registrant as Specified in its Charter)
`
`Delaware
`(State or Other Jurisdiction of
`Incorporation or Organization)
`
`2525 Dupont Drive
`Irvine, California
`(Address of Principal Executive Offices)
`
`95-1622442
`(I.R.S. Employer Identification No.)
`
`92612
`(Zip Code)
`
`(714) 246-4500
`(Registrant’s Telephone Number, Including Area 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 Registered
`New York Stock Exchange
`
`Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ; No …
`
`Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes … No ;
`
`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
`(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ; No …
`
`Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted
`pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such
`files). Yes ; No …
`
`Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) 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 a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large
`accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
`
`Large accelerated filer ;
`Non-accelerated filer … (Do not check if a smaller reporting company)
`
`Accelerated filer …
`Smaller reporting company …
`
`Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes … No ;
`
`As of June 30, 2009, the aggregate market value of the registrant’s common stock held by non-affiliates of the registrant was approximately $14,430 million based on the closing sale
`price as reported on the New York Stock Exchange.
`
`Common stock outstanding as of February 19, 2010 — 307,511,888 shares (including 3,511,177 shares held in treasury).
`
`DOCUMENTS INCORPORATED BY REFERENCE
`
`Part III of this report incorporates certain information by reference from the registrant’s proxy statement for the annual meeting of stockholders to be held on April 29, 2010, which
`proxy statement will be filed no later than 120 days after the close of the registrant’s fiscal year ended December 31, 2009.
`
`http://apps.shareholder.com/sec/viewerContent.aspx?companyid=AGN&docid=7085816&print=1
`
`12/9/2010
`
`

`
`Allergan - Annual Report
`
`Page 2 of 249
`
`Table of Contents
`
`TABLE OF CONTENTS
`
`PART I.
`
`Item 1.
`
`Business
`
`Item 1A.
`
`Risk Factors
`
`Item 1B.
`
`Unresolved Staff Comments
`
`Item 2.
`
`Item 3.
`
`Item 4.
`
`PART II.
`
`Item 5.
`
`Item 6.
`
`Item 7.
`
`Properties
`
`Legal Proceedings
`
`Submission of Matters to a Vote of Security Holders
`
`Market For Registrant’s Common Equity, Related Stockholder Matters and Issuer
`Purchases of Equity Securities
`
`Selected Financial Data
`
`Management’s Discussion and Analysis of Financial Condition and Results of Operations
`
`Item 7A.
`
`Quantitative and Qualitative Disclosures About Market Risk
`
`Item 8.
`
`Item 9.
`
`Financial Statements and Supplementary Data
`
`Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
`
`Item 9A.
`
`Controls and Procedures
`
`Item 9B.
`
`Other Information
`
`PART III.
`
`Item 10.
`
`Item 11.
`
`Item 12.
`
`Item 13.
`
`Item 14.
`
`PART IV.
`
`Directors, Executive Officers and Corporate Governance
`
`Executive Compensation
`
`Security Ownership of Certain Beneficial Owners and Management and Related
`Stockholder Matters
`
`Certain Relationships and Related Transactions, and Director Independence
`
`Principal Accounting Fees and Services
`
`Item 15.
`
`Exhibits and Financial Statement Schedules
`
`SIGNATURES
`
`i
`
`Page
`1
`
`1
`
`32
`
`50
`
`50
`
`50
`
`55
`
`56
`
`56
`
`57
`
`58
`
`87
`
`91
`
`91
`
`92
`
`92
`
`93
`
`93
`
`93
`
`93
`
`93
`
`93
`
`94
`
`94
`
`102
`
`http://apps.shareholder.com/sec/viewerContent.aspx?companyid=AGN&docid=7085816&print=1
`
`12/9/2010
`
`

`
`Allergan - Annual Report
`
`Page 3 of 249
`
`Table of Contents
`
`Statements made by us in this report and in other reports and statements released by us that are not historical facts constitute “forward-
`looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21 of the Securities Exchange Act of 1934.
`These forward-looking statements are necessarily estimates reflecting the best judgment of our senior management based on our current
`estimates, expectations, forecasts and projections and include comments that express our current opinions about trends and factors that may
`impact future operating results. Disclosures that use words such as we “believe,” “anticipate,” “estimate,” “intend,” “could,” “plan,”
`“expect,” “project” or the negative of these, as well as similar expressions, are intended to identify forward-looking statements. These
`statements are not guarantees of future performance and rely on a number of assumptions concerning future events, many of which are outside
`of our control, and involve known and unknown risks and uncertainties that could cause our actual results, performance or achievements, or
`industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking
`statements. We discuss such risks, uncertainties and other factors throughout this report and specifically under the caption “Risk Factors” in
`Item 1A of Part I of this report below. Any such forward-looking statements, whether made in this report or elsewhere, should be considered in
`the context of the various disclosures made by us about our businesses including, without limitation, the risk factors discussed below. Except as
`required under the federal securities laws and the rules and regulations of the U.S. Securities and Exchange Commission, we do not have any
`intention or obligation to update publicly any forward-looking statements, whether as a result of new information, future events, changes in
`assumptions or otherwise.
`
`Item 1.
`
`Business
`
`General Overview of our Business
`
`PART I
`
`We are a multi-specialty health care company focused on developing and commercializing innovative pharmaceuticals, biologics and
`medical devices that enable people to live life to its greatest potential — to see more clearly, move more freely and express themselves more
`fully. Our diversified approach enables us to follow our research and development into new specialty areas where unmet needs are significant.
`
`We discover, develop and commercialize specialty pharmaceutical, medical device and over-the-counter products for the ophthalmic,
`neurological, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention, urological and other specialty markets in more
`than 100 countries around the world. Our diversified business model includes products for which consumers may be eligible for reimbursement
`and cash pay products that consumers pay for directly. Based on internal information and assumptions, we estimate that in fiscal year 2009,
`approximately 72% of our net product sales were derived from reimbursable products and 28% of our net product sales were derived from cash
`pay products.
`
`We are a pioneer in specialty pharmaceutical, biologic and medical device research and development, with global efforts targeting
`products and technologies related to eye care, skin care, neuromodulators, medical aesthetics, obesity intervention, urology and neurology. In
`2009, our research and development expenditures were approximately 15.9% of our product net sales or approximately $706.0 million. We
`supplement our own research and development activities with our commitment to identify and obtain new technologies through in-licensing,
`research collaborations, joint ventures and acquisitions.
`
`In March 2006, we acquired Inamed Corporation, or Inamed, a global health care manufacturer and marketer of breast implants, a range
`of dermal filler products to correct facial wrinkles, and bariatric medical devices for approximately $3.3 billion, consisting of approximately
`$1.4 billion in cash and 34,883,386 shares of our common stock.
`
`In the first quarter of 2007, we acquired Groupe Cornéal Laboratoires, or Cornéal, a health care company that develops, manufactures and
`markets dermal fillers, for approximately $209.2 million, net of cash acquired. The acquisition of Cornéal expanded our marketing rights to
`Juvéderm and a range of hyaluronic acid dermal fillers from the United States, Canada and Australia to all countries worldwide and provided
`®
`us with control over the manufacturing process and future research and development of Juvéderm and other dermal fillers.
`®
`
`In the fourth quarter of 2007, we acquired Esprit Pharma Holding Company, Inc., or Esprit, for approximately $370.8 million, net of cash
`acquired. By acquiring Esprit, we obtained an exclusive license to
`
`1
`
`http://apps.shareholder.com/sec/viewerContent.aspx?companyid=AGN&docid=7085816&print=1
`
`12/9/2010
`
`

`
`Allergan - Annual Report
`
`Page 4 of 249
`
`Table of Contents
`
`®
`
`, and Sanctura XR (trospium chloride extended release capsules), or Sanctura XR ,
`(trospium chloride), or Sanctura
`market Sanctura
`®
`®
`anticholinergics approved for the treatment of overactive bladder, or OAB,
`in the United States and its territories from Indevus
`Pharmaceuticals, Inc., or Indevus. We launched Sanctura XR in the United States in the first quarter of 2008. In the second quarter of 2008,
`®
`we entered into a license agreement with Indevus and Madaus GmbH, which grants us the right to seek approval for and to commercialize
`Sanctura XR in Canada. In the first quarter of 2010, Health Canada, the Canadian national regulatory body, approved Sanctura XR .
`®
`®
`
`®
`
`(dapsone) gel 5% from QLT USA, Inc., or QLT, a wholly-owned subsidiary of QLT
`In the third quarter of 2008, we acquired Aczone
`Inc. for approximately $150 million. Aczone
`, approved for sale in both the United States and Canada, is indicated for the treatment of acne
`®
`vulgaris in patients 12 and older. Aczone
`contains the first new FDA-approved chemical entity (dapsone) for acne treatment since Tazorac
`®
`®
`(tazarotene) gel was approved in 1997. We launched Aczone
`in the United States in the fourth quarter of 2008.
`®
`
`®
`
`In the fourth quarter of 2008, we entered into a strategic collaboration arrangement with Spectrum Pharmaceuticals, Inc., or Spectrum, to
`develop and commercialize apaziquone, an antineoplastic agent currently being investigated for the treatment of non-muscle invasive bladder
`cancer by intravesical instillation. Under the collaboration, Spectrum is conducting two Phase 3 clinical trials to explore apaziquone’s safety
`and efficacy as a potential treatment for non-muscle invasive bladder cancer following surgery. We made an initial payment of $41.5 million to
`Spectrum and will make additional payments of up to $304 million based on the achievement of certain development, regulatory and
`commercialization milestones. Spectrum retained exclusive rights to apaziquone in Asia, including Japan and China. Allergan received
`exclusive rights to apaziquone for the treatment of bladder cancer in the rest of the world, including the United States, Canada and Europe. In
`the United States, Allergan and Spectrum will co-promote apaziquone and share in its profits and expenses. Allergan will also pay Spectrum
`royalties on all of its apaziquone sales outside of the United States. In the third quarter of 2009, the U.S. Food and Drug Administration, or
`FDA, granted Fast Track Designation for the investigation of apaziquone for the treatment of non-muscle invasive bladder cancer. Fast Track
`Designation was designed to facilitiate drug development and expedite the review of drugs intended to treat serious conditions. In the fourth
`quarter of 2009, Spectrum completed enrollment in the two Phase 3 clinical trials.
`
`In the third quarter of 2009, we entered into a co-promotion agreement with Quintiles Transnational Corp., or Quintiles, under which
`Quintiles will co-promote Sanctura XR , Latisse
`and Aczone
`, generally targeting primary care physicians. We will continue to promote
`®
`®
`®
`Sanctura XR , Latisse
`and Aczone using our existing sales forces to specialty physicians.
`®
`®
`®
`
`In the first quarter of 2010, we acquired Serica Technologies, Inc., a medical device company focused on the development of
`biodegradable silk-based scaffolds for use in tissue regeneration, including breast augmentation, revision and reconstruction and bariatric
`applications, for an aggregate purchase price of approximately $70.0 million.
`
`We were founded in 1950 and incorporated in Delaware in 1977. Our principal executive offices are located at 2525 Dupont Drive,
`Irvine, California, 92612, and our telephone number at that location is (714) 246-4500. Our Internet website address is www.allergan.com .
`1
`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, or SEC. The
`SEC maintains an Internet site at www.sec.gov that contains the reports, proxy and information statements and other information that we file
`electronically with the SEC.
`
`Operating Segments
`
`We operate our business on the basis of two reportable segments — specialty pharmaceuticals and medical devices. The specialty
`pharmaceuticals segment produces a broad range of pharmaceutical products, including: ophthalmic products for chronic dry eye, glaucoma
`therapy, ocular inflammation, infection, allergy and retinal
`
`1
`
`This website address is not intended to function as a hyperlink and the information at this website address is not incorporated by reference
`into this Annual Report on Form 10-K.
`
`2
`
`http://apps.shareholder.com/sec/viewerContent.aspx?companyid=AGN&docid=7085816&print=1
`
`12/9/2010
`
`

`
`Allergan - Annual Report
`
`Page 5 of 249
`
`Table of Contents
`
`®
`
`for certain therapeutic and aesthetic indications; skin care products for acne, psoriasis, other prescription and over-the-counter
`diseases; Botox
`skin care products and, beginning in the first quarter of 2009, eyelash growth products; and, beginning in the fourth quarter of 2007 urologics
`products. The medical devices segment produces a broad range of medical devices, including: breast implants for augmentation, revision and
`reconstructive surgery; obesity intervention products, including the Lap-Band
`System and the Orbera
`Intragastric Balloon System and
`®
`facial aesthetics products. The following table sets forth, for the periods indicated, product net sales for each of our product lines within our
`specialty pharmaceuticals segment and medical devices segment, domestic and international sales as a percentage of total product net sales
`within our specialty pharmaceuticals segment and medical devices segment, and segment operating income for our specialty pharmaceuticals
`segment and medical devices segment:
`
`Œ
`
`Specialty Pharmaceuticals Segment Product Net Sales by Product Line
`Eye Care Pharmaceuticals
`/Neuromodulator
`®
`Botox
`Skin Care Products
`Urologics
`Total Specialty Pharmaceuticals Segment Product Net Sales
`
`Specialty Pharmaceuticals Segment Product Net Sales
`Domestic
`International
`
`Medical Devices Segment Product Net Sales by Product Line
`Breast Aesthetics
`Obesity Intervention
`Facial Aesthetics
`Core Medical Devices
`Other (1)
`Total Medical Devices Segment Product Net Sales
`
`Medical Devices Segment Product Net Sales
`Domestic
`International
`
`2009
`
`Year Ended December 31,
`2008
`(dollars in millions)
`
`2007
`
`$2,100.6
`1,309.6
`208.0
`65.6
`$3,683.8
`
`$2,009.1
`1,310.9
`113.7
`68.6
`$3,502.3
`
`$1,776.5
`1,211.8
`110.7
`6.0
`$3,105.0
`
`66.5%
`33.5%
`
`65.2%
`34.8%
`
`65.8%
`34.2%
`
`$ 287.5
`258.2
`218.1
`763.8
`—
`$ 763.8
`
`$ 310.0
`296.0
`231.4
`837.4
`—
`$ 837.4
`
`$ 298.4
`270.1
`202.8
`771.3
`2.7
`$ 774.0
`
`60.5%
`39.5%
`
`62.0%
`38.0%
`
`65.1%
`34.9%
`
`Specialty Pharmaceuticals Segment Operating Income (2)
`Medical Devices Segment Operating Income (2)
`
`$1,370.8
`189.2
`
`$1,220.1
`222.0
`
`$1,047.9
`207.1
`
`Consolidated Long-Lived Assets
`Domestic
`International
`
`$3,673.2
`577.4
`
`$3,781.0
`553.8
`
`$3,702.8
`557.5
`
`(1) Other medical device product sales primarily consist of sales of ophthalmic surgical devices pursuant to a manufacturing and supply
`agreement entered into as part of the sale of the former Cornéal ophthalmic surgical device business in the third quarter of 2007,
`which was substantially concluded in the fourth quarter of 2007.
`
`(2) Management evaluates business segment performance on an operating income basis exclusive of general and administrative expenses
`and other indirect costs, restructuring charges, in-process research and development expenses, amortization of identifiable intangible
`assets related to business combinations and asset acquisitions and certain other adjustments, which are not allocated to our business
`segments for performance assessment by our chief operating decision maker. Other adjustments excluded from our business
`segments for purposes of performance assessment represent income or expenses that do not reflect, according to established
`company-defined criteria, operating income or expenses associated with our core business activities.
`
`We do not discretely allocate assets to our operating segments, nor does our chief operating decision maker evaluate operating segments
`using discrete asset information.
`
`See Note 18, “Business Segment Information,” in the notes to the consolidated financial statements listed under Item 15 of Part IV of this
`report, “Exhibits and Financial Statement Schedules,” for further information concerning our foreign and domestic operations.
`
`http://apps.shareholder.com/sec/viewerContent.aspx?companyid=AGN&docid=7085816&print=1
`
`12/9/2010
`
`

`
`Allergan - Annual Report
`
`Page 6 of 249
`
`3
`
`http://apps.shareholder.com/sec/viewerContent.aspx?companyid=AGN&docid=7085816&print=1
`
`12/9/2010
`
`

`
`Allergan - Annual Report
`
`Page 7 of 249
`
`Table of Contents
`
`Specialty Pharmaceuticals Segment
`
`Eye Care Pharmaceuticals 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 chronic dry eye, glaucoma, inflammation, infection and allergy.
`
`®
`
`, is the first, and currently the only, prescription
`(cyclosporine ophthalmic emulsion) 0.05%, or Restasis
`Chronic Dry Eye. Restasis
`therapy for the treatment of chronic dry eye worldwide. Restasis
`is our best selling eye care product. Chronic dry eye is a painful and
`®
`irritating condition involving abnormalities and deficiencies in the tear film initiated by a variety of causes. The incidence of chronic dry eye
`increases markedly with age, after menopause in women and in people with systemic diseases such as Sjögren’s syndrome and rheumatoid
`, physicians used lubricating tears to provide palliative relief of the debilitating symptoms of chronic
`arthritis. Until the approval of Restasis
`®
`dry eye. We launched Restasis
`in the United States in 2003 under a license from Novartis AG, or Novartis, for the ophthalmic use of
`®
`cyclosporine. Restasis
`is currently approved in 34 countries.
`®
`
`®
`
`brands, treat dry eye symptoms including
`and Refresh Optive
`Artificial Tears . Our artificial tears products, including the Refresh
`®
`irritation and dryness due to pollution, computer use, aging and other causes. Refresh , launched in 1986, is the best selling over-the-counter
`®
`artificial tears brand in the United States and includes a wide range of preserved and non-preserved drops as well as ointments to treat dry eye
`symptoms. According to IMS Health Incorporated, an independent marketing research firm, our artificial tears products, including the Refresh
`and Refresh Optive
`brands, were again the number one selling artificial tears products worldwide for the first nine months of 2009.
`®
`®
`
`®
`
`Œ
`
`Œ
`
`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 70 million people worldwide have glaucoma. According to IMS Health Incorporated, our
`products for the treatment of glaucoma, including Lumigan (bimatoprost ophthalmic solution) 0.03%, or Lumigan 0.03%, Lumigan 0.01%,
`®
`®
`®
`(brimonidine tartrate ophthalmic solution) 0.2%, or Alphagan
`, Alphagan
`P 0.15%, Alphagan
`P 0.1%, Combigan
`®
`®
`®
`®
`®
`Alphagan
`(brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, or Combigan , and Ganfort
`(bimatoprost/timolol maleate ophthalmic
`®
`solution), or Ganfort
`, captured approximately 19% of worldwide glaucoma market sales for the first nine months of 2009.
`
`Œ
`
`Œ
`
`Lumigan 0.03% and Lumigan 0.01% are topical treatments indicated for the reduction of elevated intraocular pressure in patients with
`®
`®
`glaucoma or ocular hypertension. Lumigan
`0.01% is an improved reformulation of Lumigan
`0.03% for sale in certain countries outside of
`®
`®
`the United States. We are also seeking approval of Lumigan 0.01% in the United States. We currently sell Lumigan 0.01% and Lumigan
`®
`®
`®
`0.03% in over 75 countries worldwide and, together, they are our second best selling eye care products. According to IMS Health Incorporated,
`Lumigan 0.01% and Lumigan 0.03% were the fourth best selling glaucoma products in the world for the first nine months of 2009. In 2002,
`®
`®
`the European Commission approved Lumigan 0.03%. In 2004, the European Union’s Committee for Proprietary Medicinal Products approved
`®
`0.03% as a first-line therapy for the reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular
`®
`Lumigan
`hypertension. In 2006, the FDA approved Lumigan
`0.03% as a first-line therapy. In 2004, we entered into an exclusive licensing agreement
`®
`with Senju Pharmaceutical Co., Ltd., or Senju, under which Senju became responsible for the development and commercialization of Lumigan
`0.03% in Japan. In the third quarter of 2009, Senju received approval of Lumigan
`0.03% in Japan. In the second quarter of 2009, Health
`®
`®
`Canada approved Lumigan
`0.01%. Lumigan
`0.01% was also approved in Brazil in 2009. In the first quarter of 2010, the European
`®
`®
`Commission granted a Marketing Authorization for Lumigan 0.01% in the 27 European Union member states.
`®
`
`4
`
`http://apps.shareholder.com/sec/viewerContent.aspx?companyid=AGN&docid=7085816&print=1
`
`12/9/2010
`
`

`
`Allergan - Annual Report
`
`Page 8 of 249
`
`Table of Contents
`
`Œ
`
`®
`
`in the European Union. Combined sales of Lumigan
`In 2006, we received a license from the European Commission to market Ganfort
`0.03%, Lumigan
`0.01% and Ganfort
`represented approximately 10% of our total consolidated product net sales in 2009, 2008 and 2007.
`®
`is now sold in over 29 countries outside the United States.
`Ganfort
`
`Œ
`
`Œ
`
`, Alphagan P 0.15% and Alphagan P 0.1%. These
`Our third best selling eye care products are the ophthalmic solutions Alphagan
`®
`®
`products lower intraocular pressure by reducing aqueous humor production and increasing uveoscleral outflow. Alphagan
`P 0.15% and
`®
`Alphagan P 0.1% are improved reformulations of Alphagan
`containing brimonidine, the active ingredient in Alphagan
`, preserved with
`®
`®
`®
`. We currently market Alphagan , Alphagan P 0.15% and Alphagan P 0.1% in over 70 countries worldwide.
`®
`®
`®
`®
`Purite
`
`®
`
`Alphagan , Alphagan P 0.15% and Alphagan P 0.1% combined were the fourth best selling glaucoma products in the world for the
`®
`®
`®
`first nine months of 2009, according to IMS Health Incorporated. Combined sales of Alphagan , Alphagan P 0.15% and Alphagan P 0.1%
`®
`®
`®
`and Combigan
`represented approximately 9% of our total consolidated product net sales in 2009, 2008 and 2007. In 2002, based on the
`®
`acceptance of Alphagan P 0.15%, we discontinued the U.S. distribution of Alphagan
`. In 2004, we entered into an exclusive licensing
`®
`®
`agreement with Kyorin Pharmaceutical Co., Ltd., or Kyorin, under which Kyorin became responsible for
`the development and
`commercialization of Alphagan and Alphagan P 0.15% in Japan. Kyorin subsequently sublicensed its rights under the agreement to Senju.
`®
`®
`Alphagan P 0.1% was launched in the United States in 2006. The marketing exclusivity period for Alphagan P 0.1% expired in the third
`®
`®
`quarter of 2008, although we have a number of patents covering the Alphagan P 0.1% and Alphagan P 0.15% technology that extend to
`®
`®
`2022 in the United States. In 2003, the FDA approved the first generic of Alphagan . Additionally, a generic form of Alphagan is sold in a
`®
`®
`limited number of other countries, including Canada, Mexico, India, Brazil, Colombia, Argentina and other countries in the European Union.
`
`®
`
`®
`
`, a brimonidine and timolol
`products, we developed the ophthalmic solution Combigan
`and Lumigan
`In addition to our Alphagan
`combination designed to treat glaucoma and ocular hypertension in people who are not responsive to treatment with only one medication and
`are considered appropriate candidates for combination therapy. In 2005, we received positive opinions for Combigan
`from 20 concerned
`®
`member states included in the Combigan Mutual Recognition Procedure for the European Union, and we launched Combigan
`in the
`®
`®
`European Union during 2006. In the fourth quarter of 2007, the FDA approved Combigan and we launched Combigan in the United States.
`®
`®
`Combigan is now sold in over 55 countries worldwide.
`®
`
`®
`
`.
`(ketorolac ophthalmic solution) 0.4%, or Acular LS
`Inflammation. Our leading ophthalmic anti-inflammatory product is Acular LS
`is a version of Acular
`that has been reformulated for the reduction of ocular pain, burning and stinging following corneal
`®
`®
`Acular LS
`refractive surgery. Acular PF was the first preservative-free topical non-steroidal anti-inflammatory drug, or NSAID, in the United States.
`®
`Acular PF is indicated for the reduction of ocular pain and photophobia following incisional refractive surgery. The Acular
`franchise was
`®
`®
`the best selling ophthalmic NSAID in the world during the first nine months of 2009, according to IMS Health Incorporated. In the third
`quarter of 2009, the FDA approved Acuvail
`(ketorolac tromethamine ophthalmic solution) 0.45%, or Acuvail
`, an advanced unit-dose
`®
`®
`preservative-free formulation of ketorolac for the treatment of pain and inflammation following cataract surgery and we began marketing
`. In the fourth quarter of 2009, the FDA approved four Abbreviated New Drug Applications, or ANDAs, for ketorolac tromethamine
`®
`Acuvail
`in the United States. Our
`ophthalmic solution 0.5%, a generic version of Acular
`, and four companies launched generic versions of Acular
`®
`®
`ophthalmic anti-inflammatory product Pred Forte
`remains a leading topical steroid worldwide based on 2009 sales. Pred Forte
`has no
`®
`®
`patent protection or marketing exclusivity and faces generic competition.
`
`®
`
`®
`
`, which we license from Kyorin and
`(gatifloxacin ophthalmic solution) 0.3%, or Zymar
`Infection. Our leading anti-infective is Zymar
`have worldwide ophthalmic commercial rights excluding Japan, Korea, Taiwan and certain other countries in Asia and Europe. We launched
`in the United States in 2003. Zymar
`is a fourth-generation fluoroquinolone for the treatment of bacterial conjunctivitis and is
`®
`®
`Zymar
`currently approved in 33 countries. Laboratory studies have shown that Zymar kills the most common bacteria that cause eye infections
`®
`
`®
`
`®
`
`5
`
`http://apps.shareholder.com/sec/viewerContent.aspx?companyid=AGN&docid=7085816&print=1
`
`12/9/2010
`
`

`
`Allergan - Annual Report
`
`Page 9 of 249
`
`Table of Contents
`
`for bacterial conjunctivitis
`as well as specific resistant bacteria. We completed our Phase 3 clinical studies of an enhanced formula of Zymar
`and filed a New Drug Application, or NDA, with the FDA in the third quarter of 2009. According to Verispan, an independent research firm,
`Zymar was the number two ophthalmic anti-infective prescribed by ophthalmologists in the United States in 2009. Zymar was the third best
`®
`®
`selling ophthalmic anti-infective product in the world for the first nine months of 2009, according to IMS Health Incorporated.
`
`®
`
`ophthalmic
`Allergy. The allergy market is, by its nature, a seasonal market, peaking during the spring months. We market Alocril
`solution for the treatment of itch associated with allergic conjunctivitis. We license Alocril
`from Fisons Ltd., a business unit of Sanofi-
`®
`Aventis, and hold worldwide ophthalmic commercial rights excluding Japan. Alocril
`is approved in the United States, Canada and Mexico.
`®
`is used for
`We license Elestat
`from Boehringer Ingelheim AG, and hold worldwide ophthalmic commercial rights excluding Japan. Elestat
`®
`®
`the prevention of itching associated with allergic conjunctivitis. We co-promote Elestat
`in the United States under an agreement with Inspire
`®
`Pharmaceuticals, Inc., or Inspire, within the