6-
`
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`
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`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`TRADEMARK EXAMINING OPERATION
`
`In re Application of
`
`AstraZeneca AB
`
`Serial No.: 78/176,053
`
`October 18, 2002
`
`Mark;
`
`:
`
`:
`
`;
`_
`-
`:
`
`"""""""""""""""""""""""""""" "X
`
`Commissioner for Trademarks
`
`BOX
`Alexandria, VA 22313-1451
`
`BOX RESPONSES
`
`NO FEE
`
`Law Office:
`
`116
`
`Exam. Atty: William Patrick Shanahan
`
`“EXPRESS MAIL” Label No.: EV477960623US
`I hereby certify that this paper or fee is being deposited with
`the United Postal Service “Express Mail Post Office to
`Addressee” service under 37 C.F.R. § 1.10 on the date
`indicated below and is addressed to the Commissioner for
`Trademarks, P.O. Box 1451, Alexandria, VA 22313-1451
`
`
`
`Signature
`
`Printed Name
`
`Date
`
`JULIO SNMONS
`
`001056’ 5, 2004
`
`RESPONSE TO “PRIORITY ACTION FINAL”
`
`AND REQUEST FOR RECONSIDERATION
`
`SIR:
`
`Responding to the “Priority Action Final” dated December 5, 2003, the Examining
`
`Attorney refused registration of the subject service mark on the Principal Register, on the ground
`
`that it is “merely descriptive” of applicant’s services. The Examining Attorney also suggested
`
`that applicant submit a claim of acquired distinctiveness under Section 2(f) of the U.S.
`
`Trademark Act. Applicant now requests amendment of this application to claim acquired
`
`distinctiveness under Section 2(f), and submits the enclosed “Declaration of Distinctiveness”
`
`NY'32589°
`
`I||||l|lllllllllllllllllllllllllllllllllllllllllll
`
`1o-o5-2004
`U.8. Puunt & TMOVOITM Mall Rcpt D1. 074
`
`

`
`
`
`‘Atty.Ref.: 08203l2.0277
`
`'
`
`Mark: PURPLEPILL.COM
`Ser.No.: 78/176,053
`Class:
`44
`
`from an officer of applicant’s related U.S. company‘ that is primarily responsible for the
`
`marketing of applicant’s “Purple Pill” medications in the U.S.A. and the promotion of said
`
`products, e.g., through the informational services offered via the “purplepill.com” web site.
`
`The declarant alleges that the subject mark has become distinctive of the goods for which
`
`the mark is sought to be registered, by reason of (a) substantially exclusive and continuous use of
`
`said mark in commerce by the applicant for said goods for more than four and one-half (4.5)
`
`years preceding the date of execution of the declaration, (b) the applicant’s registration on the
`
`Principal Register of “the color purple as applied to the goods or to containers therefor” as a
`
`trademark for pharmaceutical preparations and substances for the treatment of gastrointestinal
`
`diseases, (c) the applicant’s extensive promotion of the color purple as a trademark for its
`
`aforementioned goods, which has resulted in trade and public recognition of said color as a
`
`trademark, and (d) the widespread public awareness of the domain narne/service mark
`
`“purplepill.com” for applicant’s information services relating to the aforementioned goods,
`
`which are known to the public as “The Purple Pill”, and the association of said goods and their
`
`source of origin with the words “Purple Pill” and “purplepill.com”.
`
`Applicant had previously informed the Examining Attorney that its application to register
`
`the color purple per se was in the course of being published. Applicant can now claim
`
`ownership of Reg. No. 2,806,099, for “the color purple as applied to the goods or to containers
`
`therefor”, as a trademark for pharmaceutical preparations and substances for the treatment of
`
`gastrointestinal diseases. (Please see Exhibit “A” annexed to the enclosed “Declaration of
`
`Distinctiveness”.) Applicant’s color trademark was registered on the basis of acquired
`
`distinctiveness and we now seek registration of the related word mark “purplepillcom” on the
`
`' If so requested by the Examining Attorney, applicant (AstraZene-ca AB) will be pleased to execute a Section 2(t)
`claim in its own name.
`
`NY-325896
`
`2
`
`

`
`
`
`Atty. Ref.: 08203l2.0277
`
`Mark: PURPLEPILL.COM
`Ser. No.2 78/176,053
`Class:
`44
`
`same basis. If applicant’s purple-colored capsules have acquired distinctiveness in respect of
`
`applicant’s gastrointestinal pharmaceutical preparations, then, a fortiori, the words
`
`“purplepillcom” must also have acquired distinctiveness in respect of the service of providing
`
`information about gastrointestinal diseases and medications.
`
`The evidence set forth in the enclosed “Declaration of Distinctiveness” illustrates how
`
`applicant’s “Purple Pill” medications became the largest selling pharmaceutical product in the
`
`U.S.A. at their sales peak, and how applicant engaged in an unprecedented level of advertising
`
`and promotion, including “look for” advertising to associate the color purple and the words
`
`“PURPLE PILL” with its goods. Applicant also made extensive use of the words
`
`“PURPLEPILLCOM” as a source—identifier. Applicant achieved a high level of media and
`
`public recognition of said colors and words, e. g., “Perhaps only Welch’s, the Minnesota Vikings
`
`and Oprah Winfrey are as closely linked to the color purple as “Prilosec”. (Please see Exhibit
`
`“G” armexed to the enclosed “Declaration of Distinctiveness”.) App1icant’s efforts to promote
`
`the arbitrary, non-fiinctional color purple as a trademark, and its sales volume for its goods, far
`
`exceeded the efforts made to protect the well-known “pink” color trademark for fibrous glass
`
`residential insulation (see In re Owens-Corning Fiberglass Corporation, 227 USPQ 417 (Fed.
`
`Cir. 1985), or the showing made to achieve publication ofthe color purple for sandpaper by the
`
`3M Company i (see U.S. Appl. Ser. No. 75/488,524).
`
`NY-325896
`
`j
`
`3
`
`

`
`
`
`Atty.Ref.: 03203120277
`‘
`
`I
`
`I
`
`Mark: PURPLEPILL.COM
`Ser. No.2 78/176,053
`Class:
`44
`
`IN CONCLUSION, applicant requests reconsideration of the final refusal of registration
`
`and prays that the subject application be approved for publication in the Oflicial Gazette since
`
`applicant has complied with all outstanding requirements and established a valid basis for
`
`registration.
`
`Dated: October5,2004
`
`Of Counsel: Mark I. Peroffl Esq.
`
`Respectfully submitted,
`
`AstraZeneca AB
`
`By
`
`eith E. Danish
`
`KIRKPATRICK & LOCKHART LLP
`
`599 Lexington Avenue
`New York, New York 10022-6030
`Tel. No.: (212) 536-4063
`E-Mail: kdanish@kl.c0m
`
`Attorneys for Applicant
`
`NY-325896
`
`4
`
`

`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Atty. Ref.: 08203l2.0277
`____________________________________________________________ __X
`
`In re Service Mark Application of
`
`‘
`
`AstraZeneca AB
`
`Serial N0.:
`
`78/176,053
`
`October 18, 2002
`Filed:
`-
`PURPLEPILL COM
`Mark‘
`______________________________________________________________X
`
`Commissioner for Trademarks
`
`2900 Crystal Drive
`Arlington, VA 22202-3513
`
`‘Express Mail’ mulling labolnum r EV 7w0£23¢(s
`DatoiorffiDepgoslt
`or
`"3
`comn«'wi«§13'1"uii'u?§.i"ui3.c.: 33:3.‘ "
`Pout Omen toMdruuo' oorvloo Indotl OFR
`mo é'§'u'”unTn::u'§'n'o"r'm Truoau:|.u:o.''|u“"'1"i.
`N----tu.\mam-uu (
`..
`“ °
`
`
`Declaration of Distinctiveness
`
`To the Commissioner of Patents and Trademarks:
`
`The undersigned, Linda S. Palczuk, declares that:
`
`1)
`
`I am Executive Director, Commercial Operations of AstraZeneca Pharmaceuticals
`
`LP, a U.S. affiliate of AstraZeneca AB, which is the applicant for registration of the above-
`
`identified service mark, and I am fully familiar with the use and promotion of the subject service
`
`mark and the use and promotion of the color purple as a trademark of AstraZeneca AB in the
`
`United States of America. My company and the applicant are both owned by AstraZeneca PLC,
`
`and my company is primarily responsible for marketing of “PRILOSEC”® and “NEXIUM”®
`
`gastrointestinal pharmaceutical preparations in the United States of America.
`
`NY—323964
`
`

`
`
`
`Atty. Ref.: 0820312.0277
`Sex‘. N0.:
`78/176,053
`Mark:
`PURPLEPILL.COM
`
`2)
`
`I believe that the subject trademark has become distinctive of the goods for which
`
`the mark is sought to be registered, by reason of (a) substantially exclusive and continuous use of
`
`said mark in commerce by the applicant for said goods for more than four and one-half (4.5)
`
`years preceding the date of execution of this declaration, (b) the applicant’s registration on the
`
`Principal Register’ of “the color purple as applied to the goods or to containers therefor” as a
`
`trademark for pharmaceutical preparations and substances for the treatment of gastrointestinal
`
`diseases
`
`[see Exhibit “A”], (c) the applicant’s extensive promotion of the color purple as a
`
`trademark for its aforementioned goods, which has resulted in trade and public recognition of
`
`said color as a trademark, and (d) the widespread public awareness of the domain name/service
`
`mark “PURPLEPILL.COM” for applicant’s information services relating to the aforementioned
`
`goods, which are known to the public as “The Purple Pill”, and the association of said goods and
`
`their source of origin with the words “Purple Pill” and “purplepill.com”.
`
`3 )
`
`For almost fifteen (15) years, applicant has applied the color purple to its goods,
`
`i.e., capsules containing medications which function as “proton pump inhibitors” used to reduce
`
`acid production in the stomach and thereby to treat gastrointestinal diseases. Applicant’s brand
`
`name for the first version of said medication was “PRILOSEC”®.
`
`It was initially sold only on
`
`prescription but an over-the-counter version has now come to market as well.
`
`(The O—T-C
`
`product is not packaged in purple-colored capsules but the box for the medication is colored
`
`purple.) Applicant
`
`is distributing its newer
`
`“NEXIUM”® prescription gastrointestinal
`
`medications (“esomeprazole magnesium”) in a purple-colored capsule with two or
`
`three gold-
`
`1 Reg. No. 2,806,099, dated January 20, 2004.
`
`NY-323964
`
`

`
`
`
`Atty. Ref.: 08203l2.0277
`Ser. No.:
`78/176,053
`Mark:
`PURPLEPILL.COM
`
`colored bands displayed thereon, and is advertising (or has advertised) said product as “Today’s
`
`Purple Pill”, “The New Purple Pill”, “The Healing Purple Pill”, etc.
`
`4)
`
`There
`
`is no functional
`
`aspect
`
`to the color purple vis—a-vis
`
`applicant’s
`
`aforementioned goods, or the capsules therefor. Said color is completely arbitrary. Applicant
`
`selected the color purple for its “PRILOSEC” capsules after conducting attitudinal market
`
`research studies in the U.S.A. and determining that the color purple was viewed most favorably
`
`by consumers compared with the other choices, including capsule colors used by the applicant to
`
`market similar drugs outside the U.S.A.
`
`5)
`
`Applicant is aware of third—party use of purple—colored capsules for different
`
`types of medicines, e.g., MYCOBUTIN (antibiotic), FELDENE (anti—inflammatories), DROXIA
`
`(sickle—cell anemia) and PHRENII_.H\I (headache). However, applicant believes that it is the
`
`only producer of gastrointestinal pharmaceutical preparations which are sold in purple—colored
`
`capsules or pills.
`
`Furthermore, applicant is unaware of any third parties that have promoted the
`
`color purple as a trademark for any type of pharmaceutical preparations.
`
`6)
`
`AstraZeneca AB owns
`
`the domain name www.purplepill.com, which was
`
`registered on October 29, 1999, and, since March 1, 2000, said domain name has been used as
`
`the address of a web site which provides, via the Internet, information about gastrointestinal
`
`diseases and pharmaceutical preparations and substances for the treatment thereof. Applicant’s
`
`purple—colored capsules are prominently displayed on said web site and the color purple is used
`
`in the “dress” of the site. Annexed hereto are representative pages from the current web site for
`
`www.purplepill.com.
`
`[See Exhibit “B”]
`
`NY—323964
`
`

`
`
`
`Atty. Ref.: 0820312.0277
`Ser. No.1
`78/176,053
`Mark:
`PURPLEPILL.COM
`
`7)
`
`The words “purplepillcom” are used prominently by applicant, in advertising and
`
`promotional materials,
`
`to identify and distinguish the services set forth in Appl. Ser. No.
`
`78/176,053.
`
`[See Exhibit “C”]
`
`8)
`
`The color purple has been extensively used in connection with the advertising and
`
`promotion of applicant’s “PRILOSEC” and “NEXIUM” medications.
`
`(See Exhibit “D”)
`
`9)
`
`The sales of applicant’s “PRILOSEC” medications reached unprecedented
`
`levels and in the third quarter of 1996 it became the number-one selling pharmaceutical product
`
`in the U.S.A.
`
`The trademark “NEXIUM” was first used in 2000 and, while sales of
`
`“PRILOSEC” declined, the “NEXIUM” product (also sold in purple-colored capsules) became a
`
`large—se1ling product.
`
`In recent years, the following levels of sales were achieved:
`
`1995
`
`1996
`
`l997
`1998
`
`I999
`
`2000
`2001
`
`2002
`2003
`
`over $1 ,300,000,000
`
`over $2,000,000,000
`
`over $2,500,000,000
`over $3,500,000,000
`
`over $4,500,000,000
`
`over $5,000,000,000
`over $4,400,000,000
`
`over $2,000,000,000
`over $3,200,000,000
`
`(NEXIUM & PRILOSEC)
`(NEXIUM & PRILOSEC)
`
`10)
`
`Applicant has engaged in extensive marketing, advertising and promotional
`
`activities for its “PRILOSEC” and “NEXIUM” products and has incurred the following expenses
`
`for such activities, excluding trade samples:
`
`2001
`
`2002
`
`2003
`
`over $200,000,000
`
`over $225,000,000
`
`over $225,000,000
`
`NY-323964
`
`4
`
`

`
`
`
`Atty. Ref.: 0820312.0277
`Ser. No.:
`78/176,053
`Mark:
`PURPLEPILL.COM
`
`Prior to 2001, applicant’s marketing, advertising and promotional expenditures for “PRILOSEC”
`
`were also very substantial, as evidenced by the fact that “PRILOSEC” became the number-one
`
`selling pharmaceutical product in the U.S.A. in the third quarter of 1996.
`
`1 1) Most of applicant’s advertising from the beginning of 2000 to the present time
`
`has focused on educating the public to associate the color purple and the phrase “The Purple Pill”
`
`with its goods,
`
`i.e., “PRILOSEC”® gastrointestinal drugs and, more recently, “NEXIUM”®
`
`gastrointestinal drugs, in order that said color and phrase will be viewed as a symbol of origin
`
`and quality of gastrointestinal drugs which emanate from one source only,
`
`i.e.,
`
`from the
`
`applicant. Applicant’s advertising in visual media has depicted floating purple drug capsules,
`
`persons wearing purple—colored clothes, purple backgrounds and borders, and has referred to its
`
`aforementioned web site “purplepillcom”. Also, applicant’s advertising text has used phrases
`
`such as “Visit us at purplepill.com”, “Purple.
`
`It’s Not Just Another Pretty Color”, “Ask your
`
`doctor about the purple pill”, “Talk to your doctor about the purple pill they call PREOSEC”
`
`and “Do you know there’s a new purple pill” (referring to “NEXIUM”®).
`
`(See Exhibit “E”)
`
`Much of applicant’s advertising has invited the public to visit the web site www.purplepill.com,
`
`and the total number of advertising impressions bearing this message in the period from January
`
`1999 through May 2004 is believed to have exceeded 16.4 billion.
`
`12)
`
`Applicant has advertised “The Purple Pill” in the aforementioned manner in many
`
`publications which are widely distributed to the general U.S. public, including “Bon Appetit”,
`
`“Family Circle”, “Fortune”, “Good Housekeeping”, “Ladies Home Journal”, “Life”, “National
`
`Geographic”, “Newsweek”, “People”, “Readers Digest”, “Sports Illustrated”, “US News &
`
`NY-323964
`
`

`
`
`
`Atty. Ref.: 0820312.0277
`Ser. No.2
`78/176,053
`Mark:
`PURPLEPILL.COM
`
`World Report”, “Wall Street Journal”, and in the “Washington Post” and other U.S. city
`
`newspapers. Applicant has advertised on network and cable television, and on radio. Other
`
`promotional activities for “The Purple Pill” have included direct mail
`
`to the public and to
`
`doctors, newsletters, distribution of product samples, charts and cards to doctors, and advertising
`
`in medical publications.
`
`Applicant has also carried out “Station Domination” advertising
`
`campaigns which have involved the placing of “Purple Pill”—themed advertisements throughout
`
`the entirety of a high—traffic public place such as New York’s Port Authority Bus Terminal,
`
`Philadelphia’s 30"‘ Street Railroad Station and San Francisco’s Embarcadero BART Station.
`
`[See Exhibit “F”]
`
`13)
`
`In ruling on whether or not a television advertisement for “PRILOSEC”® (which
`
`did not mention said brand name) should be considered a “product-specific advertisement”, the
`
`Division of Drug Marketing, Advertising and Communications of the U.S. Food and Drug
`
`Administration ruled that the ad in question was a product—specific advertisement because it
`
`discussed acid—reflux disease in conjunction with “the purple pill”,
`
`and AstraZeneca
`
`manufactures PRILOSEC, “which is the only purple pill that treats heartburn due to acid—reflux
`
`disease”.
`
`14)
`
`There have been many independent, unsolicited references in U.S. print media to
`
`applicant’s “PRILOSEC” and “NEXTUM” drugs wherein news reporters or persons quoted by
`
`them have associated applicant’s goods with the color purple and/or with the words “purple pill”,
`
`e.g.:
`
`NY-323964
`
`

`
`
`
`Atty. Ref.: 0820312.0277
`Ser. No.2
`78/176,053
`Mark:
`PURPLEPILL.COM
`
`‘It’s really an incredible medication,’ [Dr.] Walker
`“And then there is Prilosec.
`‘People call
`it the little purple miracle pill’.”
`[Syracuse Herald-Journal, February 23,
`
`said.
`1996]
`
`“This is the story of a pill. The pill was colored purple so consumers would
`remember it as the purple pill. The purple pill hit the market in 1989 to treat a humble condition,
`heartburn. ...the purple pill became a financial star.
`In 1995, drugmaker Astrazeneca sold more
`than $1 billion of the purple pill in the US.
`In 1997, sales crossed the $2 billion mark. At the
`height of its popularity, in the year 2000, sales of the purple pill exceeded $4 billion. Prilosec
`was the most popular pill in the US and in the world.” [NPR: All Things Considered, April 18,
`2002]
`
`“Perhaps only Welch’s, the Minnesota Vikings and Oprah Winfrey are as closely
`linked to the color purple as Prilosec.” [Advertising Age: June 26, 2000]
`
`The drug
`“AstraZeneca will continue pushing purple in its bid for green.
`marketer is expected to shift
`its marketing theme for prescription heartburn pill Prilosec, which
`revolves around the color purple, to its successor drug Nexium. Prilosec has been a blockbuster,
`in part because of consumer campaigns pegging it as
`‘the purple pill’.
`Purple—themed
`promotions have been splashed on prime—time TV, the web site purplepill.com, even the
`floorboards in New York’s Port Authority Bus Terminal.”
`[Advertising Age, October 30, 2000]
`(emphasis added)
`
`“The heartburn and ulcer drug Prilosec — widely known as ‘the purple pill’ — will
`lose its patent protection in October.” [The Dallas Morning News, March 1 1, 2001]
`
`“General Motors Corp. spent $55 million last year for something totally unrelated
`tires — or to cars at all.
`It was for Prilosec,
`the expensive little purple pills for
`to steel,
`heartburn...’Are drug company ads driving up health care costs? You bet,’ says Woody
`Williams, GM executive director of hea1th—care initiatives.
`‘Not everyone with heartburn needs
`the purple pill.” [The Wall Street Journal, March 13, 2002]
`
`“Prilosec is one of the most recognizable drugs, thanks to a distinctive purple
`color and hundreds of millions of dollars spent on consumer ads — some telling people to ‘ask
`your doctor about Prilosec, the purple pill’.”
`[The Wall Street Journal, June 6, 2002]
`
`“Purple Prodigy”
`
`[The Wall Street Journal, June 21, 2002]
`
`“The Costly Case of the Purple Pill” — AstraZeneca has been able to keep the
`purple profits flowing....when they later found themselves sitting on a doctor’s padded exam
`table, they didn’t even have to recall
`the drug’s name. All
`they had to remember was its
`
`NY-323964
`
`

`
`Atty. Ref.: 08203l2.0277
`Ser. No.:
`78/176,053
`Mark:
`PURPLEPILL.COM
`
`9!
`
`color....even critics of the purple juggernaut got around to saying: “It’s a very good drug.’....
`[The Boston Globe Magazine, November 17, 2002]
`
`AstraZeneca’s relentless promotion of its heartburn medication over the years
`helped make Prilosec the world’s best-selling purple pill, generating $4.6 billion sales in 2002.”
`[Smart Money, June 2003]
`
`[See Exhibit “G”]
`
`15)
`
`The United States Patent and Trademark Office has recognized that “the color
`
`purple as applied to the goods or to containers therefor” for applicant’s gastrointestinal
`
`medications has acquired distinctiveness in commerce and has qualified for registration on the
`
`U.S. Principal Register.
`
`(See Reg. No. 2,806,099)
`
`A fortiori, the words “PURPLE PILL”,
`
`which are the dominant feature of the instant service mark “PURPLEPILL.COM”, should be
`
`recognized as a distinctive service mark since they have the same significance to the public as
`
`the representation of a “purple pill”.
`
`The undersigned, being hereby warned that willful false statements and the like so made
`
`are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United
`
`States Code and that such willful false statements may jeopardize the validity of the application
`
`or any registration resulting therefrom, declares that she is properly authorized to execute this
`
`declaration and that all statements made herein of her own knowledge are true and all statements
`
`made on information and belief are believed to be true.
`
`Dated: September
`
`, 2004
`
`NY-323964
`
`

`
`
`
`Thank you for your request. Here are the latest results from the TA_RR_web: server.
`
`This page was generated by the TARR system on 2004-09-22 16:10:22 ET
`
`Serial Number: 76103792
`
`Registration Number: 2806099
`
`_I'-T-_—-h--4-,—-.
`
`Mark
`~
`(4:-llllwlllglllHI;:::ll|l—lI:T”"Ih
`INIIH1I'|HHl“'”II,n'|r
`‘It'll!'Ir‘,r*l,I'.r'!f|H;I;“fl'
`.¢rIl|I[I'll:';I]||i-I||H1,Iil.h'
`-I1_LL.I.'.';_:4._;uI_:I_I.r.r.r:_I_q_'-'—-’
`
`_
`
`Standard Character claim: No
`
`Current Status: Registered.
`
`Date of Status: 2004-01-20
`
`Filing Date: 2000-08-04
`
`Transformed into a National Application: No
`
`Registration Date: 2004-01-20
`
`Register: Principal
`
`Law Office Assigned: LAW OFFICE 115
`
`If you are the applicant or applicant's attorney and have questions about this file, please contact the
`Trademark Assistance Center at Trade_r_nar_kA_ssistanceCenter@uspto.gov
`
`Current Location: 900 -Warehouse (Newington)
`
`Date In Location: 2004-08-11
`
`LAST APPLICANT(S)/OWNER(S) OF RECORD
`
`1. Astrazeneca AB
`
`Address:
`Astrazeneca AB
`Vastra Malarehamnen 9
`
`S-151 85 Sodertalje
`Sweden
`
`Legal Entity Type: Corporation
`State or Country of Incorporation: Sweden
`
`

`
`
`
`GOODS AND/OR SERVICES
`
`International Class: 005
`
`Pharmaceutical preparations and substances for the treatment of gastrointestinal diseases
`First Use Date: 1989-12-00
`First Use in Commerce Date: 1989-12-00
`
`Basis: 1(a)
`
`Disclaimer: THE REPRESENTATION OF A CAPSULE
`
`ADDITIONAL INFORMATION
`
`Description of Mark: The mark consists of the color purple as applied to the goods or to containers therefor. Tl
`broken lines in the drawing are intended to show the position of the mark and are not a part of the mark. The
`outline of the capsule is in broken lines.
`
`Lining and Stippling: The drawing is lined for the color purple.
`
`Section 2(1)
`
`(NOT AVAILABLE)
`
`MADRID PROTOCOL INFORMATION
`
`PROSECUTION HISTORY
`
`20.04-"01-2R0.-‘Registered - Principal Register
`
`2003-10-28 - Published for opposition
`
`2003-10-08 - Notice of publication
`
`2003-08-29 — Approved for Pub — Principal Register (Initial exam)
`
`2002-07-24 - Section 1(a) claim - Added
`
`2003-05-27 — Correspondence Received In Law Office
`
`2003-06-18 - Case File in TICRS
`
`2003-05-29 - PAPER RECEIVED
`
`2002-11-26 — Non-final action mailed
`
`2002-10-28 — PAPER RECEIVED
`
`2002-09-13 — Case file assigned to examining attorney
`
`2002-07-24 - Correspondence Received In Law Office
`
`

`
`
`
`2002-01-22 - Non-final action mailed
`
`2001-07-06 — Unresponsive paper received
`
`2001-01-16 - Non-final action mailed
`
`2000-12-27 - Case file assigned to examining attorney
`
`CONTACT INFORMATION
`
`Correspondent
`Mark I. Peroff (Attorney of record)
`
`MARK I. PEROFF
`TRADEMARK & PATENT COUNSELORS ET AL
`
`915 BROADWAY
`
`NEW YORK, NEW YORK 10010-7108
`
`Domestic Representative
`Trademark & Patent Counselors of America
`
`, P.C.
`
`

`
`

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`when you have acid reflux disease (GERD), stomach
`acid can "back up" into the esophagus due to
`W - -
` m inappropriate relaxation of the lower esophageal
`sphincter (LES). If left untreated, this acid can wear
`away or erode the lining of your esophagus. This
`condition is called Erosive Esophagitis (EE). Your
`stomach has a special lining that protects it from the
`acid; your esophagus, unfortunately, does not have the
`same protection.
`
`The most common symptom of Erosive Esophagitis
`
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`and/or GERD is persistent heartburn experienced on two
`or more days a week. It may be accompanied by the
`fomwmg symptoms:
`
`o Sour or bitter taste in the mouth from
`regurgitation of stomach contents
`o Difficult swallowing
`
`Only your doctor can diagnose EE and prescribe the
`most appropriate treatment plan for you.
`
`
`
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`Talk to your doctor or healthcare professional to see if NEXIUM is right for you. Most erosions heal in 4 to 8 weeks with
`NEXIUM. The most common side effects of NEXIUM are headache, diarrhea, and abdominal pain. Symptom relief does not
`rule out serious stomach conditions. Please read the important Product Information about NEXIUM and discuss it with your
`healthcare professional.
`
`SEARCH '
`
`BUUKMARK THIS SITE -
`
`SEND THIS PAGE TO A FRIEND
`
`Important product information about NEXIUM I Medial Professional Site I Privacy Statement | Legal Informabon I Feedbad< | Contact Us | Site Map
`
`/5
`AS!razeneca "/
`
`.
`This
`.
`.
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`product Information 5 Intended for US consumers only.
`206119 03/O2 Copyright © 2004 Asbazeneca LP, All rights reserved.
`
`US Corporate Site
`
`

`
`
`
`0I.II'
`
`Digestion
`Understand what causes acid reflux disease (GERD) and
`
`how it affects your digestive system.
`
`Heartburn
`
`Frequent & persistent heartburn may not be just plain
`old heartburn.
`
`Acid Reflux Disease
`
`..
`
`..
`
`..
`
`__
`
`You're not alone. You could be one of the millions of
`
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`Digestion Quiz
`
`people who suffers from acid reflux disease.
`
`Erosive Esophagilis
`
`Did you know that, over time, acid backing up from the
`stomach, can wear away the lining of your esophagus?
`
`Talk to your doctor or healthcare professional to see if NEXIUM is right for you. Most erosions heal in 4 to 8 weeks with
`NEXIUM. The most common side effects of NEXIUM are headache, diarrhea, and abdominal pain. Symptom relief does not
`rule out serious stomach conditions. Please read the important Product Information about NEXIUM and discuss it with your
`healthcare professional.
`
`SEARCH -
`
`BUUKMARK THIS SIIE -
`
`SEND THIS PAGE TO A FRIEND
`
`/;
`As! razeneca 1
`
`This produa information is intended for US consumers only.
`206119 O3/02 Copyright © 2004 Astrazeneaa LP, All rights rserved.
`
`US Corporate Srbe
`
`

`
`
`
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`
`
`lluin News
`
`Ilayocliniconu G.I.Digeol Glossary
`
`learn
`
`NEXIUM News
`NEXIUM's Acid-Relief Brief
`May0C|inic.com G.|. Digest
`
`The collected issues of the MayoClinic.com
`G.I. Digest
`
`Glossary
`Medical words and terms with their meanings
`
`Talk to your doctor or healthcare professional to see if NEXIUM is right for you. Most erosions heal in 4 to 8 weeks with
`NEXIUM. The most common side effects of NEXIUM are headache, diarrhea, and abdominal pain. Symptom relief does not
`rule out serious stomach conditions. Please read the important Product Information about NEXIUM and discuss it with your
`healthcare professional.
`
`SEARCH '
`
`BODKMARK THIS SHE '
`
`SEND THIS PAGE I0 A FRIEND
`
`/3
`As!razeneca Z
`
`This product information '5 intended for US cnrsumers only.
`206119 O3/02 Copyright © 2004 Astrazenea LP, All rights reserved.
`
`j
`US Corpoiate Site
`
`

`
`
`
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`
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`Wiatifluium? How NEXl.lHWorks Hannhin
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`FAOs
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`NEXIUM - taken once daily - is for people who suffer from frequent and persistent
`heartburn 2 or more days a week, despite treatment and changes in diet.
`
`If your doctor decides that prescription NEXIUM is right for you, we invite you to take
`advantage of the 7-day FREE trial.
`
`To get your NEXIUM coupon:
`Supply the information requested below. ALL fields marked with an (*) are required. Click
`the Submit button and your personalized coupon will appear in a separate window.
`
`Astrazeneca respects your personal health information. The information you provide may
`be used to send you health-related materials and to develop products, services, and
`programs. Astrazeneca, or third parties working on our behalf, will not sell or rent
`personal health information. Please click here to review our Privacy Statement.
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`Yes! I'd like to get a 7-Day Free Trial Coupon.
`
`‘
`
`'
`
`'L_3‘L;"m"Mm
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`Are you registering for yourself'?* Yes 5 No F
`
`Which medication do you primarily use for heartburn?* lCh005€ One?
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`‘I
`
`[‘ Yes, send me information on NEXIUM and related health information.
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`I"
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`Yes, send me information on other AstraZeneca products,
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`uodnooRep-Laa.:,g
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`For US residents only
`If you no longer wish to receive information via e—mail, please click here.
`
`step two
`
`Print out your personalized coupon and ask your doctor if the Purple Pill is right for you.
`Follow the instructions on the coupon to redeem for a free 7-day trial of NEXIUM.
`
`step three
`
`Don't let acid reflux disease hold you back.
`
`Talk to your doctor or healthcare professional to see if NEXIUM is right for you. Most erosions heal in 4 to 8 weeks with
`NEXIUM. The most common side effects of NEXIUM are headache, diarrhea, and abdominal pain. Symptom relief does not
`rule out serious stomach conditions. Please read the important Product Information about NEXIUM and discuss it with your
`healthcare professional.
`
`SEARCH '
`
`BUDKMARK THIS SITE -
`
`SEND THIS PAGE H) A FRIEND
`
`

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`Nexium”
`
`9346600
`620514-00
`
`(esomeprazole magnesium)
`DE LAYE D—RELEASE CAPSULES
`Rx only
`
`DESCRIPTION
`in NEXIUM” (esomeprazole magnesium)
`The active ingredient
`Delayed-Release Capsules is bis(5-methoxy-2-[(S)-[(4—methoxy-3,
`5-dimethyl—2-pyridinyl)methy|]sulfinyl]-1H-benzimidazole-1-yl)
`magnesium trihydrate, a compound that inhibits gastric acid secre-
`tion. Esomeprazole is the S-isomer of omeprazole, which is a mixture
`of the 5- and R-isomers. its empirical formula is (C,7H13N3O3S)2Mg x
`3 H20 with molecular weight of 767.2 as a trihydrate and 713.1 on an
`anhydrous basis. The structural formula is:
`
`me
`
`OCH;
`
`0
`N
`
`on,
`
`o
`cu, ------ g
`
`N~
`
`ocn,
`
`Mg?‘-3H,o
`
`2
`
`The magnesium salt is a white to slightly colored crystalline powder.
`It contains 3 moles of water of solvation and is slightly soluble in
`water.
`it
`The stability of esomeprazole magnesium is a function of pH;
`rapidly degrades in acidic media. but it has acceptable stability under
`alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium
`salt is about 19 hours at 25°C and about 8 hours at 37°C.
`NEXIUM is supplied as Delayed-Release Capsules for oral administra-
`tion. Each delayed-release capsule contains 20 mg or 40 mg of
`esomeprazole (present as 22.3 mg or 44.5 mg esomeprazole magne-
`sium trihydrate)
`in the form of enteric-coated pellets with the
`following inactive ingredients: glyceryl monostearate 40-50, hydrox-
`ypropyl
`cellulose,
`hydroxypropyl methylcellulose, magnesium
`stearate, rriqthacrylic acid copolymer type C. polysorbate 80, sugar
`spheres,
`talc, and triethyl citrate. The capsule shells have the
`following inactive ingredients: gelatin, FD&C Blue #1, FD&C Red #40,
`D&C Red #28,
`titanium dioxide, shellac, ethyl alcohol,
`isopropyl
`alcohol, n-butyl alcohol, propylene glycol,
`sodium hydroxide,
`polyvinyl pyrrolidone, and D&C Yellow #10.
`CLINICAL PHARMACOLOGY
`Phurmcicokinetics
`Absorption
`NEXlUM Delayed-Release Capsules contain an enteric-coated pellet
`formulation of esomeprazole magnesium. After oral administration
`peak plasma levels (CW) occur at approximately 1.5 hours (Tm).
`The CW increases proportionally when the dose is increased, and
`there is a three-fold increase in the area under the plasma concentra-
`tion—time curve (AUC) from 20 to 40 mg. At repeated once—daily
`dosing with 40 mg, the systemic bioavailability is approximately 90%
`compared to 64% after a single dose of 40 mg. The mean exposure
`(AUC) to esomeprazole increases from 4.32 pmo|'hr/L on day 1 to
`11.2 pmol*hr/L on day 5 after 40 mg once daily dosing.
`The AUC after administration of a single 40 mg dose of esomeprazole
`is decreased by 33-53% after food intake compared to fasting condi-
`tions. Esomeprazole should be taken at least one hour before meals.
`The pharmacokinetic profile of esomeprazole was determined in
`36 patients