~
`
`
`
`TTAB
`
`IN THE UNITED STATES PATENT AND TRADEMARK OF} ...._
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`LEO Pharma A/S
`
`Opposer
`
`v.
`
`Lev Pharmaceuticals, Inc.
`Applicant
`
`: Opposition No. 91171694
`: Appl. No. 76/636,322
`:
`
`Opposer’s Motion for Summary Judgment
`
`Pursuant to Federal Rule of Civil Procedure 56, Opposer, LEO Pharma
`
`A/S, by its undersigned attorneys, hereby moves for summary judgment in Opposition
`
`No. 91171694, filed by Opposer against registration of Application No. 76/636,322, filed
`
`by Applicant, Lev Pharmaceuticals, lnc..
`
`The basis for this Motion is set forth in the accompanying Memorandum in
`
`Support of Opposer’s Motion for Summary Judgment and the documentary Exhibits
`
`attached to the Memorandum.
`
`Respectfully submitted,
`
`Attorneys for Opposer
`LEO Pharma A/S
`
`A
`
`Date‘
`
`Dann, Dorfman, Herrell and Skillman, P.C.
`1601 Market Street, Suite 2400
`Philadelphia, PA 19103
`Telephone:
`(215) 563-4100
`Facsimile:
`(215) 563-4044
`
`llllllllllllllllllllllllllllllllllllllllllllllllll
`
`U2-11-2008
`
`2. Trim;/TM rail pm at
`
`3
`
`L‘ 5 Falerul
`
`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`LEO Pharma A/S
`
`2 Opposition No. 91171694
`
`Opposer
`
`: Appl. No. 76/636,322
`
`Lev Pharmaceuticals, Inc.
`
`Applicant
`
`Motion to Suspend Proceedings
`
`In view of Opposer’s Motion For Summary Judgment, which is filed
`
`concurrently herewith, Opposer, LEO Pharma A/S, by its undersigned attorneys, hereby
`
`moves from an immediate suspension of discovery and any further proceedings herein
`
`pending disposition of the Motion For Summary Judgment.
`
`It is noted that the Motion
`
`For Summary Judgement, if granted, will be dispositive of this proceeding.
`
`Respectfully submitted,
`
`Attorneys for Opposer
`LEO Pharma A/S
`
`
`
`Stephen H. Eland
`Dann, Dorfman, Herrell and Skillman, P.C.
`1601 Market Street, Suite 2400
`Philadelphia, PA 19103
`Telephone:
`(215) 563-4100
`Facsimile:
`(215) 563-4044
`
`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`LEO Pharma A/S
`
`Opposer
`
`v.
`
`: Opposition No. 91171694
`: Appl. No. 76/636,322
`:
`
`Lev Pharmaceuticals, Inc.
`Applicant
`
`Memorandum in Support of Opposer’s
`Motion for Summary Judgment
`
`

`
`Table of Contents
`
`Factual Background ................................................................................................. .. 3
`
`Summary ................................................................................................................. .. 3
`
`Argument ................................................................................................................. .. 4
`
`A. Standard for Summary Judgment ........................................................................ .. 5
`
`B. Applicant Has Not Had Service Mark Use for the Mark LEV PHARMA ............... ..5
`
`1. Applicant’s Activities are Not for the Benefit of Someone Else ................ .. 7
`
`2. Lev Pharmaceuticals’ Research is Not Qualitatively Different from the
`Sale of Goods ................................................................................................ ..9
`
`C. Applicant’s Specimen Does Not Support Service Mark Use ............................. ..10
`
`D. Applicant Committed Fraud By Alleging Service Mark Use in its Application .... ..12
`
`IV.
`
`Conclusion .............................................................................................................. ..15
`
`Table of Exhibits
`
`Page entitled “About Lev” from Lev Pharmaceuticals website
`
`Investor Presentation, dated December 2007, from Lev Pharmaceuticals website,
`pgs 1,13,14,26,27,33
`
`Page entitled “Lev Time|ine” from Lev Pharmaceuticals website
`
`Page entitled “Fundamentials — Annual Highlights” from Lev Pharmaceuticals
`website
`
`Lev Pharmaceuticals lnc., Form 10-QSB Quarterly Report, filed with the Securities
`and Exchange Commission for Period Ending September 30,
`2007, Financial Information Section (Pgs. 1-13)
`
`Applicant’s Specimen Submitted With Service Mark Application
`
`Lev Pharmaceuticals Inc. Annual Report, dated March 30, 2007 (Pgs 1, 14-15)
`
`Sinclair Oil Corp. V. Sumatra Kendrick, Opposition No. 91152940 (TTAB 2007)
`
`Applicant’s Service Mark Application
`
`Applicant’s Response to Opposer’s First Set of interrogatories
`
`Lev Pharmaceuticals Inc. Form DEF 14C, filed with the Securities and Exchange
`
`Commission on January 26, 2005 (Pgs. 1, 2)
`
`Lev Pharmaceuticals Inc. Annual Report, dated March 30, 2007 (Pgs F-20,21)
`
`A B LI
`
`071
`
`

`
`I.
`
`Factual Background
`
`Opposer, LEO Pharma A/S (“LEO Pharma”), was founded in 1908 and has
`
`been involved in the research, development, production and manufacturing of
`
`pharmaceutical products since its founding. LEO Pharma has obtained numerous
`
`trademarks around the world for pharmaceutical preparations, including U.S. Reg. No.
`
`1,777,615 for the mark “LEO” and U.S. Reg. No. 1,782,361 for the mark “LEO” with a
`
`design.
`
`Applicant, Lev Pharmaceuticals, Inc. (“Lev Pharmaceuticals”) is a start-up
`
`company founded in 2003 with the goal of developing and commercializing a line of
`
`products, including its lead product “Cinryze”. See Exhibits A and B. Since its founding,
`
`Lev Pharmaceuticals’ operations have focused on raising capital to fund operations and
`
`conducting research and development for its product to treat inflammatory disease. See
`
`Exhibit E, page numbers 6-7.
`
`Lev Pharmaceuticals filed application No. 76/636,322 to register the service
`
`mark “LEV PHARMA” for “research and development of pharmaceutical products.” Lev
`
`Pharmaceuticals alleges a first use for performing services in commerce of March 19, 2003.
`
`Interestingly, however, Lev Pharmaceuticals represents in its records that the Company
`
`wasn’t even founded until July 2003. See Exhibit C, entitled “Lev Timeline”.
`
`II.
`
`Summary
`
`Performing research and testing for your own product is not a registrable
`
`service. Yet that is exactly what Applicant is trying to do. App|icant’s own documents show
`
`

`
`that since its inception, Lev Pharmaceuticals’ goal has been to get FDA clearance for its
`
`own products. Since Applicant has not performed services for the benefit of others,
`
`Applicant has not used the Lev Pharma mark as a service mark as required by the
`
`Trademark Act and practice before the Patent and Trademark Office. Additionally, since
`
`the research and development activities are a normal and routine part of bringing Lev
`
`Pharmaceuticals’ drug to market, such activities are not the type of services required for
`
`service mark registration under the Trademark Act. Therefore, Opposer requests that the
`
`Board grant Opposer’s Motion for Summary Judgment and refuse registration of the Lev
`
`Pharma mark in the application.
`
`Further still, Applicant’s application is not supported by a proper specimen
`
`showing service mark use for the Lev Pharma mark. Instead, the specimen filed with the
`
`application is an Investor News release about the status of Applicant’s testing for its own
`
`product. Since no appropriate specimen was filed, Opposer requests that the Board grant
`
`Opposer’s Motion for Summary Judgment and refuse registration of the Lev Pharma mark.
`
`Finally, Applicant’s representation in its application that it began use of the
`
`mark for research and development services in March 2003 was false. Applicant’s filings
`
`with the Securities and Exchange Commission show that Applicant knew or should have
`
`know that it had not begun performing services under the mark “Lev Pharma” in commerce
`
`in March 2003, to justify the filing of a service mark application. Accordingly, Applicant has
`
`committed fraud, and for this additional reason, Opposer requests that the Board grant
`
`Opposer’s Motion for Summary Judgment and refuse registration of the Lev Pharma mark.
`
`

`
`lll.
`
`Argument
`
`A. Standard for Summary Judgment
`
`Summary judgment is appropriate whenever the pleadings, depositions,
`
`answers to interrogatories and admissions on file, together with supporting affidavits, if any,
`
`show that there is no genuine issue as to any material fact and that the moving party is
`
`entitled to judgment as a matter of law. Fed. R. Civ. P. 56©); Anderson v. Liberty Lobby,
`
`|_ng_., 477 U.S. 242, 250 (1986). Where the evidence taken as a whole could not lead a
`
`rational trier of fact to find for the non-moving party, there is "no genuine issue for trial".
`
`Matsushita Electric Industrial Company, Ltd. v. Zenith Radio Corp., 475 U.S. 574, 587
`
`(1986).
`
`As discussed below, the undisputed facts show Opposer is entitled to
`
`summary judgment on any one of the following bases:
`
`(1)
`
`Applicant did not have service mark use of the mark Lev Pharma in commerce
`
`when the application was filed;
`
`(2)
`
`(3)
`
`App|icant’s specimen in its application fails to show service mark use; and
`
`Applicant’s own records show that it knew or should have know that it had not
`
`begun service mark use for the mark in commerce on March 19, 2003,
`
`as represented in the application as filed.
`
`B. Applicant Has Not Had Service Mark Use for the Mark LEV PHARMA
`
`Currently, Lev Pharmaceuticals does not have any approved commercial
`
`products. See Exhibit G. As such, Lev Pharmaceuticals has had no sales, no products
`
`approved for commercial sale and has not generated any revenue, except for gains on
`
`

`
`investment holdings and currency exchanges. See Exhibit E, page 4 and Exhibit G, page
`
`14 (under “Risks related to our business”).
`
`Most telling is that the Annual Highlights of Lev Pharmaceuticals’ financial
`
`information lists “n/a” for Net Sales. See Exhibit D. Further still, the most recent quarterly
`
`report states that Lev Pharmaceuticals has never generated any revenue from any sales of
`
`services or products since the inception of the company. See Exhibit E, Condensed
`
`Consolidated Statement of Operations on pg 4.
`
`In fact, Lev Pharmaceuticals does not even
`
`show a listing for revenue, except for interest income and foreign exchange gains.
`
`If Lev
`
`Pharmaceuticals had no sales and no revenue from operations, it appears that Lev
`
`Pharmaceuticals could not have been performing services for others since March 2003,
`
`when its service mark application was filed as Lev Pharmaceuticals represented.
`
`Applicant seeks to register the mark LEV PHARMA for use in connection with
`
`research and development of pharmaceutical products. However, Applicant’s use has
`
`apparently been limited to research and development of its own candidate drug. Such use
`
`does not constitute service mark use for service mark registration purposes under the
`
`Lanham Act and Patent and Trademark Office practice.
`
`As set forth in the TMEP, there are three criteria for determining what
`
`constitutes a service:
`
`(1)
`
`(2)
`
`a service must be a real activity;
`
`a service must be performed to the order of, or for the benefit of, someone
`
`other than the applicant; and
`
`(3)
`
`the activity performed must be qualitatively different from anything necessarily
`
`done in connection with the sale of the applicant’s goods or the
`
`performance of another service.
`
`-5-
`
`

`
`E TMEP §1301.01(a). S_e3gals_o, In re Canadian Pacific Limited, 754 F.2d 992, 224
`USPQ 971 (Fed. Cir. 1985); In re Betz Pa erchem |nc., 222 U.S.P.Q. 89 (TTAB 1984).
`
`Certainly, it is clear that Applicant’s activities do not meet the second or third criteria.
`
`1.
`
`Applicant’s Activities are Not for the Benefit of Someone Else
`
`One of the principles of trademark law is that the services for which service
`
`mark registration is sought must be rendered to others. S_ee In re Dr. Pepper ComQ., 836
`
`F.2d 508, 509 (Fed. Cir. 1987). As the Federal Circuit has emphasized:
`
`“[l]t is this goodwill, established in the minds of the relevant buying public,
`which is protected by the registration of a service mark.”
`
`In re Canadian Pacific Limited, 754 F.2d 992, 994 (Fed. Cir. 1985).
`
`If there is no “buying public”, there can be no goodwill established in the minds of the buying
`
`public.
`
`Applicant does not provide research services for others.
`
`Instead, Applicant is
`
`conducting research to develop and commercialize its own product, “Cinryze”. Since the
`
`research is performed for Lev Pharmaceuticals’ own product, the research does not meet
`
`the requirement that it be for the benefit of someone else.
`
`Lev Pharmaceuticals, Inc. was formed in July 2003 and from March 2005
`
`through May 2007, Lev Pharmaceuticals, Inc. conducted Phase III trials for its product
`
`Cinryze. See Exhibits A-C. As a start-up company, Applicant has reiterated in its investor
`
`materials:
`
`“Our goal is to develop and commercialize a portfolio of C1 lNH products that
`offer improved efficacy and safety over existing treatments.”
`
`-7-
`
`

`
`See Exhibit B, page 33.
`
`Although Applicant may be conducting research, the research does not
`
`constitute a service for service mark registration purposes, unless the research is for
`
`another party. This is not a situation in which a company advertises and promotes itself as
`
`a research lab that can conduct research for other companies looking to develop new
`
`products. Applicant is doing research and clinical trials for its own product, “Cinryze.”
`
`Nowhere on Applicant’s website or in its SEC filings is there representation of
`
`performing research services for others.
`
`Instead, Applicants has continuously stated that
`
`the goal of the company is to develop and commercialize its own products. Such research,
`
`to the extent it is being performed, does not meet the “for the benefit of someone else”
`
`requirement.
`
`Applicant’s financial reports further support the conclusion that to the extent
`
`Applicant is performing research, it is for itself, rather than someone else.
`
`if Lev
`
`Pharmaceuticals were performing services for others, there would be some revenue for
`
`performing such services. However, in its own representations to its investors and the SEC,
`
`Lev Pharmaceuticals consistently reiterates that it has not generated any revenue.
`
`Lev Pharmaceuticals has had no sales, no products approved for commercial
`
`sale and has not generated any revenue, except for gains on investment holdings and
`
`currency exchanges. See Exhibit E. Lev Pharmaceuticals’ most recent quarterly report
`
`shows that it has never generated any revenue from any sales of services or products since
`
`the inception of the Company. See Exhibit E, Condensed Consolidated Statement of
`
`Operations on page 4. Specifically, the consolidated statement on page 4 does not even
`
`-3-
`
`

`
`show a listing for revenue, except for interest income and foreign exchange gains — this is
`
`true for the three month period ending September 30”‘, the nine month period ending
`
`September 30"‘ and the period from inception of the Company through September 30"‘.
`
`Additionally, the quarterly report goes on to specify that “There has been no revenue
`
`generated from sales, license fees or royalties.” See Exhibit E, Note B on page 6.
`
`In fact,
`
`in Lev Pharmaceuticals’ Annual Highlights of financial information, Lev Pharmaceuticals
`
`lists “n/a” for Net Sales. See Exhibit D.
`
`If Lev had no sales and no revenue from
`
`operations, Lev Pharmaceuticals was not performing services for others in commerce.
`
`In short, Lev Pharmaceuticals has consistently reiterated that it is a start-up
`
`company whose goal is to develop and commercialize its family of products. The fact that
`
`Lev Pharmaceuticals has not generated any income from the sales of services in 4 years of
`
`operations simply confirms the obvious: Lev Pharmaceuticals was not and is not performing
`
`services for others. Therefore, Lev Pharmaceuticals has not performed services as required
`
`for service mark registration. Accordingly, Opposer requests that the Board refuse
`
`registration of the Lev Pharma mark in Lev Pharmaceuticals’ application.
`
`2.
`
`Lev Pharmaceuticals’ Research is Not Qualitatively Different from
`the Sale of Goods
`
`Under established trademark practice, as recited in the TMEP §1301 .01 (a),
`
`there are three requirements that activities must meet to qualify as services under the
`
`Trademark Act. As discussed above, Applicant’s research does not meet the requirement
`
`that the services be for others. Additionally, Lev Pharmaceuticals’ research does not meet
`
`the third requirement recited above because the services are not qualitatively different from
`
`-9-
`
`

`
`the sale of Lev Pharmaceuticals’ own goods.
`
`Although Lev Pharmaceuticals has not yet begun the sale of products, its
`
`research activities are directed toward that goal. Of course, before a company can market
`
`a new drug for human use, the company must meet strict FDA requirements for testing and
`
`clinical trials. Such testing is widely known as a standard requirement that a company must
`
`pursue when bringing a new drug to market in the United States.
`
`Rendering a service that is normally “expected or routine” in connection with
`
`the sale of one’s own goods is not a registrable service. S_e_e_ In re Dr. Pepper Comp., 836
`
`F.2d 508, 509 (Fed. Cir. 1987); see also, 1|\_/LEE §1301.01(a)(iii).
`
`Here, Applicant’s research is the quintessential “routine or ordinary” activity
`
`associated with the sale of a new drug. When a company uses a quality control inspector to
`
`check parts before they are shipped, the inspection is part of the normal expectations in
`
`connection with the sale of the product. The same is true relative to the research and
`
`development activities of a company in bringing a new drug to market.
`
`The testing and research that Applicant may be pursuing to try to bring its
`
`product to market is still part and parcel of development of Applicant’s product, and not
`
`qualitatively different from the sale of the goods. For this additional reason, Applicant’s
`
`activities do not qualify as services for service mark registration under the Trademark Act
`
`and Patent and Trademark Office practice.
`
`C.
`
`Applicant’s Specimen Does Not Support Service Mark Use
`
`Applicant’s registration should be refused for failure to provide a proper
`
`specimen showing service mark use. The specimen filed with the service mark application
`
`-10-
`
`

`
`is simply an investor News release announcing Applicant’s progress in the FDA testing
`
`required to bring its product to market. See Exhibit F. Such an announcement is not
`
`sufficient to support service mark registration for research and development services.
`
`Applicant’s specimen is a publicity release to investors. Specifically, the
`
`specimen has the heading “|nvestors” and “News”, and is entitled “Lev Pharmaceuticals
`
`Announces Initiation of Phase III Clinical Trial.” Opposer is unclear how the specimen was
`
`approved by the Examining Attorney, because the TMEP specifically states that publicity
`
`releases are not sufficient to show use. EJ §1301.04 (“[P]ub|icity releases to news
`
`media .
`
`.
`
`. are not accepted because the do not show use of the mark by the applicant in
`
`the sale or advertising of the services.”)
`
`Further still, it is well-settled that a specimen must show an association
`
`between the mark and the services. E E3 §1301.04(b) and In re Adair, 45 U.S.P.Q.
`
`2d 1121 (TTAB 1997).
`
`In this instance, Applicant’s specimen makes no association
`
`between its mark and any services for others. Instead, the announcement explains the
`
`work being done to bring its own product to market. For example, the announcement starts
`
`off by stating:
`
`”Patient enrollment has begun in the trial designed to test the
`efficacy of the Company’s lead product candidate, C1 —esterase
`inhibitor (“C1-|NH”).”
`See Exhibit F, lines 4-7 of the first paragraph (emphasis added).
`
`The announcement goes on to provide details of the Company’s testing and information
`
`about the illness that the Company’s drug is designed to treat.
`
`-11-
`
`

`
`None of the information in Applicant’s specimen shows an association
`
`between the mark and services for others. The announcement simply discusses Applicant’s
`
`own efforts for Applicant’s own product. Accordingly, the application should be refused
`
`because it is not supported by a proper specimen showing service mark use.
`
`Opposer also notes that the lack of a proper specimen further supports the
`
`arguments above in Section B.1. Specifically, if Applicant had used the mark “Lev Pharma”
`
`for services for others, one would expect that Applicant could provide a specimen showing
`
`use in advertising or promoting such research services for others. However, Applicant has
`
`not. Instead, Applicant provided a specimen simply describing the work it has done toward
`
`bringing its product to market.
`
`D. Applicant Committed Fraud By Alleging Service Mark Use in its Application
`
`The TTAB has consistently held that a trademark application is void ab initio if
`
`an applicant commits fraud in the procurement of a registration. S_ee Medinol Ltd. v. Neuro
`
`
`Vasx Inc. 67 U.S.P.Q. 2d 1205, 1209 (TTAB 2003). A prima facie case of fraud is made if:
`
`(1) applicant filed an application based on use in commerce and signed a declaration
`
`attesting to the truth of all the statements in the application; (2) the applicant knew or should
`
`have know that the mark was not used in commerce as stated in the declaration; and (3) the
`
`application was approved for publication as a use—based application because of the false
`
`statement. See Sinclair Oil Corp. v. Sumatra Kendrick
`
`Opposition No. 91152940, pages 11-12 (TTAB 2007) (a copy is attached as Exhibit H).
`
`Lev Pharmaceuticals filed a use-based application claiming a date of first use
`
`-12-
`
`

`
`in commerce of March 19, 2003. The application was supported by representations by Lev
`
`Pharmaceuticals’ CSO, Yanina Wachtfogel, that Lev Pharmaceutical had used the mark
`
`Lev Pharma in performing services in commerce since March 19, 2003.
`
`Interestingly, the
`
`application also appointed attorneys from Kramer Levin Naftalis and Frankel LLP to
`
`represent Lev Pharmaceuticals, so surely Lev Pharmaceuticals was advised regarding the
`
`legal requirements for a use-based service mark application. See Exhibit I. Additionally, in
`
`response to Opposer’s interrogatories, Applicant reiterated its contention that the first date
`
`of service mark use was March 19, 2003. See Exhibit J, Answers to interrogatories 3 and 6
`
`on pages 5-8.
`
`Contrary to the representations in Lev’s Pharmaceuticals’ application, Lev
`
`Pharmaceuticals’ own time line on its website states that the Company wasn't founded until
`
`July 2003, four months after Lev Pharmaceuticals alleged service mark use in its
`
`application. Further still, in an SEC corporate filing on January 26, 2005, Lev
`
`Pharmaceuticals specifically stated that:
`
`“Since its inception in July 2003, Lev’s business activity has consisted
`primarily of capital raising activities, entering into contractual relationships with
`Sanquin and preparing for the commencement of its Phase III clinical trial of
`C1-lNH for the treatment of HAE.”
`
`See Exhibit K.
`
`In other papers, Lev Pharmaceuticals explained that the contracts with Sanquin were signed
`
`in September 2003 and January 2004. The September 2003 Agreement was for an option
`
`to license technology from Sanquin and the January 2004 Agreement was a distribution and
`
`manufacturing services Agreement to provide Lev Pharmaceuticals with the C1-INH needed
`
`so that Lev Pharmaceuticals could conducts clinical trials for its product. See Exhibit K.
`
`-13-
`
`

`
`In short, despite Lev Pharmaceuticals’ representations that it began
`
`performing services under the mark in commerce on March 19, 2003, Lev Pharmaceuticals’
`
`own documents show that:
`
`-Lev Pharmaceuticals was founded in July 2003 (Exhibit C),
`
`-as of September 2007 Lev Pharmaceuticals had no sales (Exhibit E, pg 6), and
`
`-as of January 2005 Lev Pharmaceuticals’ activities were limited to raising capital
`
`and preparing for testing its own product (Exhibit K).
`
`Therefore, when Lev Pharmaceuticals filed its service mark application, it
`
`knew or should have know that it had not had service mark use for the mark “Lev Pharma”
`
`in commerce as of March 19, 2003.
`
`It appears that Lev Pharmaceuticals could not
`
`accurately declare that it had proper service mark use of the Lev Pharma mark, when Lev
`
`Pharmaceuticals had sworn in its SEC filings in January 2005 that, since its inception, the
`
`Company had only been working on raising capital, negotiating contracts to obtain supplies
`
`for its testing, and preparing to commence clinical trials for its product.
`
`Since Lev Pharmaceutical made a false representation in its application about
`
`the commencement of service mark use and knew or should have know that such
`
`representation was inaccurate, Lev Pharmaceuticals committed fraud on the Patent and
`
`Trademark Office. Accordingly, Opposer requests that the Board declare the application
`
`void ab initio and refuse to register the service mark Lev Pharma based on the application.
`
`IV.
`
`Conclusion
`
`It is clear that no genuine issue of a material fact is in dispute regarding
`
`-14-
`
`

`
`Appiicant’s lack of authentic service mark use. All of the relevant facts are established by
`
`Appiicant’s own documents and representations therein. As discussed above, there are
`
`three separate bases that justify summary judgment: (1) Opposer had not used the mark on
`
`services in commerce; (2) Appiicant’s specimen did not support service mark use for the
`
`mark; and (3) Applicant committed fraud when it made representations about service mark
`
`use for the Lev Pharma mark. Each of these bases separately justify refusal to register the
`
`Lev Pharma mark.
`
`In view of the arguments, law and evidence presented in Opposer’s papers
`
`supporting summary judgment, Opposer’s Motion For Summary Judgement should be
`
`granted, the Opposition sustained and registration denied to Applicant based on its
`
`application Serial No. 76/636,322.
`
`Respectfully submitted,
`
`Attorneys for Opposer
`LEO Pharma A/S
`
`Aelzga
`
`Date
`
`Dann, Dorfman, Herrell and Skillman, P.C.
`1601 Market Street, Suite 2400
`Philadelphia, PA 19103
`Telephone:
`(215) 563-4100
`Facsimile:
`(215) 563-4044
`
`-15-
`
`

`
`CERTIFICATE OF SERVICE
`
`I hereby certify that a copy of the foregoing Opposer's Motion for Summary
`
`Judgment, and accompanying Memorandum and Motion to Suspend
`
`was served on February 8, 2008, by first class mail, postage prepaid, addressed to
`
`-
`
`‘
`
`Erica D. Klein, Esq.
`Kramer Levin Naftalis Frankel LLP
`
`1177 Avenue of the Americas
`
`New York, NY 10036
`
`as counsel for Applicant, Lev Pharmaceuticals, Inc.
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`Christine Gersbach
`
`-15-
`
`

`
`CERTIFICATE OF MAILING
`
`I hereby certify that this correspondence is being deposited with the United
`
`States Postal Service as first-class mail in an envelope addressed to Commissioner for
`
`Trademarks, P.O. Box 1451, Alexandria, VA 22313-1451 on February 8, 2008.
`
`
`
`Christine Gersbach
`
`-17-
`
`

`
`EXHIBIT A
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`

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`LEV Pharmaceuticals — Investor Relations - About Lev
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`Page 1 of]
`
`
`
`Leveraging Clinical Experience
`
`About Lev
`
`Home
`
`Cinryze (C1 inhibitor)
`
`About Lev About HAE
`
`investors
`
`Patients
`
`NE
`
`About Lev
`
`Lev Timeline
`
`Strategic Alliances
`
`Corporate Governance
`
`investor Relations
`
`About Lev
`
`m
`
`Lev is a biopharmaceutical company focused on developing and commercializing
`therapeutic products for the treatment of inflammatory diseases. Lev’s lead
`product candidate, Cinryzeill (C1 inhibitor), is being developed as a replacement
`therapy both for the treatment and prevention of Hereditary Angioedema (HAE),
`also known as C1 inhibitor deficiency, a rare. severely debilitating, life-threatening
`genetic disorder.
`
`The company was founded in 2003 around a single premise: to bring C1 inhibitor,
`a treatment that has been used to manage HAE safely and effectively for more
`than 30 years in Europe, to the waiting patient population in the United States.
`
`in 2007, Lev met primary endpoints in its pivotal U.S. Phase lll clinical trial for
`both the acute and prophylactic treatment of HAE, achieving clinical and statistical
`significance. Cinryzeil" has been granted orphan drug status for the treatment
`and prevention of HAE, potentially securing, upon approval, market exclusivity for
`seven years.
`
`Additionally, Lev is in the process of prioritizing its (31 inhibitor development
`platform for the treatment of selective other diseases and disorders in which
`inflammation is known or believed to play an underlying role.
`
`http://www.levpharmacom/phoenix.zhtm1?c=130944&p=iro1-main
`
`2/5/2008
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`
`
`

`
`EXHIBIT B
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`
`EXHIBIT C
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`

`
`LEV Pharmaceuticals - Investor Relations - Lev Pharmaceuticals Timeline
`
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`~_..a............_________WM,_a_,___,,M,‘___,,,,_,m____. W __,____,_
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`Page 1 of 1
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`_
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`___W_Mw‘
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`M
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`__“_‘k
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`_
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`Home
`
`Cinryze(C1 inhibitor) AboutLev
`
`About HAE
`
`Investors
`
`Patients
`
`N:
`
`Lev Timeline
`
`July 2003
`
`January 2004
`July 2004
`
`Lev is founded.
`Lev enters into exclusive licensing and distribution agreements with
`Sanquin Blood Supply Foundation.
`
`Lev receives orphan drug designation.
`
`December 2004 Lev merges with public shell company, Fun City Popcorn.
`
`February 2005
`March 2005
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`Lev begins trading on the OTCBB under the ticker LEVP.
`Lev initiates Phase lll pivotal trial for acute treatment of HAE.
`
`October 2005
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`Lev receives fast track status from the FDA for its C1 inhibitor program.
`
`November 2005 Lev initiates Phase Ill pivotal trial for prophylactic treatment of HAE.
`October 2006
`Lev raises $21 million in private placement.
`
`December 2006 Lev completes acute Phase III trial.
`
`March 2007
`
`May 2007
`July 2007
`August 2007
`
`Lev announces primary endpoint was met demonstrating clinically and
`statistically significant results in its pivotal U.S, Phase lll trial for the
`acute treatment of HAE.
`Lev completes prophylactic Phase lll trial.
`Lev Filesmits Biologics License Application (BLA) with the FDA for
`Cinryze
`.
`Lev raises $35 million in a registered direct equity financing.
`Lev announces primary endpoint was met demonstrating clinically and
`September 2007 statistically significant results in its pivotal U.S. Phase III trial for the
`prophylactic treatment of HAE.
`FDA accepts Cinryze BLA for filing and designates the submission for
`
`priorityreview.
`ocmber2007
`he;/Esubmits amendment to its pending BLA for prophylactic treatment of
`October 2007
`N
`b
`2007 Lev enters into a $20 million senior secured term loan facility with l\/last
`Wem er
`Capital Management for the financing of additional plasma purchases.
`November 2007 Lev appoints Henry M. Dachowitz to the Company‘s Board of Directors.
`
`Ron
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` L?“»..
`
`Leveraging Clinical Experience
`
`Lev Timeline
`
`AboutLev
`
`L°”‘"‘°""‘*
`Strategic Alliances
`
`Corporate Governance
`
`investor Relations
`
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`January 2008
`
`Lev receives FDA Action Letter on Cinryze
`
`3 LEV Pharmaceuticals. 675 Third Avenue, Suite 2200 New York. NY 10017 (212) 8500120
`
`Site Ma
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`http://www.levpharma.corn/phoenix.zhtm1?c=130944&p=irol-timeline
`
`2/5/2008
`
`

`
`EXHIBIT D
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`

`
`LEV Pharmaceuticals - Investor Relations - Fundamentals - Annual Highlights
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`Page 1 of 2
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`5
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`l Leveraging Clinical Experience
`i
`Fundamentals - Annual
`Highlights
`
`About Lev
`
`Home
`
`Cinryze (C1 inhibitor) About Lev About HAE
`
`investors
`
`Patients
`
`N4
`
`0 Corporate Governance
`
`Fundame