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`CYAN EXHIBIT 1037
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`UNITED STATES DISTRICT COURT
`MIDDLE DISTRICT OF FLORIDA
`OCALA mVIsI°N
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`Civil Action No.
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`JURY TRIAL DEMANDED
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`U.S. NUTRACEUTICALS LLC
`cllb/a VALENSA INTERNATIONAL;
`and THE BOARD OF TRUSTEES 01-‘
`THE UNIVERSITY OF ILLINOIS,
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`Plaintiffs,
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`vs.
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`CYANOTECH CORPORATION,
`and NUTREX HAWAII, INC.,
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`Defendants.
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`COMPLAINT
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`' This is a complaint for patent infringement arising under the patent laws of the United:
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`States. Plaintiffs U.S. Nutraceuticals, LLC, dba Valensa International, and The Board of
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`Trustees of the University of Illinois allege the following as their complaint:
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`THE PARTIES
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`1.
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`Plaintiff U.S. Nutraceuticals, LLC, dba Valensa. lntemational (“Valensa”), is a
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`limited liability corporation formed under the laws of the State of Florida and has a principal
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`place of business at 2751 Nutra Lane, Eustis, Florida, 32726.
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`2.
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`Valensa is an innovative, nutraceutical-focused company that develops,
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`manufactures, and sells ingredients for natural health supplements, multi-ingredient
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`nutritional formulations, and other functional compositions used to promote natural health
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`and well-being. Valensa has particular expertise with astaxanthin, including proprietary
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`extraction and stabilization techniques Valensa uses in support ofits efforts to market
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`astaxanthin, as well as patent rights covering certain uses ofastaxanthin.
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`3.
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`Plaintiff The Board ofTrustees of the University of Illinois (“University of
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`Illinois”) is a body corporate and politic of the State of Illinois with a place of business at
`352 Henry Administration Building, MC-350, 506 South Wright Street, Urbana, IL-61801.
`4.
`The University ofIllinois is an academic institution involved in extensive
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`' research activities that have earned the University of Illinois numerous utility patents,
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`including the Tso patent.
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`Upon information and belief, Defendant Cyanotech Corporation
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`(“Cyanotech") is a publicly-traded corporation formed under the laws ofthe State ofblevada.
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`with a principal place of business at 73-4460 Queen Kaahumanu Highway, Suite 102.,
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`=I(ailtia-‘I’-fona‘; Hawaii, 96740.
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`-6.73 5*
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`"Upon information and belief, Defendant Nutrex Hawaii, Inc. (“Nutrex’.’), is a
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`corporation formed under the laws ofthe State of Hawaii with a principal place ofbusiness at. .
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`73-4460 Queen Kaahumanu Highway, Suite 102, Kailua-Kona, Hawaii, 96740.
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`7.
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`- Cyanotech and Nutrex (collectively “Defendants”) market nutraceutical
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`‘ingredients and products and directly and indirectly compete against Valensa, particularly .
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`with respect to their efforts to manufacture and sell astaxanthin products. Defendants-
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`produce and sell astaxanthin products and condition-specific formulations to consumers, as
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`well as to other nutraceutical companies that repackage and rebranci the products as their own
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`and/or incorporate Cyanotech-brand astaxanthin in their own retail dosage farm products.
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`8."
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`Upon information and belief‘, Nutrex is a wholly-owned subsidiary andlor
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`division of Cyanotech, and there is nearly complete overlap in the directors and executives of
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`Nutrex with those ofCyanotech. For example, Mr. Brent Baily serves as President and Chief
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`‘Exeeuti*ve"0fiicer- of both entities, and. he also serves on-the Cyanotech Board of Directors.
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`‘Mr.’ Geraldcysewski serves as Executive Vice President and ChiefScientific Officer for
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`¥botl1'- companies, serves on the Board of Directors for Cyanotech, and has been identified as a _
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`" *1 95 ‘-founder" "ofboth companies. Mr. Cysewski also previously served. as Cyanoteclfs Chief _
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`Executive Officer. Ms. Jole Deal serves as the ChiefFinancial Officer, Vice President of
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`"~l-‘inance and Administration, Treasurer, and Secretary for_ both entities, and ‘her predecessor, ,
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`i?’>~’Ms:€Dé_ai'tfia’Spooner, also possessed those same positions with both entities. Mr. Glen ,
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`—-'.ia‘r‘t‘s'er3i‘»§'erves as the -Vice President of Operations -forboth entities. -Mr; Robert Capel_lis_erves
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`as Vice President Sales and-Market-‘ing for both entities. Similarly, the Medical Director of;
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`» 5:‘: '1 - Cyantittééli, Dr.’- Robert Corish, helped develop the formulationfor the products sold undena -__ -5
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`'Nutre:t label‘, and has been-identified as the Medical Director ofNutrex as well.
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`9.
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`Upon information and belief, Nutrex and Cyanotech operate from the exact
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`same oflices, with the same personnel using the exact same facilities and equipment. in
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`marketing materials, the entities refer to the same assets and facilities as their own, including,
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`for example, the algae farms used to grow Haematococcuspluviahs, an algae from which
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`' astaxanthin is extracted.
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`10.
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`Upon information and belief, the financial resources of Cyanotech and Nutrex
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`are, and have been, intermingled and are not kept separate. For example, Cyanotech’s public
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`filings with the United States Securities and Exchange Commission include the financial
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`inforrnation‘ofNutrex, and do not provide any financial information specific to Cyanotech
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`' and exclusiye ofNutrex.
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`Upon information and belief, Cyanotech formed Nutrex for the sole purposes
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`" " “ " bfnnirketing retail products designed by Cyanotech, for the exclusive benefit-ofCyanotech.
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`"?':':Déspf€;iie"fori‘r:ting Nutrex-Hawaii; Cyanotech has referred to-Nutrex Hawaii-branded-retail’.
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`“‘pi-’oi1uct§ is its own.
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`Upon information-and belief: Cyanotech has-ignored the separate‘ corporate
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`iiiufi-ex, and has treated‘Nutrex and its employees and resources as though.i_t'was the
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`isiainii"étitity"as"Cyanotcch'. Cyanotech has exerted’ complete. and unfettered control over the _,. J
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`To?-‘blutrex. For all intents and purposes, the two purported entities have operated-as a -
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`all actionswundertaken by Nutrex arefor -the excl-usivebenefit of, in active
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`" 3” """"g"”'.“.'T': -under-thecontrol "a'nd'direction of.‘CY&notech. -
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`~ JURISDICTION
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`13.
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`This is anaction for patent infringement arising under the Acts of Congress
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`-‘ re1hting"to patents, 35 U-’.S.C. §§ 211, 281-285.
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`i 14.‘
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`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331, 1332, and
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`‘l 338(a).
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`15.
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`This Court has personal jurisdiction over Defendants by virtue of their
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`substantial, continuous, and systematic contacts with the State of Florida, and their knowing
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`and .pl.ll'pOS‘BfI.li distribution, marketing, offers to sell. and sales ofastaxanthin products used
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`to‘ infringe the Tso patent at issue in the State ofFlorida. This Court also has personal
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`jurisdiction over Defendants because their acts of patent infringement are aimed at this
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`—
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`judicial district and/or have effect in this judicial district. For example, upon information and
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`belief, Defendants have knowingly and purposefully distributed the products at issue to
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`= customers located in Florida, through their own online retail efforts, and through the online _
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`-~ —‘ "mark‘eting'-‘efforts of their distributors and-customers. -Defendants have marketed their,
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`*‘ products through retail chains such as Whole Foods (16 stores in Florida), Walgreens (1f1_3_
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`stores in Florida), GNC, Amazon.com, The Vitamin Shoppe (60 stores in Florida), Swanson
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`Health ‘Products, 4all Vitamins, and Purel-lealingFoods.com for sale on the lntemetto ,.
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`‘=1 -‘custorners-‘lo‘cat'e‘d in Florida, and, upon informationand belief‘, in brick-and-mortar stores,
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`" " f:i”*‘¥ ‘lécatediin-':tl1e"State of Florida. Defendants have-also placed advertisements fortheir .
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`‘astaxanthin-‘products; in publications distributed tltroughoutthe country, including Florida,
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`1'45=?i‘siteli"hsi%6le=:'Foods. Magazine. Defendants-ha've alsosold astaxanthin beadlets, tabl_ets,__
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`andlor oleoresin to numerous companies with the knowle_d'ge‘and_expectation that tltpse ,,
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`companies sell products throughout the United States, --including Florida, incorporating _
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`--'Cyanotech’s astaxanthin products, for use in methods that infringe the Tso-patent. Such._.__ .
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`companies include, for exampIe,.larrow Formulas, NOW Foods, Twinlab, Health Plus,
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`. HLV/Douglas Labs, Pure Encapsulations, and Nutraceutical Science Institute.
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`16.
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`Upon information and belief, Defendants have also employed a number of -
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`1- individuals residing in the State of Florida that were involved with the development,
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`marketing, and sale of astaxanthin products for uses Defendants knew to be covered by the
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`Tso patent. Cyanotech employed Dr. Robert Corish as a Medical Director while he lived in
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`the State of Florida, a position Dr. Corish has also been identified as serving for Nutrex.
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`Cyanotech also employed and/or contracted with Dr. Leonard Smith, who served as a
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`scientist and spokesperson for Cyanotech, while he resided and continues "to reside in Florida.
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`Cyanotech also employed Mr. Marc Ketchel as Director of Sales for Cyanotech while he
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`lived in Florida. As Cyanotechfs Director of Sales, and while living and working out of _
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`-=Fioiida;=Mr. Ketchel developed formula prototypes, wrote marketing materials for «
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`‘ Defendants" MD Formulas Hawaii” astaxanthin products, and also managed a team of 25
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`salesrepresentatives working the East Coast, including Florida, in support of those products.
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`= =-Ea‘ch"of*»Dr. Corish, Dr. Smith, and Mr. Ketchel. were responsible for the design and
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`' development of Defendants’ MD Forrnulas.HawaiiTM products, which, uponinforrnation and.
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`1 "‘» ‘?"‘~'1*’»'*v"-4"-'5-'~*‘ béliefiithey did while living in Florida. The MD-Fonnulasifiproducts are some ofthe .--.
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`’-“'?-' i ipiiotit1i':i§‘tiiat=are the subject of allegations set forth in thisvcomplaint.
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`Cyanotech has also engaged. in substantial business in Florida with Vaiensa;
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`‘*" >-?“= ='inE&liidiii‘g"%‘Cyanotech.’s engagement of ‘V-alensa to-.;extr'act~Cyanotech’s biomass at--V;ale,n=sa’s.
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`' =' for and on behalf of Cyanotech. Cyanotech =l'tas-also engaged, and is engaging, in *-
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`.=' ‘ busi-nessrin Florida through sales of Haematacoccus pluvialis biomass (from which
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`= ‘astaxanthin is extracted) to Valensa.
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`I8.
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`Venue in this District is proper under 28 U.S.C. § l400(b) and 28 U.S.C. §
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`1391.
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`THE TSO PATENT
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`- I9.
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`' On June 18, 1996, the United States granted U.S. Patent No. 5,527,533 (“the
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`Tso patent”) entitled “Method of Retarding and Ameliorating Central Nervous System and
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`Eye" Damage” to Dr. Mark 0. M. Tso. The Tso patent duly and legally issued to Plaintiff
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`' University of Illinois, as assignee of the inventor, Dr. Tso. A copy of the Tso patent is
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`attached to this Complaint as EXHIBIT A.
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`' 20.
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`The Tso patent relates to methods of administering astaxanthin to, inter alia,
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`" improve vision, protect the retina, improve the condition of the retina, retard the progress of
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`' -age-related macular degeneration, improve the condition of the central nervous system, and
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`" "treat -individuals suffering from degenerative retinal disease andlor degenerative central
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`" nervous system disease. On numerous occasions, Defendants have publicly acknowledged
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`‘that Dr’.'-’I"so-‘was the person responsible for the groundbreaking discovery that astaxanthin
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`' —‘=-‘offered these benefits, and that these discoveries are the subject ofthe Tso patent.
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`21.
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`Vaiensa is an exclusive licensee ofthe Tso ptent, with. the exclusive right to
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`'-"i':‘=‘--" ¥ma'fl"<'et?dietary supplement astaxanthin productsunder the Tso patent; 2 -
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`-22=.v"'»-'3' -‘Valensa has satisfied the notice provisions oi‘-35 U.S.C. §-287. I
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`COUNT I: PATENTINFRINGEMENT
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`“ 23.
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`Defendants have infringed the Tso patent by manufacturing, ofi-‘ering for sale,
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`selling, and/or importing astaxanthin products with the specific intent and suggestion that
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`users of those products employ them in methods that are covered by one or more claims of
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`the Tso patent. Products that Defendants have advertised, marketed, sold, and are selling for
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`purposes of performing the methods claimed in the Tso patent include, but are not
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`necessarily limited to, Defendants’ MD Formulas” line of astaxanthin products, including
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`BioAstin Supreme'"“', E.yeAstin"’M, 0megaAstin"'“, JointAstinTM, DermaAstin'““, and
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`CardioAstinTM products (all of which contain BioAstin Hawaiian Astaxanthin'"‘), as well as
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`Defendants’ BioAstin° gelcaps, beadlets, and CO2 extracts (collectively “Defendants’
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`Astaxanthin Products”).
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`24.
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`Defendants expressly suggest the use of Defendants’ Astaxanthin Products to
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`perform the methods claimed in the Tso patent. For example, the product labels for
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`‘Defendants’ Astaxanthin Products include instructions and representations such as the
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`following:
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`“BioAstin° Hawaiian Astaxanthin — to support eye health."
`“BioAstin° is clinically validated to support eye health in a variety of ways.”
`1 “BioAstin works throughout our entire body — eyes, brain . . .”
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`“BioAstin Hawaiian Astaxanthin provides moreprotection from damaging effects
`of free radical or oxidative stress, helping your body to better prevent future
`" oxidative damage.”
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`‘‘BioAstin works throughout the entire body, our eyes, brain, cardiovascular
`system, muscles, and 'skin- everywhere. It supports a healthy ortidative balance
`which leads to improvements in many health conditions)’
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`“EyeAstin"’M supports healthy vision and enhances normal eye firnction. It helps
`reduce eye fatigue and strain from reading or long .-hours spent on the computer.”
`“_EyeAstin"M is the world's most comprehensive eye health formula.”
`“EyeAstin is formulated . . . to protect eyes [from damage from UV light] and
`maintain eye health."
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`25.
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`in addition, Defendants’ representatives have suggested the use of
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`Defendants’ Astaxanthin Products to protect and improve vision in sales pitches and public
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`presentations. For example, Cyanotcch’s Medical Director, Dr. Robert Corish, gave a
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`presentation at the nation’s largest health supplement convention, Natural Products Expo, in
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`which he touted Defendants’ Astaxanthin Products by stating that “macular degeneration is
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`the leading cause of blindness in people over 65 years of age in this country and there is no
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`known cure. Dr. Paul Tso out of Harvard (sic) has shown that astaxanthin embeds within the
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`macula and is able to absorb the free radicals .
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`. . .” Dr. Corish made these statements while
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`presenting, in front of an audience comprised of supplements industry executives, store
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`owners, purchasing agents, and health care professionals, a Nutrex-branded slide containing a
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`picture of the EyeAstin'"" bottle, and the following bullet points:
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`“Macular degeneration (Univ. ‘of Illinois patent)”
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`“Protects eyes from light-induced damage”
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`“Eye strain and fatigue (nine positive human clinical trials)"
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`“Visual acuity (ability to see fine detail)”
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`Dr. Corish went on to state that “astaxanthin crosses the blood-retinal barrier, so it offers
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`protection to the retina, the macula, and also the lens." Dr. Cor-ish also indicated that
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`Defendants‘ Astaxanthin Productscan be used to prevent dementia and strokes. Defendants
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`have made similarrepresentations and instructions in online marketing presentations,
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`including interviews Dr. Mercola conducted of Mr. Brent Baily and Dr. Corish (see, e.g.,
`httpzl/www.youtuhe.eorn/watch?v=W5Si-gPWFBo, and
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`http:Ilwww.youtube.co.rnlwatch?v=wNla9cvlitwZRU).
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`26.
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`Defendants also instruct customers and consumers to use Defendants’
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`Astaxanthin Products to improve and protect vision through their advertising and marketing
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`materials. For example, Defendants’ websites promote the use of Defendants’ Astaxanthin
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`Products with the following statements:
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`0
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`“Astaxanthin crosses the blood-brain barrier and brings antioxidant protection to
`the eyes, the brain and the central nervous system. Again, many antioxidants
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`(including other carotenoids) cannot cross this barrier to help protect these vital
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`organs.”
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`“Animal cell culture studies have also indicated that astaxanthin can protect skin
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`from the damaging effects of ultraviolet radiation, ameliorate age-related macular
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`degeneration . . ."
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`“BioAstin Natural Astaxanthin has demonstrated effectiveness in clinical research
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`in several areas closely associated with aging, cardiovascular health, eye and
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`brain health, as well as an anti-inflammatory for conditions such as rheumatoid
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`arthritis, carpal turmel syndrome, tendonitis and joint soreness due to exercise.”
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`“Unlike beta-carotene, astaxanthin is able to readily cross the blood-brain barrier
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`and protect the retina against photo oxidation and loss of photoreceptor cells.
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`Astaxanthin has not been shown to crystallize in the retina, though this has been
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`reported to cause asymptomatic indications with canthaxanthin in the past.
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`Furthermore, astaxanthin has the ability to protect the neurons of the retina as well
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`as those of the brain and spinal cord, from damage caused by free radicals (US
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`Patent 5.527,533).”
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`0
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`“Although astaxanthin is not normally found in the eye, research indicates that
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`Natural Astaxanthin may provide the absolute best supplemental protection
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`available for the eyes. Mark Tso, PhD, has shown that astaxanthin can cross the
`blood-brain barrier. When he fed it to rats, he found it in their eyes. He then
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`demonstrated that it protects the eyes ii-om light-induced damage, photoreceptor
`cell damage, damage to nerve bundles (called ganglions), nerve damage, and
`inflammatory damage. (Tso, et al., US Patent No. 5,527,533, 1996) Tso showed
`that astaxanthin is also effective in ameliorating retinal damage. (Tso & Lam,
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`l996)"
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`“Dr. Mark Tso of the Wilmer Eye Institute at Johns Hopkins University has aptly
`demonstrated that astaxanthin is the clear winner when it comes to protecting your
`eyes. He discovered that astaxanthin easily crosses into the tissues of the eye and
`exerts its effects safely and with more ‘potency than any of the other carotenoids,
`without adverse reactions. Specifically, Tso determined astaxanthin could
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`ameliorate or prevent light induced damage, photoreceptor cell damage, ganglion
`cell damage, and damage to the neurons ofthe inner retinal layers. Other
`researchers (Shimidzu et al, Bagchi, Martin et al, and Beutner) have since
`confirmed Dr. Tso's finding that astaxanthin is the most powerful antioxidant ever
`discovered for eye health, giving your eyes an additional layer of long-tenn
`protection."
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`0
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`“Although zeaxanthin and lutein do provide benefits to your eyes, science is now
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`revealing that astaxanthin is the ULTIMATE carotenoid for eye health and
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`prevention of blindness. Blindness is an enormous problem worldwide."
`
`As the above excerpts show, Defendants have expressly exploited, and continue to exploit,
`
`Dr. Tso’s patented discoveries in an effort to promote the sale of their own, unlicensed
`
`601391641
`
`10
`
`

`
`Case 5:12-cv-00366-V\ITH-TBS Document 1
`
`Filed 06/29/12 Page 11 of 29 Page|D 11
`
`products to both retail and industry consumers, knowing that the uses to which they are
`
`instructing their customers to put their products infringe the Tso patent.
`
`27.
`
`Users of Defendants’ Astaxanthin Products have followed Defendants’
`
`instructions. Defendants’ customers that follow Defendants’ instructions directly infringe the
`
`Tso patent.
`
`28.
`
`As Defendants’ own marketing materials touting Dr. Tso’s discoveries, and
`
`referencing the Tso patent confirm, Defendants have been aware of the Tso patent and the
`
`subject matter claimed therein for years. Further, long before filing this suit, and on
`
`numerous occasions, Valensa warned Defendants that their actions violated the Tso patent,
`
`and asked Defendants to cease and desist from further efforts to exploit the methods claimed
`
`in the Tso patent for their own gain. Defendants floutcd Va|ensa’s pleas, and continued to
`
`instruct their customers to infringe the Tso patent.
`
`29.
`
`Defendants knew, andlor were willfully blind to the fact that, their instructions
`
`for, and advertised uses of, Defendants’ Astaxanthin Products resulted in direct infringement
`
`of the Tso Patent. Despite this awareness, Defendants continued instructing their customers
`
`to use Defendants’ Astaxanthin Products to infringe the Tso Patent.
`
`30.
`
`Defendants have induced infringement of, and continue to induce
`
`infringement of, the Tso patent, by making, using, importing, selling andlor offering for sale
`
`Defendants’ Astaxanthin Products with instructions to perform, and pursuant to
`
`advertisements touting, methods covered by the Tso patent.
`
`31.
`
`Defendants have had notice of the Tso patent, and the subject matter covered
`
`by the claims of the Tso patent, for years. Despite having knowledge of the Tso patent,
`
`601391641
`
`1]
`
`

`
`Case 5:12-cv-00366-WTH-TBS Document 1
`
`Filed 06/29/12 Page 12 of 29 Page|D 12
`
`Defendants knowingly continued to induce the infringement of the Tso patent, and such
`
`infringement is willful. Defendants continued to sell and market Defendants’ Astaxanthin
`
`Products for use in the claimed methods despite a high likelihood that such sale and
`
`marketing infringed valid and enforceable claims of the Tso patent, and Defendants knew or
`
`should have known that their actions constituted a high likelihood of infringement.
`
`32.
`
`Plaintifis have been and continue to be irreparably harmed and monetariiy
`
`damaged by Defendants’ willfiul infringement of the Tso Patent. Plaintiffs will continue to
`
`be irreparably and monetarily damaged unless Defendants’ infringement of the Tso patent is
`
`enjoined.
`
`PRAYER FOR RELIEF
`
`WI-IEREFORE, Plaintiffs pray for the following relief:
`
`A.
`
`A judgment that Defendants Cyanotech and Nutrex have infringed U.S. Patent
`
`No. 5,527,533;
`
`B.
`
`A judgment that Defendants’ Cyanotech and Nutrex infringement of U.S.
`
`Patent No. 5,527,533 was willfiul;
`
`C.
`
`A preliminary injunction enjoining and restraining Defendants Cyanotech and
`
`Nutrex, their officers, directors, agents, servants, employees, attorneys and all others acting
`
`under or through them, directly or indirectly, from infringing U.S. Patent No. 5,527,533;
`
`D.
`
`A permanent injunction enjoining and restraining Defendants Cyanotech and
`
`Nutrex, their officers, directors, agents, servants, employees, attorneys and all others acting
`
`under or through them, directly or indirectly, from infringing U.S. Patent No. 5,527,533;
`
`601391641
`
`12
`
`

`
`Case 5:12-cv-00366-WTH-TBS Document 1
`
`Filed 06/29/12 Page 13 of 29 Page|D 13
`
`E.
`
`A judgment and order requiring Defendants Cyanotech and Nutrex to pay
`
`damages for infringement of U.S. Patent No. 5,527,533 in an amount sufficient to
`
`compensate for Defendants’ infringement, together with pre- and post-judgment interest
`
`under 35 U.S.C. § 284; including treble damages for willful infringement;
`
`F.
`
`A judgment and order requiring Defendants Cyanotech and Nutrex to pay the
`
`costs of this action, including all disbursements and attorney fees, because this case is
`
`exceptional as provided by 35 U.S.C. § 285, with pre- and post-judgment interest; and
`
`0.
`
`Such other and firrther relief that this Court may deem just and equitable.
`
`DEMAND FOR JURY TRIAL
`
`Plaintiffs hereby demand a trial byjury ofall issues so triable.
`
`
`
`R spectfullys
`
`ames V. Etscom
`
`Florida Bar No. 7051 I l
`BAKER & HOSTETLER LLP
`
`P.O. Box 112
`
`Orlando, Florida 32802-0] 12
`Telephone: 407-649-4000
`Facsimile: 407-841-0168
`
`jetscorn@bakerlaw.com
`
`And
`
`Todd 8. Werner (MN Reg. No. 0330l9X)
`CARLSON CASPBRS
`
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`Telephone: (612) 436.9600
`Facsimile: (612) 436.9605
`twemer@ecvl.com
`Counselfor Plainti S US Nutraceuticals LLC d/b/a
`Valensa International and Board ofTrustees offlte
`University ofIllinois
`
`eo1391e41
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`Case 5:12-cv-00366-WTH-TBS Document 1
`
`Filed 06/29/12 Page 15 of 29 Page|D 15
`
`5,527,533
`Page 2
`
`OTHER PUBLICATIONS
`
`Tho. M.0.M.. "Expct1'mcn1s on ‘final Cells by Nature and
`
`PlIotomI:cpIorMotphormuy".lnves:. Ophthnfmoi. Viv. sax.
`32. pp. 230-234 (1991).
`Mild. W.. "Biological Functions and Activities of Animal
`Camtenoids". Pure and Appl. Chem. 53(1). pp. 141-145
`(1991;
`_C
`M mm R
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`{ed.), mrkhauscr vmag. pp. 230-293 (1992).
`
`tion". Iuwsrisat-‘vs Onhthabrwloxy and WM! Science.
`aouz). pp. 2421-2454 (Dec. 1989).
`_
`.
`Tso. M-OM-.
`‘P-Ihoscn-=m= Factor! of Asins Masculnr
`D¢8€!temion”.Ophthalmotogy.92(5).pII. 628-635 (1935.
`,
`_
`__
`Y'=- 9- 9' I1» “-*m=*‘°fl“°n °‘ Rum‘ 911°!“ ‘W’! W
`Bela-Cauolcae". ARVO Aburacrx rams. Ophthalnwl. W3.
`Sci. 21! rsuppu. p. 7, (1931).
`
`

`
`{Jase 5:12-cv-00366-WTH—TBS Document 1
`
`Filed 06/29/12 Page 16 of 29 Page|D 16
`
`U.S. Patent
`
`Jun. 18, 1996
`
`Sheet 1 ol'4
`
`5,527,533
`
`FIG.1
`
`60
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`
`

`
`Case 5:12-cv-00366-VVTH-TBS Document 1
`
`Filed 06/29/12 Page 17 of 29 Page|D 17
`
`U.S. Patent
`
`Jun. 13, 1996
`
`Sheet 2 or 4
`
`5,527,533
`
`FIG.2
`
`ASTtreat=d
`
`
`
`CDI
`
`100
`
`8
`
`6
`
`4-
`
`

`
`_Case 5:12-CV-00366-WTH-TBS Document 1
`
`Filed 06/29/12 Page 18 of 29 PagelD 18
`
`U.S. Patent
`
`Jun. 18, 1996
`
`Sheet 3 of 4
`
`5,527,533
`
`
`
`DaysAfterExposure
`
`Fl6.3
`
`(959 Jad um)
`
`S1949]. uzsdopoqg
`
`
`
`0ASTtreated
`
`'5
`...''S
`
`50 0
`
`

`
`Qase 5:12-cv-00366-WTH-TBS Document 1
`
`Filed 06/29/12 Page 19 of 29 PagelD 19
`
`U.S. Patent
`
`Jun. 13, 1995
`
`Sheet 4 of 4
`
`5,527,533
`
`Fl6.a
`
`
`
`
`
`DaysAfterExposure
`
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`
`510
`
`
`
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`
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`
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`
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`
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`
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`
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`
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`
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`
`

`
`Case 5:12-cv-00366-WTH—TBS Document 1
`
`Filed 06/29/12 Page 20 of 29 PagelD 20
`
`1
`
`2
`
`5,527,533
`
`Mzn-[op or [m'm]u)[,\'G AND
`AMELIORATING CENTRAL NERVOUS
`so-51-EM AND EYE DAMAGE
`
`FIELD OF THE mpg”-"ON
`
`‘fire present invention relates to a method ofrctarditt; and
`ameliorating central nervous system and eye diseases. More
`particularly, the present invention is directed to methods of
`treating central nervous system and eye insult resulting from
`disease or injury. such as age-rrelsted rnrteulsr degeneration.
`pltotic injury. photoreceptor cell or ganglion cell damage.
`traumatic
`injury.
`iscltetrtic
`insttlbrclated diseases and
`irtilamrnatoty rliseascs.'t'he method comprises adrninisterittg
`a tltcrspcutieally-eflective amount of astartantltirt to an indi-
`vidual. either orally. topically or parerttcrslly, to ameliorate
`damage caused by the disease or injury or to retard the
`progress of n degenerative disease.
`
`BACKGROUND OF THE lNVEl\"l'lON
`
`5
`
`ID
`
`25
`
`30
`
`Many diseases and injuries of the oerttrslncwotts system
`presently are not treatable. These diseases and injuries are
`unrreatablo because. unlike many pctiphual or-gansthatcut
`he removed in vrholcorin part.or trartsplanteththeceutral
`nervous system has very limited regeneration capability and
`armor be totally excised without death. The eye is an
`ertratsion of the brain. and therefore a part or the central
`nervous system. Accordingly. in thecaseol‘ an eye injury or
`dlscasc.l.c.. arctinal injtnyordiscase,lltedscasesateoftcrt
`without treatntettt and the eye eannotbetrartsplattted. Eye
`diseases and injuries that presently are untretttable include
`retinal plrotic injury. retinal isclterttin-irtducotl eye injury.
`age-related tnacular degeneration. and other eye diseases
`and injuries that ateinduccdby frceradical species.
`lthasbecrthypothesircdtlratsutajorertuscofthcsc
`unrreutable central nervous system diseases and injuries is
`the generation and presence of singlet oxygen and other free
`radical species. Singlet oxygen and free radical species can
`bepeneratcdby acorttbirtzt1onofllghtandoxygerr.or
`during repcrfusion alter art isehcmie insult.
`The eye is subjected to continuous light exposure because
`the primary purpose of tlieeyc is light perception. Thrn-efore.
`some urttrcalable diseases and injuries to tire eye result lion!
`thecontinuousertposureofthe eye to light. coupled witlttltc
`ltrgltly-oxygenated environment in the eye.
`'i'hc process cl’ light perception is initiated in the photo-
`receptor cells. The photoreceptor cells are a constituent or’ ,9
`thcoutcrtteuronal layeroltberetina,tvhichisacontporten