MLリソース：口腔癌

MLリソース：口腔癌
Supported by Nobelpharma Co.Ltd. in a part.

【日本語版コメント1306】
日本の口腔癌の患者数は2.5万人(2005年患者調査)、死亡数は2007年6,399人と比較的少ない。
口腔癌には様々なスクリーニング方法がある。視診が最も一般的な方法であるが、その他の方法としてトルイジンブルー染色、ブラシ生検、および蛍光染色がある。　スクリーニング検査は、口腔の全扁平上皮癌の90％がそこに発生するハイリスク部位(口腔底、舌の下外側面および軟口蓋)を精査することで、さらに効率的に行うことが可能である。
【市場】

【開発中の新薬】
●「治験」ホームページ[厚生労働省]
  - 開発中の新薬[＜情報提供：日本製薬工業協会＞]
  会社別開発中新薬一覧。　検索機能なし。６８社から情報提供

治験薬記号(一般名)
 および剤型 予定される効能又は効果、
対象疾患名および症状名 開発段階 その他
国内 海外 (地域) 


●New Medicines in Development[PhRMA 米製薬協]

Registered Name Company Status Indication 備考
米 
 



【解説資料】
●メルクマニュアル第17版日本語版




【データ】
口腔癌の死亡数は(2007年)6,399人、(2006年)6,018人、(2005年)5,679人、(2004年)5,573人、(2003年)5,618人
 FROM 口動態統計によるがん死亡データ（1958年～2007年） 
患者調査による口腔癌の患者数は、2005年度25,000人、2002年20,000人







【臨床ガイドライン】
●科学的根拠に基づく口腔癌診療ガイドライン　2009年度版
　 日本口腔腫瘍学会、日本口腔外科学会　 金原出版　2009 
発行日　2009/01/30; 3,990円
ISBNコード　978-4-307-45009-6
●The NCCN Clinical Practice Guidelines in Oncology




●National Guideline Clearinghouse - 米国
Screening for oral cancer: recommendation statement.
United States Preventive Services Task Force - Independent Expert Panel.  1996 (revised 2004 Feb 24).  4 pages.  NGC:003454 
HealthPartners Dental Group and Clinics oral cancer guideline.
HealthPartners Dental Group - Professional Association.  2007 May 2.  20 pages.  NGC:005631 




●CMA Infobase -Clinical Practice Guidelines -カナダ Cnadian Medical Association
●NICE - Clinical Guidelines by 英国NHS [National Health Service]
●PDQ日本語版
口唇癌および口腔癌   【医療専門家向け】 
口腔癌のスクリーニング   【医療専門家向け】 


【総説記事・文献】



【ニュース・トピックス】



【リンク・リソース】



【主要サイト】
●日本口腔腫瘍学会
「頬粘膜癌・口底癌取扱指針」[2008.12;pdf,93p]
日本口腔腫瘍学会誌[季刊]～目次のみ公開
●日本口腔外科学会
●解説
■口腔癌

●概要

口腔癌（こうくうがん）は、口腔に発生する腫瘍である。口腔に発生する悪性腫瘍は、全悪性腫瘍の中の1~5%程度と言われている。そのうち、癌腫は90%、肉腫は10%程度である。
●分類

口腔癌の発生頻度は、全癌のおよそ３％を占めます。１９８０～８７年の８年間に、日本の口腔外科、耳鼻科、および癌専門病院二八施設で口腔癌と診断された患者３．１８７名を調べたところ、口腔癌の部位別頻度は、舌が１番多く（５６％）、次に歯肉（１６％）、口底（１４％）、頬粘膜（１０％）の順になっており、性別頻度では女性よりも男性が約２倍。年齢別には５０代（２７％）が１番多く、次いで６０代（２５％）、７０代（１８％）、４０代（１６％）の順。
　口腔癌は組織学的には扁平上皮癌が圧倒的に多く、ついで唾液腺に生ずる腺様嚢胞癌などの上皮性悪性腫瘍です。肉腫はまれですが、他部位からの転移性腫瘍や悪性リンパ腫が口腔に腫瘤や潰瘍をつくることもあります。
●臨床的分類
舌癌 /歯肉癌 /口腔底癌 /頬粘膜癌 /硬口蓋癌 /口唇癌 /口峡咽頭癌 /上顎洞癌 /顎骨中心性癌 
●組織学的分類
上皮内癌 /扁平上皮癌 /疣贅性癌 /移行上皮癌 /紡錘細胞癌 /基底細胞癌 /腺扁平上皮癌 /腺様扁平上皮癌 /基底細胞様扁平上皮癌
●疫学

日本では、40歳以降に好発である。歯肉、頬粘膜では60歳代、舌、口腔底、口唇では50歳代である。男女比は男性の方が高い。

●症状

●原因

●診断

●検査

●治療

●薬物治療

●予後
●参考資料
●データ

●臨床ガイドラインなど

●総説記事・文献

●ニュース・トピックス

●リンク＆リソース

●主要サイト

[1306]●ViziLite Plus（Zila Pharmaceuticals)

[1306]●製品 ViziLite Plus（Zila Pharmaceuticals)

　日本語版註）ViziLite Plus（Zila Pharmaceuticals)
　【別名】ViziLite(R) Blue Oral Exam Kit　【開発元】Zila ,Inc　 [DBR_ID]x
　【化学名】ViziLite Test Kit (a.k.a. ViziLite Comprehensive Exam Tray and the OralLite Test Kit and Acetic Acid Rinse) and TBlue630 (Zila Tolonium Chloride (ZTC(TM))) Oral Lesion Marking Systemの二つから構成。
　【承認】FDA申請=、FDA承認= 、米国発売=2005.10;　【製剤】　【適応】used only as an adjunct to the conventional oral mucosal examination.　【用法用量】
　【作用】　【特徴】　
【製品情報】www.vizilite.com　【添付文書】ViziLite Plus-PI
　【提携】Dentaid(2008.8;仏独西、ポルトガル他)、英Panadent Limited(2008;英・アイルランド)、Intertrade Dental A.E.S.A.(2008.7;ギリシャ)、DentalMed Russian Alliance(ロシア、ベラルーシ) 　【EU】英承認2008.1、カナダ発売2007.11　
【日本】未開発　【その他】
【日本語版コメント1306】
日本の口腔癌の患者数は2.5万人(2005年患者調査)、死亡数は2007年6,399人と比較的少ない。
口腔癌には様々なスクリーニング方法がある。視診が最も一般的な方法であるが、その他の方法としてトルイジンブルー染色、ブラシ生検、および蛍光染色がある。　スクリーニング検査は、口腔の全扁平上皮癌の90％がそこに発生するハイリスク部位(口腔底、舌の下外側面および軟口蓋)を精査することで、さらに効率的に行うことが可能である。
　→詳細は参考資料●MLリソース：口腔癌に纏めた。
＜日本語版コメント要約＞
・若年層に増えている口腔癌のスクリーニング法として、蛍光とトルイジンブルー組織染色を組み合わせた検査キットViziLite Plusをとりあげた。
・本キットは歯科医向けに販売されている。
・本キットを用いた視覚的検査は、一部の高リスク患者においては有用な可能性を示しているものの、一般住民のスクリーニングに本法を用いるべきだという十分なエビデンスはない。
●承認データ：FDA

●Device@FDA - 510(k) Database

★Device Name(s)        =vizilite eyewear
510(k) No.   =K080043
Decision Data=04/04/2008
Applicant    =zila, inc
Summary      =Summary


★Devoce Name(s)        =vizilite-blue oral exam kit
510(k) No.   =K033033
Decision Data=11/22/2004
Applicant    =trylon corp
Summary      =Summary
●Zila ,Inc

 - http://www.zila.com/ ; (Nasdaq:ZILA) 本社Scottsdale, Arizona
口腔癌の予防・検出・治療用の診断薬メーカー
主力製品ViziLite(R) Plus with TBlue(R) (“ViziLite(R) Plus”), 
Zila Pharmaceuticals, Inc.,は子会社

●Products
ViziLite Plus

●News　－Press Releases
Zila Board Finds the Intelident Proposal Not Superior to Tolmar Offer[2009.7.10]
 -Intelident Solutions Inc.からの買収案(１株$0.42)よりTolmar Holding, Inc.の買収案(１株$0.38)を選択。
Zila Enters into Merger Agreement with Tolmar[2009.6.25]
 -
Zila Reports Fiscal 2009 Third Quarter Financial Results[2009.6.9]
 --- Net revenues were $8.5 million, compared with $11.2 million for the third quarter of fiscal 2008.
 Sales of ViziLite(R) Plus were $2.7 million, compared with $3.6 million for the third quarter of fiscal 2008. 
[]
 -
Zila Completes First Phase of Global Marketing Initiatives for Oral Cancer Screening Product, ViziLite(R) Plus[2009.2.11]
 -北米販売体制整う。
　2008.5 西欧での販売体制確立。現在英・独・仏・Ireland, Spain, Portugal, Greeceで販売。
Zila Receives FDA 510(k) Clearance for ViziLite Eyewear[2008.4.22]
 -
Zila to Launch ViziLite Plus in the United Kingdom[2008.3.4]
 -
Zila Receives Approval to Launch ViziLite Plus in Canada[2007.10.16]
 -
Zila, Inc. to Acquire Professional Dental Technologies, Inc.[2006.11.14]
 -
Zila Completes Strategic Divestiture of Nutraceuticals Division[2006.10.3]
 -
Zila, Inc. Announces Strategic Divestiture of Zila Nutraceuticals, Inc.[2006.8.14]
 -
U.S. Oral Cancer Rates Increase: Zila's Technology for Early Detection of Oral Lesions, ViziLite(R) Plus Now Available Nationwide[2006.2.15]
 -
[]
 -


■Investors
●SEC Filings
10-K Annual report[2008.10.6] - [pdf,104p] - [doc] - [xls]




●会社決算

($ 000) 2008/7 2007/7 2006/7 2005/7 2004/4
売上高 45,061 28,801 2,822 1,199 162
売上原価 17,363 11,857 1,925 
営業利益 (13,106) (23,012) (23,738) 
経常利益 (16,133) (28,773) (26,043) 
中止事業損益 (254) 5,941 (3,300) 
当期純利益(継続事業) (16,124) (19,105) (26,046) (17,678) (14,350)
当期純利益 (16,378) (13,164) (29,346) () ()
研究開発費 2,424[5.4%] 7,482[26.0%] 7,158[253.6%] 
従業員数[連結] 367 
Vizilite Plus売上 13.700(+107.1) 6,600(+143) 
中止事業売上Nutraceuticals - 1,629 21,473 
中止事業売上Pharmaaceuticals - 3,694 6,176 






●ViziLite(R) Plus
【2008】ViziLite(R) Plus with TBlue(R) is a patented medical device cleared by the FDA as an oral lesion identification and marking system that is used as an adjunct to the conventional head and neck examination. It consists of a chemiluminescent light source (ViziLite(R)) to improve the identification of lesions and TBlue(R), the oral lesion marking system, to mark those lesions differentially identified by ViziLite(R). ViziLite(R) Plus with TBlue(R) is designed to be used in a patient population at increased risk for oral cancer. 

ViziLite(R) can assist a dentist, hygienist and other healthcare providers in identifying an abnormality in the oral cavity for further evaluation and follow-up. The efficacy of ViziLite(R) in identifying oral abnormalities has been demonstrated in four Zila-sponsored clinical trials in the United States and numerous studies independently performed at academic institutions throughout the world. ViziLite(R) consistently demonstrates a high degree of sensitivity in the identification of pathological lesions in both high risk and general screening populations. These studies demonstrate that ViziLite(R) can assist dental and medical professionals in identifying an abnormality in the oral cavity for further evaluation and follow-up. 


TBlue(R) is a patented, pharmaceutical-grade toluidine blue-based metachromatic dye used to further evaluate and closely monitor changes in ViziLite(R)-identified lesions. TBlue(R), packaged in an easy to use three swab system, provides a deep blue staining that allows ViziLite(R)-identified lesions to be seen clearly under normal patient lighting. ViziLite(R) Plus is recommended for use annually for all new and re-care adult dental patients following the standard head and neck exam. We believe that patients with a history of oral cancer should receive at least semi-annual ViziLite(R) Plus exams. We developed and use the term Lumenoscopytm to describe the examination conducted with ViziLite(R) Plus. 


【2008 競合】ViziLite(R) Plus oral lesion identification and marking system with TBlue(R) is a patented, FDA-cleared device used to detect oral mucosal abnormalities. ViziLite(R) Plus competes with the conventional method of simple visual and tactile testing for abnormalities that has previously been the only available methodology for identifying lesions. While there are other technologies that claim utility as general screening tools, ViziLite(R) Plus is still the only technology that has been validated in numerous single-center and multi-center studies evaluating general screening populations. 


【2008 販売契約】In fiscal 2008, we selected Panadent Limited, a leading supplier of dental products in the United Kingdom, including England, Wales, Scotland and Ireland, as our exclusive distributor for ViziLite(R) Plus in those markets. In July 2008 we selected Intertrade Dental A.E.S.A. as the exclusive distributor of ViziLite(R) Plus in Greece, Cyprus and the Greek Isles and in August 2008 we selected Dentaid as the exclusive distributor of ViziLite(R) Plus in France, Germany and the Iberian Peninsula, which includes Spain, Portugal, The Canary Islands, Madiera Islands, Andorra and the Azores. We also selected DentalMed Russian Alliance as the exclusive distributor of ViziLite(R) Plus in Russia and Belarus. All of these agreements provide for a period of time for product registration and initial marketing efforts, with orders of our product required after successful completion of the regulatory process. All distributors are granted authority to use our trademarks for so long as the agreements are in effect. 


【2008 政府規制】In January 2005, the Food and Drug Administration (the “FDA”) cleared the product, ViziLite(R) Blue Oral Exam Kit (ViziLite(R) Plus), which contains the ViziLite(R) chemiluminescent device to identify abnormalities in the oral mucosa and the TBlue(R) marking device, an adjunct to ViziLite(R). TBlue(R) is used to further evaluate and monitor lesions by providing physical marking of the lesions already differentially identified by ViziLite(R) for patients at increased risk for oral cancer. We introduced our ViziLite(R) Plus product at the October 2005 annual meeting of the American Dental Association and commenced sales of ViziLite(R) Plus in our second fiscal quarter 2006. 


In October 2007, we classified ViziLite(R) Plus as a Class I medical device with Health Canada. We began to market and sell ViziLite(R) Plus in Canada in November 2007. 


In January 2008, the Medicines and Healthcare Products Regulatory Agency (“MHRA”) in the United Kingdom determined that ViziLite(R) Plus met the criteria for a Class I medical device. This classification allowed for ViziLite(R) Plus to be CE marked, thus allowing for distribution throughout the United Kingdom and the rest of the European Union. 


【2008 特許】In February 2006, we acquired from Shared Medical Resources, LLC all of the rights, titles and interests in the ViziLite(R) technology including patent numbers 5,179,938, 5,329,938 and 6,496,718 issued January 19,1993, July 19,1994 and December 17, 2002, respectively, which expire in 2010, 2011 and 2020, respectively. Together, the patents cover the apparatus and method for endoscopic examination of certain body cavities using a chemiluminescent light source. 


The ViziLite(R) trademark has been granted registration in the United States, Europe, Australia, China, Hong Kong, Japan, Korea, Singapore and Taiwan. The T-Blue(R) trademark has been granted registration in the United States, Europe, Hong Kong, Singapore and Taiwan. Applications for these and related marks, are pending in the United States and 11 additional countries. We coined the term Lumenoscopytm to describe examination of the oral cavity using ViziLite(R) Plus and filed a United States application for its registration. The term Better Screening Saves Lives(R) has been granted registration in the United States. 


On September 30, 2004, we filed an International application for a technology covering the use of the ViziLite(R) Plus chemiluminescent technology entitled “Light-Directed Method for Detecting and Aiding Further Evaluation of Abnormal Mucosal Tissue.” We also filed National applications in 13 countries, including the United States, Canada and several European countries. 


On September 28, 2004, we filed an International application covering the use of a wavelength specific lens with the ViziLite(R) chemiluminescent technology entitled “Methods for Detecting Abnormal Epithelial Tissue.” We also filed National applications in 15 countries, including the United States, Canada and several European countries. 


In 2008, we filed a U.S. patent application entitled “Improved Light Stick” directed to an improved retractor. 


We are developing improvements to our ViziLite(R) technology and expect to seek patent protection for such improvements as is appropriate for our business goals. In addition, we are prepared to assert our trademark, trade dress and copyright rights to the ViziLite(R) products and packaging, as is necessary, to protect the ViziLite(R) brand. With respect to our ViziLite(R) related patents, to the extent any infringement of the patents began before they expire, we intend to aggressively protect our patent rights. 
株式会社メドレット Medlet Japan KK
〒103-0024 東京都中央区日本橋小舟町１２－１０共同ビル（掘留）５Ｆ　久永&Co気付
tel.03-3664-2020 fax.03-3666-3188　URL:www.medmk.com/mm/ 　E-Mail: support@medmk.com

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関連●--------------------------------
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■2009 -------------------------------
★★1306★25/04★09.02.23★015★口腔癌のスクリーニング/2p●MLリソース：口腔癌
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作成：2009.5.25　最終更新:2009.7.13　小菅博之
The Medical Letter日本語版
●追加メモ to 1306
On Drugs and Therapeutics

このページは［The Medical Letter日本語版］の補足データとして添付しています。　［The Medical Letter］は新薬の厳正な評価誌であり、ここに収録される製品は新しくＦＤＡ承認された新薬に対する評価を中心としています。
　企画意図の第一は、収録製品についての米国内・世界での背景情報です。　例えば、各製品の承認関連データ、競合品との、あるいは市場での位置づけ、疫学データなど。　第二は、日本での該当製品や市場の情報。　市場の主要製品売上、開発中の治験薬等。　調査項目としては、■製品■解説■データ■臨床ガイドラインなど■総説記事・文献■ニュース・トピックス■リンク■主要サイト

治験薬記号(一般名) および剤型	予定される効能又は効果、対象疾患名および症状名	開発段階		その他
		国内	海外 (地域)

($ 000)	2008/7	2007/7	2006/7	2005/7	2004/4
売上高	45,061	28,801	2,822	1,199	162
売上原価	17,363	11,857	1,925
営業利益	(13,106)	(23,012)	(23,738)
経常利益	(16,133)	(28,773)	(26,043)
中止事業損益	(254)	5,941	(3,300)
当期純利益(継続事業)	(16,124)	(19,105)	(26,046)	(17,678)	(14,350)
当期純利益	(16,378)	(13,164)	(29,346)	()	()
研究開発費	2,424[5.4%]	7,482[26.0%]	7,158[253.6%]
従業員数[連結]	367
Vizilite Plus売上	13.700(+107.1)	6,600(+143)
中止事業売上Nutraceuticals	-	1,629	21,473
中止事業売上Pharmaaceuticals	-	3,694	6,176

●ViziLite(R) Plus
【2008】ViziLite(R) Plus with TBlue(R) is a patented medical device cleared by the FDA as an oral lesion identification and marking system that is used as an adjunct to the conventional head and neck examination. It consists of a chemiluminescent light source (ViziLite(R)) to improve the identification of lesions and TBlue(R), the oral lesion marking system, to mark those lesions differentially identified by ViziLite(R). ViziLite(R) Plus with TBlue(R) is designed to be used in a patient population at increased risk for oral cancer. ViziLite(R) can assist a dentist, hygienist and other healthcare providers in identifying an abnormality in the oral cavity for further evaluation and follow-up. The efficacy of ViziLite(R) in identifying oral abnormalities has been demonstrated in four Zila-sponsored clinical trials in the United States and numerous studies independently performed at academic institutions throughout the world. ViziLite(R) consistently demonstrates a high degree of sensitivity in the identification of pathological lesions in both high risk and general screening populations. These studies demonstrate that ViziLite(R) can assist dental and medical professionals in identifying an abnormality in the oral cavity for further evaluation and follow-up. TBlue(R) is a patented, pharmaceutical-grade toluidine blue-based metachromatic dye used to further evaluate and closely monitor changes in ViziLite(R)-identified lesions. TBlue(R), packaged in an easy to use three swab system, provides a deep blue staining that allows ViziLite(R)-identified lesions to be seen clearly under normal patient lighting. ViziLite(R) Plus is recommended for use annually for all new and re-care adult dental patients following the standard head and neck exam. We believe that patients with a history of oral cancer should receive at least semi-annual ViziLite(R) Plus exams. We developed and use the term Lumenoscopytm to describe the examination conducted with ViziLite(R) Plus. 【2008 競合】ViziLite(R) Plus oral lesion identification and marking system with TBlue(R) is a patented, FDA-cleared device used to detect oral mucosal abnormalities. ViziLite(R) Plus competes with the conventional method of simple visual and tactile testing for abnormalities that has previously been the only available methodology for identifying lesions. While there are other technologies that claim utility as general screening tools, ViziLite(R) Plus is still the only technology that has been validated in numerous single-center and multi-center studies evaluating general screening populations. 【2008 販売契約】In fiscal 2008, we selected Panadent Limited, a leading supplier of dental products in the United Kingdom, including England, Wales, Scotland and Ireland, as our exclusive distributor for ViziLite(R) Plus in those markets. In July 2008 we selected Intertrade Dental A.E.S.A. as the exclusive distributor of ViziLite(R) Plus in Greece, Cyprus and the Greek Isles and in August 2008 we selected Dentaid as the exclusive distributor of ViziLite(R) Plus in France, Germany and the Iberian Peninsula, which includes Spain, Portugal, The Canary Islands, Madiera Islands, Andorra and the Azores. We also selected DentalMed Russian Alliance as the exclusive distributor of ViziLite(R) Plus in Russia and Belarus. All of these agreements provide for a period of time for product registration and initial marketing efforts, with orders of our product required after successful completion of the regulatory process. All distributors are granted authority to use our trademarks for so long as the agreements are in effect. 【2008 政府規制】In January 2005, the Food and Drug Administration (the “FDA”) cleared the product, ViziLite(R) Blue Oral Exam Kit (ViziLite(R) Plus), which contains the ViziLite(R) chemiluminescent device to identify abnormalities in the oral mucosa and the TBlue(R) marking device, an adjunct to ViziLite(R). TBlue(R) is used to further evaluate and monitor lesions by providing physical marking of the lesions already differentially identified by ViziLite(R) for patients at increased risk for oral cancer. We introduced our ViziLite(R) Plus product at the October 2005 annual meeting of the American Dental Association and commenced sales of ViziLite(R) Plus in our second fiscal quarter 2006. In October 2007, we classified ViziLite(R) Plus as a Class I medical device with Health Canada. We began to market and sell ViziLite(R) Plus in Canada in November 2007. In January 2008, the Medicines and Healthcare Products Regulatory Agency (“MHRA”) in the United Kingdom determined that ViziLite(R) Plus met the criteria for a Class I medical device. This classification allowed for ViziLite(R) Plus to be CE marked, thus allowing for distribution throughout the United Kingdom and the rest of the European Union. 【2008 特許】In February 2006, we acquired from Shared Medical Resources, LLC all of the rights, titles and interests in the ViziLite(R) technology including patent numbers 5,179,938, 5,329,938 and 6,496,718 issued January 19,1993, July 19,1994 and December 17, 2002, respectively, which expire in 2010, 2011 and 2020, respectively. Together, the patents cover the apparatus and method for endoscopic examination of certain body cavities using a chemiluminescent light source. The ViziLite(R) trademark has been granted registration in the United States, Europe, Australia, China, Hong Kong, Japan, Korea, Singapore and Taiwan. The T-Blue(R) trademark has been granted registration in the United States, Europe, Hong Kong, Singapore and Taiwan. Applications for these and related marks, are pending in the United States and 11 additional countries. We coined the term Lumenoscopytm to describe examination of the oral cavity using ViziLite(R) Plus and filed a United States application for its registration. The term Better Screening Saves Lives(R) has been granted registration in the United States. On September 30, 2004, we filed an International application for a technology covering the use of the ViziLite(R) Plus chemiluminescent technology entitled “Light-Directed Method for Detecting and Aiding Further Evaluation of Abnormal Mucosal Tissue.” We also filed National applications in 13 countries, including the United States, Canada and several European countries. On September 28, 2004, we filed an International application covering the use of a wavelength specific lens with the ViziLite(R) chemiluminescent technology entitled “Methods for Detecting Abnormal Epithelial Tissue.” We also filed National applications in 15 countries, including the United States, Canada and several European countries. In 2008, we filed a U.S. patent application entitled “Improved Light Stick” directed to an improved retractor. We are developing improvements to our ViziLite(R) technology and expect to seek patent protection for such improvements as is appropriate for our business goals. In addition, we are prepared to assert our trademark, trade dress and copyright rights to the ViziLite(R) products and packaging, as is necessary, to protect the ViziLite(R) brand. With respect to our ViziLite(R) related patents, to the extent any infringement of the patents began before they expire, we intend to aggressively protect our patent rights.