- 學位論文
透明質酸技術發展與廠商能力探討 : 以美國專利為基礎之研究
Hyaluronic acid in technology Development and Corporation Competence : A Study Based on USPTO Patent
摘要
摘要 透明質酸（Hyaluronic Acid, HA）又稱玻尿酸，為一種帶多負電的生物高分子，存在於動物軟結締組織中，其具有高生物相容性、高含水量特性，以及獨特的黏彈性及滲透性等性質，在生物體中提供潤滑、保護、支持等重要的生理作用。因此，在關節腔之黏性補充物質、整形手術、眼科醫學、創傷癒合、手術後組織抗沾黏、藥物釋放、輔助診斷疾病、保健食品及化妝品工業等領域上有廣泛的應用。 本研究採用專利分析法，利用連穎科技股份有限公司之軟體Patent Guider來探勘美國專利局檢索透明質酸專利之相關技術，利用各項專利指標，並依國際專利分類（International Patent Classification，簡稱IPC）進行實證研究，以分析透明質酸相關之專利技術發展。分析結果發現全球透明質酸技術正處於專利件數衰退階段；而美國為全球透明質酸技術專利領先國家，義大利次之。加拿大Hyal Pharmaceutical公司為全球透明質酸專利的領先專利權人，義大利Fidia Advanced公司次之。此外，Fidia Farmaceuti為透明質酸專利被引證次數最高的公司，Biomatrix公司次之。Biotrics公司中之專利04141973為專利案內引證次數最高者，Fidia Farmaceuti公司中之專利04851521次之。專利發明人以Falk與Rudolf Edgar的專利件數為27件最高，為透明質酸技術領域的研發翹楚，於1996至2001年期間專利產出最大，但2001年後幾無有專利產出，反之，Weigel與Paul兩位發明人於2003至近期均有專利產出，其中於2006年有10件專利產出，為近期最活躍的發明人。 依據IPC專利技術之三階展開，美國在A61L落後於義大利外，其餘各分類專利件數美國均領先其他國家，而為技術領先者。如以IPC專利分類四階展開，透明質酸的專利數於IPC分類的前三名分別為A61K031、C08B037及A61K047，顯示A部類技術領域為企業所重視，其中Hyal Pharmaceutical公司在A61K類，尤其是A61K031領先其他競爭公司。 目前透明質酸技術近年處於衰退階段，顯示研究尚待突破，企業若貿然投入大量人力及資源來開發透明質酸的相關技術，會有較大的風險。Biotrics 及Fidia Farmaceuti等公司已擁有透明質酸技術之關鍵專利，對其他公司及其他潛在的市場進入者具有威脅。然而，近年來生醫材料成長相當十分迅速，具有相當的市場深耕開拓之機會，因此台灣可考慮採以靈活運用採取合資或是授權方式，取得國際大廠的專利授權，而得以進入如中國大陸等之新興市場，或研發具有特定區域市場之產品，以進行差異化市場之深耕。
關鍵字
透明質酸並列摘要
ABSTRACT Hyaluronic Acid （HA）, residing in soft connective tissue of animal body, is a biopolymer with multi-negative charges. Due to its high biocompatibility, high water contents, unique viscosity, and permeability, HA enables lubrication, protection, support, and other imperative physical functions to organism, and has been comprehensively applied to sticky supplementary substance of joint cavity, cosmetic surgery, ophthalmology, wound healing, anti-adhesion between tissues after operation, drug release, auxiliary disease diagnosis, health products, cosmetics, and industrial fields. This research introduces patent analysis by the Patent Guider software of Learning Tech. Corp., using various patent indicators and according to classifications of International Patent Classification （IPC）, to explore related technologies of HA with regard to the patent search in the US Patent and Trademark Office for the analysis of the development of patent technologies with regard to HA. According to the analysis, it is found that global HA technology reported a declining position in terms of number of patents; USA is a leading country in HA technology, followed by Italy, the second leading in the world, and Hyal Pharmaceutical from Canada is a company which takes lead in HA patent rights, followed by Fidia Advanced from Italy. Moreover, Fidia Farmaceuti also reported highest number of citations in HA technology, followed by Biomatrix. The patent publication No. 04141973 of Biotrics is the highest cited patent, followed by publication No. 04851521 of Fidia Farmaceuti. Being the best in R&D of HA technology field, the patent investors – Falk and Rudolf Edgar reported the highest number of patents with 27 patents owned in total, with the largest quantity of patents generated between 1996-2001, however, there is no patent generated since 2001; on the contrary, Weigel and Paul, these two investors reported patents from 2003 to now, with 10 patents generated in 2006, and are the most active inventor recently. According to the 3-level IPC patent classification, USA falls only behind Italy on A61L and is ahead of other countries for the rest of other classifications in terms of number of patents, and is proclaimed as technology leader. If follows 4-level IPC patent classification, A61K031, C08B037 and A61K047HA are ranked top 3 HA patents, respectively. It shows that A-category technology field is highly attended by the enterprises. Hyal Pharmaceutical in A61K, particularly in A61K031, is ahead of other competitors. Currently, being positioned in a declining stage of HA technology and requiring a breakthrough of study in recent years, it will be riskier for enterprises if they input bulky manpower and resources to develop HA related technologies hastily. Biotrics and Fidia Farmaceuti and other companies that possess key patent rights in HA technology have enabled a threat to other companies or other potential market competitors. However, biomedical materials report a rapid growth in recent years with market potential; therefore, a flexible joint venture or patent authorization manner can be considered by Taiwan to obtain the patent authorization to enable an entry to Mainland China and other new emerging markets, or develop products in niche markets to proceed profound development in different market segments.