標題: 專利藥廠與學名藥廠之專利訴訟策略
Patent Litigation Strategy between Generic and Brand Name Pharmaceutical Companies
作者: 孫偉棟
Sun, Wei-Tung
Liu, Shang-Jyh
關鍵字: 學名藥;專利藥;專利連結;專利訴訟策略;橘皮書;藥品價格競爭及專利期展延法案;generic drug;brand name drug;patent linkage;patent litigation strategy;orange Book;Hatch-Waxman Act
公開日期: 2013
摘要: 製藥業是個錯綜複雜的產業,雖然研發新藥是一項高成本,技術密集且高風險的產業,但並非所有藥廠都以研發新藥為主要業務。整體而言,學名藥廠通常較不進行新藥的研發。就定義而言,專利藥廠或原廠係指其主要以研發新藥為其主要的業務,反之,學名藥廠則是以製造專利已過期之原廠藥為其主要業務之藥廠。以公眾利益而言,兩種藥廠都有其存在的必要,專利藥廠可持續提供藥品及其技術上的改良與創新。而學名藥則以更經濟實惠的價格提供較社會大眾,可靠且安全的藥品,對於醫藥普及與結省政府醫藥支出有著莫大的供獻。因兩種藥廠質上的不同而所產生的衝突為貫穿本文而持續出現的議題,本文將會以專利藥廠和學名藥廠如何以主張專利權等法律行為來達成各自的目地。即專利藥廠會以主張專利侵害等其它法律上的主張來阻止學名藥上市的時間來確保其市場獨佔,相反的,學名藥廠則希望在原廠藥專利過期後能及早上市來分食市場大餅。   本文將以介紹製藥業的起源與其演變歷史為開始並對其產業特性加以著墨。後對美國藥品市場加及其早期藥品管制機制加以介紹。本文將以解析與批判Hatch-Waxman Act 和專利連結制度(Patent Linkage) 為介紹美國法之重點。作者將對本法如何對藥廠間之訴爭可啟全新的戰場和訴訟策略加分析,自Hatch-Waxman Act以後,「處方用藥改善及現代化法案」(Medicare Prescription Drug Improvement and Modernization Act of 2003),為另一項指標性的立法。作者將會對本法如何成功的將數十年來因Hatch-Waxman Act所生訴訟的亂象改正加以剖析,分析其成功和未盡之處。   除美國外,本文亦對其它國家(澳洲,加拿大和韓國)對藥廠間的訴爭所採取修法上的措施加以分析比較。文末將加以參照台灣獨特的醫療環境和當地特色,這些當地的因素如何在藥廠中的抗爭中有著重大的影響。   最後,所然台灣尚未引進專利連結等美國法相關制度,然而各大跨國專利藥廠已經使用部份它們於美國常用的主張對抗台灣本土藥廠。隨著貿易持續性的開放與許多明星專利藥的陸續到期,藥廠間的訴爭應會持續燃燒。希望本文能提供台灣法院和立法者就藥廠間的訴爭有多一個觀察的面向和進而幫助立法者和法院提出一個更符合當地需求的法律機制和判決論理的過程。
Pharmaceutical industry is a complex business. While it is without a doubt that researching new drug is a capital-intensive and risky business; however, no all drug makers are engaged in this perilous endeavor. Broadly speaking, generic drug maker is an exception of this trend. By definition, pioneer drug maker, also known as brand name company, are referring to drug maker whose primary mode of business is engaging in researching new drugs; on the other side of the spectrum, is generic drug maker. Generic drug maker are pharmaceutical company that primarily engaged in manufacturing of known drugs whose patent term already expired. From public policy’s perspective, both types of company are useful. Brand name company provides new pharmaceutical innovation and improvement; while generic company facilitates accessibility and provides more economically friendly drug to general public and healthcare provider alike. This conflicting interest will be the main theme throughout this paper and how brand name and generic company use litigation, especially asserting patent right, to further each their own interests i.e. Brand name will want to delay the entrance of generic drug into the market for as long as possible; in contrast, generic drug maker will want to market its drug as soon as possible. This paper will begin by providing an introduction on the history of pharmaceutical industry and its unique characteristics that distinguish this industry from other business. Followed by an introduction on U.S. drug market and some of U.S.’s earlier attempt to control the conflicting interests between brand name and generic drug maker, this paper will start in earnest by providing a critical analysis on Hatch-Waxman Act and patent linkage system that comes with it. The author will comment on some of act’s success and failure and how it opens an era of wild litigation battles between brand name and generic companies. Following Hatch-Waxman Act is another revolutionary piece of legislation known as “Medicare Prescription Drug, Improvement, and Modernization Act” which is American’s attempt to fix problems and abuse created or afforded by Hatch-Waxman Act. As will discuss in detail in this paper, while Medical Moderation Act did successful in eliminating some of the problems that have plagued Hatch-Wax Act for decades, some of its problem remain unresolved and some of act’s half measure inadvertently opens door for more abuses. However, U.S. is certainly not the only country in the world that had become battleground for pharmaceutical companies. This paper will provide a comparison of different regulatory regime implemented by Australia, Canada and Korea to combat these problems. In the latter part of this paper will present some of uniquely Taiwan element that will play a significant role in re-balance the interests. Finally, though Taiwan have yet to fully adopt the American system in controlling drug marketing process, many of the multinational brand name company have already tried their legal tactic used in States in Taiwan’s court. Hopefully, this paper will provide some observation to Taiwan’s court and legislators when or if Taiwan decides to fully implement American system.
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