Patent Litigation Strategy between Generic and Brand Name Pharmaceutical Companies
|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|
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。
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.