美國專利連結制度對於藥廠間競爭行為影響之探究

Exploring the Competitive Behaviors among Pharmaceutical Companies under the U.S. Patent Linkage System

洪淑瑗(Hung Shu-Yuan)

指導教授 ： 宋皇志

國立政治大學/商學院/科技管理與智慧財產研究所/碩士(2020年)

https://doi.org/10.6814/NCCU202001796

摘要

隨著新興科技發展以及人口數成長趨動下，同時醫療及藥品的需求也不斷增加，藥品為藥廠帶來豐厚利潤，專利幫助藥品在市場中站穩優勢地位。美國擁有專利連結制度，將專利與藥品許可證做連結，達到鼓勵原廠創新，及促進學名藥廠挑戰原廠專利，幫助學名藥上市。美國將此制度作為簽訂雙邊或多邊貿易協定之籌碼，我國亦在2019年公告並正式實行專利連結制度，由於美國施行該制度已逾30年，台灣藥廠勢必會參考美國製藥產業競爭樣態，進行商業策略規劃。
本研究試圖透過梳理專利制度與藥廠競爭行為影響，希望可以了解製藥產業在專利登錄及專利挑戰的競爭行為。利用深度訪談法與文獻分析法，藉以回答研究問題，企圖宏觀描述專利連結制度下之製藥產業的競爭行為與針對過去相關爭議進行探究。研究發現專利連結制度與美國藥廠競爭關係環環相扣，過去為之詬病的是有原廠會濫登專利或是原廠濫訴學名藥廠，進而拖延學名藥上市之現象。
關於專利登錄問題，經過多次修法，已明確規定橘皮書可登錄專利類型，並且原廠必須切結誠實登錄專利。本研究認為由於登錄專利得以取得學名藥上市前通知，因此原廠希望盡可能地登錄專利，但伴隨不實登錄會有罰則，並且濫登之專利難以在未來訴訟中獲勝，實務上藥廠會考量到訴訟成本、效益以及股價變動等面向，並不是隨意興訟，受訪者亦認為現行美國原廠主要都會遵循法規。若真的對於專利與藥品的相關性存疑，在現行法律的規範下，若有爭議則由法院裁決。對學名藥廠來說，藥品專利公開減少檢索成本，降低學名藥上市後面臨侵權訴訟機會；但整體而言，透過專利挑戰使學名藥有機會在原廠藥仍有專利權時提前上市，可以獲取更大的利益，同時讓消費者更早獲取較廉價之藥品。
現有的法律使得原廠與學名藥廠間相互抗衡，也因此可以刺激製藥產業不斷進步，藥廠亦可研發新藥與販售學名藥，藥廠間競爭關係不斷變動，如何在專利連結制度與競爭激烈的環境下獲利，是藥廠須持續關注的議題。

關鍵字

專利連結 ； 專利登錄 ； 專利挑戰 ； 藥廠競爭 ； 橘皮書

並列摘要

With the development of emerging technologies and the trend of population growth, the demand for medical therapy and drugs is also increasing. Brand drugs have brought huge profits to pharmaceutical companies, and patents help Brand drugs to monopoly the market. The United States has a patent linkage system, which links patents with drug licenses to encourage original manufacturers to innovate and promote generic drug companies to challenge brand drug patents. The United States uses this system as a bargaining chip for signing bilateral or multilateral trade agreements. Taiwan also announced and officially implemented the patent linkage system in 2019. Since the United States has implemented the system for more than 30 years, Taiwanese pharmaceutical companies will inevitably refer to the competition in the US pharmaceutical industry.
This study attempts to sort out the impact of the patent system and the competitive behavior of pharmaceutical companies, hoping to understand the pharmaceutical industry's competitive behaviors in patent registration and patent challenges. Using in-depth interviews and literature analysis methods to answer research questions, this study attempts to describe the competitive behavior of the pharmaceutical industry under the patent linkage system and explores related disputes.
The study has found that the patent linkage system is closely related to the competition between American pharmaceutical companies. In the past, there was a controversial issue that the original manufacturer would abuse the patent and delay the generic drugs into the market by suing. The patent registration issue has been clearly stipulated after many amendments to the law. The Orange Book can register certain types of patents, and the original manufacturer must be responsible for the honest registration of the patent. In addition, the registered patent can obtain the pre-market notice of the generic drug. Although the original manufacturer wants to register the patent as much as possible, there are penalties for false registration. In practice, pharmaceutical companies will also consider litigation costs, benefits, and stock price changes before suing other companies. The interviewees also believe that the current US original companies will mainly follow regulations. If there is any doubt about the relevance of patents and medicines, this problem would get into the court, and the court shall decide. For generic companies, the disclosure of drug patents reduces search costs and reduces the opportunity for infringement litigation after generic drugs into the market. However, on the whole, through patent challenges, generic drugs have the opportunity to be listed in advance when the original drug still has patent rights. Therefore, the more generic drugs into the market, the cheaper drug and the bigger profit the consumers would obtain.
In the pharmaceutical industry, the compete among original companies and generic companies is getting more and more fierce and complex. In the future, the pharmaceutical company may also develop new drugs and sell generic drugs. How to profit from the patent linkage system and face the fierce competition environment is an important issue that pharmaceutical companies must continue to pay attention to.

並列關鍵字

Patent Linkage ； Patent Listing ； Patent Challenge ； Competition in pharmaceuticals ； Orange Book

參考文獻

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