由美國專利實務探討專利侵害之實驗免責

The Study on the Experimental Exemption from the U.S. Patent Practice

陳文吟(Wen-Yin Chen)

《臺北大學法學論叢》 64期 (2007/12) Pp. 85-120

https://doi.org/10.6774/TULR.200712.0085

摘要

專利制度藉由賦予專利權人排他性權利、鼓勵研發，達到提昇產業科技的目的。專利權人因此享有排除他人未經其同意而使用其技術的權利；是以未經其同意而使用其專利技術者，構成專利權的侵害。然而，基於公益及公平性等因素之考量，多數國家均允許特定事由之使用不構成侵害，實驗目的之使用便為其一。西元二○○二年，美國聯邦巡迴上訴法院於Madey v. Duke University乙案中指出，被告Duke University使用原告專利技術之行為構成專利權之侵害，渠等有關實驗免責之抗辯並不成立。此判決首次揭示大學的使用未必符合實驗研究目的，故仍有構成專利權侵害之虞。Madey乙案衍生兩項課題：一、阻礙科技發展，二、上位概念技術的賦予專利，可能箝制下位概念技術的發展。論者疾呼國會應立法從寬界定實驗免責。
就提昇產業科技的意旨而言，固應予以第三人適度的研究實驗的機會（無論僅為印證專利技術、衍生其他發明、抑或改良該發明），使其行為不致構成侵權；然而，同時應顧及專利權人之權益。蓋以，實驗免責係專利權人得行使排他性權利之例外，過於擴張適用實驗免責，將使專利權人之排他性權利喪失其意義。所謂藉保護專利權以達鼓勵發明、提昇產業科技之目的，勢必無法達成。
實驗免責並不足以、亦不適於解決所有行為人不得不實施他人專利技術之行為，倘專利權利之行使確有阻礙產業科技之情事，應重新就制度面檢討專利權利之賦予有無限縮之必要，抑或從嚴界定申請專利範圍；甚至，輔以強制授權（特許實施）等措施。
我國專利法修正草案第五十七條第一項第二款，既已刪除「非營利行為」之限制，無論大學或任何業者，均得以研究實驗主張免責規定之適用。此除涵蓋美國法35 U.S.C. § 271(e)(1)之規定，更與美國實務之從嚴適用實驗免責截然不同；適足以兼顧專利權益暨產業科技的提昇。

關鍵字

實驗免責 ； 專利侵害 ； 研究工具 ； 申請專利範圍 ； 生物科技 ； 大學研究 ； 原理實驗 ； 法定禁止 ； 可實施性要件

並列摘要

In most of countries, patent law system provides the patent holder with exclusive right upon his/her invention; anyone who uses the patented invention without patentee's consent shall be liable for patent infringement. However, the system also establishes certain exceptions (or defenses) due to the public policy, such as experimental use, prior users…etc.
Under the American patent system, experimental use defense is a common law doctrine, it was originated in Justice Story’s 1813 opinion in Whittemore v. Cutter. Since then, it has been successfully asserted as a legitimate defense at numerous patent infringement cases. 1995, the Congress established experimental exemption for generic drug industries under 35 U.S.C. § 271(e)(1).
In the academic society, utilizing patented invention to do the research by professors/researchers has never been questioned until Madey brought patent infringement lawsuit against Duke University in 1998. And, in 2002, Federal Circuit rejected an experimental use defense asserted by Duke University. It is still unknown how the decision may affect academic research as well as industrial society.
However, it shall be noted that Bayh-Dole Act of 1980 which encourages the establishment of university-industry research relationship causes most of university researches, even basic ones, lead to commercial interests. And, in the field of biotechnology, it is inevitable for researchers (either from university or industry) to take experiments on patented inventions so as to realize their technique and functions. According to Madey case, those uses constitute patent infringement and the experimental exemption would not be applied. Would that be the case, does it help the industrial development due to the thorough protection on patent rights, or does it harm the industrial development due to discouragement on scientific research. Some writers suggested broadexperimental exemption so as to promote industrial technology. Others were concerned the upstream patents or patented research tools may diminish downstream inventions due to the strict experimental exemption.
The author of this article suggests the balancing test between patent holders' right and the public interest of higher industrial technology. If the upstream patent may prevent downstream inventions, the problem should not be whether the experimental exemption is broad enough, but whether the patent is too broad that should not be issued, or the whole patent system should be reformed.
Although our patent law also provides experimental use defense, it is seldom bought out at patent infringement cases, whether by universities or by industries. Owing to the growing relationship between universities and industrial society, and development of biotechnology, it's time for us to realize the definition of experimental exemption. Clause 1, Section 1 of Article 57 under our patent law does not clarify the definition of non-profit activity of research/experiment. The 2006 revised draft does establish the exemption, which consists of the conduct as provided under 35 U.S.C. § 271(e)(1) and any other experiments.

並列關鍵字

Experimental Use Defense ； Experimental Exemption ； Patent Infringement ； Research Tools ； Patent Claims ； Biotechnology ； University Research ； Philosophical experiment ； Statutory Bar ； Enablement Requirement

參考文獻

UC and Genentech Announced Patent Settlement of Patent Infringement Lawsuits

Bauer, Richard, Comment(2005).Why Not Try the Experiment and Stop Pointing the Finger? Modern University Research Unaffected by Narrow Experimental Use Exception.TEMP. J. SCI. TECH. & ENVT`L. L..24,121.

Cai, Michelle, Note(2004).Madey v. Duke University: Shattering the Myth of Universities` Experimental Use Defense.BERKELEY TECH. L.J..19,175.

Eisenberg, Rebecca(1989).Patents and the Progress of Science: Exclusive Rights and Experimental Use.U. L. REV..56,1017.

Eisenberg, Rebecca(2003).Patent Swords and Shields, 299.SCI.