Sufficiency of Disclosure in U.S. Patent Law
|關鍵字:||專利法;揭露充分性;生物技術;可據以實施性;書面說明;最佳實施態樣;生物寄存;Patent Law;sufficiency of disclosure;biotechnology;enablement;written description;best mode;biological deposition|
This thesis comprises an introduction of sufficiency of disclosure in U.S. patent law and the application of such requirement. Sufficiency of disclosure is difficult to assess, particularly in biotechnology, because of the unpredictable nature of the subject, the necessity to conduct further experimentation by others and the accessibility of organisms in biotechnique. Sufficiency of disclosure imposes an obligation upon an inventor so as to ensure that the people in society receive something of value to justify the patent rights of 20 years conferred to an invention, as procured by the patent owner. An invention described in the specification must meet enablement, written description and best mode requirements, so that the sufficiency of disclosure mandated in U.S. patent Law can be satisfied. In regard to enablement, the specification of an invention must teach a person skilled in the art how to make and use the full scope of the invention without undue experimentation so as to meet this requirement. Whether or not the experimentation conducted by those skilled in the art when making and using the same invention based on the disclosure in the specification originally filed is undue is crucial to an inventor when considering the necessity of deposit organisms in a depositary authorities in biotechnological cases. Written description established by U.S. Court of Appeals of Federal Circuit requires that the specification of an invention must clearly demonstrate that the inventor was in possession of the invention at the time the patent application was filed and conveyed it clearly to those skilled in the art. Thus, this requirement not only imposes a much higher obligation of disclosure of a claimed invention to the inventor but also functions to restrain amendment of claims during patent prosecution. The purpose of the best mode requirement is to prevent inventors from obtaining patent protection while concealing from the public the preferred embodiments of their inventions. This requirement imposes to an inventor a disclosure obligation higher than that by enablement so that the preferred embodiments contemplated by the inventor at filing can be clearly specified in the specification. If the specification of an invention does not satisfy this requirement, the patent obtained may be held unenforceable. Sometimes, violation of the best mode requirement will be deemed as violation of this duty of candor, which is referred to as inequitable conduct. Having understood the application of the sufficiency of disclosure in U.S. patent law,the research suggested that the enabling requirement in the Patent Law in our country may be further amended to specify that the specification of an invention should enable those skilled in the art to make and use the invention. Furthermore, written description should be introduced in our country and clearly stipulated in our patent law. The stipulation of our Patent Law directed to the deposit of organisms should be deleted and should be instead be included in the Enforcement Rule of the Patent Law, so that the Patent authority of our country may take necessary measure to ensure availability of organisms.
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