Elliott George
United States Patent and Trademark Office, Technology Center 1600 (biotechnology, organic chemicals and pharmaceuticals), Alexandria, VA, USA.
AAPS J. 2007 Aug 24;9(3):E317-24. doi: 10.1208/aapsj0903035.
The patent system plays an important role in stimulating the economy and advancing the quality of life in the United States. It serves as an incentive for innovation by giving inventors an exclusive right to their inventions for a limited period of time. It also increases and hastens the publication of useful knowledge by requiring inventors to disclose their invention to the public. Patents are particularly important in the pharmaceutical and biotechnology industries because they provide a mechanism by which the extremely high product development costs may be recouped. The United States Patent and Trademark Office acts as a gatekeeper in the patent system to prevent patents that do not meet the legal requirements from being thrust on the public. The legal requirements for obtaining a patent are discussed, particularly as they relate to pharmaceutical and biotechnological inventions. The process of examining an application for a patent is briefly described, along with some of the burdens faced by examiners when deciding the patentability of therapy-related inventions.
专利制度在美国刺激经济和提升生活质量方面发挥着重要作用。它通过在有限时间内赋予发明人对其发明的专有权,为创新提供激励。它还通过要求发明人向公众披露其发明,增加并加速了有用知识的传播。专利在制药和生物技术行业尤为重要,因为它们提供了一种机制,通过该机制可以收回极高的产品开发成本。美国专利商标局在专利制度中充当守门人,以防止不符合法律要求的专利强加给公众。本文讨论了获得专利的法律要求,特别是与制药和生物技术发明相关的要求。简要描述了审查专利申请的过程,以及审查员在确定与治疗相关发明的可专利性时面临的一些负担。