Taipei Veterans General Hospital, Division of Experiemental Surgery, Tiapei, Taiwan.
Hum Vaccin Immunother. 2012 Oct;8(10):1443-9. doi: 10.4161/hv.21184. Epub 2012 Aug 16.
The US Patent and Trademark Office (USPTO) adopts recent patent courts' opinions (such as KSR In re Fisher and Ariad v. Lilly) in patent examinations, which would certainly create barriers to biotech patent prosecution. To identify the barriers to Candida vaccine patent prosecution, we analyzed 99 US-granted patents from January 2001 to May 2012 related to Candida vaccines. The rejections were based on factors that included obviousness, novelty, indefiniteness, double patenting, enablement, written description and utility. Based on this investigation, we find that some of these rejections were actually avoidable, and then further provide workable solutions to avoid some of the barriers, especially those related to patentability. These principles recited in this study should also be applicable to other fields of vaccines and immunotherapeutics.
美国专利商标局（USPTO）在专利审查中采用了最近的专利法院意见（如 KSR 案中 Fisher 对 Lilly 案和 Ariad 案），这肯定会给生物技术专利诉讼带来障碍。为了确定 Candida 疫苗专利诉讼的障碍，我们分析了 2001 年 1 月至 2012 年 5 月期间与 Candida 疫苗相关的 99 项美国授权专利。驳回的理由包括显而易见性、新颖性、不确定性、双重专利、可实施性、充分描述和实用性。基于这项调查，我们发现其中一些驳回实际上是可以避免的，然后进一步提供可行的解决方案来避免一些障碍，特别是那些与可专利性相关的障碍。本研究中所述的这些原则也应适用于疫苗和免疫疗法的其他领域。
