Patents and nanomedicine
Patents and nanomedicine
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DOI：
10.2217/17435889.2.3.351
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发表时间：
2007-06-01
期刊：
影响因子：
5.5
通讯作者：
Bawa, Raj
中科院分区：
文献类型：
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作者：
Bawa, Raj
大型制药公司依靠几款畅销产品来产生利润的商业模式显然已经崩溃。近年来，许多畅销药品的专利到期已经改变了药品的格局。制药公司还面临着其他挑战，这些挑战需要开发和实施新的研发战略，包括那些专注于纳米技术和小型化的战略。显然，人们对纳米医学的潜在影响有着巨大的兴奋和期待。然而，确保有效和可辩护的专利保护将是至关重要的。尽管对纳米药物商业化的早期预测令人鼓舞，但也存在许多瓶颈。其中一个主要障碍是新出现的专利权利要求，这主要是由于专利的激增以及美国专利商标局（PTO）持续发布的专利范围之广令人惊讶。更令人困惑的是，从纳米医学的角度来看，美国国家纳米技术计划被广泛引用的纳米技术定义是不准确和不相关的。这也是PTO最近公布的专利分类制度不完善的原因。所有这些都在纳米医学的各个领域创造了一个混乱、纠结的专利格局，竞争对手不确定众多已发布专利的有效性和可执行性。如果这种趋势持续下去，可能会扼杀竞争，限制某些发明的获取。因此，PTO迫切需要改革，以解决专利质量差、审查实践有问题、检索能力不足、人员流失率上升、员工士气低落以及专利申请积压如山等问题。只有健全的专利制度才能刺激商业上可行的纳米药物产品的开发，从而大大提高患者的生活质量，降低医疗成本。
Big pharma's business model, which relies on a few blockbusters to generate profits, is clearly broken. Patent expiration on numerous blockbusters in recent years is already altering the drug landscape. Drug companies are also facing other challenges that necessitate development and implementation of novel R&D strategies, including those that focus on nanotechnology and miniaturization. Clearly, there is enormous excitement and expectation regarding nanomedicine's potential impact. However, securing valid and defensible patent protection will be critical. Although early forecasts for nanomedicine commercialization are encouraging, there are numerous bottlenecks as well. One of the major hurdles is an emerging thicket of patent claims, resulting primarily from patent proliferation as well as continued issuance of surprisingly broad patents by the US Patent and Trademark Office (PTO). Adding to this confusion is the fact that the US National Nanotechnology Initiative's widely cited definition of nanotechnology is inaccurate and irrelevant from a nanomedicine perspective. It is also the cause of the inadequate patent classification system that was recently unveiled by the PTO. All of this is creating a chaotic, tangled patent landscape in various sectors of nanomedicine where the competing players are unsure of the validity and enforceability of numerous issued patents. If this trend continues, it could stifle competition and limit access to some inventions. Therefore, reforms are urgently needed at the PTO to address problems ranging from poor patent quality and questionable examination practices to inadequate search capabilities, rising attrition, poor employee morale and a skyrocketing patent application backlog. Only a robust patent system will stimulate the development of commercially viable nanomedicine products that can drastically improve a patient's quality of life and reduce healthcare costs.