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印度专利法中的公共卫生保障措施如何在实践中影响药品专利授予?

How do public health safeguards in Indian patent law affect pharmaceutical patenting in practice?

机构信息

Columbia University, USA.

出版信息

J Health Polit Policy Law. 2013 Aug;38(4):735-55. doi: 10.1215/03616878-2208594. Epub 2013 May 3.

DOI:10.1215/03616878-2208594
PMID:23645877
Abstract

The 1995 Trade Related Intellectual Property Rights (TRIPS) agreement required developing countries to grant product patents in pharmaceuticals. Developing countries have since explored various measures to ameliorate potential negative effects of the new laws on public health. A prominent example is India, whose post-TRIPS patent laws include a provision, section 3(d), that restricts patents on incremental pharmaceutical innovations. Its critics and supporters alike suggest that this provision makes Indian patent law very different from that in other jurisdictions. Yet there are concerns that given resource constraints facing the Indian patent office, this novel feature of Indian patent laws on the books may not have an effect on Indian patent prosecution in practice. We test this by examining the prosecution outcomes of 2,803 applications filed in both India and Europe, coded by whether they include claims that trigger 3(d) considerations. We find that having the 3(d) provision on the books does not translate into very different patent outcomes in practice in India, relative to Europe, a jurisdiction without this provision.

摘要

1995 年的《与贸易有关的知识产权协定》(TRIPS)要求发展中国家在药品方面授予产品专利。此后,发展中国家探索了各种措施来缓解新法律对公共卫生的潜在负面影响。一个突出的例子是印度,其 TRIPS 后专利法包括一项规定,即第 3(d)条,限制对药品增量创新的专利。它的批评者和支持者都认为,这一规定使印度专利法与其他法域的专利法非常不同。然而,有人担心,鉴于印度专利局面临资源限制,该法案中有关印度专利法的这一新颖特征在实践中可能对印度的专利诉讼没有影响。我们通过检查在印度和欧洲提交的 2803 份申请的诉讼结果来检验这一点,这些申请是根据它们是否包含触发 3(d)考虑的权利要求进行编码的。我们发现,相对于没有这项规定的欧洲,在印度,该法案的存在并没有在实践中导致非常不同的专利结果。

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