Department of Health Policy and Management, Mailman School of Public Health, Columbia University, New York, NY, United States of America.
NBER, Cambridge, MA, United States of America.
PLoS One. 2018 Apr 2;13(4):e0194714. doi: 10.1371/journal.pone.0194714. eCollection 2018.
India, like many developing countries, only recently began to grant pharmaceutical product patents. Indian patent law includes a provision, Section 3(d), which tries to limit grant of "secondary" pharmaceutical patents, i.e. patents on new forms of existing molecules and drugs. Previous research suggests the provision was rarely used against secondary applications in the years immediately following its enactment, and where it was, was redundant to other aspects of the patent law, raising concerns that 3(d) was being under-utilized by the Indian Patent Office. This paper uses a novel data source, the patent office's first examination reports, to examine changes in the use of the provision. We find a sharp increase over time in the use of Section 3(d), including on the main claims of patent applications, though it continues to be used in conjunction with other types of objections to patentability. More surprisingly, see a sharp increase in the use of the provision against primary patent applications, contrary to its intent, raising concerns about potential over-utilization.
印度和许多发展中国家一样，直到最近才开始授予药品专利。印度专利法包含一项条款，第 3(d)款，旨在限制“二次”医药专利的授予，即对现有分子和药物的新形式的专利。之前的研究表明，该条款在颁布后的几年中很少被用于对抗二次申请，而且即使被使用，也与专利法的其他方面重复，这让人担心印度专利局对 3(d)款的利用不足。本文利用了一个新颖的数据来源，即专利局的首次审查报告，来考察该条款的使用变化。我们发现，随着时间的推移，第 3(d)款的使用急剧增加，包括对专利申请主要权利要求的使用，但它继续与其他类型的可专利性异议一起使用。更令人惊讶的是，我们发现该条款被用于对抗主要专利申请的情况急剧增加，这与该条款的意图相悖，让人担心可能存在过度使用的情况。
