title: How do public health safeguards in Indian patent law affect pharmaceutical patenting in practice?
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.
authors: Columbia University, USA.
authors: Bhaven N
authors: BN
authors: Sampat
authors: Tahir
authors: T
authors: Amin
mesh_terms: D003906:Developing Countries; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D016568:Drugs, Generic; D005060:Europe; D006297:Health Services Accessibility / Q000331:legislation & jurisprudence; D006801:Humans; D007194:India; D007391:International Cooperation / Q000331:legislation & jurisprudence*; D010330:Patents as Topic / Q000331:legislation & jurisprudence*
chemical_list: D016568:Drugs, Generic