Category: Patent

In 2008, more than a dozen shipments carrying off-patent generic drug from India were detained by customs authorities in European Union [EU] countries on grounds of alleged infringement of EU intellectual property. The consignments were destined for Brazil transiting through the European ports and airports. India together with Brazil had taken the issue to WTO’s [World Trade Organization] disputes settlement body in May 2010 against the EU and Netherlands, where the shipments were detained. Other countries viz. Canada, Ecuador, China, Japan and Turkey had joined the dispute. India argued that the seizures violated the multilateral Trade Related Intellectual Property Rights [TRIPS] agreement of the WTO, as the medicines were off-patent both in India as well as the country [read Brazil] to...

According to a recent study published in the Journal of the American Medical Association [JAMA], it costs a company just $648 million on an average in research and development [R&D] to bring a cancer drug to the market — a small fraction of the $2.7 billion the pharmaceutical industry claims is the average cost of drug discovery. It further shows that within about four years of approval [no drug is allowed to be marketed without taking prior authorization/registration from national regulator under the relevant jurisdiction], revenue from the sale of the drugs studied was on average nine-fold higher than the R&D spending. Even accounting for what the money would have earned if invested in the market, the returns are seven times the costs. The...

The 2017 Trade Policy Agenda unveiled by Trump administration on March 2 pushes for a stricter regime for intellectual property rights and patents. While, agreeing that India’s reforms on IPR are encouraging, the document says “India’s new National Intellectual Property Rights Policy [NIPRP] should protect US innovations”. Specifically, US concerns are articulated in recent observations of Patrick Kilbride, Executive Director (International IP) of US Chamber of Commerce’s Global Intellectual Property Centre (GIPC). He has lamented that IP-intensive American firms continue to face severe challenges in the Indian market concerning Section 3[d] of the Indian Patents Act and compulsory licensing [CL]. The GIPC, in its annual IPR report, has ranked India in the bottom three for having a weak IPR and...