Pharmaceutical Patent Enforcement: A Developmental Perspective

Although standards for the grant of intellectual property rights often take center stage in the literature on intellectual property and development, intellectual property enforcement is largely ignored. This paper seeks to fill this gap, albeit to a limited extent, by focusing on the standards for the grant of injunctions in patent infringement suits. This is particularly relevant, as a number of developing countries, such as India, are faced with burgeoning patent disputes disputes that have enormous implications for the future of innovation and the issue of access to patented goods, notably pharmaceuticals. Given that interim injunctions are largely dispositive of intellectual property disputes in many cases, this chapter focuses largely on such injunctions. The standards for the grant of injunctions ought to be calibrated in a manner that appropriately balances the interests of the patentee in securing timely and effective enforcement of her rights with the public interest in guarding against erroneous injunctions (i.e. where the patent turns out to be invalid or not infringed after trial). Such wrongly granted injunctions harm not only competitors against whom they are granted, but also consumers who are forced to pay a monopoly price during the subsistence of the injunction/restraining order. We recommend that, when faced with a complex patent dispute where it is difficult to legitimately assess the strength of each party’s case at the interim stage and effectively predict who is more likely to win at trial, courts move directly to the trial stage - a suggestion that is coming to be increasingly adopted by the Indian Supreme Court. We argue that this is a TRIPS flexibility that developing countries, such as India, can legitimately exploit. We also highlight issues of institutional capacity and ask: Should developing countries such as India institute specialist intellectual property courts to decide patent infringement suits? Would this make for more optimal intellectual property adjudication? Though specific to India, most of the suggestions in this chapter could prove useful for a number of other developing countries, particularly those that follow common law and are yet to experience a significant number of patent infringement cases.