THE INDIAN NOVARTIS CASE OPENS A NEW CHAPTER FOR GENERIC MEDICINES IN DEVELOPING COUNTRIES

On 1 April 2013, the Supreme Court of India issued a precedent-setting judgment that will forever influence positively access to essential medicines especially generics in developing countries. According to the Supreme Court decision, India will remains a major supplier of affordable essential generic medicines in the developing world including Kenya.

In effect, the decision has given life to section 3(d) of the 1970 Indian Patent Act as amended in 2005 to comply with the Trade Related Intellectual Property Rights (TRIPS) Agreement. Section 3(d) disqualifies as an invention a ‘mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance…’ This means that India will be able to produce generic versions of patented medicines after the expiry of the first patent term which is usually 20years. Any renewal of an existing patent will have to pass a very strict test of enhancing ‘known efficacy’. This requirement will drastically curb the ‘ever-greening’ of patents, a problem that has hindered generic competition in the past. Another outcome of this decision is that pharmaceutical companies will now have to focus their research and development on new medicines as opposed to modifying existing ones.

All in all, this case is bound to affect positively access to essential medicines situation in developing countries. Lastly, it will also challenge the current patent philosophy by encouraging developing countries to adopt a more stringent patentability criteria especially for second or third patents.

For the decision, visit: www.scribd.com/doc/133343411/Novartis-patent-Judgement.

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