Aftermath of judgment on Novartis

The Glivec judgment has triggered a fresh public discourse on a large gamut of issues. But mainstream media's response has been woefully short of depth that is warranted on a subject as important as this, given the public interest standpoint The Swiss drug multinational Novartis suffered setback in the Supreme Court. The giant drug Pharma's patent application for anti-blood cancer drug Glivec was rejected by the apex court once and for all. The impact of this is huge. Nine years back, Glivec was being priced at US dollar 2,600, while its generic versions available in India in comparison was as low as US dollar 200. The difference was to the tune of 300 per cent. The implication for Indian patients battling blood cancer is obvious; figures speak for themselves. The Glivec judgment has triggered a fresh public discourse on a large gamut of issues. But mainstream media's response has been woefully short of depth that is warranted on a subject as important as this, given the public interest standpoint. However, none � absolutely none � can deny the glowing praise for the bench for this � to a great extent � historic judgment. It is, however, important to recapitulate the long drawn legal battle. The battle of Novartis started in 2007, when the Indian patent office rejected their patent application saying it was only a new version of an old drug under Section 3 (d) of the Indian Patent Act. The Swiss biggie went to Chennai High Court on two grounds; firstly, against the patent rejection and more importantly, against Section 3 (d) contending that it was unconstitutional. The Chennai Court rejected the application on both counts. In 2009, the company approached the Supreme Court against Section 3 (d) as enacted by the Parliament in 2005. With the current focus on Section 3 (d) of the Patent Act, it is necessary to comprehend what this statutory provision stands for. Section 3 (d) requires increased therapeutic efficiency for granting a new patent for a revised drug molecule. Novartis argued that its new form ensured more bio availability of the drug in the human body. Interpreting the law in its real perspective, the Chennai High Court was explicit; efficacy meant only therapeutic efficacy in healing the ailment and nothing else. Demystifying the complex technicalities of the issue would be pertinent. It is a common and often fraudulent exercise indulged by the drug MNCs that they try to make cosmetic changes in the molecules of an existing drug and claim improved efficacy and an innovation for achieving this. This, in turn, is claimed as the legitimate basis for a new patent. In common parlance, this obnoxious exercise is referred to as `ever greening' of a patent. Now the Supreme Court has put the attempted legal coup by Novartis to rest. No praise can be enough for the alertness of registration officers in our patent office; not to speak of the judicial acumen of our benches in Chennai or the apex court. But in our moment of glory over our judicial system, one cannot overlook the common refrain that `law is an ass'. The judiciary's hands are tied to the points raised in a petition. And, it can do precious little, unless there is an appropriate provision in our statute books to deal with such willful attempts to stage a legal coup aimed at maximize profit at the cost of public interest. Therefore, the widespread welcome with which the Supreme Court judgment has been greeted should not deflect us from the imperative to recall the intense battle that led to the incorporation of Section 3 (d). It is this backdrop which went missing in the discourse in mainstream media. It is recorded in history that the Agreement on Trade Related Intellectual Property Rights (TRIPS) was one of the most controversial and bitterly fought agreements that ultimately constituted part of the WTO agreement in 1995. A wide ranging array of political forces, spearheaded by the Left, bitterly contested the attempts by the then government to benignly capitulate before the machinations of international finance driven efforts to prise open the markets of underdeveloped and developing economies through the commissioning of the WTO. TRIPS was key element in that battle for encroachment in our economies with little regard for the interests of the poor. It is important to note that TRIPS was an instrument to perpetuate and secure profits for the global rich at the cost of the global poor � across nations and within nations. But given the international balance of forces at that conjuncture, the battle for ensuring a degree of equitability in the provisions of the TRIPS suffered a setback. This was despite a vigorous resistance to the complete pusillanimity of the Indian government to meaningfully engage and moderate the WTO process. This forced an amendment to the progressive Indian Patent Act of 1970; the immediate ramification being an imminent escalation of drug prices in the country. Consequently, process patent - basis for the 1970 Act metamorphosed to product patent as necessitated by India's association in the WTO, and in its turn, to the TRIPS agreement. However, that reversal did not lead to a complete sense of resignation. The battle was joined when Parliament under the TRIPs compulsion took up the task of amending the Patent Act. The BJP-led NDA government ensured two sets of amendments in 1999 and 2000. In December 2003, further amendments were proposed which was referred to the Parliament Select Committee but the amendments that were proposed by the opposition could be only flagged as note of dissent. However, the NDA could not conclude the legislation. With the first UPA government in place, ironically with the support of the Left which was in forefront of this battle, they revived dittoing the Bill prepared by the erstwhile NDA government. Commentators were predicting that this issue could be the first major flashpoint between the UPA and the Left, if not the actual break-up. But the battle of nerves went in favour of forces that were defending public interest. History always has its surprises. Thus, the proposed Left amendments which could only find its place as note of dissent for the NDA sponsored legislation became part of the official amendments moved by the UPA government and became the official enactment in 2005. Section 3 (d) was thus a reality. It showed that with political will the flexibilities offered within TRIPs and simultaneously invoking clause 6 of the Doha Declaration of WTO which allowed invoking of public health emergencies, some safeguards could be built in the respective national legislations. It is this amendment which has saved us from the surreptitious attempt by Novartis to exploit our cancer patients. This has a lesson. The struggle for government formation cannot remain limited to a futile discourse on branding of `leaders' like Modi or Rahul; neither can it be directed to frivolous discussion on the efficacy of a `dual-centre model' or otherwise. It is about issues, policies and modalities which accord highest priority to the interests of the Indian people.