Novartis AG plea for cancer drug Glivec patent rejected by Supreme Court

Swiss pharma major Novartis AG today lost a seven-year long legal battle for getting its blood cancer drug Glivec patented in India and to restrain Indian companies from manufacturing generic drugs, with the Supreme Court rejecting the multinational company's plea. A bench of justices Aftab Alam and Ranjana Prakash Desai dismissed the claim of the Swiss firm for getting exclusive rights for manufacturing the cancer drug on the ground that a new substance has been used in the medicine. The judgement, which was keenly watched by pharma companies across the world, will clear hurdles coming in the way for the manufacture of generic drugs in India for cancer patients. While a one-month dose of Glivec costs around Rs 1.2 lakh generic drugs, manufactured by Indian companies, for the same period are priced at Rs 8,000. The judgement is a victory for Indian companies as they can now manufacture cheaper drugs so long as there is no patent over a medicine. Patents will now be granted only for genuine inventions and not on repetitive inventions. The Supreme Court said there was no new invention in the Novartis' drug. There should be no fear that foreign firms would be affected with today's verdict since as long as they have genuine inventions, patents will be given to them. In its judgement, the apex court also held that 'imatinib mesylate' used in Glivec is a known substance and Novartis can't claim patent over the drug for using this chemical. Novartis had approached the apex court in 2009 against the order of Chennai-based Intellectual Property Appellate Board (IPAB), which had rejected its claim for patent. The multinational company (MNC) had applied for patent in 2006. Novartis' claim was opposed by Indian pharma companies, which are manufacturing generic drugs, as well as by health aid activists in the apex court. They had claimed that the MNC is not entitled for patent and it is indulging in "ever-greening" of patent by simply changing the composition of the ingredients of the drug. Ever-greening of patent right is a strategy allegedly adopted by the innovators having patent rights over products to renew them by bringing in some minor changes such as adding new mixtures or formulations. It is done when their patent is about to expire. A patent on the new form would have given Novartis a 20-year monopoly on the drug. Earlier, the Comptroller General of Patent and Design had denied patent to Glivec on several grounds including its alleged failure to meet stipulations under sections 3(d) and 3(b) of the Indian Patent Law. Section 3(d) restricts patents for already known drugs unless the new claims are superior in terms of efficacy while Section 3(b) bars patents for products that are against public interest and do not demonstrate enhanced efficacy over existing products. During the arguments earlier, Novartis had tried to dispel the impression that its drug would be beyond reach of poor cancer patients due to its high cost.

"The purpose is not to make money from the poor. This is not the purpose, but am I not entitled for patent for our drug? We are fighting the case on principle," senior advocate Gopal Subramanium, appearing for the company, had said. He had submitted that there should be no cause of concern that the poor would not get treatment and had claimed that 85 per cent of such patients are treated free under its scheme. "The court has held that the drug is not novel, not inventive and does not satisfy the requirements of section 3(d) (of the Indian Patent Law). "Section 3(d) is important as it was brought in specially under the new patent law and does not allow new form of known substances to be patented unless they are significantly more efficacious," he said.

North Korean rhetoric

North Koreas threat to attack the US and its allies like South Korea after two nuclear -capable B-2 American bombers flew over the Korea peninsula last week has led to increased activity in Washington DC and North-East Asian capitals. The B-2 sorties, as the US explanation goes, were aimed at demonstrating that Washington DC was fully prepared and capable of defending and protecting its interests in the region and beyond. But the North Korean leadership appears to have taken it in a different context use of force to get Pyongyangs controversial nuclear programme abandoned. And hence the North Korean declaration on Saturday of being in a state of war with South Korea, which, like Japan, depends on the US for meeting threats from North Korea, suspected to have developed lowgrade nuclear weapons. Though communist North Korea and South Korea have been technically in a state of war with each other since they ended their 1950-53 conflict after signing an armistice, they never got engaged in a full-scale war since then. However, Pyongyang has been issuing threats now and then of doing whatever it can to protect its interests militarily. Its threatening statements have been interpreted as nothing but rhetoric to gain global attention for bargaining for financial aid owing to its growing economic difficulties. This time, however, the US has taken the North Korean threat seriously, though with the rider that there is nothing to fear about. The difference between the earlier threats and the latest one issued by North Korea is that the young North Korean ruler, Kim Jong-un, has signed an order putting its missile units in a state of readiness to attack American interests in the US mainland and South Korea. Japan is also feeling uneasy following these developments. The world should not take the present North Korean leaders rhetoric in the same manner as it treated the threats by his father. The new ruler seems to be more irresponsible than his father was because of being young and some other factors. Flexing muscles, as the US has done to prevent Pyongyang from taking to an adventurous course, will not do. China, which has friendly relations with North Korea, needs to be involved immediately in the goings-on to bring Pyongyang to the negotiating table to sort out the issues relating to its controversial nuclear programme.

IMF's New View on Capital Controls

In December 2012, the International Monetary Funds (IMF) Executive Board endorsed a new institutional view on capital account liberalisation and the management of capital flows. The same

institution that once told emerging market and developing countries to liberalise their capital accounts has shifted gears to say that, under certain circumstances, it is adequate to regulate cross-border finance. The Fund thus now endorses although only half way the perspective of many emerging and developing countries. This new view will give official guidance to IMF surveillance and reporting efforts. In particular: The IMF now recognises that capital flows carry risks, and that the liberalisation of capital flows before nations reach a certain threshold of financial and institutional development can accentuate those risks. It also acknowledges that under certain circumstances, cross-border capital flows should be regulated to avoid the worst effects of capital flow surges and sudden stops. It rightly says that nations that are the source of excessive capital flows should pay more attention to the potentially negative spillover effects of their macroeconomic policies. Finally, the IMF boldly notes that its new view on capital flow management may be at odds with other international commitments, such as in trade and investment treaties that restrict the ability to regulate cross-border finance

CURE FOR MEDIA Ever since he took over the chairmanship of the Press Council of India in October 2011, justice Markandey Katju has been in the news not so much for reviving the virtually defunct Press Council but for airing his views on a range of subjects from politics to foreign policy to the media. He was applauded for his intervention on the paid news phenomenon leading to an investigation that exposed the extent to which major media houses willingly sold editorial space to politicians. Yet he was criticised for his off-thecuff and generalised remarks on the state of the media. The latest in his diatribe against the media is his suggestion that minimum qualifications be made mandatory for journalists just as they are for doctors and lawyers. In principle, there is nothing wrong in this suggestion. In fact, the majority of mainstream media houses do insist on minimum qualifications, usually a university degree, and in some cases also a diploma in journalism. While some smaller newspapers might not insist on degrees and do recruit people without them, this is not the norm. Also, many Indian language papers with district editions have enlisted stringers who are not trained journalists. But their inputs are processed by professionals. The advantage of having such stringers has become evident in the expansion of news coverage to areas that remained outside the purview of most media. And then there are several small community newspapers and radio stations that have come up in the last decade serving the needs of their immediate community or region. These rural journalists, many of them women with only basic literacy skills, have learned how to report, interview and edit. If justice Katjus recommendation of minimum qualifications were to be applied, none of this vibrant community media would exist. There are several aspects of justice Katjus recommendation that are problematic. For one, he is conflating the problem of a drop in standards in the media with the absence of educational qualifications in journalists. A major reason for fall in standards is the state of our institutes of higher education. Where

once a basic university degree was considered an achievement, today it is barely enough for entry-level jobs. Every profession is faced with the poor quality of learning in those who are products of the majority of our educational institutions. Merely raising the bar on minimum qualifications for any profession is no guarantee that the people recruited will be better equipped for the job. What is also forgotten is the absence today of mentoring or on-the-job training within media houses to the extent it prevailed in the past. This is important because apart from some basic book knowledge, journalism is a skill that can best be learned on the job. Today, in the highly competitive environment that prevails, this kind of training is largely absent in most media houses. As a result, journalists with paper degrees but without the necessary skill sets are expected to jump into the deep without knowing how to swim. Another crucial reason for the fall in standards, particularly ethical standards, in the media is because of the change in media structures and ownership. With the media becoming a business rather than an institution meant to serve a larger social purpose in a democracy, such a fall in standards was inevitable. Today what sells is news. Thus neither paid news nor the decision to black out news about large parts of the country is questioned, simply because questioning will not sell the product. Producing saleable news does not require special qualifications barring subservience to the owners of the media house. Schools and colleges do not teach us this; the way society operates in India is the school where every professional learns how to fall in line and survive. As for the falling standards of ethics in the media, the solution clearly does not lie in more educational qualifications. In every profession, including medicine and law, education does not act as a bar to corruption or unethical behaviour. Why should it be different in the case of journalists? Even if media ethics is taught as a subject, and indeed it is in most journalism courses, this will not necessarily produce journalists who cannot be bought. Therefore, while justice Katju is right in castigating the media for its falling standards, his recommended remedy is off the mark. He needs to recognise that even the most highly qualified group of journalists can do little in a media industry where the bottom line takes precedence over quality and ethics. What we need are regulations to prevent media monopolies through cross-media ownership, ways to restrict commercial and political interests dictating media content as well as greater professionalism in the recruitment of journalists and their conditions at work.