There's a long (paid column inches I am sure) rant in almost all Indian newspapers today by the chief of Novartis lamenting the death of innovation. I couldn't be bothered to read it.
The front page headlines that weren't paid for ran with the conventional wisdom that the ruling was good for the people. On Tue, Apr 2, 2013 at 8:15 PM, Eugen Leitl <eu...@leitl.org> wrote: > > > http://www.guardian.co.uk/world/2013/apr/01/novartis-denied-cancer-drug-patent-india > > Novartis denied cancer drug patent in landmark Indian case > > Supreme court ruling paves way for generic companies to make cheap copies > of > Glivec in the developing world > > Sarah Boseley, health editor > > The Guardian, Monday 1 April 2013 14.10 BST > > Healthcare activists say the ruling against Novartis ensures poor people > will > be able to access to cheap versions of cancer medicines. Photograph: Rajesh > Kumar Singh/AP > > The Indian supreme court has refused to allow one of the world's leading > pharmaceutical companies to patent a new version of a cancer drug, a > decision > campaigners hailed as a major step forward in enabling poor people to > access > medicines in the developing world. > > Novartis lost a six-year legal battle after the court ruled that small > changes and improvements to the drug Glivec did not amount to innovation > deserving of a patent. The ruling opens the way for generic companies in > India to manufacture and sell cheap copies of the drug in the developing > world and has implications for HIV and other modern drugs too. > > Campaigners were jubilant. A ruling in Novartis's favour would have reduced > poor people's access to the drug, said Jennifer Cohn, of Médecins Sans > Frontières (MSF). "The fact that India says patents are to reward > innovation > as opposed to small changes does stay true to the concept of what a patent > should be." > > But Novartis said the decision "discourages future innovation in India". > Ranjit Shahani, the firm's vice-chairman and managing director in India, > said > the ruling was "a setback for patients that will hinder medical progress > for > diseases without effective treatment options". > > He said the Swiss company will be cautious about investing in India, > especially over introducing new drugs, and seek patent protection before > launching any new products. It will continue to refrain from research and > development activities in the country. "The intellectual property ecosystem > in India is not very encouraging," Shahani told reporters in Mumbai after > the > ruling. > > Glivec is an important drug in the treatment of myeloid leukaemia and has > transformed prospects for patients in rich countries. It is a targeted, > biological therapy that blocks cancer growth in patients with a particular > gene mutation. But like all targeted therapies, it is very expensive, > costing > more than £1,700 a month. > > Historically India only had limited patent protection on drugs and generic > companies in the country made versions of many medicines. It was only when > Indian firms began to make cheap copies of HIV drugs that it became > possible > more than a decade ago to contemplate the treatment of millions of people > in > impoverished countries of Africa, where the Aids epidemic was at its worst. > > But in 2005, India became compliant with World Trade Organisation rules on > intellectual property and now grants patents on innovative new drugs. > Patents > usually run for 20 years or more from the date they are taken out. > > Glivec was already on the market, however, so Novartis decided to seek a > patent on a slightly altered version, potentially giving it a longer period > of market exclusivity. The supreme court has thrown out the application, > saying the new drug is not significantly different from the old version, > and > ordered Novartis to pay costs. > > At stake in the legal battle was not just the right of generic companies to > make cheap drugs for India once original patents expire but also access to > newer drugs for poorer countries in much of Africa and Asia. India has long > been known as the pharmacy of the developing world. > > Dr Unni Karunakara, the president of MSF, said: "The supreme court's > decision > now makes patents on the medicines that we desperately need less likely. > This > marks the strongest possible signal to Novartis and other multinational > pharmaceutical companies that they should stop seeking to attack the Indian > patent law." > > In a statement, the Cancer Patients Aid Association in India (CPAA), which > had opposed the patent application, said: "We are very happy that the court > has recognised the right of patients to access affordable medicines over > profits for big pharmaceutical companies through patents. Our access to > affordable treatment will not be possible if the medicines are patented. It > is a huge victory for human rights." > > The case hinged on the interpretation of section 3(d) of the Indian Patents > Act, which does not allow patents of new versions of known drug molecules, > unless they make the medicine significantly more effective than before. > > Novartis argued that better physicochemical qualities, such as shape of the > molecule, stability, hygroscopicity and solubility, would satisfy the test > of > enhanced efficacy. > > But the court decided that the changes were simply an attempt at > "evergreening" – refreshing the drug so that a new patent would be granted > – > which is common practice in Europe and North America. > > Anand Grover, senior counsel and director of Lawyers Collective HIV/Aids > Unit, who represented the CPAA in the courts, said: "The supreme court's > interpretation of section 3(d) keeps it intact. It is alive and kicking. It > gives life to parliament's intent of facilitating access to medicines and > of > incentivising only genuine research. > > "By refusing patent monopolies on minor changes to known molecules, this > judgment will facilitate early entry of generic medicines into the market > for > other medicines and diseases too. The impact will be felt not only in > India, > but also across the developing world." > > The ruling is thought likely to affect drugs belonging to several other > companies. Pfizer's cancer drug Sutent and Roche's hepatitis C treatment > Pegasys lost their patented status in India last year. They may now find it > harder to obtain a patent on new versions. > > In an interview with before the ruling, Novartis threatened to stop > supplying > India with new medicines if it did not get the patent protection it > believes > its investment and innovation deserve. "If the situation stays as now, all > improvements on an original compound are not protectable and such drugs > would > probably not be rolled out in India," Paul Herrling, who headed the > company's > legal battle in India, told the Financial Times. "Why would we?" > >
