Apr 022013
Indian Court Makes Landmark Drug Patent Decision The ramifications of this case are huge. It means that the big pharmaceutical companies can no longer make a minor tweak to a drug formula in order to extend its patent – and keep their prices high. Thus enabling just-as-effective cheaper, generic drugs to be made and distributed around the world. Supreme Court Rules for Cheap Cancer Drug By Subodh Varma, TNN  – April 1, 2013 http://timesofindia.indiatimes.com/business/india-business/Supreme-Court-rules-for-cheap-cancer-drug/articleshow/19331267.cms NEW DELHI: The Supreme Court on Monday rejected pharma giant Novartis AG’s plea to preserve its patent over a life-saving cancer drug, Glivec, drawing a huge sigh of relief from thousands of patients in India and in dozens of developing countries as the fear of an almost 15-fold escalation of drug costs receded. It is the biggest setback for multinational pharma companies, which have been denied patent protection for a series of life-saving drugs in recent years. Click here to view the embedded video. Invented in 1991, Glivec is a miracle cure for a type of blood cancer called chronic myeloid leukemia (CML). In this form of cancer, certain bone marrow cells go rogue and produce excessive white blood cells, causing mild fatigue and hip pain initially, but slipping into an out-of-control crisis of zooming platelet and white cell counts. It used to be fatal, but with Glivec, the survival rate is over 95%. Imanitib, the active component, is on the National Essential Drugs List in India. India has an estimated 3 lakh CML patients, with 20,000 added every year. Glivec is sold by Novartis for about Rs 1.2 lakh per month. Indian manufacturers sell the same drug at a monthly cost of Rs 8,000. This was the reason why Novartis launched a seven-year-long legal battle to protect its patent on the drug. Novartis, which reported a net profit of $9.6 billion in 2012 on sales of $57 billion, criticized the judgment. In a statement Ranjit Shahani, vice chairman and managing director, Novartis India said, “This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options.” When the drug was first commercially sold in 2001, India was moving over from the old patent regime to a new one after signing the international trade and patent related agreements in 1995. The new patent law came into force in 2005. Novartis could not get a patent on Glivec as it dated (more…)
Mar 202013
from the nothing-to-fear? dept One of the initiatives gaining momentum around the world is open data — the idea that, for example, non-personal data affecting the public should be made freely available. That’s partly to improve transparency, so that citizens are more informed about what is happening, and partly to stimulate new kinds of business that build products and services based on that data. An important category of open data that boosts transparency concerns basic drug safety information. Last month, Techdirt wrote about the AllTrials initiative that seeks to have key information about clinical trials placed in the public domain. As part of a wider move towards greater openness, the European Medicines Agency, the main body that licenses drugs in Europe, is starting to make available information that has hitherto been withheld. Although doctors and patients are rejoicing at this greater transparency, not everyone is pleased by the move. AbbVie, the pharma company spun out of the Abbott Laboratories at the beginning of this year, for example, is taking legal action to stop it: AbbVie, a pharmaceutical company has sought an injunction to block Europe’s medicines regulator from releasing “confidential” and “commercially-sensitive” information on its blockbuster rheumatoid arthritis drug, a spokeswoman for the U.S. drugmaker confirmed on Sunday. The Chicago-based company had taken legal action against the European Medicines Agency to stop it from releasing data on the effects in individual patients in clinical trials for its drug Humira, the Financial Times reported earlier on Sunday. Except, of course, this isn’t “confidential” and “commercially-sensitive” information: it’s just basic data about its safety and efficacy. Doctors and patients surely have a right to know this before using products that could potentially have serious, even fatal, side-effects.Another EU body, the European Food Safety Authority (EFSA), is also opening up: The project is part of EFSA’s continuing commitment to openness and addresses recommendations made by an independent evaluation report of the Authority’s performance to further enhance transparency in its decision-making processes. EFSA’s Science Strategy also highlights the importance of the Authority playing a leading role in making relevant scientific data more accessible to all interested parties. Here’s one particular set of data that it has now released: Given the level of public interest, EFSA will make all data on genetically modified (GM) maize NK603 publicly available on its website today (14 January). Once more, that seems reasonable, since the public ought to be able to find about what is going into (more…)