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Medicine patent and compulsory licensing in India






The Pharmaceutical industry in India is the world's third-largest in terms of volume and stands 14th in terms of value.
Medicines are developed through years of research and thus helps in curing diseases. R&D takes high cost. Innovations can be expected through R&D only. To promote innovations patent is granted(as far as other fields are concerned). The patent protection helps the company to carry on it’s R&D as there is no threat from any competitor and they will be the sole seller of that product. India has had lax patent laws compared with other countries. They allow Indian companies to produce generic versions of drugs that are under patent elsewhere. The competition between manufacturers drives down the price of the drug.
For many years, India did not recognise drug patents at all. However, in 1994, India signed up to the TRIPS agreement (Trade Related Aspects of International Property Rights), an international law that gives drug companies a 20 year patent on the production of drugs. TRIPS required India to introduce patents on medicines in 2005. In contrast to other countries in the TRIPS agreement, India also introduced laws that prohibited an industry tactic called evergreening. Evergreening is where a company extends its patent on a drug by patenting slightly modified versions of the drug. For example, they might release the original drug in its salt form, even if this does not bring a therapeutic improvement. Two major cases were decided recently recently relating to the Medicine patenting in India. Fortunately both the judgements are in favour of Weaker section (we the customers). Supreme court recently declined the patent application of swiss based Novartis on the grounds of evergreening. It tried to expand it’s patent on Glivec. It launched better version of Glivec and demanded patent for it, which was out rightly rejected as India does not permit patent for Evergreening. One more judgement was passed recently which was a case relenting to compulsory licensing of drugs. Compulsory licensing is give to drug companies under which it can produce and sell the already patented product of some other company at a lower price. This is given for lowering down the price of medicine which is highly charged by company having patent of that product. Natco company had applied for a compulsory licensing to sale drug. India has invoked its compulsory licensing rules for the first time, allowing the domestic drugmaker Natco Pharma to make and sell a version of Bayer's cancer drug Nexavar--despite the fact that Nexavar is still on patent. Natco will pay a 6% royalty, but given the fact that it's going to be selling Nexavar at a substantial discount, that payment probably won't be very significant. It's the patent board's ruling that's significant. Now that the Indian government has granted one license, more generic drugmakers are expected to petition for their own.Compulsory licensing is a contentious affair; globally, it's uncommonly used. The idea is that, in a public health crisis, generic drugmakers should be able to sell lower-cost versions of branded drugs, so that more patients can get access to treatment. Some multinational companies have granted their own licenses to low-cost drugmakers for public health (and public relations) reasons, particularly on AIDS drugs for sale in Africa. Government compulsion is a different story; branded drugmakers view that approach as an assault on their intellectual property rights.
One can argue that cost Research and development is much higher than what all revenue generated at normal rates of distribution. But that is so not true. Agree that cost incurred in R&D is much higher that’s why they expect patent protection so as to create a monopoly and sell at higher prices. In this manner they are making it available to only few people who can afford. In this manner they earn revenue only from small proportion of needy people. If they lower up the cost or if the patent protection is not granted they would be forced to lower the prices and thus manner large number of people would be able to afford it. Which will lead to economies of scale and more profit. Because of it now more number of people will prefer buying it compared to earlier situation where most people prefer to die instead of buying such costly medicines. Also the currency of every country fluctuates. And the company applying for patent has worked in R&D and is very well established as a multi national company operating all over the world like Ranbaxy, Novartis. The cost incurred for producing the drug is the same everywhere and prices actually charged varied from country to country. Their prices for developing country like India and underdeveloped country shall be different compared to what they charge in developed countries. They are earning a lot already from selling it at global market. They don’t need a patent to cover up a R&D cost and if they want to earn the real more profit then they should try to focus on inclusive growth than fragmented growth. They should lower the cost and their sales would include a new customer base which is far more than the earlier creamy layer. As rich people are always fewer than poor. Ex- If a price of medicine is 20,000 and there are 100 people. Out of which 20 are rich are 80 are either middle class or poor. Only 20 people can afford this. They earn 20,000x20= 400000 Rs. Only. And suppose if price reduced to 5000 Rs. Now say 80 can afford it(considering the rest 20 to be extremely poor) now also they can earn 5000x80= 400000 Rs. The same as earlier situation. Then why not benefit the society by reaching out to a large number of population than being contended with mere small proportion of population. The more you reach out to people, the more goodwill it is and popularity too which is extremely necessary in this era to make mark in the long run.







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