|
India has introduced a new product patents regime, covering drugs, foods and chemicals. This is in compliance with the Trade-Related Intellectual Property Rights (TRIPS) agreement of the World Trade Organisation (WTO). India has an enviable record of fully adhering to its international obligations. More over, strong patent laws are expected to encourage foreign investment in research and development projects and consequently benefit the Indian economy.
Parliament has approved the third Patents (Amendment) Bill 2005 with the Rajya Sabha passing it on March 23, 2005. Earlier, the Lok Sabha passed the Bill after the Government incorporated several amendments.
Replying to the discussion, the Commerce Minister Shri Kamal Nath said the new legislation would not lead to an increase in the prices of essential drugs as most of these were not covered by the patents regime. He assured the House that “all safeguards” had been built into the legislation to protect the interests of the Indian pharmaceutical industry and prevent an inordinate rise in prices.
Amendments
The controversial third Amendment to the Indian Patents Act, 1970 relates to India’s obligations under the global agreement on TRIPS, adopted in 1994 as one of a package of agreements that member states of the World Trade Organization (WTO) must adhere to. Under the agreement, developing countries like India have to introduce patent protection for pharmaceutical and agro-chemical products by January 1, 2005.
The Indian patent law has already been amended twice-in 1999 and 2002 to comply with TRIPS. Thanks to earlier amendments, the term of patent protection has been extended from seven to 20 years, and Exclusive Marketing Rights (EMR) are available for drugs and agro-chemicals, allowing manufacturers a monopoly over products even before their patent applications are approved.
At present, Indian law provides patent protection for processes-not products-in the pharmaceutical and food sectors. Since a process patent gives the owner exclusive right only over the manufacturing process, anyone can make and sell a particular product as long as they use a different process to produce it.
On the other hand, a product patent prevents others from manufacturing, selling, distributing or importing the patented product - even versions produced through different processes - without authorization. The process patent regime that has prevailed so far, and the competition that it has allowed, has kept the prices of medicines in the country amongst the lowest in the world. With the introduction of a product patent regime, patent owners will be able to monopolize the market for 20 years and, in the absence of competition, get away with exorbitant prices.
Safeguards
The Bill has built in some safeguards against “ever greening” whereby unscrupulous drug companies seek to extend the life of existing patents by introducing minor variations. The Bill stipulates that only a “new entity” involving “one or more inventive steps” will fit the criterion of patentable pharmaceutical substances. This language improves on the earlier formulation, but still falls short of a specific definition of “new entities”. On compulsory licensing of life-saving drugs and pre-grant opposition, the bill has incorporated the necessary safeguards. Finally, the unnecessary restrictions have been removed on the export of patented drugs manufactured generically in India under compulsory license to less developed countries-such as the sale to African nations, at much lower prices, of anti-retroviral to combat AIDS.
The government has the power to revoke a patent, which is found to be mischievous to the state or prejudicial to the public. Also, compulsory licences would be issued to a local drug firm to make a patented drug, if it is not available for public at “reasonably affordable price and if the patent is not workable in the territory of India”.
The National Intellectual Property Organisation (NIPO) has welcomed the Government’s decision to implement the new patent regime from January 1, 2005.
“The new regime allows for both pre-and post-grant opposition to proposed new patents and not allowing new-use patents”, said NIPO in a statement.
The NIPO urged the Union Government to immediately set up a committee to monitor the prices of essential medicines that could suggest ways to handle the change so that the average consumer was the least-affected. It also stressed the need to create awareness among the public about intellectual property rights and its role to convert one’s intellectual knowledge into potential wealth and encouraging incremental innovations.
Concerns
However, doctor’s voluntary organizations, health sector activists and even some pharmaceutical companies believe that the new patent regime, enacted by Parliament could take life-saving drugs out of reach of the common man.
Treatment may become unaffordable for AIDS, heart, diabetics patients and those afflicted with mental ailment belonging to the low income and even middle income groups as new drug inventions would get product patent and the patent holders would charge royalty to recover the research and development costs.
Existing drugs for the treatment of a number of ailments may continue to be available at affordable costs. “But all drugs get obsolete with time as pathogens undergo changes and often become drug resistant”, said Delhi Science Forum Vice-President Prabir Purakayastha. “Under such circumstances newer drugs need to be constantly developed”.
Doctors fear that the problem could arise not only in the treatment of life threatening diseases but also with regard to treating common ailments.
In Public health emergencies such as in the case of epidemics and pandemics, the unfettered product patents rights could accentuate the problem of making medicines available and affordable for the masses. Although the new patent regime has provisions for “compulsory licensing”, under which patented medicines can be licensed to be manufactured by companies other than the patent-holder, the procedures are too complicated to provide immediate relief, said a representative of Affordable Medicine and Treatment Campaign.
Upto now, India provided patents for the process of manufacturing medicines but no patents were granted for the product as such. This allowed generic drug makers to produce copycat medicines of patented products and made these available cheaper in the market.
Impact
India had agreed, on January 1, 1995, to suitably amend its intellectual property rights regime to introduce a product patent regime 10 years from that day. Therefore, what remained of interest was not the introduction of product patents per se, but the safeguards provided for. And, on that count, the government seems to have done well. New time limits for processing applications and objections have been introduced. Nearly 8,500 patent applications have already been deposited in the ‘mail box’, mostly by MNC’s. Since only 20-odd molecules have been discovered globally over the past 10 years, the eligible period for claiming a patent, the bulk of these applications seek to take advantage of the new patent regime and make a fast buck. Time-bound pre-grant opposition would stop that. If challenge is possible only post-grant, the result would be bad patents, messy legal challenges and milking of the patent in the interim period.
Likewise, the decision not to allow new-use patents will ensure that patent holders are not able to extend the patent life of their drugs by finding and patenting a different use for their drugs. Even mail-box applications would get patents only with prospective effect, which would obviate a lot of litigation in the industry. Retention of the right to issue compulsory license without a time bar or conditions is also welcome. However, India would need to exercise this provision with caution and an eye on commercial credibility.
For the Indian pharma industry, this amendment is a relief as well. It will be relieved that the law narrows down the definition of patentability. The new law tries to prevent foreign companies from claiming new product patents on existing drugs by making “superfluous” changes (called evergreening). It says a pharma patent will have to be a new entity, involving one or more inventive steps. It also says new use of an existing product will not be patentable.
Those who oppose India honouring its commitment under the GATT (General Agreement on Tariffs and Trade) of which Trade Related Intellectual Property Rights (TRIPS) was a part, often forget that the country has much to gain by being a member of the global community, considering that it is among the fastest growing economies and perhaps the second largest repository of scientific and technical talent in the world. Myopic visions of some interest groups do not help broader macro-economic considerations, affecting various sectors of the Indian economy, whether they are in textiles, other manufactured goods or agriculture. Unlike individual stakeholders in a particular sector, the Government needs to take a balanced view to ensure that overall national interests are protected.
*Freelance Writer
|
