Issue Date: January 29, 2007
India Mulls Stricter Patents
A FIVE-PERSON PANEL of some of India's top scientists and legal experts has recommended that the country adopt tighter rules to protect pharmaceutical patents. Detractors say stricter patent protection will weaken the country's generics industry and lead to higher drug prices for poor Indians.
The committee was formed in the spring of 2005, when India started implementing a new law granting patent protection for pharmaceutical molecules registered in India after 1995. That law has been unclear on whether natural organisms can be patented and on whether there can be patent extensions for pharmaceuticals already on the market.
In its report, released earlier this month, the committee came out in favor of both patent extensions and the patentability of natural organisms. Essentially, it found that India would not be complying with its World Trade Organization obligations without these additions to the new law.
In most WTO member countries, patent extensions are granted for discovering a new use of a known drug or for devising a new way to deliver a drug to a patient. But the law India implemented protects only "new chemical entities."
The idea of further strengthening India's patent laws is controversial. The Indian Drug Manufacturers Association claims that India's drug industry owes its vigor to patent regulations, in force between 1970 and 2005, that allowed copycat versions of internationally patented drugs as long as the manufacturing processes were novel. Stricter patent laws will weaken the industry, IDMA says. The trade group, which represents many of India's generic pharmaceutical companies, adds that a stringent patent regime will also reduce the affordability of drugs for poor Indians.
Yusuf K. Hamied, managing director of Cipla, one of India's largest producers of generic drugs, concurs. He says the 2005 regulations were a mistake: "India's patent laws should serve the Indian people first, not the international community." Hamied finds it particularly improper that the new law has been providing retroactive patent protection for pharmaceuticals registered since 1995.
He says it's a pipe dream to expect that stronger patent laws will pave the way for Indian companies to develop drugs with huge worldwide sales. There is more to launching blockbusters than strong patent laws, Hamied says. He notes that Japanese drugmakers have never launched a drug successfully worldwide, despite their expensive R&D programs and the high degree of patent protection in that country.
Taking a contrary view, Swati A. Piramal, a senior executive at Nicholas Piramal India with overall responsibility for R&D, strategic alliances, and corporate communications, contends that better patent laws will yield new drugs and provide lower drug prices. As things stand, almost all drugs sold in India were invented abroad. She believes that being dependent on foreign discoveries is not the way to ensure a reliable supply of affordable drugs for Indians. Moreover, she says, India can contribute in its own manner to the invention of cheaper drugs.
FOR EXAMPLE, Nicholas Piramal is developing a cancer drug that will provide the same therapeutic effect as the Novartis drug Gleevec but at a tenth of the cost, she says. The drug, based on a plant found in the Indian subcontinent, is undergoing Phase II clinical trials. Strengthened patent protection does not cause drug prices to rise, Piramal believes. "The opposite is true in the long run." Nicholas Piramal operates a modern drug discovery lab in Mumbai that employs several hundred scientists.
Mukund S. Chorghade, president and chief scientific and technology officer of the New Jersey-based firm Thinq Pharma and a native of Pune, India, agrees that beefed-up patent regulations will further spur innovation in India. He says price controls similar to those in effect in many other countries can be used to protect India's poor.
"It is time to let India's research come to the fore and let it really become a player in the global pharmaceutical industry," he says. Stricter patent protection has encouraged the world's pharmaceutical giants to collaborate on research with companies in India, he adds. Thinq Pharma itself is a contract research and manufacturing company that has the bulk of its operations in India.
The Indian patent committee was chaired by R. A. Mashelkar, the director general of the Council of Scientific & Industrial Research. Its other members were Goverdhan Mehta, director of the Indian Institute of Science; Asis Datta, director of the National Centre for Plant Genome Research; N. R. Madhava Menon, director of the National Judicial Academy; and Moolchand Sharma, director of the National Law Institute University. Its report was prepared for the Indian Ministry of Commerce & Industry.
The committee cautioned against indiscriminate patenting and urged that patent extensions be granted in accordance with detailed guidelines that India has yet to produce. Without such guidelines, the group said, the country risks granting frivolous patents that lead to artificially high drug prices. Similarly, it said, patents for microorganisms should be granted only if their existence was the result of human intervention and if the organisms are proven to be useful.
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