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Pharmaceutical companies spend billions of dollars on research. It is estimated that, of every thousand potential drugs screened, only 4-5 reach clinical trials and only one is actually approved for marketing. Pharmaceutical companies patent the drugs that they develop and thereby obtain exclusive marketing rights; the costs of research and the profits due to the shareholders are recovered through appropriate pricing mechanisms from the patients who receive the patented drugs.
Internationally, drug patents and the exclusive marketing rights associated therewith are awarded for a period of 20 years; during this time, no other drug company is allowed to manufacture or market the same drug. After the patent expires, other companies are permitted to manufacture and market the drug; their brands are known as generic versions.
In the early 1970s, the Indian Patents Act was passed under the Indira Gandhi government to permit greater access of medicines at lower rates to the poor in the country. According to the Act, process patents but not product patents would be recognized. Expressed otherwise, India would award patents not to individual drugs but to the process whereby the drug was manufactured. This allowed Indian drug companies to manufacture the same drug using other processes (this is otherwise known as reverse engineering). As the Indian companies incurred little expenditure on research and development of new drugs, it became possible to make new drugs available to the country at affordable rates.
As India sought to improve its presence in the global market, it became clear that it could no longer protect domestic consumers in its patent policy. India is a member of the World Trade Organization. India therefore requires a new patent law to fulfil its obligations under the trade-related aspects of intellectual property rights (TRIPS). India became a member of the Paris convention and signed the Patent cooperation treaty with effect from December 7, 1998. Since then, amendments to the Patent Act were enacted in April 1999 and May 2002. The third amendment became due. The necessary bill to make the Indian Patents Act TRIPS-compliant was supposed to have been tabled during the 2004 winter session of Parliament; instead, an ordinance was passed on December 26, 2004, which came into effect on January 1, 2005. This ordinance modified the Indian Patents Act. This ordinance was itself modified and the Patents (Amendment) Bill was passed by the Lok Sabha and Rajya Sabha on March 22 and March 23, 2005, respectively. The President signed the bill on April 5, 2005, making it an Act of Parliament.
A small consolation is that the bulk of the neuropsychiatric pharmacopoeia is out of patent and will remain available in the generic form.
At present, there is a strong lobby trying to persuade the government to allow evergreening; that is, the patenting of molecules which differ slightly from the parent molecule. The argument is that molecules are patented very early during the process of drug discovery, but unique clinical characteristics or benefits are not discovered until much later, when clinical trials are conducted, if at all. Therefore, it is unreasonable to ask that unique characteristics of a slightly altered molecule be described at the time of the application for the patent, itself. Evergreening is not necessarily a disadvantage to India. For example, if evergreening is permitted, Indian companies may be able to develop and patent incremental advances on patented drugs.
A government-appointment committee on patent laws, headed by R. A. Mashelkar, a former chief of the Council for Scientific and Industrial Research, favored the grant of patents to all incremental innovations made to a drug, but not to frivolous evergreening. The report was widely interpreted to permit most forms of evergreening. The report also favored the grant of patents on microorganisms to make the Indian Patents Act TRIPS-complicant. The report was withdrawn in mid-February, 2007, after it was discovered that a part of the report was lifted, without acknowledgement and verbatim, from a paper published by a UK-based organization which had been funded by the pharmaceutical industry. In March, 2007, the Government requested the Mashelkar committee to revise and resubmit its discredited report.
On a related note, the patents act does not define how unique the new molecule must be; therefore, an element of subjectivity enters the decision-making process for the grant of a patent. In this context, the pharmaceutical industry is concerned that the officials involved in the grant of patents may not be sufficiently qualified to understand the nuances in molecular behavior that justify novelty and hence the grant of a patent.
On January 26, 2007, the Union Ministry of Chemicals and Fertilisers announced that it was considering the formation of a committee which would suggest a system of price negotiation for patented drugs so that such drugs could be made available at an affordable price within the ambit of the National Pharma Policy. Without negotiated pricing, these drugs would not be given marketing rights in India. The committee would be headed by a Director (Chemicals) and would have representatives from all concerned ministries, including the ministries of health and commerce. The recommendations of the committee, if approved, would need to be made a legal requirement through an amendment of the Drugs and Cosmetics Act. A 7-member committee has now been set up.
The USA allows gene patents; therefore, individuals or private organizations can own the intellectual rights on genes that determine health and disease. This will allow such individuals or organizations to permit or deny others the permission to research or even test for these genes or diseases. This adversely impacts upon medical progress and even individual healthcare. At present, over 20 human pathogens are privately owned, including Hemophilus influenzae and the Hepatitis C virus. The scandalous implications were well-discussed by Crichton.
Several ministries and departments are involved in the areas discussed in this report. The most important is The Controller of Patents, Government of India. This is the authority which will screen applications for patents, award patents and award compulsory licenses.
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Conflict of Interest: None declared.