The new patent regime: Implications for patients in India

Abstract

Byline: Chittaranjan. Andrade, Nilesh. Shah, Sarvesh. Chandra 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. At present, the scenario in India is as follows *India will respect product patents. However, the patents so respected will only be those issued in India. *Product patents will be respected for a period of 20 years from the time of application and not from the time of grant of the patent. About ten thousand applications for patents were pending with the government in 2005; these date back to 1995 and are designated as mailbox applications. It will take several years to screen all the applications and award patents as appropriate. This will increase the breathing space for Indian pharmaceutical companies and Indian consumers. *New applications for patents will also be processed; again, the grant of patent will be for 20 years from the date of application. This is in accordance with the Patent Cooperation Treaty which India has signed, which will make it possible for a new invention to be simultaneously patented in a large number of countries. *Other agencies interested in the product will be provided an opportunity to oppose the grant of patent. Both pre-grant and post-grant opposition will be entertained. In the December 2004 ordinance, pre-grant opposition had been emasculated to a written application with no further representation allowed on the part of the opposer; in contrast, under the previous patent act, pre-grant opposition was a more powerful procedure with the opposer having a right of audience to the proceedings involved in the grant of patent. …