Novartis Will Wait Until Indian Court Issues Decision in Patents Act Challenge Before Deciding How To Proceed
Swiss pharmaceutical company Novartis recently said it will wait until an Indian court rules on the company's challenge to a section of the country's Patents Act that aims to restrict certain kinds of patents before deciding how to proceed, Dow Jones reports (Parussini, Dow Jones, 5/14). A two-judge panel of a court in Chennai, India, last month reserved its verdict in a case brought by Novartis against a section of the act. Novartis also brought a civil lawsuit against the Indian government after the country in January 2006 rejected the company's attempt to patent a new version of its leukemia drug Gleevec on the basis that the drug is a new formulation of an existing drug. India's patent law, which went into effect in January 2005, allows patents for products that are new inventions developed after 1995, when India joined the World Trade Organization, or for an updated drug that exhibits improved efficacy.
Indian Health Minister Anbumani Ramadoss last month urged Novartis to withdraw its challenge over concern that it could disrupt the global supply of antiretroviral drugs. Although some Indian drug companies and groups say that Gleevec is a new formulation of a drug developed before 1995, Novartis says that it is an improved drug. If Novartis wins the case, it potentially could set a precedent for other pharmaceutical companies seeking patent protection for drugs, including antiretrovirals, some HIV/AIDS advocates have said (Kaiser Daily HIV/AIDS Report, 4/11).
Thomas Wellauer, head of corporate services and a member of the executive committee at Novartis, said the company will "wait for the decision of the high court ... and then evaluate that decision and make up our mind to decide whether we will continue the court case and take this further." Wellauer added that he expects a decision in June. According to Dow Jones, critics have said that the changes Novartis is seeking in the case would make it more difficult for low-income people living with HIV/AIDS and other diseases to obtain access to low-cost medication (Dow Jones, 5/14).
Gilead Says Indian Generic Drug Makers Will Not Be Required To Pay Royalty Fees for Generic Version of Viread
In related news, Gilead recently said that 10 Indian generic drug makers will not be required to pay a 5% royalty fee on a generic version of the company's antiretroviral Viread if Gilead loses a case challenging India's Patents Act, the Economic Times reports (Prasad/Singh, Economic Times, 5/15). Gilead in August 2006 announced it was in negotiations with 10 Indian generic drug companies to assist them in producing generic versions of its patented antiretroviral drugs. Under Gilead's proposals, generic drug companies would be allowed to sell generic versions of the antiretrovirals -- including Truvada and Viread -- only in developing countries, and the drugs would look different from the patented versions (Kaiser Daily HIV/AIDS Report, 9/26/06).
HIV/AIDS advocacy groups Delhi Network of Post People and Indian Network for People Living With HIV/AIDS in May 2006 filed an opposition application with the New Delhi patent office to oppose Gilead's application to patent Viread (Kaiser Daily HIV/AIDS Report, 5/12/06). A hearing with the patent office had been scheduled for Tuesday but was postponed for technical reasons. Indian drug makers by the end of 2007 are expected to launch generic versions of Viread, the Times reports (Economic Times, 5/15).