Novartis Will Not Pursue Patent Application for Antiretroviral Atazanavir in India
Swiss pharmaceutical company Novartis will not pursue a patent application for its antiretroviral drug atazanavir in India after the patent was declared "abandoned" by the country's patent office, India's Business Standard reports (Mathew, Business Standard, 8/25). Atazanavir, sold under the brand name Reyataz, is used in second-line HIV/AIDS drug treatments. Under World Health Organization guidelines, atazanavir is best taken with a booster drug, usually Abbott Laboratories' ritonavir (Kaiser Daily HIV/AIDS Report, 10/24/06).
According to the Standard, the patent office made the declaration on Aug. 16, after Novartis failed to respond to its inquiries within the allotted time. The patent office declares an application abandoned if a company shows no interest in pursuing it after warnings from the office are issued, the Standard reports. Novartis officials in Mumbai said the patent application for atazanavir was not filed by the company's Indian subsidiary, adding, "Several patent applications have been filed by the company's international arms, and an immediate response on the issue would not be possible."
Some nongovernmental organizations involved in HIV/AIDS treatment access said that any patent granted to atazanavir would have prevented generic drug makers from introducing lower-cost versions of the drug until 2017. Patents granted in India also could have implications worldwide because several developing countries depend on generic drugs manufactured in India, according to the Standard.
Indian patent law includes a provision that gives Novartis the option of appealing the office's decision, the Standard reports. According to Gopakumar Nair, a Mumbai-based patent expert, most companies do not use the provision. Nair added that when companies apply for international patents, they often try to avoid a negative response from smaller markets to protect their patents in larger markets. "There are several instances of multinational companies having decided to forego the patent rights of their medicines in India when they were doubtful about the outcome of the patent examination," Nair said (Business Standard, 8/25).
The patent office's decision follows the rejection by an Indian court of Novartis' challenge to a section of the country's Patents Act that aims to restrict certain kinds of patents. 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. 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. The court in its ruling said that it does not have jurisdiction over whether Indian patent laws complied with the WTO's intellectual property laws (Kaiser Daily HIV/AIDS Report, 8/6).