Novartis drops AIDS drug plea

Move prompted by fears of Glivec-type rejection.

Swiss pharma major Novartis has chosen not to pursue the patent application for its AIDS drug Atazanavir in India after the patent was declared "abandoned" even as it continues to fight for the licence rights of its cancer drug Glivec in the Indian patent office.

The patent department made this declaration on August 16 after Novartis had failed to respond to its queries within the prescribed time. The patent office declares an application abandoned if the company shows no interest in pursuing it even after intimations from the office over a specific period of time.

Pharmaceutical firms normally opt to drop patent claims in this manner if they fear a negative verdict from the patent office.

Since patent offices in several countries seek the patent status of the same drug in other countries before giving a verdict on an application, a rejection is not always in the applicant company's global interests, experts said.

"The patent rejection of Novartis's Glivec (against which an appeal is pending with the appellate authority) in India could influence the patent examination in another country," an expert told Business Standard.

Atazanavir is an important second-line AIDS drug, used by patients who develop resistance to first-line medicines over a period of time.

Though a majority of Indian HIV patients (estimated to be over 5 million) are yet to receive the first-line treatment there are reports of deaths owing to the lack of affordable second-line AIDS medicines.

NGOs active in AIDS treatment pointed out that any patent grant to Atazanavir would have prevented the generic companies from introducing low-cost variants of this medicine till 2017. The implication of a patent on this drug would not be limited to India since several developing countries are dependent on Indian generic medicines, they say.

Global NGOs like the Clinton Foundation have committed $2 million to $3 million for the first two years of second-line AIDS treatment in India. The availability of a generic version of Atazanavir was expected to bring down the costs of these drugs significantly.

Novartis officials in Mumbai said the patent application was not filed by the Indian subsidiary of the pharmaceutical major. "Several patent applications have been filed by the company's international arms and an immediate response on the issue would not be possible," they said.

However, the Indian patent law provides an option for an appeal to reconsider the application.

"Though there is a provision for appeal the companies do not normally utilise that option," said Gopakumar Nair, a Mumbai-based patent expert.

He said when a company went for international patents, it would try to avoid a negative response from smaller markets to protect its patents in bigger 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.