US-based Gilead Sciences is scouting for partners to issue multiple 'manufacturing licences' for its AIDS drug, Tenofovir, in India and 97 other countries including those in Africa, the Caribbeans and Latin America.
It is in talks with all the big names in India including Ranbaxy Labs, Dr Reddy's Labs, Cipla, Nicholas Piramal, Emcure and Aurobindo for issuing the non-exclusive licence that will cover all the 98 countries. The Nasdaq-listed $2 billion biopharmaceutical company is looking at a royalty rate of 5 per cent of the revenues as part of the agreement.
Gilead has started collaboration talks with eight-nine Indian companies even as its patent on the drug is facing a challenge in the country from patient groups at the pre-grant stage.
The caveat in the arrangement, however, is the clause that Gilead's partners would not market the AIDS drug beyond the specified 98 countries, especially the developed ones where Gilead itself is marketing the drug.
So the twin-edged strategy entails earning royalty from regions where the innovator doesn't wish to market the drug itself and ward off generic competition where it does.
"We are looking for quality generic manufacturers to offer non-exclusive, voluntary licenses for manufacture of Viread (tenofovir disoproxil fumarate) to India and other least developed countries under our access programme," said Gregg H Alton, senior vice-president & general counsel, Gilead Sciences.
Cipla already produces a generic version of the drug. However, Alton declined to comment whether it has an edge over the other companies.
"The cost of the drug depends on the generic manufacturer. We believe Indian companies have the capability to render it at extremely competitive prices", added Alton.
The patent on the drug ran into opposition from Delhi Network of Positive People, working under the aegis of the Indian Network of People living with HIV/AIDS.
The Alternative Law Forum has filed the pre-grant opposition at the Delhi arm of the Indian Patent Office for the drug on which Gilead enjoys global patent till 2018. Tenofovir is used in the second-line treatment of HIV/AIDS, when patients develop resistance to the first-line of drugs.
Reacting to the opposition, Alton said, "We believe we can protect our interests while catering to the larger one as well. Tenofovir represents significant innovation and is already patented in 50 countries. We believe it to be patentable."
Even though the company has no presence in India either through a subsidiary or a manufacturing base, it is open to all opportunities of acquisition and in-licensing in the country.
"Be it pharmaceutical, biopharmaceutical or biotech, we would look at any IPR centric company with innovative therapies in anti-retroviral segment," explained Alton.
Although the company has a product in India being marketed by Nicholas Piramal and is looking for partners in Tenofovir, it is still wary of setting up shop here.
"There are concerns on the patent law and its implementation. Patents ought not to be seen as a barrier to deny access to patients," he added.
