Patent On AIDS Medicine Denied In India; Seen Unlocking Market

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A decision by the Indian Patent Office to reject a patent on an AIDS drug last week has drawn acclaim from civil society and Indian generic pharmaceutical industries. The decision was not based on a controversial article of Indian law aimed at preventing patent extensions but rather on the grounds of non-inventiveness. Abbott Laboratories, meanwhile, presented Intellectual Property Watch with justification for its Indian patent request.

The HIV combination drug ritonavir/lopinavir was manufactured by Abbott, a United States-based company, which submitted several patent requests in India. The rejected patent was for “a method of preparing solid pharmaceutical dosage form,” according to the decision [pdf], a heat-stable form of rinotavir and lopinavir, according to sources.

The patent application was filed in March 2006 under the Patent Cooperation Treaty managed by the World Intellectual Property Organization. It was opposed in August 2008 by Initiative for Medicines, Access, & Knowledge (I-MAK), a US-based non-governmental organisation working on access to medicines. Three Indian pharmaceutical companies also opposed the patent.

On 30 December, the Indian Patent Office decided not to grant the patent to Abbott, on the grounds that the subject matter did not involve an inventive step and did not constitute an invention.

“This groundbreaking victory for patients sets an important precedent to stop pharmaceutical companies from gaming the patent system, making a new era of hope for millions of people living with HIV all over the world,” I-MAK said in a statement.

About 130,000 lives could be saved from “opening up the market for this drug alone,” the group said, adding that Abbott Laboratories holds at least 75 patents on lopinavir/ritonavir alone in the US.

Article 3(d) of Indian patent law patents disallows modifications of existing compounds, so-called patent “evergreening,” often used by companies to extend patent monopolies. This article has been cited by industry several times as being non-compliant with India’s international trade obligations, and in particular with the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.

The opponents of the patent claimed that Abbott’s drug fell under Article 3(d) of the Indian patent law, which states “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.” However, the decision discarded this claim.

According to Brook Baker of the US-based, non-governmental Health Global Access Project, it seems there is “growing evidence that the India Patent Office is not being uniformly rigorous in applying its strict patentability standards under Section 3(d), and thus is incorrectly allowing occasional patents on new uses, chemical variations, new formulations, and new combinations … it seems more important that there be resources devoted to expert opposition procedures in India.”

A December WIPO economics seminar series presentation by Bhaven Sampat, a professor at the School of International and Public Affairs at Columbia University in New York, came to a similar conclusion (IPW, WIPO, 17 December 2010).

Abbott Defends Inventiveness

According to Dirk Van Eeden, director of public affairs for Abbott, “new formulations of Kaletra [the combination drug] have provided physicians and patients with real improvements in its use, dosing and convenience.”

“The heat stable tablet,” he told Intellectual Property Watch, “solves specific convenience limitations of Abbott’s earlier version, which required refrigeration and had to be taken with food. These challenges have been resolved with the new tablet, and there is significant benefit for patients in developing countries and resource limited settings.”

Abbott is “reviewing this decision and determining its next steps,” Van Eeden said.

I-MAK Director Tahir Amin, meanwhile, said other Abbott patents on the drug are being challenged in India.

Although the Indian Patent Office decision is presented as a landmark, and will unlock the market for Indian generic companies, the ability of those companies to export to developing countries will depend on the patent status of the drug in those countries.

According to intellectual property lawyer Peter Maybarduk of Public Citizen, a US advocacy group, the Indian decision is highly significant.

In cases where there are patents on any components of the drug in a recipient country, one of the solutions could be for that country to issue a compulsory licence. This “would be much simpler” than going through the so-called paragraph 6 decision of the WTO, an exception within TRIPS meant to ease access to generic versions of patented medicines in countries that lack the manufacturing capacity to make the drugs themselves, Maybarduk said.

If there is no patent in the drug exporting country, such as in this case India, a compulsory licence can be issued by the importing country without using the paragraph 6 mechanism, which implies a more burdensome mechanism, he told Intellectual Property Watch.

Separately, according to news source Livemint, the Indian government is considering capping foreign direct investment allowed in the pharmaceutical industry in an effort to prevent its drugmakers from being taken over by foreign interests.

Catherine Saez may be reached at info@ip-watch.ch.

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