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AIDS Drugs - Have Patent Rights Triumphed Over Patients’ Rights?

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However, India’s new patent law, passed by the Lok Sabha in March 2005, recognized product patents and provided monopoly patent protection to innovations for up to 20 years.

Under the new law, domestic manufacturers would not be able to make generic versions of patented drugs discovered before 1995. Moreover, in order to obtain a patent, the new formulation had to be superior to the old drug and not merely the result of a minor chemical or manufacturing process variation. However, those drugs discovered after 1995 and before January 1, 2005 could be patented if the applicant had already applied for the patent to the Indian government before the new law came into effect.

Humanitarian organizations like Medecins Sans Frontieres (MSF) were looking to source TDF from India for its treatment programs across the world. MSF supported the pre-grant opposition as it felt that granting the patent to Gilead could jeopardize patients’ access to the drug in India as well as other developing countries.

Gilead defended its patent application but assured protesters that it would use the patent responsibly, and would not block access to medication in India or to other resource-limited countries.

The company also announced that it was pursuing a broad policy of nonexclusive voluntary licensing under this patent to Indian companies for the Indian market as well as for export to 97 developing countries included in its access program.

As the number of people infected with HIV/ AIDS rises worldwide, the debate regarding AIDS drug pricing had clearly not died down. Research-based pharmaceutical companies were concerned about the diminishing rate of return from their products and pushed for patent protection, while patients’ rights groups claimed that patent protection resulted in high drug prices, which could not be afforded by the vast majority of those infected with HIV/AIDS in resource limited countries.


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