Decision illustrates need to safeguard ?pharmacy of the developing world?
January 7, 2011, New Delhi—The Indian Patent Office has just rejected patent applications related to two AIDS medicines – lopinavir/ritonavir and atazanavir - on the basis that they did not merit patents under India’s patents law. The decisions mark a major victory for public health, and keep the door open for the production of more affordable generics that health providers such as Doctors Without Borders/Médecins Sans Frontières (MSF) rely on to treat patients across the developing world.
“This news comes as great relief for AIDS treatment programs and the growing numbers of people who have become resistant to their first combination of AIDS medicines and need ‘second-line’ therapy,” said Dr. Tido von Schoen-Angerer, Executive Director of MSF’s Campaign for Access to Essential Medicines.
Atazanavir (ATV) and lopinavir/ritonavir (LPV/r) are recommended by the World Health Organization for second-line AIDS therapy. LPV/r is also sometimes used as first-line therapy for infants born with HIV.
The patent for atazanavir bisulphate, filed by Bristol-Myers Squibb, was rejected because it ‘lacked inventive ingenuity’ and the patent for lopinavir/ritonavir tablet, filed by Abbott Laboratories, was rejected because it did not involve an ‘inventive step.’ However the companies have filed other patent applications in relation to these two drugs which are still pending.
“These decisions show how India’s patent law, which prevents routine improvements from being patented, works in favor of public health by only granting patents for drugs that are truly innovative,” said Leena Menghaney of MSF’s Campaign for Access to Essential Medicines.
In the absence of Indian patents, generic manufactures can continue supplying affordable versions of the medicines to treatment providers such as MSF, the Indian government and others across the developing world.
“Before 2006, there was no generic production of lopinavir/ritonavir, and Abbott was able to charge exorbitant prices – close to US$6,000 per person per year in some developing countries,” said Menghaney. “Once producers in India began to make generic versions of the drug, we watched prices fall substantially. Today, lopinavir/ritonavir is available for $440 per patient per year. This ruling by Indian patent office allows generic production to continue and is an encouragement to other producers to come in and lower the price further.”
These decisions also illustrate the need to safeguard India’s role as ‘pharmacy of the developing world.’ India’s Patents Act contains a number of provisions that allow generic manufacturers to produce affordable medicines, including rigorous standards to ensure that only new medicines are granted a monopoly. But as a part of ongoing free trade agreement negotiations, the European Union is now pushing for India to accept ‘data exclusivity’ provisions that would effectively block the production of more affordable generics – even when a drug does not merit a patent under Indian law.
“Affordable medicines produced in India have played a major role in helping expand AIDS treatment to more than five million people across the developing world,” said Dr. von Schoen-Angerer. “It is vital that India stands firm and rejects Europe’s attempts to bring in monopoly protection for medicines through the backdoor.”