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Cancer drug patent woes mount for Novartis

If Novartis wins its patent case, Indian generic companies may be banned from manufacturing cheaper versions of the cancer drug.

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MUMBAI: Members of the European Parliament (MEPs) have written to the president of the Parliament’s health committee seeking civil society action against Novartis following a hearing on the company’s challenge to India’s patent law.

“If Novartis wins its case, a lot of patients in developing countries, in particular those suffering from HIV-AIDS, who mainly rely on affordable drugs from India, would not have access anymore to drugs,” said the letter.

Five MEPs from different political parties have joined the initiative.

Earlier, Medecins Sans Frontieres (MSF), a global NGO group, had urged the European Parliament to look into the matter seriously as it would have an adverse impact on access to medicines of millions of people worldwide. Rights groups like MSF have long contended that the commercial interests of a company should not come before the general interest and the rights of nations to protect and promote public health and access to medicines.

Novartis had filed an appeal challenging the rejection of its patent application for leukemia drug Gleevec (imatinib mesylate) by the Madras patent office on the ground that it was a new form of a known substance. Under section 3(d) of the Indian Patent Act, any new use or new variant of an old substance cannot be patented unless found to have significant improved efficacy.

The MNC had claimed that the new drug could be absorbed more easily by the body. Further, in its challenge, the company argued that section 3(d) did not conform to the WTO agreement on Trade Related Aspects of Intellectual Property Rights (Trips).

Novartis stated that the case was a question of intellectual property and not about access to medicines. But, MSF held that the pharma major had challenged section 3(d) of the Indian Patent Act, which protects against ever-greening and frivolous patents.

If the company’s arguments prevail, Indian generic companies may be banned from manufacturing cheaper versions of the drug, which sell at about one-tenth of the $2,600 Novartis charges for a month’s course.

The hearing took place on January 23 in Brussels. Besides the MEPs, officials of Novartis, MSF, International Mutualities Federation, European Generic medicines association, International AIDS Vaccine Initiative attended the hearing.

India remains a major supplier of affordable medicines to the developing world. About 50% of people living with HIV/AIDS in the developing world, and 85% of MSF’s patients depend on Indian generic medicines.

Meanwhile, the Novartis issue seems to be taking a turn for the worse as the Mumbai-based Cancer Patient Aids Association (CPAA) has sent a defamation notice to the company’s chairman and CEO, Daniel Vasella, and demanded $0.5 million in damages.

In an article titled ‘Novartis persists with challenge to Indian patent law despite adversity,’ Vasella is said to have written that generic companies were often behind patient groups in India and he would not be surprised if they gave money to the groups.
CPAA asked the company to retract its statement and to issue an unconditional apology over the company’s website and on Intellectual Property Watch.

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