Londiwe Buthelezi
Swiss drug manufacturer Novartis would experience a twofold blow if other countries following the same line of argument as India or if more markets started importing the Indian generic equivalent of patented drug Glivec, law and health experts said yesterday.
On Monday, Novartis lost a seven-year battle to get a patent in India on its leukemia drug, Glivec. The drug, which is patented in more than 40 countries worldwide, costs R862.50 for each 400mg tablet in South Africa’s private sector.
However, the generic equivalent is sold by Cipla for just R86 in India because there is no patent protection.
When a drug is under patent protection, it enjoys exclusive marketing rights and only the company that developed the drug is allowed to sell it.
The dismissal of Novartis’s appeal to have the enhanced form of Glivec patented not only makes room for India to produce it at a fraction of Novartis’s cost but allows the possibility of India exporting the cheap generic version to other markets.
Médecins Sans Frontières/ Doctors Without Borders (MSF) said the ruling set a strong example for South Africa to follow as the Department of Trade and Industry was drafting amendments to the country’s patent laws.
MSF argued that secondary patents blocked access for South Africans and unnecessarily drove up drug prices and medical aid contributions.
“South Africans are missing out on affordable versions of life-saving medicines because generic competition is blocked by frivolous patents,” said Julia Hill of MSF’s access campaign.
But Ryan Lobban, a health-care research analyst at Frost & Sullivan, said there was a loophole in India’s patent laws that did not exist in the laws of other countries, including South Africa.
“In India, if there is a patent, the court can deviate away from the Trips agreement,” he said referring to the Trade-Related Aspects of Intellectual Property Rights (Trips) agreement.
“But it doesn’t mean that the product can be exported. There may be international laws to mitigate (exporting).”
In South Africa’s case, Lobban said, it would depend on whether Trips allowed the country to import the Indian generic.
Novartis could also question patent protection locally.
“It is interesting that now is the second time a multinational pharmaceutical firm has lost a patent dispute with the Indian government. What is happening in India is emerging as a problem, but it doesn’t entail that the same rulings will apply globally,” said Lobban.
Last year, an Indian court gave an Indian manufacturer the go-ahead to produce a generic version of a cancer drug made by Bayer health-care. The court cited the need to make medicines available to people at affordable costs.
Novartis has been challenging the Indian Patents Act since 2006 to get a patent for Glivec. The company has never been granted an original patent for the drug in India, even for the initial product. The enhanced Glivec was approved for use in the US in 2001.
Rowan Forster, a director specialising in patent law at Edward Nathan Sonnenbergs, said that if the Glivec patent was challenged in South Africa, the local courts would apply existing legal tests and precedents. If it was found that Glivec was not original, then the patent would not be sustained.
Forster said Novartis could consider seeking a non-litigious settlement to its problem if it felt that South African courts were likely to reach a similar decision as India.