The Supreme Court verdict on Novartis India’s appeal seeking patent for its formulation Glivec a week back gave patients of chronic myeloid leukemia something to cheer about.
Glivec would not be patent-protected in India; generic versions, available for a tenth of its cost of Rs. 1.2 lakh for a month’s dose, could flood the shelves. That’s only part of the story.
The other part is that the judgment is a piece of a larger narrative on patents versus pricing of drugs critical to the treatment of lifestyle diseases, now on a rise in the country.
While the judgment interpreted Section 3 (d) of the Indian Patent Act to prevent ever-greening — manufacturers’ way to extend patents on their drugs by introducing incremental changes — the government and the Indian Patent Appellate Board (IPAB)’s recent decisions show an effort to increase patients’ access to quality drugs for lifestyle diseases such as cancer and diabetes.
The government has used Compulsory Licence (CL) route to put a premium on affordability though a drug/formulation is patent-protected. Also, a mechanism is on the cards to regulate prices by the National Pharmaceutical Pricing Authority to determine the lowest price the maximum price of that drug.
“It’s now official, India is siding with cancer patients, especially the poor, over profits for multinationals,” pointed out Zarir Homi Charna, independent pharmaceutical consultant. Activists around the world hailed the verdict as a landmark one. Even the usually acerbic global press pointed out patient benefits that would follow.
The Nexavar saga, unfolded last year, exemplifies the CL method. An innovation to treat liver and kidney cancer developed by Bayer, it was priced at R2.8 lakh for a month’s dose of 120 tablets. The government issued a CL to Hyderabad-based Natco Pharma last March to manufacture the generic version at 97% lower price. Bayer would get six per cent royalty on the production.
The company appealed to the IPAB, which upheld the government decision. In its final order last month, the IPAB concluded that though Bayer had a patent for the drug from 2008, it could not make Nexavar available on a large scale at an affordable price so far. Bayer will appeal in the HC, said a spokesperson.
“It’s clear now that multinationals cannot use patent route to keep prices high or apply same price here in rest of the world. They cannot ignore realities about affordability in India,” said Shashikant Joag, secretary general of Indian Pharmaceuticals Association.
Added Chinu Srinivasan of LOCOST, Vadodara-based NGO that provides unbranded versions of patent-protected drugs: “The difference between the price of a branded drug and its generic counterpart is staggering. Generics are 10 times cheaper.”
The Nexavar-Glivec outcome has meant more applications for CL for other patent-protected drugs. It is also a boost for Indian companies such as Lupin, Cipla, Natco that manufacture generics.
(with Zehra Kazmi)
Low-cost generic drugs come to his rescue
This woman needs funds for treatment