Indian judiciary needs to keep a tight check on big pharmas
Legal battles make headlines when they end in a landmark judgment. Some judgments prove to be milestones due to their long-term impact on people and their lives.
Five years ago on April 1, the Supreme Court had delivered such a judgment in a patent case involving a costly cancer drug. The court had rejected the patent application of Swiss pharmaceutical company, Novartis, for an upgraded version of cancer drug Glivec.
This allowed Indian companies to make cheaper versions of the same drug. Novartis was trying to extend its patent coverage by claiming some features which the court ruled were not novel or innovative. Big companies adopt the tactics known as "evergreening" of patents to continue selling their patented products much after the original patent expires.
Five years down the lane, several thousand cancer patients are able to live longer without their families being driven to poverty, thanks to the Supreme Court ruling.
Yogendra Kumar Sapru, founder of the Mumbai-based Cancer Patients Aid Association, who waged the patent battle, says the Glivec case continues to guide patent offices and courts in India while dealing with "evergreening" patent applications from multinational drug companies.
The latest such instance was earlier this month when the patent office in Kolkata refused to grant a patent to Japanese company Otsuka for its anti-psychotic drug, aripiprazole. Sapru became a champion of patient rights after he saw the plight of a child suffering from cancer in a Mumbai hospital while working with Johnson & Johnson India, from where he retired as its executive director in 1999.
The patent ruling has proved to be a boon to patients of chronic myeloid leukemia (CML), a cancer that affects blood and bone marrow. Until the 1980s, it was considered incurable. The only treatment was bone marrow transplant, which is expensive.
Today, 90 per cent of CML patients can achieve complete cytogenetic remission after five years of continuous treatment with imatinib (the molecule on which Glivec is based), provided they can afford the treatment and are monitored optimally.
“In 2001, imatinib was priced at $26,000 (Rs 16,82,000) for a one-year course and Novartis used to call the price "high but fair". The price increased gradually every year and rose to $1,32,000 (Rs 85,39,000) in 2014 and is $1,46,000 (Rs 94,45,000) today. Global sales of patented imatinib were about $4.7 billion (Rs 30,406 crore) in 2015. On the other hand, 10 manufacturers of the Indian generic equivalent sell the same drug between Rs 1,000 and Rs 12,000 for a monthly dose,” said Sapru.
As regards efficacy, he says, hospital-based studies have found generic versions to be equally or more effective than Glivec. CPAA is providing treatment to over 1,000 patients of CML for free.
The apex court recognised the right of patients to access affordable medicines over profits of big pharma companies through evergreening of patents. It’s time the government does the same by identifying such drugs and giving compulsory licence to Indian companies.
There are several such drugs which can save lives but are artificially kept unaffordable on flimsy patent protection. The Indian law protects genuine innovation, even incremental innovation, but extending patent life solely for profits should not be allowed.
(Courtesy of Mail Today)
Read this story in Bangla