The Swiss pharma giant fighting in Supreme Court for patent on anti-cancer drug
A case being heard in the Supreme Court on Tuesday could signal a death sentence for Loon Gangte.
Mr. Gangte is not accused of any crime. But he — and thousands of other HIV positive people — will be avidly following the Supreme court's hearing of the Novartis vs Union of India, Cancer Patients Aid Association & others, because if the Swiss pharmaceutical giant wins its case, the drugs that keep Mr. Gangte alive could become too expensive for him.
“For us, it's about life and death,” Mr. Gangte said on the eve of the hearing. “We can't let them win.”
In the latest battle of a six-year long war, Novartis has taken the Indian government to court, challenging the legal interpretation of a critical public health safeguard in the nation's patent law — Section 3(d) — that limits the patenting of new forms of old medicines. If Novartis wins, much of the Indian generic drug industry — which acts as the pharmacy for the entire developing world — could be in trouble.
The Swiss company is fighting for a patent on a new crystalline salt form of the anti-cancer drug imatinib mesylate, which it sells under the brand name ‘Gleevec'. Since the original molecule is out of patent in India, generic drug companies produce and sell Gleevec to chronic myeloid leukemia patients for about Rs.8,000 per month, while Novartis sells the drug for about Rs.1.2 lakh per month. A patent on the new form could give Novartis a 20-year monopoly on the drug, thus “ever-greening” the patent.
In 2006, the Indian patent office ruled that the new salt form did not deserve a new patent, since it did not meet the provision of “increased efficacy” required under Sec. 3(d). Novartis argued that the salt form would have higher levels of availability in the body of the patient, but the Madras High Court clarified that “efficacy” means “therapeutic efficacy in healing a disease”. Having lost its case in the lower court, Novartis is now asking the Supreme Court to interpret “efficacy” in a way that will allow its patent.
So why does a case about an anti-cancer drug matter to an HIV positive person like Mr. Gangte?
“This is the first such case to reach the Supreme Court, and it's being viewed as a test case by the industry,” says Amit Sen Gupta of the People's Health Movement. “It would open a Pandora's Box.”
Patent applications for a number of other drugs, including treatments for HIV/AIDS and tuberculosis, have been withdrawn or denied on the basis of Sec 3(d). If the provision is diluted, the cost for these treatments could shoot up by up to 40 times, making them unaffordable for the majority of patients.
“I was diagnosed in 1997, but I could not afford treatment at all until the Indian generic drugs started becoming available four years later,” says Mr. Gangte, who is secretary of the Delhi Network of Positive People. “The government started its own free HIV treatment programme in 2004, once cheaper generics were freely available.
It is not just Indian patients who are worried. “About 80 per cent of anti-AIDS drugs and 92 per cent of drugs to treat children with AIDS across the developing world comes from the Indian generic manufacturers,” says Leena Menghaney of Medecins Sans Frontieres (translated from French as Doctors Without Borders). “India is literally the lifeline of patients in the developing world, especially in the poorest parts of Africa…If Sec. 3(d) is overturned, it means any meaningful effort to make these vital medicines available will be put in jeopardy.”
“When I look through my photo albums from the early years, I can see that almost all those friends are now dead,” says Mr. Gangte. “I hope the Supreme Court does not condemn us all.”
This is a classic case how pharmaceutical companies make money by threatening death upon the poor millions. What for the innovations in medical research if it helps only a few companies to get rich while apparently killing many patients? Nothing except to throw novartis out of the medicinal arena and allow the poor to live and survive.
I am a sufferer from Novartis being the sole distributor of certain
drugs for my wife's ailment for which I had to shell out a huge sum,with
difficulty. But there are tens of thousands of people who cannot afford
costly medicines and eventually come to avoidable early grief.Some
solutions to help the poor has to be found out and it is our earthly
moral duty.
In their attempts to "evergreen" patents, Pharma companies adopt numerous and at times dubious means to extend the patentability of their original drug formulations. However, as the question before the Supreme Court in the instant case involves efficacy of the cancer drug, and not its novelty or utility per se, the following three questions might be relevant: 1) does the new formulation of the drug allow a quicker assimilation of the drug into the human body? 2) as a result, do the drug molecules attack the cancer cells more aggressively leading to a higher "kill" rate? 3) does the new formulation also simultaneously improve the well-being of the patient? The Supreme Court needs to demand from Novartis comparative test results involving a significant patient population to uphold the claim but should otherwise annul the relevant patented claim(s).
efficacy pharmacological definition is maximal effect a drug can produce. While more levels in the body means greater bio-availability, what it means is a drug is absorbed lot better so you would need less amount of the drug than before there would not be any difference in the efficacy of drug with greater bioavailabilty. For starters it is like getting protein from chicken vs protein from vegetarian diet - you just need to eat lot more veggies to get same amount of protein from chicken that doesn't mean the protein from chicken is any different from veggies, it is just difference in rate of absorption.
We should win this case, novartis is wrong also they just made an anti-body against something which basic sciences research found out spending public money they just did the easy part. If we didn't win then government should amend the law saying lifesaving medications cannot be patented esp if they are too expensive or company should provide cheaper version for poor.
This appears to be a skewed & biased view on the whole story. The article somehow looks more like anti-patents in general. Patents are not given for higher prices, they are given to ensure that the inventors have rights over their invention & benefit from them. In India there are concepts like compulsory licensing, Drug Price Control, using patented inventions by govt. for public interest etc. which should ensure that people shouldn't die because of non-availability of a patented drug. Kindly understand that patents are aimed at supporting innovation, because of which the drug probably got invented in the first place. If there are no patents and everybody becomes generic, how are we to have new drugs for better treatment. The whole story sounds as if patent filers & professionals are all villains and want to enjoy profits at the cost of human life. As a patent consultant I very much want each & every patient to get best possible treatment too.
It will boil down to the usual issues of "does prior art exist", plus crucial tests of utility and inventiveness. If Novartis have invented something that really is different and better than prior art, then they will be able to patent it. If it's just a minor change, then the courts should throw it out. It's a fact that many new drugs are developed in the West and developers will try to recoup their investment. The courts have to decide whether the formulation of the drug is significantly different from prior art. It is pertinent to recall the Neem case, where prior art was cited against a Neem oil formulation. India is signatory to the TRIPS agreement and is required to allow patents on products as well as processes, but material to be patented must still meet tests of novelty and utility. Previously only process patents were allowed and this allowed the generics busines to boom in India. One should note that Indian pharma companies are now very keen to patent their own new drugs.
We all hope for that our apex court will take into account the views of suffering people and voluntary organisations in India, before it concludes its session on the issue.
It's time that the Indian patent law is reviewed thoroughly, keeping in mind the fantastic contributions made by Indian pharma industries by manufacturing generic drugs to developing countries. While pharma industries (and pharmacies dispensing these drugs) are often guilty of excessive profiteering (in South Africa this was a big problem and were eventually taken to task by the government), Indian pharmaceutical industries have done a tremendous job of supplying affordable drugs to the world, creating jobs at the same time.It's also time that we have a regulatory body (like the FDA/CE) to oversee and certify medical devices manufactured and sold in the country. At present it's highly unregulated and hence the market is open to many untested devices.
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