India's Supreme Court dealt Big Pharma giant Novartis a blow on Monday with a landmark ruling that campaigners say marks a victory for "people over profit," and will make potentially life-saving drugs far more accessible worldwide.
The court ruled against the Swiss pharmaceutical corporation in its years-long challenge to patent a newer version of its cancer drug Glivec, saying the new version wasn't a new medicine, thus allowing generic versions of the drug to be manufactured.
Critics have referred to corporations' practice of getting a 20-year patent on a drug and then making minor changes to it and re-patenting it as "evergreening," and derided it for preventing the manufacture of cheaper, generic versions of the drug.
Providing some background is the Guardian's health editor, Sarah Boseley, who writes that multinational drug companies
with support from the US and European governments which want a profitable drug industry, have worked to tighten patent protection for new drugs through national laws and trade agreements. India has been the main focus in its historical role as the pharmacy of the developing world.
Under the World Trade Organisation's trade-related intellectual property rights (Trips) rules, India agreed to bring in patents for drugs in 2005. Drugs without patent protection before that date can still be copied and sold cheaply to developing countries by generics companies.
Novartis began seeking patent protection for its cancer drug Glivec as soon as the law came into force, but as the drug was already on the market the Swiss firm could not make a standard application. Instead, it sought a patent for a slightly altered version that it said was easier for patients to absorb. Novartis argued that this was innovation under Indian law and deserving of a patent.
But India included in its laws a safeguard clause known as Section 3(d) to prevent abuse of patents, humanitarian organization Doctors Without Borders (MSF) explained, and hailed Monday's ruling as "a major victory for patients' access to affordable medicines in developing countries."
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“Novartis's attacks on 3(d), one the elements of India's patent law that protect public health, have failed,” Leena Menghaney, India Manager for MSF’s Access Campaign, said in a statement. “Patent offices in India should consider this a clear signal that the law should be strictly applied, and frivolous patent applications should be rejected.”
Dr. Unni Karunakara, MSF’s international president, added that the decision "now makes patents on the medicines that we desperately need less likely. This marks the strongest possible signal to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian patent law.”
But the effects of the ruling spread beyond India, Boseley noted:
At stake in the legal battle was not just the right of generic companies to make cheap drugs for India once original patents expire but also access to newer drugs for poorer countries in much of Africa and Asia. India has long been known as the pharmacy of the developing world.
The Cancer Patients Aid Association in India (CPAA) also celebrating the ruling, stating, "We are very happy that the court has recognised the right of patients to access affordable medicines over profits for big pharmaceutical companies through patents. Our access to affordable treatment will not be possible if the medicines are patented. It is a huge victory for human rights," the Guardian reports.
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The MSF Access Campaign has video of Menghaney responding to the verdict outside the Supreme Court on Monday: