In a landmark case, the Supreme Court of India has rejected Novartis' application to patent an updated version of its cancer drug Glivec (imatinib), ruling that the product fails the tests of invention and patentability requirements of India's patent law.
The long-running Indian case, which began with the initial rejection in January 2006 by the Patent Controller in Chennai of a patent application filed by Novartis in 1998, has been welcomed by patient groups, who point out that while the cost of treatment with Glivec is around per patient $2,600 per month, the generic version is available for about $17 monthly. India’s Cancer Patients Aid Association said the Supreme Court ruling would mean "the difference between life and death" for cancer patients.International aid organisation Medecins Sans Frontiers (MSF) added that the decision will be a huge relief for the millions of patients and doctors in developing countries who depend on affordable medicines from India, and for treatment providers such as MSF.
"The Supreme Court's 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," said MSF International president Dr Unni Karunakara.
Pratibha Singh, a lawyer for Indian drug maker Cipla, which makes a generic version of Glivec, also welcomed the Court's setting of a precedent that would prevent international drugmakers from obtaining fresh patents in India on updated versions of existing drugs. "Patents will be given only for genuine inventions, and repetitive patents will not be given for minor tweaks to an existing drug," she said.
"Patent offices in India should consider this a clear signal that the law should be strictly applied, and frivolous patent applications should be rejected," added Leena Menghaney, India manager for MSF's Access Campaign.However, Novartis India chairman Ranjit Shahani described the ruling as "a setback for patients that will hinder medical progress for diseases without effective treatment options."
"We strongly believe that original innovation should be recognised in patents to encourage investment in medical innovation, especially for unmet needs," he said. Novartis will continue to file for patents in India and to invest in the country, but with caution, Mr Shahani added, and also pointed out that Novartis has never been granted an original patent for Glivec in India, despite having had patents granted in nearly 40 countries.
The Supreme Court gave its decision in a highly-detailed, 112-page document which notes that the questions involved were debated "intensely and at great length" and "within a very broad framework.""The Court was urged to strike a balance between the need to promote R&D in science and technology and to keep private monopoly (called an 'aberration' under our Constitutional scheme) at the minimum," the judges write.
"Arguments were made about India's obligation to faithfully comply with its commitments under international treaties and counter arguments were made to protect India's status as 'the pharmacy of the world.' The Court was reminded of its duty to uphold the rights granted by the statute, and the Court was also reminded that an error of judgement by it will put life-saving drugs beyond the reach of the multitude of ailing humanity, not only in this country but in many developing and under-developed countries, dependent on generic drugs from India," they add.
Novartis says that it will continue to provide Glivec free of change to 95% of patients prescribed the drug in India, currently numbering more than 16,000. "The remaining 5% of patients are either reimbursed, insured or participate in a very generous co-pay programme," says the firm, adding: "since Novartis began its first donation programme in 2002, the company has provided more than $1.7 billion worth of Glivec to patients in India."
- The Chennai patent office's initially rejected Novartis' patent application for Glivec in January 2006 on a number of grounds, including that it failed the requirements of Section 3(d) of India's 2005 Patents Act which states that new forms and new uses of known substances cannot be patented unless they demonstrate a significant increase in efficacy.
In May 2006, the Swiss firm filed two legal challenges in the Madras High Court, one seeking to appeal the rejection of the patent and the other to have Section 3(d) declared contrary to the World Trade Organisation (WTO)'s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and the Indian Constitution.In August 2007, the Madras High Court rejected Novartis' challenge to Section 3(d) and also ruled that the clause would require the firm to show an increase in therapeutic efficacy for the drug.
In June 2009, India's Intellectual Property Appellate Board rejected Novartis' appeal, and in August the firm brought its case to the Supreme Court of India, seeking to challenge the interpretation and application of Section 3(d) by the country's courts and patent offices.