India denies patent for new cancer drug
On 1st April, the Supreme Court of India denied one of the world’s leading pharmaceutical companies Novartis’ plea to patent a new version of its anti-cancer drug, Glivec.
A patent allows the drug to be sold only by the company which produced it, unlike generic drugs which can be manufactured and sold in countries where the medicine is not patent protected.
Sold at a premium under its chemical name Imatinib Mesylate, a month’s dose of Glivec in India costs around Rs1.2 lakh (equivalent to £1,450), while generic drugs manufactured by Indian companies are priced around Rs8,000 (£97).
According to industry reports, one million cancer cases, 50 per cent of which are curable if detected early, are reported each year in the country, and are prescribed anti-cancer drugs including Glivec to treat chronic myeloid, leukaemia and other sorts of cancers.
The verdict has certainly brought smiles and a sigh of relief to many cancer patients, especially from lower income groups who now have an option to buy the cheaper, life-saving products.
However, the judgement comes as a blow to Western pharmaceutical firms who had been in line to grab the opportunity to stake patent claim on their drugs in future, had Novartis been successful.
The Supreme Court of India rejected the plea of Novartis on two counts, of “invention” and “patentability” under the amended Patents Act 1970.
The bench of justices, Aftab Alam and Ranjana Prakash Desai, dismissed the claim of Novartis for getting exclusive rights for manufacturing the drug. They said: “Patents will now be granted only for genuine invention and not on repetitive inventions,” and, “Glivec did not satisfy the test of novelty or inventiveness”.
Explaining the judgement, the bench added: “We certainly do not wish the law of patent in this country to develop on lines, where the scope of patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skilful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products, but to search for someone who may be sued for infringement of the patent.”
Basel-based Novartis had initially applied for a patent for Glivec in 2006, when the Indian patent office in Chennai rejected its application for a variant of the drug that the company patented in the US and other developed countries in 1993 under the Indian Patent law’s Section 3(d) and 3(b).
Section 3(d) “restricts patents for already known drugs unless the new claims are superior in terms of efficacy” and Section 3(b) “bars patents for products that are against public interest and do not demonstrate enhanced efficacy over existing products”.
Novartis challenged the ruling in Chennai’s High Court, stating that the judgement violated World Trade Organisation (WTO) rules on intellectual property set in 2005 that India had adopted, but its request was rejected by Chennai’s court in 2007.
The Swiss firm, however, did not give up and appealed to the Supreme Court of India in 2009, arguing that Glivec was a “new product” under section 3(2) of the Act, attributed to beta crystalline form of Imatinib Mesylate.
For this reason, the drug in question, they claimed, had much better properties: it was easier to absorb, had better thermodynamic stability and lower hygroscopicity and therefore qualified for a fresh patent.
However, the court discovered that the package of the drug described its product as Imatinib Mesylate and not the beta crystalline form of the compound.
As a result, they rejected the plea based on a law aimed at preventing companies from getting fresh patents, making only minor changes to existing drugs, a practice known as “evergreening”.
The bench also explained the meaning of the word “invention” when it ruled out the plea, as “something different from a recent previous or one regarded as better than what went before or in addition to another or others of the same kind” and Glivec failed to fulfil any such features and certainly did not qualify enough to warrant a patent.
Novartis has since condemned the courts’ decision stating that the courts ruling will “stifle country’s access to new medicines” and it “discourages future innovation in India”.
Nonetheless, the decision has been accepted across the country with jubilation by common man, cancer aid charities and generic drug-makers who will now continue to buy, sell and produce copies of the drug at a lower and much affordable price.