Novartis And India: Patent Wars

The bitter pill: On April 1, 2013 the Supreme Court ruled against Swiss pharmaceutical firm Novartis’ plea to patent its cancer-fighting drug Glivec. Novartis had contested the rejection of its application by the Intellectual Property Appellate Board (IPAB) and had challenged IPAB’s interpretation of section 3(d) of the Indian Patent Act.

Which is? Section 3(d) of the Indian Patent Act does not support patents for inventions which are small modifications on existing products and it aims to check any attempts by manufacturers to monopolise rights over the creation of such products.

So what is this wonder drug? Glivec is a drug to treat blood cancer and Novartis fought a case in India for seven years to get the right to claim exclusive rights over its production. If Novartis had won the case, it would have meant a monopoly over the manufacture of the drug – and perhaps a push-up in costs. A month’s dosage of Glivec made by Novartis costs around Rs 1.2 lakh while a month’s dosage of similar medicines made by one of the Indian companies costs Rs 8,000.

And while Novartis sulks, what does this mean for Indian pharma companies? The Supreme Court decision gives a lifeline to Indian manufacturers, who are Novartis’ competitors. Major pharmaceutical companies like Ranbaxy and Cipla fought Novartis.

Setting a precedent? Not really. Indian companies have a poor track record of intellectual property rights and patents over their creations. But Western nations and industries have misused patent laws to establish monopoly over products over which people have universal claim – from the wheel to thong diapers.

Is this the first time the Indian government has fought a patent lawsuit? Conflict over intellectual property rights bothered even some of our rickety coalition governments of the license permit-quota raj era. Through late 1991 and early 1992, the VP Singh-government opposed the Dunkel Draft, a proposal moved by the General Agreement on Tariffs and Trade (GATT) director Arthur Dunkel, which was later instrumental in shaping the framework of the World Trade Organisation. The Draft sought to bring the copyright over specific agricultural products and medicines in different parts of the world under one rubric. India, then part of GATT, was the biggest opponent of the idea. The man who conveyed the bad news to Dunkel in May 1992 was our current Finance Minister, P Chidambaram.

Has the Indian government successfully challenged any patents of Indian ingredients or products? Well, in September 1997, the Indian government successfully challenged the US patenting of turmeric or haldi which led to the cancellation of the patent. The patent had been granted in March 1995 to use turmeric powder as a wound-healing agent. The Indian Council of Scientific and Industrial Research challenged the patent in October, 1996. More recently, in March 2005, the European Patent Office in Munich upheld revoking the patent granted by it for the preparation of a fungicide created from the seeds of the neem tree.

Getting back to Novartis, which law was used to win the Novartis case? Section 3(d) and Section 3(b) of Indian Patent Law which rule against claims to assert copyright over products that are just a “discovery” of a “new form” of a “known substance”.

And the moral of the patent story is…For all our weak laws regarding intellectual property rights, this decision shows India’s pharmaceutical industry and Indian patent laws’ have wherewithal. And companies will react when push comes to shove.

And there’s another patent war heating up as you read this. A few hours after the Supreme Court take-down of Novartis’ patent claim, Indian anti-diabetes medicine maker, Glenmark has brought out its own version of Januvia, a drug made by American pharmaceutical company Merck. Both companies have been fighting a patent war over the last few years.