PRactitioner Amal Gadkari provides a bit of perspective on the issue that Swiss pharmaceutical company Novartis is taking on the Indian government for.
On September 11, final arguments in the Indian Supreme Court case of Novartis vs. Government of India began. The verdict will have definite repercussions for healthcare and drug delivery in India and other developing countries. What is the Novartis case all about and how does it affect us? Here’s a bit of history and perspective…
Until 2005, India did not grant patents on medicines. Drug manufacturers were allowed to freely produce generic versions of medicines patented in other countries, thereby pushing down the prices of these medicines. As a member of the World Trade Organization (WTO), India started to grant patents in 2005. This was also designed to regulate the fierce price competition between the original manufacturers of patented drugs and those making affordable and generic versions of these.
Usually, a drug patent is valid for a period of 20 years, giving pharmaceutical giants monopoly in the marketplace during this period. The company with the patent can charge a premium price and also prevent others from manufacturing, selling or even importing the medicine for as long as the patent is valid.
Global pharma companies often try to extend the patent validity period by way of very minor alterations or improvements in the original drug. This is called ‘evergreening’ of the patent. Section 3(d) of The Indian Patents Act does not permit this kind of a patent extension unless the modification yields clear improvement in therapeutic effect as compared to the original drug.
In 2006, the Indian patents office rejected a similar ‘evergreening’ patent sought by Novartis for imatinib mesylate (Glivec®), a drug used for the management of leukemia, on the grounds that the new patent was based on an existing compound. The Swiss company took the matter to court the same year, challenging the patent office’s decision as well as Section 3(d) on which it was based. In asking the court to overrule the patent office, Novartis is arguing that the new mesylate salt form of the original drug Imatinib offers increased bioavailability and that translates into greater efficacy.
But in 2007, the Madras High Court ruled that efficacy should mean a ‘therapeutic effect in healing a disease’ and rejected Novartis’s application. In 2009, The Intellectual Property Appellate Board also rejected the company’s appeal. Soon after this, Novartis launched a fresh attack, this time in the Supreme Court of India
If the Supreme Court rules in favor of Novartis, India will see patents being granted on a wider scale, as they currently are in developed nations. The patents will not be restricted to new drugs alone; many will also hold good for new formulations of existing medicines. Affordability is likely to become an issue. Treatments for life-threatening ailments such as cancer may be priced out of the reach of many as long as the drugs involved are under patent.
On the flip side, a favorable result for Novartis also will signal to other multi-national drug companies that India will support their investment in the country with adequate levels of patent protection.
Will the ruling be friendly to drug manufacturers and help their foray into the Indian market? Or will it hinge on the key issue of affordability for millions of Indians and people in other developing nations? We are likely to know the answer soon.