Techdirt has been following the important story of the kidney and liver cancer drug marketed under the name Nexavar since March, when India granted a compulsory license for the first time since re-instating patents on pharmaceuticals. Naturally, the patent holder, Bayer, fought back, and appealed against that decision. Now we learn from Intellectual Property Watch that Bayer has lost:
Last Friday (14 September), the Chennai-based Intellectual Property Appellate Board (IPAB) which is responsible for hearing appeals on patent applications, rejected a petition by German pharma major Bayer AG, seeking a stay on an order of India’s Controller of Patents granting a compulsory licence (CL) to Indian generic drug maker Natco Pharma Limited, for a drug used to treat liver and kidney cancer.
It's quite possible that Bayer will try to appeal to a higher court, but what's noteworthy is that this is just one of several other important pharma cases in India at the moment. For example, the Delhi High Court held that Roche’s patent on the cancer drug Tarceva was valid, but that an Indian generics manufacturer had not infringed on it because it had only been selling a variant of the drug. Another high-profile case concerns the blood cancer drug Gleevec, sold as Glivec in India, whose manufacturer, Novartis, is fighting India's refusal to grant it a patent. Here's the background:
The legal dispute in the Glivec case centres around a provision of India’s 2005 patent law, called Section 3(d), which states that "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant." The dispute brings to the fore a fundamental question: what is an "invention"? Or more precisely, how much innovation is required to obtain a patent in India?
Novartis insists that it is not fighting in order to get more money, but to vindicate its "honor". What this probably means is that it is trying to establish the principle that patents can be given for new forms of drugs, even if they provide no enhancement over earlier versions. If it loses the Gleevec/Glivec case, that could have serious repercussions for future patent applications by the company in India.
More generally, this current round of high-profile drug patent cases may well have major knock-on effects in other regions of the world. Western pharma companies are probably worried that their recent failures in India to gain certain patents or block local manufacturers of generics could be repeated elsewhere as emerging countries wake up to the flexibilities within the TRIPS agreement that India is currently exploiting. The Intellectual Property Watch article mentions three nations that are already considering this -- Botswana, South Africa and Swaziland.
An article in the leading medical journal The Lancet agrees that India's growing success might well encourage others:
In trying to limit compulsory licences and avoid efficacy tests on products, the Bayer and Novartis cases are seeking to undermine public health considerations aimed at improving access and therapeutic advantage. The TRIPS Agreement does not limit the grounds on which compulsory licences can be granted, and does not prevent patent applicants from having to demonstrate enhanced efficacy for their allegedly new and useful inventions. There are many problems facing access to and rational use of medicines in India but the provisions within the country's patent laws, if more extensively and properly applied, should help rather than hinder such access. India's laws and experiences could provide a useful example for low-income and middle-income countries worldwide.
Watch this space.
Follow me @glynmoody on Twitter or identi.ca, and on Google+