Bid to water down pharma patents

Section 3(d) incorporates a strict bar for what constitutes an invention and clarifies what is not patentable in India: “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 of a known substance…” This single provision, cited in a slew of cases, has prevented the runaway pricing of medicines seeking patents

Ten years have passed since the Indian Patents Act, 1970, was amended in 2005 to bring the country’s laws in line with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The most important of the 2005 amendments was the introduction of product patents for 20 years, including for pharmaceutical products, but with the following safeguards: the amended Section 3(d) of the Patents Act that put paid to attempts to evergreen patents (extending patent protection by making minor changes to the original drug), the expanded compulsory licence (CL) provisions and the retention of pre-grant (and the introduction of post-grant) opposition to patents.

Section 3(d) incorporates a strict bar for what constitutes an invention and clarifies what is not patentable in India: “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 of a known substance…” This single provision, cited in a slew of cases, has prevented the runaway pricing of medicines seeking patents—notably Novartis’s Glivec (imatinib mesylate, an anti-cancer agent).

The case of the CL on Bayer’s patent on Nexavar (sorafenib tosylate, also an anti-cancer agent) issued to Natco clarified the circumstances under which a CL could be issued. These cases have subsequently shown the true cost of manufacture once generic competition sets in. Several of these patent case rulings since 2005 have taken cognisance of the overpricing and consequent lack of access to patented medicines. In the Natco case, they constituted sufficient grounds for the issue of a CL.

The recent protests over the price of the anti-Hepatitis C medicine sofosbuvir have brought again into sharp focus the high prices of medicines—in the United States (US) as much as in India. Gilead, the multinational that launched this medicine (which it had bought from another company), has tried to circumvent the issue of an astronomical $84,000 for a 12-week course of treatment in the US by co-opting Indian companies—including some leading companies that have been in the forefront of patent oppositions of the many “new” medicines.

Gilead entered into voluntary licences with seven leading Indian pharma companies to make the product cheaper (but still unaffordable in India). Gilead in return got the silence of these Indian licensee companies who de facto agreed to “cooperate” and not litigate the patentability of sofosbuvir. The Indian corporate voluntary licensees are also told which countries they can export to. Also, in a blatant violation of privacy of Indian patients, Gilead has been attempting to monitor which patients purchase these medicines to assure themselves that traders in the guise of patients do not buy these medicines “cheap” in India and sell them “dear” to foreign patients.

In truth, there is nothing voluntary about voluntary licensing. It is an act that ties the hands of Indian pharma by dangling short-term profits and convenience at the expense of longer term autonomy and agency. Section 3(d) as well as the CL provisions in the Patents Act have been painted the villains of the piece by pharma lobbies in the US and European Union (EU), and their governments. Every time one of the foreign pharma companies loses a patent-related case in India, or when the Government of India talks of price control of patented medicines, there is a chorus of voices from these embedded lobbies that India is violating TRIPS provisions.

Or that India is not investment friendly, the reality notwithstanding. Every one of the 2005 amendments is well within the TRIPS provisions and the World Trade Organization’s (WTO) 2001 Doha clarification on patents and public health. If anything, it is the Indian government, especially the Narendra Modi government, that seems to have developed cold feet because it thinks that diluting the balance in India’s patent laws by agreeing to data exclusivity (likely to be introduced first for pesticides) and introducing pro-evergreening provisions will help it cosy up to its “strategic” partners in the West.

A similar piece of sad capitulation is the dithering on bilateral trade negotiations, including whether to agree to private arbitration beyond the pale of Indian courts and the reluctance to argue for the issue of CLs. A government-appointed committee, with scant regard to conflict of interest of its members, is elucidating an IPR policy that conflates innovation with patent protection, ignores open source and open access models, and pays mere lip service to “public interest.”

Let us state it clearly. Going by this trend, no patented medicine in India on cancer, HIV/AIDS, infectious/chronic diseases, et al, can be sold at affordable prices or their access made easy. Nor can price control on these high-priced patented medicines be an option as these companies will simply not sell in India arguing that the prices are too low. And if the prices are set high, issuing a CL would be difficult as these companies will argue that they are selling at government-approved prices.

If we need patented medicines at affordable prices, they have to be made in India by Indian pharma companies for Indian patients, and for those in developing countries without restrictions or conditions. Compulsory licensing of high-priced patentable/patented medicines is the only option—an option exercised by even smaller countries like Thailand which has a relatively smaller pharma industry. A misguided Government of India is caught in a tragic hesitancy and pusillanimity fuelled by its wish to get a seat at the high table. If this continues, the moniker of India as the “Pharmacy of the Third World” will soon be history. (www.epw.in)