Gloom was the predominant mood on the sunny day this autumn when Medecins Sans Frontieres (MSF) explained to Delhi journalists how it lost a long legal battle with Pfizer over the pneumococcal conjugate vaccine, or PCV. The US pharma major had been granted a patent for Prevnar 13, said Leena Menghaney, South Asia head of MSF바카라s Access Campaign. That meant a 68 per cent rise in the cost of the vaccine available to developing countries.
The Indian patent authorities바카라 decision means each dose of the vaccine available to parents will cost Rs 3,800. Moreover, the spike in cost of procurement disables even the government to make the PCV available under the Universal Immunisation Programme.
Pfizer바카라s claim on the patent in India was based on assembling together serotypes (or different strains) of streptococcus pneumonia into a single carrier. The 1849-founded company already held the patent for a 7-valent PCV which also, according to MSF, an international humanitarian NGO, denoted a mere addition of serotypes to a vaccine available in the public domain. Simply put, Pfizer found a way to add more ingredients to an already available essential mix. This, critics say, is part of a bid to 바카라evergreen바카라 the patent, or maintain monopoly and control prices.
New York-headquartered Pfizer fiercely defends its right to monetise the fruits of its research. Its press statement in response to Geneva-based MSF바카라s allegations of evergreening said: 바카라Supported by extensive clinical research and real-world experience, each dose of PCV13 requires 400 different raw materials, 580 manufacturing steps, 678 quality tests and two and a half years to produce.바카라 It claimed keenness in further enhancing access to this vaccine in India, 바카라both in the market as well as through partnership with the government바카라. The vaccine is available at a discounted rate for the Indian government, Pfizer says, through GAVI바카라the global public-private vaccine alliance. The GAVI commitment covers only a five-year period, after which the government will have to pay over $10 for each dose.
The decision on PCV13, to many, reflects a new state of affairs. India바카라s patent laws, touted to be one of the strongest until a few decades ago, have now succumbed to pressures from developed countries, and in turn foreign MNCs with vested interests. The short-term effect it has is on health costs for the average Indian. In the long run, it keeps prices high by creating an environment that does not encourage indigenous invention and R&D.
The agreement on Trade Related Aspects on Intellectual Property Rights (TRIPS), followed globally for laws on patent rights, was implemented in India in 2005 by amending the Indian Patent Act of 1970. Section 3(d) of the present law says 바카라new forms of old substances cannot be patented unless they differ significantly in properties with regard to efficacy바카라. This should be a vital bulwark against evergreening, yet it hasn바카라t been so.
The first celebrated case after TRIPS was when Novartis applied at the Chennai patent office for drug Glivec in 1998, a slightly different version of its anti-leukaemia drug for which it had a 1993 patent. When the patent officials rejected the application, the Swiss multinational petitioned the courts to declare Section 3(d) non-compliant to the TRIPS agreement. Taken up after India settled its patent regime by 2005, a seven-year-legal battle ensued. The Supreme Court finally rejected the petition, ruling in favour of public availability and access.
This was a standalone case, according to T.C. James, former director (IPR) in the commerce ministry바카라s department of industrial policy and promotion (DIPP). 바카라Since then a long list of patents has been allowed with minor modifications and no change in efficacy,바카라 he says. Since that 2013 judgement, the US and UK have tried to get Indian laws diluted. 바카라MNCs perceived a threat from the steady growth of Indian pharma companies before 2005,바카라 says James. 바카라So, several attempts were made to tweak laws in their favour.바카라
The US even had India put on the 바카라priority watchlist바카라 of its trade representative바카라s Special 301 report, which lists barriers to American business. 바카라Being put on the watchlist could mean loss of trade benefits. This was a pressurising tactic by the US, which wanted laws to be changed in their favour,바카라 says K.M. Gopakumar of Third World Network. A high-level India-US working group set up in 2014 has since managed to tweak Indian patent laws every year, he adds.
바카라The influence of MNCs is such that, last year, a training camp for Indian patent officers was organised by the India-US joint business council. This council바카라s members are mostly big pharma MNCs. So patent officers were being trained by pharma majors on patent laws!바카라 he says. A DIPP official admits countries like the US and UK do use pressure tactics on behalf of their commercial lobbies, but India usually does not succumb to them. 바카라Our laws on patents are very strong,바카라 she says, but avoids comment on the Pfizer case.
A month ago, the USTR again used the threat of putting India on the watchlist in the wake of medical devices being brought under a price cap in the past year. This was spearheaded through a letter by a collective of medical device manufacturers, AdvaMed, who lobbied the USTR in a letter to revoke India바카라s trade sanctions.
An IPR policy for a country like India should seek to balance health rights with the need to protect assets. Yet, since 2005, patent laws have been seen less from a public interest perspective. Says Dr A. Damodaran, an expert on IPR: 바카라The patent law was revised in a hurry in 2005, making it friendlier towards multinationals as compared to Indian companies.바카라
This is clear in the lack of compulsory licences that bedevils Indian generic manufacturers바카라such a licence would allow them to produce a patented drug or vaccine without taking the patent-holder바카라s permission. Several countries use compulsory licence as a tool to provide affordable healthcare, but Indian patent offices have issued it only once.
Dinesh Abrol, convenor of the national working group on patent laws, suggests this is because the current disposition believes granting of such licences will dissuade FDI in pharma. 바카라The government believes stronger patent laws would attract more FDI even though there is no evidence to show that,바카라 he says. The DIPP official, though, says, 바카라There바카라s a fixed procedure for compulsory licensing. There is no resistance by the government to granting such licences.바카라
Abrol바카라s studies suggest stronger patent laws (favouring MNCs) actually dissuade investment within India. 바카라What is required for pulling in FDI is better infrastructure and manufacturing hubs, not strong patents,바카라 he says. The situation, he says, is so bad the committee for compulsory licensing doesn바카라t even meet. 바카라The provision is on the statute, but not implementing it seems to be the government바카라s way of being prudent,바카라 he says.
Companies and organisations can appeal to the courts under the present law before or after the grant of a patent, but the provision is often not used since such appeals take eight to ten years to resolve. 바카라In the meantime, no one has access to the technology or even the current drugs in the market,바카라 explains Menghaney. So even in the Pfizer case, MSF chose to seek a review by the patent office.
The changing laws have done no favours to Indian manufacturers. According to a paper published by Abrol, patents have created barriers to innovation. Indian companies find it more profitable to collaborate with MNCs, avoid R&D costs and instead simply market the products in India. Since 2013, over 500 of the pharma patent applications in India were received from MNCs; it was just around 100 from Indian companies.
The lack of public funding options exacerbates this, says the DIPP official. In order to revive local R&D, the government needs to invest more in public-funded R&D in drugs. Fostering local industry and standing up to developed nations would offer the best immunity programme for millions of Indians.
