Source: Times of India
Rupali Mukherjee, TNN | Aug 16, 2012, 05.20AM IST
MUMBAI: India’s tag of ‘pharmacy of the developing world’ is at a serious threat. Not only has the US devised new treaties to challenge generic drugs being shipped from India, the EU has also upped the ante. Worse, Big Pharma is increasingly adopting tactics to protect its intellectual property, challenging domestic industry in courts, all of which may adversely impact access to legitimate generic medicines in developing countries.
At stake is a huge portion of the $10-billion drugs exported from the country to save lives of millions, particularly in developing countries.
At the centre of it lies the new round of plurilateral treaties initiated by the US over the last few months, which include Anti-Counterfeiting Trade Agreement (ACTA) seeking to create an additional framework for IPR protection (going beyond the TRIPS Agreement), and the Trans-Pacific Partnership Agreement (TPPA) which aims at extra judicial enforcement, even as its companies are urging the government to take a “hard line” against countries like India and Brazil to stem the issue of compulsory licences.
The European pharma industry, on its part, has again stressed that the threat of ‘counterfeit medicines’ is substantive and growing.
One of the biggest barriers for the generic industry was put in place in 1995, according to industry experts, when India signed the WTO TRIPs agreement. Implemented in 2005, it is now restricting generic companies to manufacture affordable copycat versions for domestic use, and for exports. So newer medicines were invented post-1995 – crucial for HIV, Hepatitis C and cancer treatment – and are patented, creating roadblocks to their manufacture, sale and availability in India.
Long-drawn-out expensive legal patent disputes, infringement suits and huge damages claimed by multinational companies have made generic companies wary, with very few challenging the Big Pharma even when the patents itself are weak. Natco and Cipla are, however, exceptions to the rule.
“This has had a chilling impact; companies’ freedom to operate has gone down significantly as they can only manufacture new drugs invented before 1995,” says Leena Menghaney, lawyer with Medecins Sans Frontieres, a global medical aid organization.
This is impacting access on the ground. For example, a new HIV medicine raltegravir patented in India costs over $2000 per patient per year. “The generic industry is at a risk like never before, and mainly because of a new round of plurilateral treaties like ACTA and TPPA in the US, and intellectual enforcement measures undertaken by Europe,” says D G Shah, secretary general of Indian Pharmaceutical Alliance.
The Indo-EU free trade agreement being negotiated at present, particularly the proposed IP (intellectual property) enforcement measures, may create roadblocks to the supply of generic drugs shipped from the country, similar to seizures by agencies in 2009 at European airports. The proposed IP enforcement provisions may have harmful impact on generics production as it may lead to legitimate drug shipments getting blocked when shipped from the country if an MNC claims infringement of their IP.
These “excessive intellectual property enforcement provisions” in ACTA and the EU-India FTA are aimed at stamping out competition through intimidation, industry experts say.
The IP enforcement provisions in ACTA and the EU-India FTA negotiations also dictate the way disputes around patents and trademark infringements will be managed by Indian courts, adds Menghaney. “The Indian judiciary will have its hands tied and will no longer be able to balance intellectual property rights with people’s right to health. The stringent provisions also target third parties – including treatment providers – by exposing them to the risk of punitive action in trademark and patent infringement allegations. The EU wants India to agree to IP enforcement measures that could block medicines at Indian ports on their way to patients in other developing countries, and could even draw treatment providers into court proceedings”.
Over the last couple of months, the US government has expressed its “dismay and disappointment” at the compulsory licence given to Natco to launch generic cancer drug, Nexavar, in the domestic market at 97% of the price charged by MNC Bayer. In fact, in her testimony before the US Congress, US Patent and Trademark Office deputy director Teresa Stanek Rea reportedly states that her agency was trying to stop these compulsory licences, and stem the tide of IP infringement in countries like India, Thailand and Brazil.
Industry body OPPI, which represents MNCs’ views, feels the grant of compulsory licence should be taken after exhausting all other access improvement measures. Its director general Tapan Ray says: “While none can deny that all citizens of India should have access to innovative and life-saving medicines, as will be required for their medical treatment, it appears rather impractical to envisage that routine grant of CL by the Indian Patent Office, as has been done recently to Natco, will be able to resolve the critical issue of access to patented medicines, on a long term basis.”
Another showdown against the generic industry – being keenly watched the world over and approaching this month – is the Novartis case in the Supreme Court, where it is defending its patent on blockbuster cancer drug Glivec.
In 2006, Novartis had sued the Indian government for not granting a patent for Glivec, and also challenged the validity of Section 3(d) of the Indian Patent Act, which deems any incremental or frivolous innovation non-patentable.