Pending cases against India's patent laws threaten public health and misinterpret international intellectual property (IP) agreements, researchers argue in a special report in The Lancet this week.
The challenges being brought by Bayer and Novartis to key provisions of India's Patents Act "are seeking to undermine public health considerations aimed at improving access and therapeutic advantage," write Peter Roderick and Allyson Pollock of the Centre for Primary Care and Public Health at Queen Mary, University of London.
Last week, it was reported that India's Intellectual Property Appellate Board had reserved its decision on Bayer's appeal against the first compulsory licence granted in India. The licence, for the manufacture of Bayer's advanced liver and kidney cancer drug Nexavar (sorafenib), was granted to generics firm Natco earlier this year.
And today (September 11), the Indian Supreme Court is due to hear Novartis' "sustained" legal challenge to India's rejection in 2006 of the company's patent application for its leukaemia treatment Glivec (imatinib).
This month also sees the resumption of talks between Indian and European Union (EU) negotiators for a Free Trade Agreement (FTA), which would reportedly extend patent protection in India beyond the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), drawn up at the World Trade Organisation (WTO) in 1994 to harmonise IP protection, the authors note.
One of TRIPs' most far-reaching requirements for many countries was mandatory patentability of pharmaceutical products. India, which had previously only allowed patents for pharmaceutical processes, amended its 1970 Patents Act three times - in 1999, 2002 and 2005 - to comply with its TRIPs obligations.
Mr Roderick and Prof Pollock point out that, in theory, several "lawful opportunities" exist for developing countries to minimise the impact on TRIPs on access to medicines. For example, they are entitled to pay close attention to: - the preconditions for patent availability; - the permitted criteria and categories for excluding patentability; - the disclosure requirements of applications; and - the discretions expressly granted in these connections. They can also set limited exceptions to the exclusive rights conferred by a patent. Such a move was upheld by the WTO dispute panel when it rejected the EU's challenge to Canada's pro-generics law, which allowed third parties, without the patent holder's consent, to "make, construct, use or sell the patented invention solely for uses reasonably related to the development and submission of information required" for marketing approval.
However, taking advantage of these "lawful opportunities" requires political will, legal expertise and administrative effort, they add.
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," say the authors. TRIPs does not limit the grounds on which compulsory licences can be granted, nor does it prevent patent applicants from having to demonstrate enhanced efficacy for their "allegedly new and useful inventions," they point out.
"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 access," Mr Roderick and Prof Pollock conclude, adding: "India's laws and experiences could provide a useful example for low-income and middle-income countries worldwide."
The views expressed in the following comments are not those of PharmaTimes or any connected third party and belong specifically to the individual who made that comment. We accept no liability for the comments made and always advise users to exercise caution.