India’s goal of becoming a world-leading centre for pharmaceutical R&D could be jeopardised by a clause in the country’s new patent law, a leading industry figure has warned.

In 1995, the start of a new era for India as a significant player on the world R&D stage was signalled when it signed the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPs) agreement, writes Professor Trevor Jones, in a paper published by the Creative and Innovative Economy Center (CIEC) at George Washington University Law School.

In order to become TRIPs-compliant, India has amended its patent laws, but the new legislation contains a clause which Prof Jones believes could seriously compromise not only the ability of entrepreneurs and established companies in the country to become world leaders but also inward investment in R&D from foreign firms.

At issue is the patent law’s Clause 3d, which sets out restrictions as to which pharmaceutical/biotechnological products can be regarded as patentable inventions. Specifically, it states: “Salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes combinations and other derivatives of known substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”

One of the fundamental problems here, says Prof Jones, is that a test such as “efficacy” is almost impossible to perform at a time when patents are filed. Also, the fact that Clause 3d is very specific and precise with regard to pharma/biotech seems incompatible with the TRIPs requirement that its conditions should apply across all fields of technology. Moreover, and very importantly, the clause severely restricts incremental innovation, which is both the major means by which significant health benefits continue to be improved and an area of research activity in which India has very well-developed skills, he writes.

Clause 3d fails to appreciate that incremental inventions not only improve therapeutic/clinical efficacy but can also provide significant benefit in terms of patient safety and compliance as well as manufacturing efficiency, he says. Most importantly, they can result in improvements to product stability during storage and transport, which is vitally important in India and in many parts of the developing world.

“As it stands, Clause 3d will exclude these important developments which, arguably, should be a significant component of the next stage of economic growth for pharmaceutical and biotech R&D in India, in parallel with its growing ability in more fundamental drug discovery,” writes Prof Jones.

Access to medicines

He also rejects the argument that, without Clause 3d, patients in developing countries would be denied access to life-saving medicines, pointing out that India and other countries have introduced safeguards in the form of price controls or, as a last resort, compulsory licensing to deal with such emergencies. The reasons why millions of patients in India and elsewhere have no access to medicines - despite the availability of the very cheapest, often generic medicines - are poverty, absence of funding, inadequate health care services and personnel, and poor logistics for distribution and supply, he writes.

Prof Jones calls on developed and developing nations alike to address these issues but adds that the establishment of proper intellectual property rights (IPR) that encourage rather than inhibit innovation for the benefit of mankind must surely be a necessary way forward. Clause 3b puts at a watershed the opportunities presented by India’s “almost limitless” capability through its talented scientists and entrepreneurs, he writes, adding: “It would be a tragedy for India if the success that has been achieved in recent years is compromised in this way.”

– Prof Jones, a past director-general of the Association of the British Pharmaceutical Industry (ABPI) and director of R&D at The Wellcome Foundation Ltd, is a member of the World Health Organization (WHO) Commission on Intellectual Property Rights, Innovation and Public Health (CIPH), which in April 2006 published recommendations for boosting R&D for diseases primarily affecting the developing world.

Its report stated that, as market demand for diagnostics, vaccines and medicines to address such health problems is small and uncertain, the incentive effect of IPR may be “limited or non-existent”; therefore other incentives, financial mechanisms and collaborative efforts are needed. The report acknowledged the significant progress made in recent years, particularly in initiatives by stakeholders to promote innovation, but said this momentum for change was insufficient.

In a minority dissenting report on the Commission’s conclusions, Prof Jones made similar points about problems of access to medicines as he does in his new CIEC paper. His minority report also expressed “serious reservations” and disagreement with a number of the Commission’s conclusions.

For example, he said, its implication that there is a direct link between the possession of a patent, the price of that product and access to it in the developing world is incorrect. Nor, he added, did the report adequately explain company pricing policies, or recognise sufficiently the research-based pharmaceutical industry’s contribution to tackling the diseases which primarily affect the developing world.