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Ranjit Shahani

Choosing not to choose is a choice in itself. Earlier this month, the High Court in Chennai chose not to determine the future of pharmaceutical innovation in India. The Court deferred the decision on compliance of Section 3(d) of the Indian Patent Law with World Trade Organisation (WTO) standards. As India celebrated the 60th anniversary of its Independence, we have had the opportunity to review our growth and success as a sovereign nation. We have made significant strides in our industrial development, demonstrating that India is entering the scene as a global player in trade.

These advances should be commended, but we must ensure our country is aligned with international standards for valuing innovation. In choosing not to choose, the Court gave a clear signal: we do not recognise genuine innovation. If allowed to stand, this declaration will have a lasting effect on industry, innovation, and ultimately patients and public health.

The Indian patent law currently does not acknowledge advances achieved through incremental innovation. Section 3(d) is a hurdle to recognising genuine innovation, and will hinder development of the pharmaceutical industry and of future medicines. The law as stated says: “For the purposes of this clause, 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.” Drug substances can occur in various physical forms, including liquid, semi-solid, amorphous and crystalline, and the crystalline forms themselves can vary significantly. Drawing an analogy from this, the element carbon can exist as soot, graphite or diamond, depending on how it was crystallised. The same element —yet, what a difference in terms of value.

There is a strong link between global trade facilitation and economic growth. India has moved away from being a commodities producer to being a provider of efficient manufacturing and services based on plentiful and inexpensive labour. However, it is increasingly apparent that human capital — the capacity to create value from scientific, technological and business expertise — will drive the development of India’s economy, and both foreign and domestic research-based companies will invest where the returns are best.

There is no doubt that our growing intellectual capital holds the potential to provide greater returns. We have before us the opportunity to become a major global competitor — a modern, knowledge-based economy — rather than a supplier.

When India joined the WTO in 1995, we opened our country to enormous opportunity. Domestic producers gained credibility to trade on an international level. We have increased access to goods produced outside of India. In addition to these opportunities, we chose to take on responsibilities — among those, adequate protection for intellectual property — which benefit Indian industry as well.

The government has clearly demonstrated its support for the information technology industry, and over the past 10 years India has become an international player in this area. While our domestic pharmaceutical industry undoubtedly has the capacity for this kind of development, it has until very recently adhered to imitating rather than innovating.

That scenario is steadily changing with more and more R&D-oriented Indian pharmaceutical companies beginning to devote more and more resources to research and development, and if innovation is not protected in India, they will be at a disadvantage within the global market. If we are committed to the goal of continued domestic industry growth, we cannot circumvent global standards for innovation. Choosing to protect intellectual property rights is choosing to encourage research and development, leading to a stronger pharmaceutical industry in India.

Medical progress happens through incremental innovation — innovation by steps — providing important value for patients. From improving a medicine’s side-effect profile and tolerability to treating previously untreatable diseases, incremental innovation provides exceptional value for patients. Over 70 per cent of medicines in the market today were developed through incremental improvements on a base compound or existing medicine. Lack of patent protection will stifle such research, providing as it does no incentive; this will, in turn, negatively impact patients and healthcare.

Improved safety, side-effects, tolerability: An improved side effect profile benefits patients already using a drug, and can extend the possibility of treatment to others who were previously unable to use the drug.

Faster treatment: Having a drug that responds quickly to patient needs can help avoid more radical treatment options, facilitating recovery and allowing patients to avoid unnecessary hospital visits.

Enhanced multi-drug therapy: When compared to treatment with only one medication, combination therapy is proven to be more effective, to save additional lives and to decrease the chances of resistance in infectious diseases. It can als o improve compliance by reducing the overall pill burden to patients.

Convenience for patients: Medicines with reduced dosage, administered once per year, versus once per month, help patients to lead normal day-to-day lives, even as they undergo treatment to manage a disease.

Individualised treatment for special populations: More options allow drugs to be tailored to patients, instead of the other way around.

New indications: Exploring different applications for one innovation can potentially treat patients with several unrelated diseases.

Novartis brought this case forward because it was the right thing to do for patients. Patents save lives by stimulating research that leads to innovative medicines. Only with effective patent laws can research-based companies continue to bring therapeutic improvements, and it is clear that there are inadequacies in Indian patent law that will have long-term consequences for patients.

Activist groups regard the decision on Section 3(d) as a victory for access to medicines in developing countries. On the contrary, manufacturing generic versions of medicines does not solve the problem of access. Access to medicines is a matter of making medicines available.

There are several issues that need to be addressed to ensure access to medicines for the larger population; lack of diagnosis, infrastructure and distribution, among others.

Medicines are made available through a variety of means, including tiered pricing solutions, public-private partnerships, shared contribution models and donation programmes. It is for governments, non-governmental organisations (NGOs) and companies to work together to find innovative solutions to these issues.

The story with Coartem is one example: in partnership with the WHO, Novartis provides Coartem — a patented malaria medicine — at no profit to developing countries.

During 2006, 62 million Coartem treatments were delivered to more than 30 African countries, demonstrating how large-scale health threats can be successfully combated through a collaborative approach between industry, governments and NGOs. Novartis is committed to finding new models to address changing needs.

A long-term solution for access must include the research-based pharmaceutical industry because new therapies are needed the better to treat different populations, to counter resistance and to address new and changing diseases. Without pharmaceutical research and development leading to innovative medicines, people will continue to suffer from treatable diseases, such as tuberculosis, malaria and dengue fever.

Section 3(d) will discourage access to future innovative medicines by hindering the research and development needed to bring them to patients.

India enjoys the rights that international agreements bring, and ensuring effective protection for intellectual property is not only part of our responsibility, but benefits India. We have made significant progress in advancing intellectual property rights, but more needs to be done.

The choice is ours: to choose or not to choose. By choosing not to choose we mortgage the future for the present; we mortgage the future of public health, not only for ourselves but also for our children and our children’s children.

More Stories on : IPR | Courts/Legal Issues | Pharmaceuticals

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