'Are product patents anti-consumer?'

Eventually, the debate boils down to whether removing patent rights will lead to lower R&D in diseases that are important for patients in developing economies.

Ranjit Shahani
Vice-Chairman & Managing Director,
Novartis India Limited

If people don't get a fair return in innovation, they won't invest in finding new cures for disease "" this will be disastrous for patients

There is no doubt that patients are the ultimate beneficiaries of pharmaceutical research and development. Thousands of public health needs go unmet each day simply because there is still a cure out there waiting to be found. Product patents serve as encouragement to innovation, providing impetus to both investors and innovators. It has been argued that by denying product patents, India will encourage domestic generic production and, therefore, access to medicines. However, generics alone are not the solution to access. Access to medicines is about making medicines available and this can happen in several ways; through innovative models such as tiered pricing, public-private partnerships and patient assistance programmes. By not acknowledging innovation, India risks access to future medicines impacting public health. Further, product patents are the precursor to generics. Let us not kill the proverbial goose that lays the golden eggs.

Sustainable access to medicines in developing countries is complex and requires much more than the availability of generics drugs. Two factors account for access-to-medicines problems, neither of which has much to do with patents: a lack of funding from all sources; and a lack of infrastructure for healthcare delivery. In reality, prices, industry structure and patents in the pharmaceutical field have little to do with access to drugs. Denying patents and allowing generic companies to freely copy new drugs cannot be the solution to deliver medications to the patients too poor to buy them, be it in rural India or elsewhere.

India has both the physical and intellectual infrastructure in place to be so much more than just imitators. A free-and-fair patent-award system doesn't just benefit pharma companies. It's time for us to see the benefits of a strong intellectual-property regime: sustained foreign investment and, in turn, a good start towards steady economic growth.

India is the second-largest talent pool in the world. Yet, investments by global companies continue to gravitate to China, Hong Kong and Singapore. India received $8 billion in FDI last year as against China's $63 billion!

We have the opportunity to become a major global competitor "" a modern, knowledge-based economic titan, rather than a mere copycat supplier to the developed world. We can only make this transition with an environment which encourages innovation and provides patent protection.

In the case of pharmaceuticals, in particular, the economics of intellectual property must address the cost of innovation "" in this case, the investment of hundreds of millions of dollars to create a new drug. There is too much at stake here: the health of our people; the future of our pharmaceutical sector; the ability to attract other research-based industries; and our continued progress as an emerging economic player. Let us not mortgage the future for the current as we are still a long way from having innovative products to prevent, cure or even treat all the illnesses we know about.

K M Gopakumar
Research Officer,
Centad, New Delhi

That product patents raise medicine prices is well known "" there is also evidence to show such patents do not induce more R&D in neglected diseases

Product patents provide a legal monopoly over the patented product and prevent others from producing or selling the product without the authorisation of the patent owner. Therefore, pharmaceutical MNCs are the main users of product patents for shielding their products from competition. The TRIPS Agreement, an agreement initially drafted and propagated mainly by the pharmaceutical and agro-chemical companies (sponsored by developed countries), virtually universalised product patent protection.

The universalisation of the product patent regime incapacitated developing country governments from providing medicines to their people, who are in acute need of life-saving medicines. Thousands of people in developing countries, especially in Africa, lost their lives because neither the people nor their government could afford the price of many life-saving drugs.

Lack of access to affordable medicines was the main reason for the vast majority of deaths that occurred in developing countries due to HIV/AIDS. For instance, a first-line patent protected ARV (anti-retroviral) drug for the treatment of HIV/AIDS was available for $10,000-12,000 per person per year before the competition from generic players dramatically reduced the prices. Thus, product patents facilitated a new form of genocide in developing countries. Further, there is evidence to show that product patents neither induce R&D in neglected diseases nor increase R&D investments.

In addition, high prices arising out of product patent monopolies create fissures in the social security systems of many developed countries including the US. They make the lives of people outside the social security net really impossible. Secondly, contrary to popular perception, a medicine is not protected through a single patent "" this is done through multiple patents on different forms of the chemical substance, including the new use of the substance. These multiple patents create a web of patents having different expiry dates, which help the patent holder to extend the patent beyond the expiry of original patents. Thus multiple product patents on a medicine not only delay generic competition but also prevent further R&D on the same substance by others. It is also documented that delays in generic competition force other MNC competitors to introduce "me-too drugs" (drugs with the same therapeutic effect) in the market. The introduction of "me-too drugs" thus results in the reinvention of the wheel and wastage of resources for R&D.

Thirdly, product patents have the potential to prevent the introduction of user-friendly fixed dose combination (FDC) of drugs to be used for disease conditions like HIV/AIDS malaria. The introduction of FDCs becomes nearly impossible when different companies own the patents for different drugs.

For consumers, especially those residing in developing countries that constitute only 8-10 per cent of the global pharmaceutical market, product patents are a barrier to access affordable medicines.