Patent Pains and the Promise of a Better Future

The recent decision on pharmaceutical patent rights, rendered by the Supreme Court of India has, made ripples across the world. In summary, the Court ruled that Novartis did not enjoy exclusive rights in India to produce and sell it’s leukaemia-fighting drug Gleevec (also sold as Glivec). The court found that since the first patent on the original molecule was granted in 1993, prior to the 1995 threshold for exclusivity under newer laws, the company did not enjoy exclusive patent on the slightly modified, newer molecule. Cipla and Natco, India-based producers of the generic equivalent, appear to have “won” this eight year battle. The Indian government has expressed support for the decision too. Novartis still has the right to request a review, and will probably exercise this right, but the key pieces of the decision will likely hold.

The Court’s decision is significant for several reasons. It clearly reinforces the 1995 cut-off for patent exclusivity. This threshold was the cornerstone of fairly stringent legislation effected by the Indian government in 2005 as a condition for membership to the World Trade Organisation. Indian generic manufacturers, producing or planning to produce pre-1995 drugs, will now have the certainty to pursue more aggressive production and sales. The ruling also strikes down the widespread practice of “evergreening”. Through minor tweaks to formulations, companies argue for extensions of patents for these “new” drugs. The US grants these generously, but India’s highest court has set an example by refusing this. Conversely, it also enforces the exclusivity of post-1995 patents. Any drug patented over the last 18 years, enjoys patent protection and market exclusivity going forward (though recent judicial decisions in lower courts, that stripped Merck, Bayer and Pfizer off their patents on critical, life-saving drugs say otherwise). This divide may deny India and much of the world access to affordable versions of newer, life-saving medicines.

India’s pharmaceutical industry supplies medicines to much of the developing world. Cipla’s cheap HIV drugs have made a huge difference in how the devastating spread of AIDS has been checked in Africa. Over half of the $26 billion in sales that Indian pharmaceutical companies generated last year came from outside of India. Other countries like Canada’s generics manufacturers have also built a significant interest in the global generics market, supplying drugs to Africa, but also to residents in the United States where patent protection, evergreening and low-access to healthcare have kept life-saving treatments out of the reach of many. Courts and governments across the world have taken note of this decision, and are likely to be more activist in the future, in balancing the right to profit with the duty to save lives.

Patent rights are not an easy issue to take a position on. One the one hand, pharmaceutical companies invest and risk billions of dollars in research and development of new drugs, and have to spend even more to meet government-mandated and -regulated testing and approval procedures before they can be made available. This investment on a company’s part merits a certain return and profit to keep it in business, and to fund further research and innovation.

On the other hand, much of the world lives in relative poverty, and cannot afford to access some of these life-saving drugs because of their cost. Two thirds of India’s population subsist on less than $2 a day. Gleevec in comparison retails in India for $2,200 for a month’s supply, and in Canada for over twice that amount. The generic version comes in at $170, much less, but still inaccessible to the average Indian.

Should the cost of access impact saving a life? This is the hard choice that has to be made. At the end of the day, this is about people’s lives, and the value we attribute to them as a society.

In 1955 at the height of the Polio epidemic, Jonas Salk developed a vaccine for this killer disease.  He made the unprecedented decision not to patent his vaccine for polio, forsaking significant profit, but also saving billions of lives in the 60 years since by making it available to the world for free. He worked tirelessly till his death in 1995, trying o find a cure for AIDS. There is a case to be made for such an approach to be enshrined in health policy globally.

Governments have an interest in the well being of their people. They should pool some of their formidable resources into partnering with pharmaceutical companies and research institutions to fund research into critical, life-saving drugs to tackle widespread diseases. In return, they can require that any resulting drugs be sold at a reduced profit, and at an affordable price across the world. The Gates Foundation and other philanthropic institutions have already stepped up to fund such initiatives to tackle widespread, killer diseases such as HIV and Malaria. It is time now for governments of all stripes to step up to make for a better, healthier world…

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