Case that could reverse gains in war against HIV

By Dann Okoth Kenya and the rest of the developing world is staring a drugs procurement crisis in the face after a multi-national drugs manufacturer moved to court to stop the production of generic medicines by Indian drugs companies.

India is often called the ‘pharmacy of the developing world’ because it produces affordable generic versions of medicines that are used the world over.

More than 80 per cent of the antiretroviral medicines (ARVs) used by organisations involved in HIV and Aids programmes in Kenya come from producers of generics based in India, just as 80 per cent of the ARVs purchased with donor funds globally come from India.

Deathly blow
But if Novartis Pharmaceutical Corporation of Switzerland succeeds in its suit lodged at India’s Supreme Court and whose hearing started on July 10 — it could see prices of essential medicines such as ARVs and cancer drugs skyrocket by more 1,200 per cent — dealing a deathly blow to cancer patients and some 500,000 people in Kenya already on life-sustaining HIV treatment.

 “It would be a disaster,” declares Jennifer Cohn of Medecins Sans Frontieres’ (doctors without borders). “More than 80 per cent of the ARVs used by MSF in its HIV and Aids treatment programmes in Kenya come from producers of generics based in India, we also rely on Indian generics for malaria and tuberculosis treatments a change in the patent laws and hence tougher rules on generics production would be devastating,” she adds.

India became the key producer of affordable medicines because until 2005, the country did not grant patents on medicines, allowing generic manufacturers to freely produce more affordable versions of medicines patented elsewhere.

Fierce competition among producers drove prices down dramatically – whereas ARVs for one person per year cost US$10,000 in 2000, today, they cost just less than one per cent of that figure.

India had to start granting patents for medicines in 2005 because of its obligations as a member of the World Trade Organisation. This means that price-busting competition between generic and originator drug producers will be blocked for drugs that receive patents – for example, for several newer medicines to treat HIV and Aids.  

Patent law
When designing its patent law, however, India decided only drugs that show an improved therapeutic effect over existing ones deserve patents. This part of the law – ‘Section 3d’ – intends to prevent companies from continually extending their 20-year drug patents by making minor changes or improvements – a process called ‘evergreening’.

Along these lines, the Indian patent examiner in 2006 rejected the patent that Swiss pharmaceutical company Novartis sought for the leukemia drug Imatinib mesylate (marketed as Glivec), because it was based on a compound that already existed.

Novartis claims that Imanitib mesylate has 30 per cent increase in bioavailability — the body’s ability to absorb the drug — and should therefore deserve a patent under the terms of ‘increased efficacy’.
In response to its drug patent being rejected, Novartis took the Indian government to court in 2006, not only challenging the rejection of its patent, but also the part of India’s law, Section 3(d,) that formed the basis of the decision.

Lower the bar
By challenging the interpretation of section 3(d), Novartis is seeking to lower the bar on patentability in India and force the country to grant more patents. Indeed if Section 3d were overturned, it would mean patenting would become much more widespread in India, severely limiting the production of more affordable generics.

The protracted legal battle saw Novartis file a case in the Madras High Court in 2006 challenging the constitutionality of section 3d. However, in 2007 they lost in the High Court in Chennai which, in a landmark decision, decided to uphold the constitutionality of Section 3d of India’s Patents Act.
The company was also unsuccessful in its appeal before the Intellectual property Appellate Board (IPAB) in June 2009 to overturn the patent rejection of Imanitib mesylate.

However, having never given up Novartis again brought a new case to India’s Supreme Court (the county’s highest judicial authority) trying to attack and weaken the interpretation of Section 3d.
A narrow or a broad interpretation is likely to have a significant impact on the patents regime in India. What the court decides will then be applied to any subsequent application for any patent for any drug.

After a series of false starts and delays throughout 2011 and 2012, final arguments started on July 10 in India’s Supreme Court in New Delhi with stakeholders in the health and pharmaceutical sectors crossing their fingers.