Novartis in India - An Update

Novartis has been strongly criticised of late for its stance on production of generic versions of the leukaemia drug, Glivec, in India.

And now a petition has been launched by Medicins Sans Frontieres (MSF) to oppose the case and its potential to prevent the production of cheaper generic versions of the drug. In a press release, MSF International Council President, Dr Christophe Fournier, said, "This key source of medicines cannot be allowed to dry up."

In an earlier post, Novartis and the Challenge to Indian Patent Law, a background to the dispute was provided, together with a brief analysis of the claims.

Novartis had obtained exclusive marketing rights for 5 years for its cancer drug, Glivec (marketed as Gleevec in the US) , but because it was decided that the invention was not an invention, the exclusive marketing rights were withdrawn (new form of a known substance). Section 3(d) of the Indian Patents Act, which provides that "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance" will not be sufficiently inventive to warrant patentability. In other words, India is refusing to allow Swiss-type claims. And this is what Novartis wants to challenge, arguing that the law is not TRIPS compliant (Art 27(1)) and is unconstitutional. However, arguably TRIPS does not go as far as mandating the protection of new use, as discussed on IPMed previously. The case will be heard in Madras, 29 January.

To accompany the petition, MSF has also provided a backgrounder as well as a timeline for the case. Commentators have suggested that it may bring the same kind of pressure that saw the end to the South African litigation (which also involved Novartis among others) over HIV medicines in 2001.

Nigerian Law to Increase Local Production of Essential Medicines

Nigeria is about to pass a law to allow local manufacturers to produce drugs to treat malaria and HIV/AIDS, two of Nigeria's most deadly diseases, according to a recent Reuters report.

According to the report, current production levels of necessary drug treatments are insufficient. At present, 14 companies in Nigeria are producing anti-retroviral (ARVs) for the treatment of HIV/AIDS and 8 are producing artemisinin-based combination therapies (ACTs) for the treatment of malaria. At the current levels of production, local companies are able to meet only 30% of the demand for malaria drugs, the rest being supplied by imports from China. Artemisinin (chemical formula at right) is extracted from Artemesia annua, mostly grown in China, but Chinese experts are advising programmes to grow the plant in Nigeria to meet higher production levels.

Ahmed Abdulkadir, special adviser to the Nigerian president, heads a taskforce to produce the essential medicines. In an interview with Reuters, during an anti-malaria conference in China, Abdulkadir said, "We will try to have the legislation passed. We've done all administrative work, it's at the final stage." He said further, "We will dismantle all those barriers so that our local industries are able to produce all of these drugs," explaining that local drug companies were preparing for increased production levels following the passage of the new law. As well as lessening the need for imports, Abdulkadir explains that the law would allow Nigeria to supply west and central Africa.

The World Health Organization (WHO) reports that between 300 and 500 million people contract malaria every year (map at right), with over a million fatalities (1 person every 30 seconds). The vast majority of these deaths (90%) occur in Africa, and most of the victims are children.

The WHO also reports that there were 4.3 million new infections of HIV/AIDS in 2006, with 2.8 million (68%) occurring in sub-Saharan Africa. In 2006, 2.9 million people died from AIDS related illnesses. In Nigeria, largely due to the HIV/AIDS epidemic, there has been a decrease in average life expectancy since 1991, to just 45/46 years (m/f).

Aldulkadir says that the WHO (of which Nigeria became a member in 1960) insists developing countries are given access to these essential medicines, "and that is what we are trying to make sure we have."

Ethical Pharmaceuticals

Best wishes for 2007 from all of us at IPMed.

While we have been on a brief break, an important development in the campaign on access to medicines and needs-based research has been announced.

Professor Sunil Shaunak, Imperial College, and Professor Steve Brocchini, of the School of Pharmacy, University of London, have announced a new model of development and delivery, which they call "ethical pharmaceuticals." The researchers claim that by altering the molecular structure of essential expensive drugs, such as the drug for Hepatitis C, they will be able to develop and market a cheaper alternative, without infringing the original patent or involving pharmaceutical firms. Indeed, pharmaceutical companies have been relying upon such "second generation" innovation to extend the life of a profitable drug before the expiration of patent protection.

With Dr Mire Zloh of the School of Pharmacy, the researchers haved worked to improve the availability and lower costs of existing treatment for Hepatitis C. Dr Zloh has identified the interdisciplinary approach in the research as one of the key factors towards paradigmatic shifts and important developments towards the model for ethical pharmaceuticals. The Schering-Plough drug used to treat Hepatitis C is called PEG-Intron (PEGylated interferon), which means it has a polyethylene glycol (PEG) side-chain on the interferon molecule. The researchers are still using a pegylated interferon but, from the reports, have discovered a way of locating an additional side-chain (second generation pegylation) elsewhere on the molecule. This achieves a more pure modified interferon much more cheaply, effectively creating a "new medicine" that is not protected by the patent. However, the industry has suggested that such drugs will still require safety trials and may potentially result in "a huge intellectual property issue."

PolyTherics (Imperial College spin-out company) was developed to build upon the work of Shaunak and Brocchini, and has teamed with the Indian company, Shantha Biotechnics. In this way, Shaunak and Brocchini will be able to develop and market the TheraPEG without selling publicly funded research to "big pharma" to take to market. Speaking to the BBC, Professor Shaunak said, "We in academic medicine can either choose to use our ideas to make large sums of money for small numbers of people, or to look outwards to the global community and make affordable medicines."