Big Pharma talks patent nonsense

Big Pharma never ceases to surprise but the demand from Novartis that the NHS uses one of its expensive products rather than a cheaper one really takes the biscuit.

In a bid to reduce drug costs, four NHS areas in the south of England are using a cheaper alternative to Lucentis to treat a common cause of loss of vision known as wet AMD.

Lucentis, which costs around £740 per injection, is the treatment officially recommended to the NHS in England by the independent advisor NICE.

Avastin, also made by Novartis, is not officially approved for eye conditions, but is being used when it is prescribed by a qualified opthamologist. It costs around £60 per injection.

"Avastin is internationally recognised as an effective treatment for AMD, and for example over 50% of AMD patients in the United States are treated with Avastin," the NHS trusts say.

Novartis is now going to court to claim that the hospitals are putting hospital patients at risk by using Avastin instead of Lucentis, which, coming from an industry known for all sorts of data manipulation, is really too much.

In the end, it’s about the corporation’s profits, much of which comes from supplying drugs to the NHS. The health service’s annual drugs bill is £12 billion, almost double the total cost a decade ago.

The judicial review launched by Novartis comes as the corporation renews its challenge in India against a law which prohibits indefinite extension of patents. For over six years, it has challenged a clause that prevents “evergreening”, a practice in which companies continuously extend the life of a patent by slight modifications.

This prevents generic manufacturers from producing the drug. India is a major exporter of generic medicines to developing countries, including 80% of the medicine now used to treat over 6.6 million people living with HIV/AIDS.

According to Nature magazine, Novartis is also seeking a 20-year patent on a new version of its 11-year-old anti-cancer drug Gleevec, which costs roughly $30 for one 100-milligram pill. A generic version of the drug can cost as little as $3.

Leena Menghaney, campaign coordinator of Medecins Sans Frontieres in India, who is leading the fight against the Novartis challenge, says the country is also facing a diplomatic offensive from the European Union and the United States. They want India to give into Big Pharma’s demands.

When India signed up to the World Trade Organisation's agreement on trade-related aspects of intellectual property rights (TRIPS) in 2005, the country won a clause that states that a drug must show a marked difference in efficacy from previous versions to be patentable. “Whereas US patent offices often grant frivolous patents on routine pharmaceutical improvements to a drug, India's law is more stringent,” says Menghaney.

With final hearings in the Supreme Court scheduled for July, she warns: “If Novartis wins, many other medicines, even those that show no increased therapeutic efficacy, will be patentable in India, and the availability of affordable medicines will be threatened… Abusive “evergreening” practices, where drug companies maintain artificially high prices on medicines well beyond the original patent period by securing fresh patents on minor modifications of existing drugs, will become rampant in the future.”

Big Pharma – the top 20 corporations have an estimated $150 billion in resources – is more interested in protecting patents than developing new drugs against common diseases, or in persuading people to buy “lifestyle” drugs they don’t really need.

Scientists say that little new has come out of the industry over the last decade. Meanwhile, universities are starved of resources and money devoted to research. Big Pharma has an unhealthy grip on society’s collective throats that requires a strong dose of revolutionary medicine to get rid of.

Paul Feldman

Communications editor