Supreme Court to Decide What Is Patently Obvious
It is fast approaching D-day in the Supreme Court between Big Pharma and the Indian government. Starting this Wednesday the court will hear the summary arguments in a precedent setting case over drug patents. The protagonists in the case are Novartis AG, the Swiss drug manufacturer and the Indian Patent Office. The decision may significantly change the operating environment for America’s healthcare sector and possibly curbing the profits it makes as the Worlds medicine cabinet. The final judgment should come within 2 months.
Novartis Patent Issues with Drug, Glivec
The Indian Patent Office is staunchly refusing to grant a national patent to Novartis for the cancer treatment called ‘Glivec’. The Indian contention is that this is not a ‘new’, drug simply an alteration to a well-known compound. Patents give the big drug companies time and market exclusivity so that they can profit from their research expenditure. It also prohibits other small drug companies from copying and underselling the big company. The Indian government would like this to happen so that many more of the country’s poor can get affordable access to the drug.
This is not the first time that India and a drug manufacturer have locked legal horns. The Patent Office removed Bayer AG’s exclusivity rights to Nexavar. Because it was priced way beyond what ordinary Indians could afford. Big Pharma want access to the huge lucrative Indian market but they want it on their terms. They are however concerned by India’s ‘poor’ protection of intellectual property rights.
Affordable Generic Drugs
India is the World center for cheap generic drug production and export. The authorities there not only want to get cheap drugs to their own people they want to profit from making cheap generic copies of brand names.
Glivec has been approved and patented in America since 2001. It sells under the brand name of ‘Gleevec’ for $70,000 a year with the patient taking up to 2 pills daily. It costs a lot less in poorer countries like India through company discount programs. The Indian made generic version costs just $2,500 a year. Generic drug manufacturers do not have the overheads or research costs of Novartis and the other Big Pharma players.
If the Court decision goes against the drug company the loss in money terms would be insignificant because Glivec brings in $4.7 billion a year from worldwide sales. The big issue for Novartis and the rest of Big Pharma is that India would be confirmed as the hardest place to obtain patents and may give a lead to other countries seeking to break the multinationals stranglehold on pharmaceuticals.
The nub of the issue for the Supreme Court justices to decide upon is this, just how much chemical engineering is required to make an innovated compound into a ‘new’ product? Novartis have been claiming enough innovation in Glivec since 2006 warrants a new patent. It is a significant advance in treatment for chronic myeloid leukaemia and some gastrointestinal cancers.
A spokesman for Novartis says:
“The patent for Glivec is not really the issue here. It is just an example of us wanting very clear legal clarity about what kind of innovation is patentable.”