India's Supreme Court has issued a major judgment against Swiss pharmaceutical company Novartis AG, denying a request to issue a patent for its cancer drug, Glivec.
Monday's ruling hurts multinational drug companies by not allowing them a monopoly on their products, opening the way for competition from much cheaper generic drugs, produced and distributed without patent protection.
India has a huge, $26bn generic drug industry, which is estimated to provide about one-fifth of the world's generic drugs.
Al Jazeera's Sam Bollier spoke with James Love, director of Knowledge Economy International and an expert on pharmaceutical drug policy, about the court's ruling.
How did India become such a major hub for generic drug production?
The decision by Prime Minister Indira Gandhi and the India parliament to abolish patents on pharmaceutical products in 1970 led to the development of a strong manufacturing sector for pharmaceutical drugs in India.
This took place despite all sorts of other problems in India’s economy, including extensive regulation of investments and a very poor population. India today has thousands of drug companies, including dozens of very important firms that manufacture drugs for the US and EU markets, as well as the rest of the world.
Since the India patent law was changed in 2005 to permit the patenting of new pharmaceutical products, a number of India’s generic companies have been purchased by large multinational firms from the United States, Europe or Japan. India remains, however, a highly competitive market for the supply of high-quality generic drugs.
Will this ruling have any immediate effects for people in India or elsewhere in the developing world?
This is a huge victory for patients around the world, including those living in developing countries. It does not solve all of the concerns about patents on health-related inventions, but it clears out many of the patents that have been used to inappropriately extend monopolies.
"As the debates over innovation and access to drugs continue, policy makers need to look beyond drug monopolies as the only tool to promote innovation. "
- James Love, director of Knowledge Economy International
As the debates over innovation and access to drugs continue, policy makers need to look beyond drug monopolies as the only tool to promote innovation.
The new de-linkage paradigm - of separating drug development rewards from drug prices to boost innovation and access - is seen as important.
What does the Supreme Court ruling mean for India’s generic drug industry?
The domestic Indian drug companies that manufacture generic drugs will be free from many of the follow-on patents, many of them on minor innovations, that would otherwise delay market entry.
India’s patent law excludes the grant of patents for “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”.
In the United States, Europe and in many other countries, a practice has evolved to grant patents on new forms and uses of older drugs.
Examples of this would be the late patents on AZT, a product first discovered in 1964. In 1985, Burroughs Wellcome filed a patent on the use of AZT to treat AIDS, and later Glaxo obtained a patent for use of AZT in combination with another drug, 3TC, to treat AIDS.
These types of patents are not granted in India.
Under what conditions can drugs in India receive patent protection?
India has always granted patents on the processes to manufacture drugs. Since 2005, patents on pharmaceutical products can be granted for new substances that have improved efficacy, and plenty of such patents have since been granted.
Does the court’s ruling conflict with India’s obligations laid out by the WTO?
Novartis and others argued that the India patent law violates Article 27 of the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement, which requires that “patents shall be available for any inventions … provided that they are new, involve an inventive step and are capable of industrial application”.
Switzerland, Japan, the US and the EU have all declined to bring a case against India on this issue - and certainly this is because India would be expected to successfully defend its patent law.
Making it much more difficult for India to lose such a case is the language from the 2001 WTO Doha Declaration on TRIPS and Public Health, which among other things says that the TRIPS agreement “should not prevent members
from taking measures to protect public health” and should “promote access to medicines for all”.
In the Novartis case, the Court made it clear they acted in a way to “promote access to medicines for all".