Inside Story

Protecting patents or patients?

As the Swiss drug company Novartis loses its patent renewal battle in India, we ask who the real winner is in this case.

I think that this judgment today, coming from Indian Supreme Court … it’s a good decision for millions of patients not just in India, but all over the world … today’s decision, is not about all kind of patents, so if there are some really innovative and new drugs and innovations, they are still patentable and this today’s decision has nothing to do with that.

– Aziz Ur Rehman, policy advisor for Doctor without Borders 

Swiss drug maker Novartis has lost a battle in India’s highest court to patent an updated version of its cancer drug Gilvec.

The Supreme Court has dismissed the application, saying the new version was only slightly different from the old one. The landmark ruling sets a precedent covering patents on all existing drugs in India.

Updating medicines to gain new patents is known as ‘evergreening’. Novartis has declared the modification took years of research and makes the drug more effective, and the company has succesfully patented the new version in nearly 40 other countries. 

“We brought this case because we strongly believe the patents safeguard innovation and encourage medical progress, particular for unmet medical needs.” Novartis Indian managing director said. 

Meanwhile, Doctor Without Borders, an international medical humanitarian organisation, warned that the victory for the pharmaceutical company would have limited access to important medicines for millions of poor people around the world.

India does grant patents on new pharmaceutical drugs for 20 years …. What the India decision is, it’s not whether or not you grant patents on new drugs and it shouldn’t be portrayed like that … iIt’s really a decision about whether or not you can extend a patent beyond the first 20 years for a new product and that’s why the court has rejected this case.”

– James Love, director of Knowledge Ecology International

India’s $26bn generic drug industry, supplies much of the cheap medicines to the developing world. Many of the drugs used to treat HIV and AIDS, are copied in the country but that does not guarantee these cheaper drugs are always available where they are needed.

Phamaceutical companies spend billions of dollars on research and development. And patents are vital for protecting what they produce.

Patents usually protect the sales of a drug for around twenty years. Once a patent expires, other companies can jump in and make cheaper copies of the original ones.

There is a lot at risk. In the next five years, prescription drugs with combined annual sales of $290bn are expected to lose their patent protection, and it can prove costly.

So who is winning the battle in a multi-billion dollar industry pitting profits against provision for the poor?  Should generic drug companies be allowed to rip off the pharmaceutical giants?

To discuss this, Inside Story, with presenter David Foster, is joined by guests: Aziz Ur Rehman, a policy advisor for Doctors Without Borders; and James Love director of the NGO Knowledge Ecology International and a specialist on intellectual property policy.

“The Indian companies will be making a version of this drug,  which is very cheap. The Indian companies have the technology, and if a drug is off-patent then its benefit should go to the patients. And that’s the thinking which has been brought in through the amendments which the Indian government made in 2005, and that thinking has now been validated by the Supreme Court’s decision.  

“In fact if you see the laws of Brazil, even of US and Europe, it is quite difficult to get a patent for a polymorph, it is like saying, now there is a pill which is now pink in color and give me a patent. It is very difficult to get a patent like that in many other countries, it’s a strategy to extend the life cycle of an expired drug, which is not encouraged in any country of the world.” 

– Rajeshwari Hariharan, a lawyer for Natco Pharma Limited, an Indian pharmaceutical company committed to manufacturing affordable medicine