Glivec Patent Case in India

Hi David, This is about patent law and generics.... they did not change the formula- just tried to patent the salt form of imatinib- i.e the mesylate bit. This was an attempt to stop the Indian generics industry from selling their copy of imatinib. Long standing fight by Pharma to protect their intellectual property rights.

If anyone is interested in this debate- i.e access to expensive drugs- R&D by pharma- excessive profit or just business - then here are a few links to the various viewpoints and opinions.
It is not easy and there is no simple answer to this- given that most people would not agree to paying any increase in taxes, it is highly improbable that any government would develop innovative drugs, so who else but industry? Some people (usually those without any experience of a diagnosis with a life threatening/limiting disease) have said that those of us unlucky enough to 'get' cancer should just accept it and take the consequences. Obviously that is an extreme view but- if we are to see the fruits of our increasing scientific knowledge and end suffering/cure disease etc. then we have to accept that it costs money and someone has to pay. Last time I looked, no one was signing up to a Socialist Paradise of free healthcare for all, never mind increasing spending on research and development of life saving therapy....I could go on ;o) but won't!

Sandy

The Novartis Decision: Is the Big Win for Indian Pharma Bad News for Investment?
http://world.time.com/2013/04/01/the-novartis-decision-is-the-big-win-fo...

Novartis Media releases
April 01, 2013 08:57 CET

'Supreme Court denial of Glivec patent clarifies limited intellectual property protection and discourages future innovation in India
Patent denied despite global recognition of Glivec as a life-saving, breakthrough drug for certain forms of cancer, with patents granted in nearly 40 countries
Novartis has never been granted an original patent for Glivec in India
More than 9 out of 10 patients currently taking Glivec in India will continue to receive drug free of charge through Novartis Oncology Access programs
Patents are the foundation of innovative drug discovery and essential to advancing medical science and treatment of patients'
http://www.novartis.com/newsroom/media-releases/en/2013/1689290.shtml

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Although the World Trade Organization’s (WTO's) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) obliges all WTO members, including India, to grant patents on medicines, nothing obliges developing countries to replicate the patent systems of wealthy countries. An important flexibility in this respect is the right of WTO member states to define what deserves a patent and what doesn’t, in accordance with their particular national priorities. This is precisely what India did when it amended its patent law in 2005.

At the time of implementing the TRIPS Agreement, India benefited from the experience of other countries where a large number of patents on new uses and new forms of known medicines had been granted, which was creating longer patent barriers and high prices in developing countries. So, along with patent protection for new innovative medicines, Indian lawmakers introduced a specific provision, Section 3(d), in the patent law that excludes from patentability new uses and new forms of known medicines. The system India has is not perfect, but it does prevent pharmaceutical companies from getting unjustified 20 year monopolies every time they come up with a new use or a new form of a known medicine.

What Novartis says: “Section 3(d)—as it relates to evergreening—is not applicable at all to Gleevec.”

Medecins Sans Frontier (MSF) have been campaigning for access to life saving medicines in developing countries for some time and in the case of imatinib (Glivec) since Novartis challenged the producers of generic drugs in India since 2006.

MSF says in a briefing document published on FEBRUARY 14, 2012
"Patents on medicines are a key barrier to making medicines affordable, as it prevents access to those who cannot afford it."

see here : http://www.doctorswithoutborders.org/publications/article.cfm?id=5770&ca...

and here: http://www.doctorswithoutborders.org/publications/article.cfm?id=5768&ca...

"Novartis Takes the Indian Government to Court

In response to its drug patent being rejected, Novartis took the Indian government to court in 2006, not only challenging the rejection of its patent, but also the part of India’s law, Section 3(d), that formed the basis of the decision. If Section 3(d) were overturned, it would mean patenting would become much more widespread in India, severely limiting the production of more affordable generics.

MSF Launches the Original DROP THE CASE Campaign—and the Fight Continues

"The campaign resulted in extensive media coverage and increased public awareness of the role of India as "pharmacy of the developing world." While the company never dropped its case, the Madras High Court in August 2007 ruled against Novartis.
Undeterred, the company has continued to appeal against each legal reversal, with the result that India’s final court—the supreme court—is now due to hear the case in February 2012."

"Section 3(d) is about ensuring that innovation is rewarded with a patent only when it deserves to be. Under this provision, new forms of existing medicines cannot be patented in India unless the patent applicant can show a significant increase in efficacy.

Novartis is seeking a patent in India on the salt form (mesylate) of imatinib (brand name: Gleevec). Claiming a patent on a salt form of an existing medicine is a common practice of pharmaceutical companies to extend the patent life—and therefore the monopoly and the high prices—of medicines. This is known as "evergreening," and companies do this routinely to prevent generic competition.

An example of this is the HIV drug abacavir. Although the abacavir molecule was first developed and patented in the 1980s, pharmaceutical company GSK applied for a patent in 1997 on abacavir sulphate (salt form) in developing countries, with the intention of obtaining a patent monopoly until 2017. In the countries where the patent was granted, this has blocked access to affordable generic forms of abacavir."

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Yesterday, Ranjit Shahani, Vice Chairman and Managing Director of Novartis India said

"Patented products constitute a very small percentage of drugs sold in India and Indian companies such as Cipla and Natco Pharma make generic versions of Glivec and sell it at a fraction of the price sold by Novartis."

“We brought this case because we strongly believe that patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. We have to test the system all the time. The issue is not about Glivec. We will not stop the supply of medicines to India. More than 9 out of 10 patients currently taking Glivec in India will continue to get the drug free through Novartis Oncology Access programmes. There are 1,200 oncologists in India in cities mainly and they know about the access programme,...”

http://www.thehindu.com/business/Industry/will-not-invest-on-rd-in-india...

An interesting statement from Novartis CEO which outlines future strategy here:
Novartis CEO Joseph Jimenez has consistently argued that the industry needs to make big changes in order to survive in the long run, like redefining blockbusters and getting paid for positive outcomes instead of just transactions.
His own company just came face to face with one of the industry's big threats, weaker patents and generic competition. Gleevec, a flagship cancer drug, was denied patent protection in India by the country's Supreme Court. Those sorts of rulings are a huge risk when research and development costs can reach billions of dollars.

Read more: http://www.businessinsider.com/novartis-ceo-on-how-pharma-can-survive-20...