India had a process patent regime prior to its WTO entry and today India follows a product patent – where only the molecule or the base product can be patented. The earlier process patent enabled Indian drug companies to reverse engineer the drug/molecule and sell it in the market – undercutting the original inventors. In 2002, India adapted the TRIPS agreement of WTO on product patent – and thus began a new patent regime. However Indian Generics could not be deterred by the new patent regime. Indian Generic drug manufacturers found a new lucrative market for making generic versions of the drugs losing the patent protection. Indian generic manufacturers were able to make rapid gains in overseas market – US & Europe for the drugs which was going out of patent protection: Simvastatin (Zicor), Atorvastatin (Lipitor)
Companies which invented these drugs therefore had to develop new ways of protecting their best selling drugs from competition from generics. This has led to idea of patenting “incremental innovations” such as drug delivery systems, polymorphic forms, and recombination. Patenting such innovations is seen as a technique for providing patent cover for the drug for an additional 20 years after the original patent for the molecule/product has expired. This leads to a perpetuality of the patent. The original inventor can get infinite extensions to patent protection on a drug – contends Indian pharmaceutical alliance.
This issue is now being contested in Indian courts. Novartis has filed a patent application to patent “Glivec” which is a polymorphic form of Imatinib mesylate. This patent was contested by Natco Pharma – which markets a generic version of Imatinib mesylate under the brand name “Veenat”. Novartis lost the first round in the legal battle and has moved the Chennai high court for a review of the ruling by the lower court. The courts will now decide if incremental innovations to a drug can be patented & if its approved it may spell bad news for patients – especially in poor countries such as Africa, Asia & India.
Also See:
- Why Invest in India: Innovation & Creativity
- Knowledge Management - The blood & lifeline of any company
- Creating a Culture for Innovation and Protecting Intellectual Property - Part 1
- Creating a Culture for Innovation and Protecting Intellectual Property - Part 2
- Protecting IP Assets of an Organization
- Types of Intellectual Property
- Business Creativity and Innovation
- Indian Style of Innovation
1 comment:
On August 7th 2007, Chennai High Court dismissed Novartis claim that Indian patent laws violated World Trade Organization rules and should be removed.
Groups such as Doctors Without Borders and Oxfam International had criticized Novartis for filing the suit, leading to months of bad publicity for Novartis. They argued that if Novartis were successful in changing Indian law, drug companies would be able to patent meaningless changes to drugs.
"This ruling is a lifeline for the millions of people who cannot afford brand-name drugs, and ensures that essential medicines from India will reach those who rely on them"
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