On April 1, 2013, Novartis lost patent protection case on its cancer drug Glivec. The difference in cost of Glivec and its generic variant is such that cost of a month’s supply of Glivec costs around Rs 1.2 lakh while that of a generic costs around Rs. 8000; Glivec is approximately 10 times costly as its generic variant. [Reference]
What is Glivec?
Gilvec is a cancer drug by Novartis. This drug can be used for treatment of all phases of Philadelphia-positive chronic myeloid leukemia (Ph+ CML), as well as for certain patients with KIT+ gastrointestinal stromal tumors (GIST). [Reference]
What is Glivec Patent case?
Novartis filed for patent protection of Glivec in year 2006. Court ruled that new and earlier Glivec versions were not different enough to call innovation and thus patent protection cannot be granted. The term to slightly modify a patented product to extend patent is called “Evergreening”.
How do patents work?
Patents usually protect the companies for 20 years of exclusive sales. After that, it is open to other firms who can make cheaper copies of the original drug. Patent is generally filed at the inception of idea which can be long before the product is industrially produced and sold.
Once the protection expires, the first company to challenge the patent gets an exclusive right to sell the copy for 180 days.
After 180 days, more companies can sell the generic versions, potentially resulting in a further price drop.
What’s the section of law that was enforced?
3. What are not inventions? The following are not inventions within the meaning of this Act (only section d has been given for conciseness)
(d) 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 or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;
What may be long term impact?
- Pharmaceutical companies would be careful while filing patent protection on the evergreening practices.
- Generic companies would gain and pharma companies may be reluctant to invest much in Research and Development in India. However, pharma companies may not stop selling their medicines in India because of India’s big market.
- India supplies drugs to many African countries. Availability of cheaper drugs would have a positive impact on developing countries worldwide. [Reference]
Novartis can file a review petition within 90 days. [Reference]