Updated on 1 April 2013
Imatinib mesylate - Branded by Novartis as Gleevec in the US and as Glivec in China and India
What is Glivec?
Glivec or imatinib mesylate is the first of a class of drugs that specifically inhibits a target enzyme, receptor tyrosine kinase, which is characteristic of a particular cancer cell. It thus effectively targets only the cancer cells. It holds the record for the fastest approval time in US FDA history, obtained in 2001. In its heyday, it was hailed as a magic bullet to cure cancer. It is used for a number of therapies, including those for chronic myelogenous leukemia (CML), gastrointestinal stromal tumors (GISTs) and a number of other malignancies.
Is Glivec a recently released drug?
No. It was developed in the late 1990s and was approved by the US FDA in 2001.The first patent was obtained in 1993 for the imatinib molecule, which was never used in patients. After years of research, the beta-crystalline salt of imatinib mesylate was developed, which is new, and this has been granted patent protection in 40 countries now.
Is it called 'Glivec' or 'Gleevec'?
It is the same drug and is marketed as ‘Glivec' in nearly 40 countries including China, Russia, Mexico, Taiwan, Germany, UK, and India, and as ‘Gleevec' in the US.
What's all the fuss all about?
Novartis has appealed for a patent on the beta-crystalline salt of imatinib mesylate, a new version of Glivec. If granted, it will give a 20-year monopoly to Novartis for marketing the drug in India. An earlier ruling in 2006 saw the Indian patent office reject this plea, saying that it did not show any "enhanced efficacy" to be granted a new patent. Novartis then with the help of two writ petitions challenged section 3d of the Indian patent law against the non-granting of patent to Glivec. The current case is regarding the latter.