Compulsory License On Imatinib Mesylate – Drug Determined To Be Of Public Interest By The Colombian Government

Author:Ms Miriam Silvestri
Profession:Moeller IP Advisors
 
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WHAT THE GOVERNMENT CLAIMS

The Colombian Ministry of Health, through its Minister Alejandro Gaviria, seeks to declare the drug product Glivec® of public interest, meaning it would improve the well-being of the general population The product is used to treat Leukemia,its active ingredient being polymorph β of Imatinib mesylate and is currently marketed by Novartis, holder of exclusive rights the drug. This is the first step for the Colombian Superintendence of Industry and Commerce to declare the compulsory license for the production of the drug product by generic laboratories, which would allow the commercialization of the drug product at a lower price.

Novartis holds the invention patent No. 29270, called «Crystal Modification Of a N-Phenyl-2-Pyrimidineamine Derivative, Processes for its Manufacture and its Use», granted by the Superintendence of Industry and Commerce through Resolution No. 24250 of April 25, 2012, in force until July 9, 2018.

The patent claims the polymorphic form β of the compound Imatinib mesylate and it is intended for the treatment of all the stages of Philadelphia chromosome-positive leukemia and Chronic Myeloid Leukemia (Ph+ CML), metastasis and/or KIT (CD117)-positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST), as well as other types of cancer). Patients receiving Glivec® show a survival rate of 90% and can often achieve a long and productive life. To the contrary, patients who are not treated with Glivec® show a life expectancy of only 30%.

The patent application was filed before the Colombian Superintendence of Industry and Commerce on July 9, 1998. In 2003, after the examination process, the application was rejected for non-compliance with the patentability requirements of novelty and inventive step, pursuant to Decision 486. The resolution of denial allowed Colombian laboratories to manufacture and commercialize the generic products of the same molecule for several years. Novartis appealed the decision before the State Council: the company obtained a favorable ruling and the patent was finally granted in 2012. As a consequence, the domestic laboratories were forced to withdraw their generics out of the market and they had no choice but to negotiate a patent license with Novartis.

According to Colombian Ministry of Health, the granting of the patent resulted in a significant growth of the costs of public health regarding the treatment of leukemia. The Ministry tried to set...

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