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

Last Updated: 21 September 2016
Article by Miriam Silvestri

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 the price of Glivec® at 140 Colombian pesos (equivalent to USD 0.05) per mg, (less than 50% of the annual USD 15,000 that the Government spends per treatment per patient) –but Novartis rejected the proposal.

This decision boosted the Ministry of Health to declare the molecule Imatinib (Glivec®) of public interest; and, for the first time in Colombia, a compulsory license would force Novartis to negotiate the price of this product with other laboratories.

The Ministry argues the existence of a growing pressure on the health budget requires putting an end to Novartis' control on Imatinib supply and the issuing of a compulsory license as an exception to a patent when deemed a matter of public interest.

The imposition of a compulsory license, however, would not lead to similar measures for other drug products as this is a legal but exceptional decision, according to the Ministry.

Glivec® was Novartis' most sold product last year, generating incomes of USD 4,700 billion. Sales drop dramatically after a cheaper generic version was launched into the US market in February.

The debate over Imatinib could set a precedent for other countries facing rising drug prices.

WHAT NOVARTIS CLAIMS

Novartis opposes a declaration of public interest. The company argues that there is no legitimate basis for the Ministry of Health to issue a compulsory license on Imatinib patent. This position is founded on the following grounds:

  • 1. The patent in question has been legitimately granted for the crystal form of Imatinib mesylate, marketed in Colombia as Glivec®.
  • 2. Sanitary records for Novartis Glivec are in force.
  • 3. There are already other four pharmaceutical companies on the market that commercialize Imatinib and do not infringe Novartis' patent. In the INVIMA [Colombian National Institute for Medicine and Food Surveillance] there are 19 sanitary records of new drug products pending approval.
  • 4. The existence of Glivec® patent does not affect patients' access to treatment. The molecule is part of the treatment of Chronic Myeloid Leukemia included in the Colombian Compulsory Health Plan (POS).
  • 5. Glivec® price has been set and controlled since 2011 by the National Government.
  • 6. A public interest declaration on Glivec® does not represent a solution to the financial challenges faced by the Colombian healthcare system.
  • 7. There is no threat of Imatinib shortage: Novartis has always guaranteed adequate and uninterrupted access to the treatment.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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