Brazil Superior Court denies extension of Novartis Glivec/Gleevec patent

Brazil’s Third Chamber of the Superior Court of Justice (STJ) has unanimously denied extending by almost a year the patent of Swiss drug major Novartis’ (NOVN: VX) imatinib (marketed as Gleevec in the USA and Glivec in Europe and Latin America).

Novartis maintains that its patent on imatinib is valid until March 2013. However, the STJ confirmed the agreement of Brazil’s intellectual property agency, the INPI, that had granted the patent until April 2012. The drug, first approved in May 2001 by the US Food and Drug Administration, is used for the treatment of patients with chronic myeloid leukemia and people with metastatic malignant gastrointestinal stromal tumors.

This ruling is in line with that of the STJ in the cases of Pfizer’s erectile dysfunction drug Viagra (sildenafil) and blockbuster cholesterol lowerer Lipitor (atorvastatin). The latest case refers to a mechanism created by Brazilian legislation known as the “pipeline.” The current Industrial Property Law, published in 1996, included the pipeline to protect inventions of pharmaceutical and chemical patents that could not be patented before. This considers the possibility of protecting under the patent system chemical substances, compositions and products, in particular for the chemical, pharmaceutical and food industries that were already known. Through this mechanism the INPI argues that protection in Brazil should be counted from the “first filing” abroad.