The European take on the Bolar provision: conclusions from Astellas v Polpharma

The European equivalent of the US Hatch-Waxman Act of 1984 (which encouraged the manufacture of generic drugs by the pharmaceutical industry) is the change made on March 31, 2004 to Article 10, point 6 of Directive 2001/83/EC, which introduces regulations into European law in the light of which “conducting the necessary studies and trials … and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products” if they are performed so as to meet the requirements defined in pharmaceutical law in connection with procedures to obtain a marketing approval (MA) for a medicinal product, in particular a generic product, given effect through the introduction of appropriate changes to the national patent laws of EU member states, including the German Patentgesetz (§11 Nr. 2b PatG) and the Polish Prawo własności przemysłowej (Article 69 ust.1 pkt 4 IPL).