Case C-681/16, Pfizer Ireland – Specific Mechanism suppresses drug circulation

The internal market in pharmaceuticals can be partitioned by EU law. For example, the EU’s ‘Specific Mechanism’ will sometimes allow patent holders to stop the import of drugs into the ‘old’ Member States from the ‘new’ Member States, where prices are markedly lower. In this case, the drug company patent holder Pfizer wants to stop cheap imports of a psoriasis and arthritis drug from entering into Germany – and to that end, it has invoked the Specific Mechanism. In contrast, the importer contends that the Specific Mechanism does not apply; consequently, the EU principle of the free movement of goods should be allowed to operate. More

Case C-567/16, Merck Sharp – SPC Lazarus law

Drug companies can increase their profits by extending the life of their patents. In the EU, extensions can be granted with an ‘SPC’. However, these need to be applied for and their award is governed by the rules laid down in the EU’s ‘SPC’ Regulation 469/2009. In this case, a drug company applied for an SPC but it failed to provide a required document, and instead enclosed a different piece of paper. Does the omission kill the application? And if so, then is the application really dead? Can it be reanimated by dint of the fact that when the company had made its application the document did not exist but the company had offered to supply it at some point in the future? More