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-644/16, Synthon – resisting its impounded documents being inspected by a rival

How can you prove your case when the other party has in its possession the evidence you need? Perhaps you will need to instigate a search-and-seize raid on the other party? In this case, a Japanese pharmaceutical firm did just that. It organised Dutch court bailiffs to raid a Dutch firm suspected of making patent-infringing drugs. However, once the materials had been seized, the Japanese firm then asked the Dutch court for access to inspect them. This stumped the Dutch judges. What rules and standards should they apply to determine that request in light of the ‘evidence’ rule in Article 6 of the EU’s ‘enforcement’ Directive 2004/48? More

Case C-557/16, Astellas Pharma – measuring the data exclusivity period on a marketing authorisation

Pharmaceutical drugs need a marketing authorisation before they can be sold in the EU. In 2005, a company obtained one for a particular drug. In 2010, it re-marketed the same drug to treat a slightly different illness and got a fresh marketing authorisation. What then should be done for a rival company who is asking for a marketing authorisation for its cheap generic alternative? Should this be granted because the legal protection associated with the initial authorisation has now elapsed? 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

Case C-293/16, Sharda Europe – Deadline missed? Schade!

The problem in this case is twofold. First, what is to be done where EU legislation sets a deadline but the language versions of the legislation are said to diverge? Second, even if the EU legislation sets a date, then can its legal effect still be interpreted away with the aid of national procedural law? More