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-642/16, Junek Europ-Vertrieb – can its sticky label stop the artificial partitioning of the internal market?

A German company sells a trademark medical dressing. Having exported some of its stock to Austria, it was surprised to see this subsequently turn up in a German pharmacy. Unsurprisingly, the German company wants to stop its German prices from being undercut. Consequently, it has invoked the EU’s ‘trade mark’ Regulation 207/2009. This is because Article 13(2) allows it to prohibit the further commercialisation of its goods ‘in particular’ where these have been changed or their quality impaired. In that context, the German company is objecting to the Austrian importer-exporter having applied a sticky label to the packaging. However, the legal question is: does Article 13(2) bite at all because the sticky label was only on an otherwise blank part of the outer-packaging so there has been no change to the goods or impairment of their quality. 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-329/16, SNITEM – against state diktats for healthcare software

When doctors write prescriptions for patented or brand medicines rather than generics this behaviour can cost a national healthcare system dear. Consequently, the French State has had a bright idea. Henceforth, any software running on prescribing-doctors’ computers must be approved of by the French State. Approval will only be granted where for example that software tells doctors about the existence and price of generic medicines. Unsurprisingly, industry objects to this French cost-cutting wheeze. It claims that this type of software is a ‘medical device’ within the scope of the EU’s ‘devices’ Directive 93/42/EEC. Accordingly, these criteria for obtaining French State approval are nothing other than technical state measures that are akin to quantitative import restrictions, and those are banned by Article 34 TFEU. However, the success of industry’s legal argument depends on whether such software can really be said to be a ‘medical device’ at all. More

Case C-267/16, Buhagiar – Gibraltar, guns and the constitutional order

The Supreme Court of Gibraltar has made its first preliminary reference to the CJEU, and the burning issue is the free movement of hunters’ firearms. More