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-528/16, Confédération paysanne – against new herbicide-resistant plants

American fields are being planted with seeds that have benefited from new techniques of genetic engineering like gene editing. These new seeds have been modified to produce plants that will even survive being sprayed with lethal herbicides. However, French environmental groups anticipate that these new seeds will be soon imported into the EU. They fear that the EU rules on genetically modified organisms in Directive 2001/18/EC are just not able to regulate these new seeds properly. The French courts simply wonder if the EU rules contravene the EU’s ‘precautionary principle’ enshrined in Article 191(2) TFEU. More

Case C-229/16, Ministério da Saúde – not just any old debtor but a public health debtor

There is a rule in the EU’s ‘late payment’ Directive 2000/35 that an invoice should be paid within 30 days. The question is: does the Directive apply to the Portuguese Ministry of Health in respect of the money it owes to the people who run Portugal’s pharmacies? More