Medicinal products authorised under the "well-established use" procedure benefit from 10-year protection period says Advocate General

On 20 May 2014, Advocate General Wahl handed down his opinion in a case brought before the EU Court of Justice by the Latvian Supreme Court (Case C 104/13 Olainfarm).

The Latvian Court wants to know first whether human medicinal products authorised under the "well-established use" procedure of Article 10a of the Human Medicines Directive (2001/83) can serve as a reference product for generic medicinal products and second whether the marketing authorisation holder of the reference product has a right under EU law to challenge the legality of a marketing authorisation issued for a generic product.

The Advocate General's response to the first question is positive: well-established medicinal products may serve as a reference product. The safety of the product is demonstrated on the basis of scientific literature which is in the public domain. The generic application can thus make reference to a complete dossier which is available to national regulators and which demonstrates the safety and efficacy of the reference product. There is consequently no public health concern. The Advocate General points out that the EU Commission Notice to Applicants (which is not legally binding, but serves as a helpful reference) supports his view.

In response to the Latvian Court's second question, the Advocate General recalls the importance of the 10-year data and marketing exclusivity which is intended to ensure that pharmaceutical companies contributing to innovation are not placed at a disadvantage as compared with manufacturers of generic products. The Advocate General considers that - during this 10 year period - marketing authorisation holders should have the means to enforce and protect their exclusivity and should thus be entitled to challenge marketing authorisations of competing generic products.

More importantly, the Advocate General goes on to state that products containing well-established substances and approved under the "well-established use" procedure should also benefit from the 10-year data and marketing exclusivity period. The Advocate General acknowledges that the level of innovation for well-established products is arguably lower compared to the cost for developing a product containing a new active substance. Nevertheless, he points out that "not affording market exclusivity (and accordingly, a right to challenge a decision allowing registration of a generic with a view to maintaining exclusivity) for well-established products when they are used as reference products for generics would give an unwarranted competitive advantage to manufacturers of generics who could make unlimited use of the file compiled by the holder".

The Advocate General explains in this context that it is cheaper and faster for a competitor to apply for an Article 10 marketing authorisation for a generic of a well-established product than to make use of Article 10a (and compile the file itself using the publicly available data). The data protection period is also justified because it prevents generic companies from free riding on the marketing efforts already made in relation to the reference product, since it can be assumed that the holder, irrespective of the procedure under which the reference product was approved, has had a degree of success in marketing that product.

Although the final judgment in this case is still pending and it remains to be seen whether the Court will follow the opinion, the statements made by the Advocate General on the importance of data protection are encouraging. They are a welcome further acknowledgment of the importance of data protection for the maintenance of innovation in the pharma sector.

Please click on the links below for the other articles in the June 2014 IP/IT newsletter:

• Advocate General considers absolute ban on parallel trade of paralleltraded plant protection products is incompatible with free movement
• SPCs may be issued for safeners used in plant protection products according to EU Court of Justice
• Advocate General considers "legal high" products do not fall under the legal definition of a "medicine"
• Decisions of the Board of Appeal of ECHA
• New actions before the European Courts