Parallel import of pharmaceutical product from Poland not allowed

Case no. 214/2014
Judgment delivered on 8 April 2016

Orifarm A/S
vs.
Merck Canada Inc.
Merck Sharp & Dohme B.V.
MSD Danmark ApS

Orifarm imported a pharmaceutical product to Denmark from Poland where it had been put into circulation by the patent owner (MSD). MSD objected, stating that the product was covered by a supplementary protection certificate extending the period of protection of the patent in Denmark. An injunction was then issued against the import, and the case concerned whether this injunction was warranted.

Under section 3 of the Danish Patents Act, a patent owner's exclusive right does not extend to acts concerning products put on the market in an EEA country by the patent owner or with his consent (principle of exhaustion)

The Act of Accession covering, among other things, Poland's accession to the EU was concluded in 2003. This Act included an exception to the principle of exhaustion, stating that if the pharmaceutical product was protected by a patent or a supplementary protection certificate in one of the old member states, and the owner of such patent could not obtain this protection in Poland, the owner could prevent parallel import of the pharmaceutical product from Poland.

A Regulation was adopted in 2006, according to which the protection certificate was extended for six months subject to certain conditions regarding examination of the product's effects on children.

The dispute before the Supreme Court concerned whether the transitional arrangement in the Accession Act of 2003 also covered the six-month extension of the certificate under the 2006 Regulation.

Considering the wording and intention of the rules, the Supreme Court found that MSD could also prevent parallel import for the six months for which its protection certificate had been extended.

In addition, MSD was awarded compensation for the losses suffered due to the parallel import.

The Maritime and Commercial Court had come to the same conclusion.