Pfizer v. Orifarm - Court of Justice of European Union Rules in Favour of Patent Owner and Thwarts Parallel Imports of Medicines from New Accession Countries
- 25/06/2018
- Articles
On 21 June 2018, the Court of Justice of the European Union (the “ECJ”) ruled in favour of patent owners in the pharmaceutical sector when applying the Specific Mechanism to European Union-bound imports of patented medicines from new accession states (Bulgaria, Czech Republic, Croatia, Estonia, Latvia, Lithuania, Hungary, Poland, Romania, Slovenia and Slovakia). Under the Specific Mechanism, pharmaceutical product patents and supplementary protection certificates (“SPCs”) can be used to prevent parallel imports from a new accession state, if (i) the patent applications were filed in the “core” EU Member States when the accession state did not permit that sort of protection; and (ii) the person intending to import or market the product has given one month’s prior notice to the holder or beneficiary of the patent or SPC.
This rather straightforward principle was at stake in patent litigation pitting Pfizer against Orifarm, a parallel trader in pharmaceutical products. Enbrel® had been given a first marketing authorisation in Switzerland in 2000. That authorisation also applied in the European Union. On the back of this approval, the patent protection covering this product had been prolonged by an SPC and by a paediatric extension in the “old” EU Member States.
When the accession countries joined the European Union in 2003, 2005 and 2012, these countries did not provide for patent protection for inventions such as those disclosed in the Enbrel® basic patent at the time the Enbrel® patent was filed. The owner of the Enbrel® patent, Wyeth (which was later acquired by Pfizer), was therefore unable to obtain a basic patent in these accession countries and, as a result, also unable to secure an SPC or a paediatric extension of that patent. Enbrel® could thus legally be put on the market in those accession countries.
Orifarm then sought to import Enbrel® from the new accession countries into EU Member States which had patent protection, arguing that the principle of free movement of goods should prevail.
Pfizer objected and relied on the Specific Mechanism. The issue arose because, even though patent protection had not been available in the accession countries at the time of filing, the situation had changed by the time the SPC was applied for in the old EU Member States, as the accession countries then did afford the protection provided by SPCs. Pfizer argued that a pre-condition for an SPC was that a basic patent should be in force. It maintained that if the country did not provide for a basic patent at the time of filing, then the subsequent availability of an SPC was not relevant. Pfizer added that it had diligently sought patent protection where and when such protection was available. If Pfizer did not benefit from a patent in the active substance for Enbrel®, it was because Pfizer had not been able to secure a patent at that time, and not that it had chosen not to obtain one.
The ECJ, following the Advocate General, sided with Pfizer and held that the Specific Mechanism must be interpreted as authorising the holder of an SPC to oppose the parallel importation of a medicine from new Member States which did not provide for a basic patent at the time the application for a basic patent or SPC was filed with the result that it was impossible for the patent holder to obtain an equivalent patent and SPC in the exporting states.
The ECJ added that the Specific Mechanism also applies to the extension provided for in Article 36(1) of Regulation No. 1901/2006 on medicinal products for paediatric use.
The judgment of the ECJ in case C-681/16, Pfizer Ireland Pharmaceuticals v. Orifarm, can be found here.
