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Important European Court Opinion on the Specific Mechanism - What Does This Mean for Parallel Trade?

on Wednesday, 18 April 2018.

The recent case of Pfizer Ireland Pharmaceuticals v Orifarm GmbH has resulted in an important opinion from the EU's Advocate General on the interpretation of the Specific Mechanism.

The case involves the parallel importation of a pharmaceutical product from certain 'new' EU Member States into Germany. His opinion favoured the patentee, Pfizer.

The Specific Mechanism

The Specific Mechanism is an exception to the European law principle of the exhaustion of intellectual property rights concerning pharmaceutical patents. The Specific Mechanism essentially provides that, if at the filing date of a patent or SPC (supplementary protection certificate) for a pharmaceutical product in the 'old' Member State of import (eg Germany), equivalent patent protection was not available in the 'new' Member State of export (eg Poland), the patentee can prevent traders from importing and selling the product in the old Member State.

The Specific Mechanism is a transitional measure. It was principally introduced to prevent a flood of cheap pharmaceutical imports coming into western Europe following the accession of the new Member States to the EU. There will come a time when equivalent patent protection was available in each of the new Member States at the filing date of all patents and SPCs in the old Member States. At such time, the Specific Mechanism will cease to have any application.

The Facts of the Case

The parallel trader, Orifarm, imported Pfizer's Enbrel® product (used to treat arthritis) from a number of new Member States into Germany. During the relevant period, Enbrel® was protected in Germany by an SPC owned by Pfizer (an SPC extends the term of certain patents protecting pharmaceutical products by a maximum of five years).

At the filing date of the basic patent protecting the API (active pharmaceutical ingredient) in Enbrel® in Germany (which had since expired), equivalent patent protection was not available in any of the new Member States of export. However, at the filing date of the corresponding German SPC, equivalent protection was available in those new Member States.

The referring German court seeks clarification on whether, in those circumstances, a patentee such as Pfizer can rely on its rights under an SPC in an old Member State (Germany) to prevent importation of the relevant product from the new Member States during the term of the SPC.

The Advocate General's Opinion

The Advocate General's opinion was that Pfizer could indeed invoke its rights under the German SPC to prevent Orifarm's trade in Enbrel®. He considered the Specific Mechanism to be clear that the test is whether equivalent protection for that particular product was available in the new Member State(s) at the filing date of the German SPC. Here, even though SPC protection was generally available in the new Member States at the SPC's filing date, Pfizer could not have applied for an SPC for the API in Enbrel® in those countries at that time. This was because basic patent protection was unavailable in the new Member States at the filing date of the German patent protecting Enbrel®. Therefore, at the filing date of the German SPC, an equivalent patent protecting Enbrel® could not have existed in any of the new Member States upon which to found an SPC application to extend such patent. Hence, equivalent SPC protection was not available for Enbrel® at the filing date of the German SPC and the Specific Mechanism applies.

The Advocate General also considered that:

  • the key date for considering the availability of equivalent basic patent protection in the new Member State is the filing date (not the publication date) of the patent in the old Member State
  • the question is whether the patentee could have obtained such a patent in the new Member State, not whether it did
  • a paediatric extension (which extends the term of the corresponding SPC by six months) falls within the scope of the Specific Mechanism (even though paediatric extensions are not expressly mentioned)

Comment

In deciding the case, the Court of Justice of the European Union is not obliged to follow the Advocate General's opinion. However, if the Court does agree with the Advocate General, this would appear to be a sensible decision. It is clear that equivalent protection for Enbrel® was not available in the new Member States at the filing date of the German SPC. This is notwithstanding that SPC protection was generally available at that time. Therefore, the Specific Mechanism should apply.


For advise on the application of the Specific Mechanism, or if you are involved with parallel trade and would like to discuss further, please contact Tom Cahill in our Pharmaceuticals and Life Sciences team on 01923 919 330.

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