Extension of patent protection by supplementary protection certificates

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The Court of Justice of the European Union (ECJ) recently provided guidance as to how various aspects of the EU law on supplementary protection certificates (SPCs) should be interpreted, in the Medeva, Georgetown, Queensland, Yeda and Daiichi judgements. The High Court has now issued its first decisions in which these judgements were considered and applied in the UK.

The ECJ’s judgements had indicated that an SPC could not be granted relating to active ingredients which were not specified in the wording of the claims of the patent on which the SPC was based. The ECJ also ruled that an SPC cannot be granted for a single active ingredient in isolation in the event that the relevant patent claims a product composed of two active ingredients, and does not claim the active ingredients individually.

In the case of MedImmune v Novartis the High Court felt it was not obvious how the “specified in the wording” test should be applied. Although the ECJ had made it apparent that the test was more than a pure infringement test, such that it was not enough for the active ingredient to fall within the scope of the claim, it had not provided any clearer guidance than this. It was therefore viewed as uncertain whether it would be sufficient for the product to be described in functional terms, or perhaps as part of a general formula, or whether the active ingredient in question needed to be explicitly stated in a claim.

It was suggested that this issue should be referred back to the ECJ for more
clarification and it was noted that a related litigation between the two parties
was pending before the Court of Appeal, which would be the best placed forum
to make the referral. Several cases where this question is at issue are pending in other national courts in Europe and it remains to be seen whether they also feel the test is not sufficiently clear.

In the case of Queensland v the UK Intellectual Property Office, it was agreed by all parties that some of the SPC applications under consideration now had to be refused, as they covered combinations of active ingredients where some of these active ingredients were not in any way identified in the wording of the claims. These applications could only have succeeded in the event that the ECJ had set out a pure infringement test as the correct approach.

For the remaining applications, it was clarified that it was allowable to have more than one SPC application based on a single patent. In this regard it was confirmed that although EU law does impose a limitation in terms of the number of SPCs that can be obtained per patent, this restriction should be understood as being that there can only be one SPC per product per patent. Therefore the UK courts will allow more than one SPC based on a given patent provided that each SPC is for a different active ingredient.