Supplementary protection certificates: when is a product protected by a basic patent?

In Ranbaxy v Warner-Lambert (February 21 2008), the Court of Appeal of The Hague has provided criteria for assessing Article 3(a) of the Supplementary Protection Certificate Regulation (1768/92).

Previously, in assessing whether an application for a supplementary protection certificate complied with Article 3(a) of the Supplementary Protection Certificate Regulation (1768/92), the Netherlands Patent Office (NPO) analysed the scope of protection of the corresponding basic patent under Article 69 of the European Patent Convention and its protocol. This analysis consisted of deciding whether the product for which the supplementary protection certificate was requested would infringe the patent on which the application was based.

Article 3(a) of the regulation states that “a certificate shall be granted if, in the member state… (a) the product is protected by a basic patent in force”.

Two years ago the NPO changed its interpretation of Article 3(a) radically, taking a far more restrictive approach. The NPO seems to be of the opinion that in order for the requirement of Article 3(a) to be met, the product must be “part of the explicit disclosure of the basic patent or of what the skilled person would immediately read in it”, such that it is part of the subject matter of this patent. Consequently, if the NPO believes that a product is not part of the subject matter of the basic patent, the certificate is refused.

One typical consequence of this practice is that where a patent contains claims for compound A and/or a composition comprising compound A, the patentee may obtain a supplementary protection certificate for an authorised drug containing compound A in combination with compound B only if compound B is mentioned in the patent.

The NPO believes that it should refrain from assessing the scope of protection of the patent, as such assessment falls within the exclusive competence of the civil courts. In order to reconcile its current practice with the provisions of the regulation, the NPO asserts that the phrase ‘is protected by’ does not mean ‘falls under the scope of protection of’. Arguably, this practice is at odds with the objectives of the regulation and has no basis in the provisions of the regulation or the case law of the European Court of Justice.

In Ranbaxy v Warner-Lambert, the Court of Appeal of The Hague confirmed that the courts have exclusive competence over infringement cases, thereby apparently affirming the NPO’s current practice. The decision states explicitly that the doctrine of equivalence cannot play a role in relation to the Article 3(a) analysis. In addition, the court held that:

“the question that the NPO must decide is whether the product is part of novel and inventive subject matter for which exclusive rights have been granted by the European Patent Office.”

However, the only provision of the Netherlands Patent Act which is relevant to the assessment of “exclusive rights granted by the European Patent Office” has the same wording as Article 69 of the European Patent Convention. No other legal provision refers to the assessment of exclusive rights.

Therefore, the Court of Appeal seemed to rule out the scope of protection of the basic patent as the decisive criterion. However, the new criterion set out in the decision uses the exact wording of the provision which defines the ‘scope of protection’ in the Netherlands. This view seems to be supported by the factual considerations of the decision.

It remains to be seen how this decision will influence the NPO’s practice. Arguably, the only fair interpretation of the decision would be that the scope of protection of the basic patent (not taking into account the doctrine of equivalence) is decisive. Returning to the abovementioned example, the requirement of Article 3(a) would thus be met, as the question of whether the combination of compounds A and B is covered by a claim concerning compound A is not a matter of equivalence.

It is recommended to take this issue into account when drafting patent applications in the pharmaceutical field and to incorporate as many ‘predictions’ as possible with regard to combination products that may eventually hit the market.