Supplementary Protection Certificate Update

In October 2009, the English Court of Appeal referred two questions to the European Court of Justice on Article 13(1) of Regulation No 1768/92 (now Regulation No 469/2009) (the "SPC Regulation") on Supplementary Protection Certificates ("SPCs"). The ECJ judgment is not expected until next year.

In addition we report on an ECJ ruling following a referral by the Dutch courts on Article 3 of the SPC Regulation, on the conditions under which an SPC will be granted.

Finally we review a case on interpretation of legislation relating to the 'paediatric extension'.

Duration of SPCs - As we reported in the last newsletter, the first case (Generics (UK) Limited v Synaptech (Case C-427/09)) concerned the duration of SPCs under Article 13(1) of the SPC Regulation. Article 13(1) provides that SPC protection is calculated by reference to the period from the date of application for the basic patent until the first marketing authorisation in the EU.

The SPC was based on a Swedish marketing authorisation granted in 2000, although earlier marketing authorisations concerning the same active ingredient had been granted in Germany and Austria that were not compliant with Directive 65/65/EEC (replaced by Directive 2001/83/EC) ("the Directive").

Synaptech argued that the "first marketing authorisation" under Article 13(1) of the SPC Regulation meant an authorisation granted only in accordance with the Directive. Generics (UK) claimed that the SPC should have expired in 2008 or earlier on the basis that the earlier authorisations were 'deemed' approvals although not compliant with the Directive.

This decision was appealed by Generics (UK) and the Court of Appeal decided to refer the above the question to the ECJ. As the questions overlapped with those referred by the English Patents Court in Synthon v Merz (Case C-195/09) in March 2009 the Court of Appeal requested that both references be joined.

Comment - The ECJ judgment in the Generics/Merz reference is not expected until next year

Multiple SPCs - The second case, AHP Manufacturing BV v Bureau voor de Industriele Eigendom ("BIE") (Case C-482/07), was the subject of a reference to he ECJ following a refusal by the Dutch Patent Office (BIE) not to grant Roche an SPC in respect of the medicinal product, Enbrel, as three certificates had already been granted to separate holders of basic patents covering the same product.

The Dutch Patent Office based its decision on a strict interpretation of Article 3(c) of the SPC Regulation in the light of Article 3(2) of Regulation No 1610/96 which provides for similar certificates in respect of plant protection products. The SPC Regulation provides that an SPC shall be granted if the product (i.e. the active ingredient) has not already been the subject of a SPC. Regulation 1610/96/ provides that the holder of one or more patents for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for this product may be issued to each of these holders.

Roche appealed the decision of the Dutch Patent Office and the Dutch court decided to refer the following questions to the ECJ for a preliminary ruling.

The ECJ held that the Regulations permit the grant of an SPC to the owner of a basic patent for a product when one or more certificates have already been granted to one or more patentees for the same product.

Comment - The ECJ had already decided in Biogen Inc. v SmithKline Beecham Biologicals SA (Case C-181/95) that different owners of basic patents can obtain separate SPCs for the same product although only one SPC may be granted for each basic patent. Regulation No 1610/96 came into force after the date of the Biogen judgment, and expressly refers only to a situation where multiple applications by different patentees are co-pending. The ECJ extended this principle to permitting the grant of an SPC for a product for which, at the time the SPC application is submitted, one or more SPCs have already been granted to one or patentees (i.e. as opposed to being pending).

Guidance on the 'Paediatric Extension' - The Court of Appeal in EI du Pont Nemours & Co v United Kingdom Intellectual Property Office (2009) has given guidance on the requirement to include a statement indicating compliance with an agreed paediatric investigation plan ("PIP") under Article 8(1)(d) of the SPC Regulation as amended by the Paediatric Regulation 191/2006, in an application for the 'paediatric extension', and on the meaning of "irregularity" in Article 10(3) of the SPC Regulation.

The UK Intellectual Property Office decision to refuse its application for a paediatric extension because: a) the marketing authorisation did not carry a statement indicating compliance of the application with the agreed completed PIP, as required by Article 8(1)(d)(i); and b) the product was not authorised in all Member States as required by Article 8(1)(d)(ii).

E I du Pont appealed arguing that the application was not deficient and, in any case, if it was deficient, this could be cured under the provisions of Article 10(3) whereby the Comptroller can ask the applicant to cure an "irregularity" within a stated time.

The Court held that "irregularity" should be given a wide enough to cover cases, such as the present one, where the defect is cured after the date of application. There was nothing specific indicating that everything must be in the application, or capable of being in the application, by the deadline for making it, and this did not seem necessary taking into account the purposes of the Paediatric Regulation.

The Court stated that the Article 10(3) time period should, unless the applicant has behaved unreasonably, be extended to enable the applicant to comply with the requirements. The Court held that the deficiencies could be rectified under Article 10(3), and that the appeal would therefore be allowed, and the extension granted.

The Court also gave guidance on complying with Article 8(1)(d) reiterating that under Article 8(1)(d)(i) an applicant must include in the marketing authorisation a statement as to compliance with the PIP, and under Article 8(1)(d)(ii), a marketing authorisation modified to take account of the PIP results is required in each Member State.

Comment: This case has both positive and negative implications for patentees wishing to take advantage of the paediatric extension. The strict interpretation of the Article 8(1) (d) requirements means that patentees must be careful to follow these to the letter, although the severity of this has been tempered somewhat by the wide meaning given to "irregularity" under Article 10(3). The Court of Appeal's purposive approach in making its decision should be noted, and the fundamental purpose of the Paediatric Regulation – to ensure that the relevant research is conducted and the results of that research disseminated – borne in mind.