7 March 2013

1st Annual Life Sciences Law Forum: confusion over SPCs

Recent Court of Justice of the European Union (CJEU) judgements on the interpretation of supplementary protection certificate (SPC) regulations are not clear and have left judges frustrated, said Huw Evans, a partner at Norton Rose LLP, speaking at the 1st Annual Life Sciences Law Forum in London.

Article 3 (a) of the European SPC regulation says that supplementary protection certificates extending the life of a patent by up to five years to compensate for the time it takes to bring a product to market can be granted if the product applied for “is protected by a basic patent in force.” Under Article 3 (b), SPC applicants must also have a valid marketing authorisation (MA) for the product.

But Evans said judges and practitioners, particularly in the UK, are confused over what “protected by the basic patent” means and are unsure of how closely SPCs should match MAs.

Evans cited Medeva v Comptroller General, which was referred to the CJEU by the UK Court of Appeal and concerned Medeva’s vaccine for whooping cough with two active ingredients.

Medeva had applied for SPCs to extend the patents covering its vaccine but its applications were rejected by the UK Intellectual Property Office (IPO) because its MAs included additional active ingredients.

The Court of Appeal asked the CJEU whether SPCs could be based on MAs containing additional active ingredients besides those covered in the SPC application, and whether an SPC could be granted for a product that contains additional ingredients to those specified in the claims of the basic patent.

In its response, the CJEU said that SPCs could be granted based on MAs for the active ingredients in combination with others, and that: “the active ingredients representing the product must be specified in the wording of the claims of a basic patent.”

The court delivered a similar judgment in Georgetown University v Comptroller General and in Yeda and Queensland.

But in a dispute between Novartis and MedImmune concerning the antibody ranibizumab, judge Justice Arnold said: “It is unclear precisely what is meant by ‘specified (or identified) in the wording of the claims’. Does this mean that it is sufficient for the product to fall within the scope of the claim on its true construction, or is something more required and if so what? … Even in combination cases, it is not clear to me how the test enunciated by the Court should be applied”.

Evans commented: “What we see from recent judgments is that UK judges are becoming increasingly frustrated with the CJEU. Arnold has twice said how he thinks regulations should be interpreted. And perhaps we need further clarification on the purpose of SPCs. Is it just to reward innovation? Because if companies don’t get adequate protection, research will be impeded.”

The effect of the Unitary Patent Court on SPCs remains to be seen and could cause further confusion, he said, but added: “it can’t be worse than what’s happening at the moment.”

To ensure SPC protection is granted, Evans recommended assigning dedicated teams of attorneys to individual products and SPC applications.

He also said companies filing applications should do so on time (within six months of marketing authorisation being granted) and should explicitly state if an application is based on case law or point of law assumptions, to avoid the application being viewed critically at a later date.

The 1st Annual Life Sciences Law Forum was organised by Practical Law Company, and finished yesterday.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk