Supplementary protection certificates

United Kingdom

More than one for the same product certainly - but who to? - and what about the damages?

In the last patent review we reported the Advocate General's Opinion in the European Court of Justice (ECJ) in Biogen -v- SmithKline Beecham Biologicals (SBB). The Court has adopted the Advocate General's Opinion.

The facts are as follows. Biogen is the holder of two European patents. The relevant product, Engerix-B, is sold by SBB under four Belgian marketing authorisations. Biogen required copies of those authorisations in order to apply for a Supplementary Protection Certificate (SPC). SBB refused to supply those copies. However SBB did provide copies of the marketing authorisations to the holder of other patents covering the product.

On application to it the ECJ held:-

  • Where a product is protected by a number of basic patents held by a number of patent holders each patent could be granted one SPC.

  • The regulations did not require the holder of a marketing authorisation to provide the patent holder with a copy.

  • Where the holder of a basic patent and a marketing authorisation were different and the product holder was unable to provide a copy of the authorisation, the application for an SPC could not be refused on that ground alone. It was open to the national authority granting the SPC to get a copy of the marketing authorisation from the national authority which issued it.

This decision raises the question as to what is the position if a pharmaceutical group has made a number of inventions which are embodied in a single pharmaceutical product and the patents are held by a number of different companies in the group, who have perhaps invented the different features, or just applied for the individual patents, or into whose names the patents have perhaps been transferred, simply so that a number of SPCs can be sought? Would SPCs be granted to each company? Ones instinctive reaction is "No" - but on reflection on the ECJ's decision "Why not?" And for a valuable product in suitable circumstances the cost of such an application might be well worthwhile, even if only because the threat of the grant of an SPC might deter competition, just as the existence of UK patent extension proceedings in the past deterred competition.

But of course if they are worried about damages for infringement the companies concerned will have to be careful to see that appropriate licences or appropriate company structures are in place to ensure that they will be able to recover damages, at least in England, following the Court of Appeal's decision in Gerber -v- Lectra (Reported in the 1997 UK Patent Review) confirming that the patentee's loss must be strictly proved.

Supplementary Protection Certificates - but not from a clinical trial

In the BTG Limited's Application the Comptroller held that a clinical trial authorisation, which was only an authorisation to carry out the particular trial, and which did not comply with the requirements of Directive 65/65/EEC or 81/85/EEC, as required by Article 3 of Regulation 1768/92, and did not contain the required summary of product characteristics, was not an authorisation which could be used as the basis of an application for a Supplementary Protection Certificate.