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1 May 2010EuropeHampus Rystedt

Product definition in Swedish SPCs

A supplementary protection certificate (SPC) grants an extension in time to the protection conferred by a patent relating to certain products that require expensive and protracted procedures for marketing authorisation, most notably pharmaceuticals but also plant protection products. The legal basis for SPCs is provided by EU regulations 469/2009/EC, for pharmaceutical products, and 1610/96/EEC, for plant protection products. In order to get an SPC, there must be a basic patent covering the product authorised for marketing.

The SPC is not an extension of the basic patent itself, but rather a standalone protection. The protective scope conferred by an SPC is governed by Article 4 of 469/2009 and only extends to the product covered by the marketing authorisation. However, recitals 13 and 17 of 1610/96 further extend the protective scope by saying that the SPC gives the same rights as the basic patent and that when the basic patent covers an active ingredient and its derivatives (salts and esters), the SPC confers the same protection.

A key court decision on the scope of protection conferred by an SPC is European Court of Justice (ECJ) case C-392/97 (Farmitalia), where the court concluded that the applicant was entitled to an SPC that defined a product as the neutral form of the active ingredient and associated salts, while only one specific salt was actually authorised for sale as a pharmaceutical product.

Following C-392/97, it has been the custom in Sweden to provide a product definition with an application for an SPC, though this is not required by the regulation. In fact, an old version of the official application form provided by the Patent Office actually included a box for providing a product definition, which would then be published in the official journal Svensk Patenttidning.

A few years ago, the application form was updated and the box for providing a product definition was replaced with a box for providing the name of the authorised product. If, however, a different product definition is provided, this is still published in the official journal.

The question arises whether a published product definition affects the scope of the SPC, if the SPC is used in an infringement suit. There are few cases, if any, in Sweden where the scope of protection of an SPC has been decided by a court and this question has not been addressed.

On the one hand, it could be argued that a published product definition cannot have any effect on the scope of protection since the scope of protection is governed solely by the scope of the basic patent and the marketing authorisation, and not by the SPC itself, according to Article 4 of 469/2009.

“There are few cases, if any, in Sweden where the scope of protection of an SPC has been decided by a court”

On the other hand, it could be argued that the publication of a product definition serves to tell the public what actually is protected by the SPC. So if the patent office has decided to publish a product definition, then the public should be able to rely on that information. This would support the idea of a court giving the published product definition at least some weight when considering the actual scope of protection for an SPC.

It could be argued that, if the published product definition is narrower than the scope of the protection conferred by the wording of Article 4, the narrower definition, suggested by the applicant and made available to the public by way of official publication, should limit the scope of the protection conferred by the SPC.

The above confusing and unsatisfactory situation is brought about by the slightly conflicting provisions of EU regulation 469/2009 and the ECJ decision in C-392/97. Article 11 of 469/2009 stipulates that a notification of a granted SPC application shall comprise the product identified in the marketing authorisation. C-392/97 on the other hand gives the applicant the right to request that the SPC is published with a broader product definition.

So is it wise to use this right?

It is worth revisiting the history of C-392/97. This case originated from a German SPC application refused by the German Patent Office in 1993. The German and Dutch practice at the time was very strict on product definitions issued in SPCs—only the exact authorised product could be mentioned in an SPC. The practice in the UK and Italy, for example, was more generous, and SPCs were granted with broader product definitions.

This diverse practice was unfortunate since the aim of a council regulation is to harmonise practice across Europe. It was therefore desirable that at least one case made its way to the ECJ, which is the only court that can issue a harmonising decision.

The ECJ issued its decision in C-392/97 in 1999. However, EU regulation 1610/96 on SPCs for plant protection products was adopted in 1996. Recitals 13 and 17 also provide an interpretation of the protective scope of a granted SPC for pharmaceuticals, without requiring an applicant to provide any product definition other than what is provided in the marketing authorisations.

The benefit of providing a product definition broader than the exact product authorised for marketing, in compliance with C-392/97, is that the applicant makes clear that the actual protective scope of the SPC is not limited to the authorised product.

Before the adoption of EU regulation 1610/96 in 1996, there was a definite reason for an applicant to make this clear to third parties since the wording of the then applicable SPC regulation (1768/92 from 1992) appeared to provide a very narrow protection. However, since the introduction of 1610/96, this no longer appears to be necessary. Nonetheless, the practice has survived in Sweden.

In view of the potential negative impact of an unintentionally narrow product definition submitted with an application for an SPC, it appears to be safer to name only the actual authorised product in any SPC application filed with the Swedish Patent Office.

Hampus Rystedt is a partner and head of the patent department at Brann AB. He can be contacted at: hampus.rystedt@brann.se

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