CJEU: SPCs not available for new uses of old products

The judgment of the Court of Justice of the EU (CJEU) in the so-called Santen case has major implications for pharmaceutical manufacturers and clarifies the application of both EU legislation and earlier case law, said patent law expert Jules Fabre of Pinsent Masons, the law firm behind Out-Law.

SPCs are provided for in EU law to enable pharmaceutical patent holders to effectively extend the period for which they can exercise monopoly rights over the sale of medicinal products they have invested a lot of time and money into developing. Patent protection lasts 20 years but it takes drugs companies several years to develop new medicines, carry out mandatory clinical trials and gain marketing authorisation. This means that the period of patent protection available to pharmaceutical manufacturers during which they can commercialise their products is typically much shorter than that which applies in other, less regulated, sectors. The SPC framework in the EU was developed to account and compensate for that.

Pharmaceutical companies are only eligible for SPCs if they meet the criteria for protection under the SPC Regulation. The case before the CJEU concerned one aspect of the criteria and how it should be applied.

Article 3(d) of the SPC Regulation states that the marketing authorisation serving as a basis for the SPC application must be "the first authorisation to place the product on the market as a medicinal product".

In an earlier case in 2012, known as the Neurim case, the CJEU determined that Article 3(d) does not preclude pharmaceutical companies from obtaining an SPC for a 'different application' of the same product for which a marketing authorisation had already been granted "provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate". 

In the underlying dispute, the product had been the subject of an earlier marketing authorisation for veterinary use, whereas Neurim had applied for an SPC on the basis of a marketing authorisation for human use.

The Neurim case was often considered to be controversial, as it departed from earlier case law and failed to provide guidance as to what should be considered a 'different application' – notably as to whether the ruling only applied to a situation where the earlier marketing authorisation was for another species or whether it was broader than that. This has led to the Neurim judgment being interpreted differently by patent offices and courts across EU member states since, resulting in a fragmentation of rights for pharmaceutical companies within the internal market.

In the more recent Abraxis case in 2019, the CJEU gave some further clarification. It said that new formulations of an old active ingredient are not eligible for SPC protection. However, the CJEU did not give general guidance on how to apply the 'different application' test in other circumstances and did not confirm if the test was limited to the specific facts of the Neurim case.

Now, however, the CJEU has clarified that Article 3(d) must be interpreted as meaning that "a marketing authorisation cannot be considered to be the first marketing authorisation, for the purpose of that provision, where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of a marketing authorisation for a different therapeutic application".

The CJEU's ruling follows the view expressed by advocate general Pitruzzella in January, who assessed and then issued a non-binding opinion on the questions put to the court.

In doing so, the CJEU said that the concept of 'product' under Article 3(d) of the SPC Regulation should be interpreted consistently with the strict definition of 'product' under Article 1(b) of the SPC Regulation, which according to the CJEU "must be interpreted as meaning that the fact that an active ingredient, or a combination of active ingredients, is used for the purposes of a new therapeutic application does not confer on it the status of a distinct product where the same active ingredient, or the same combination of active ingredients, has been used for the purposes of a different, already known, therapeutic application".

The CJEU was asked to address the issue of the interpretation of Article 3(d) by the Paris Court of Appeal in a case in which pharmaceutical laboratory Santen is seeking to overturn a previous decision by France's National Institute for Industrial Property (INPI) to reject its application for an SPC for ciclosporin for use in treating keratitis – an inflammation of the eye's cornea – on the basis that ciclosporin had been previously approved for another eye treatment for which marketing authorisation was granted in 1983.

The CJEU also reviewed the requirement from the Neurim ruling that the "application is within the limits of the protection conferred by the basic patent". The court found that there is no need to take into account the limits of the basic patent when defining the concept of the first marketing authorisation, which, it said, would be contrary to the definitions contained within the SPC Regulation.

Fabre said: "The Paris Court of Appeal specifically asked the CJEU to clarify its Neurim judgment, and it has now done so. There is now no doubt that an SPC cannot be granted for a new use of an old product, which had been the subject of an earlier marketing authorisation." 

In another case currently pending, the CJEU is being asked to decide on a similar question, but this time on the basis of Article 3(c) of the SPC Regulation, which requires that the "the product has not already been the subject of a certificate". As the question ultimately also relates to the interpretation of the concept of 'product' under the SPC Regulation, and whether a new use confers the status of distinct product, it seems likely that the CJEU will give a similar answer, Fabre said.