Irish SPC ruling may allow nuanced approach to Santen ruling

Out-Law News | 25 May 2021 | 10:04 am | 4 min. read

It may be possible for supplementary protection certificates (SPCs) to be granted to medicinal products combining two or more components, even if a marketing authorisation has already been granted covering the co-administration of those components, a court in Ireland has ruled.

The judgment of the Irish Court of Appeal, in a case involving Merck Sharp & Dohme (MSD) and Clonmel Healthcare, will be welcomed by pharmaceutical manufacturers exploring the repurposing of existing medicines, experts in resolving intellectual property disputes in the life sciences sector have said.

Sarah Taylor  and Erika O’Donnell of Pinsent Masons, the law firm behind Out-Law, said the ruling was one of the first by a national court across Europe to interpret Article 3(d) of the SPC Regulation since the EU’s highest court, the Court of Justice of the EU (CJEU), issued its decision in a case involving pharmaceutical manufacturer Santen. Taylor said, however, that the Irish court’s judgment indicated that the previous characterisation of the Santen decision may have been oversimplified in certain situations.

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. 

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 the Santen case, the Court of Justice of the EU (CJEU) ruled 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 considered the concept of 'product' under Article 3(d) of the SPC Regulation in reaching its decision. It said the term "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".

In the case before the Irish Court of Appeal, the court assessed whether Inegy, a product developed by MSD which is designed to help lower cholesterol, was eligible for an SPC given the criteria set out under Article 3(d), in addition to Articles 3(a) and 3(c). 

Inegy combines ezetimibe with simvastatin. Ezetimibe inhibits the reabsorption of cholesterol in the human body, while simvastatin is a type of statin that is known to lower cholesterol in the bloodstream. MSD was granted a marketing authorisation to sell tablets of the combination product featuring any one of four specific compositions of ezetimibe with simvastatin in 2005.

MSD had previously, in 2003, been granted a marketing authorisation for another product called Ezetrol. That authorisation permitted the marketing of 10mg tablets of ezetimibe for treating homozygous familial hypercholesterolemia (HoFH) – a condition that children are born with that makes them susceptible to high cholesterol as a result of their genetic make-up passed down by their parents. The authorisation provided for the tablets to be co-administered with a statin. MSD was subsequently granted an SPC for Ezetrol.

Clonmel Healthcare argued that MSD had, with its Ezetrol SPC, already secured an SPC based on a marketing authorisation for the combination of ezetimibe with a statin as it specifically mandated that, in respect of one of the permitted indications, ezetimibe was required to be used with a statin, and simvastatin was expressly identified as one of four such specific statins. This, it claimed, precluded MSD from being granted an SPC in respect of Inegy. However, the High Court in Ireland rejected that argument in 2019, and the Court of Appeal has now dismissed Clonmel’s appeal against the earlier finding.

The Court of Appeal said there were some important differences between the marketing authorisations granted for Ezetrol and Inegy.

The court said that where a clinician treats a patient for HoFH using Ezetrol, the quality and quantity of ezetimibe is fixed at 10mg but the particular statin and the dosage of the statin is a matter for the clinician to determine. It further held that while the co-administration of ezetimibe with a statin is mandatory when treating HoFH, co-administration of two products is not to be equated with a combination product.

In respect of the SPC for Ezetrol, the Court of Appeal held that the product comprised one active ingredient, ezetimibe, but for one indication in the authorisation it was required to be co-administered with a statin. The summary of the product characteristics for Ezetrol referred to clinical trials co-administering ezetimibe with simvastatin in specific dosages which were subsequently reproduced in the summary of the product characteristics for Inegy. However, the Court of Appeal said that this did not amount to a marketing authorisation of a combination product comprising ezetimibe and simvastatin. Inegy, therefore, had not been the subject of a previous SPC, it ruled.

Despite its findings in relation to Inegy meeting the Article 3(d) criteria for being granted an SPC, the Court of Appeal upheld the High Court’s findings that the product failed to meet  the other criteria under Article 3 of the SPC Regulation and was therefore not eligible for an SPC.

Erika O’Donnell of Pinsent Masons said: “The Court of Appeal did not directly refer to the CJEU’s Santen ruling, however the finding that the co-administration of two separate products permitted by the first marketing authorisation does not equate to a marketing authorisation for the combination product Inegy, and therefore that the product had not been the subject of a previous marketing authorisation, indicates that there may be some limited circumstances in which there is flexibility in the application of the Santen principle.”

However, Sarah Taylor added: “Only time will tell - it will be interesting to see how national courts apply Santen in future. We are also waiting for the first UK SPC case post-Brexit to see how the UK courts apply existing CJEU decisions, and whether the UK courts have the appetite to deviate from such decisions”.

Co-written by Erika O’Donnell of Pinsent Masons in Dublin.