CJEU to clarify criteria for SPCs on second medical use products

The Court of Justice of the EU (CJEU) has been asked by the Paris Court of Appeal to clarify EU case law on the issue 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.

A formal judgment from the CJEU is not anticipated for a number of months yet, but the advocate general in this case is due to publish its non-binding opinion on Thursday 23 January.

The underlying dispute

Santen obtained patent protection in 2008 for a new formulation, an emulsion, of ciclosporin and its use in the treatment of eye conditions such as keratitis. The company was subsequently granted authorisation to market the product, under the name Ikervis, in 2015. Ikervis is indicated for the treatment of severe keratitis and is in the form of an emulsion administrated as eye drops.

Santen subsequently applied for an SPC based on its patent and marketing authorisation. The rationale for SPCs is to compensate patent holders for the period of patent protection during which they are prevented from commercialising their products owing to the lengthy approval process. 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.

The INPI, however, rejected Santen's application in 2017 on the basis of Article 3(d) of the SPC Regulation. Under Article 3(d) 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".

Ciclosporin was the active ingredient in another treatment for which marketing authorisation was granted in 1983. That product, known as Sandimmun, was in the form of an oral solution and had several therapeutic indications, including the treatment of endogenous uveitis - an inflammation of the uvea.

Santen has challenged the INPI's decision before the Paris Court of Appeal, which has asked for the CJEU to help it resolve the case by setting out how Article 3(d) of the SPC Regulation should be interpreted.

CJEU case law on Article 3(d)

Article 3(d) of the SPC Regulation and the concept of 'first marketing authorisation' has been considered a number of times by the CJEU following referrals by national courts. Its current position on the issue was set the so-called 'Neurim' judgment in 2012.

In that case, the marketing authorisation on the basis of which the SPC was applied for concerned the human use of the product, whereas an earlier marketing authorisation for the same product had been granted for veterinary use.

In what has been viewed as a reversal of its earlier case law on the issue, the EU court said that "the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has 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".

However, this attempt from the CJEU to provide clarifications on the meaning of Article 3(d) raised additional questions.

The meaning of "a different application of the same product", in particular, has subsequently been interpreted differently by patent offices. Some patent offices interpreted it narrowly as being limited to the facts of the case, namely to situations where the earlier marketing authorisation was for veterinary use and the subsequent authorisation was for human use, or vice versa. Other patent offices adopted a broader interpretation and wondered whether new indications, new formulations, new dosage regimens or new modes of administration may also be considered as a 'different application' under the case law developed in Neurim and therefore qualify for SPC protection.

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.

The questions for the CJEU

The Paris Court of Appeal has asked the CJEU to provide clarification on aspects of its ruling in the Neurim case, namely what the CJEU meant when it said SPCs can be issued based on a 'different application' of the same product for which a marketing authorisation has been granted.

Specifically, the Paris court has asked whether the concept of 'different application' must be interpreted narrowly, such as whether itis limited to cases where the second medical use of a product is for humans and the first use was for veterinary application, or, more generally, to cases where there is a new indication within a new therapeutic area or for which the product has a different mechanism of action, or broadly as also including new formulations, dosage regimen or modes of administration.

In a second question, the Paris Court of Appeal has asked the CJEU to clarify another aspect of the Neurim judgment, namely the requirement that the different application must be "within the limits of the protection conferred by the basic patent". The Paris court has queried whether that wording means that "the scope of the basic patent must be the same as that of the marketing authorisation relied upon" and that the basic patent must therefore "be limited to the new medical use corresponding to the therapeutic indication of that marketing authorisation".

In the Santen case before it, the basic patent was not limited to the use of ciclosporin in the treatment of keratitis as it also included product claims covering ciclosporin as an emulsion. As a result, the scope of the basis patent was broader than the scope of the new marketing authorisation. On that basis the INPI took the view that the conditions outlined in the Neurim judgment were not met for this reason as well.

What we can expect from the opinion

It is open to the CJEU just to shortcut to a direct answer to the Paris court's questions when it comes to issue its formal judgment, but we can expect the advocate general to forensically address each of the potential interpretations outlined by the Paris court in the opinion this week.

The advocate general's views are non-binding and the CJEU could rule differently, but the opinion will nevertheless be essential reading for pharmaceutical companies exploring whether second medical uses of products they have identified will qualify for an SPC.

More generally, the CJEU in this case will be given the opportunity to finally provide general guidance on an issue that has been much debated over the years. Guidance on this issue would hopefully allow national patent offices to apply Article 3(d) in a consistent way.

Depending on the outcome, this may close, or, to the contrary, open the door to an entire class of SPCs and the consequences for the industry are therefore potentially colossal.