Supplementary Protection Certificates (SPCs) are intended to ensure that medicinal products requiring marketing authorisation (MA) are adequately protected. They safeguard a sufficient return for, and thereby incentivise, pharmaceutical research involving significant preclinical and clinical work. However, SPCs do not usually extend the term of an entire patentper se, but rather extend patent protection only for a particular authorised product.

The Court of Justice of the European Union (CJEU) has dealt a blow to innovators in two recent significant judgments, addressing questions posed by national courts struggling to judge the eligibility of SPC applications.

Boston Scientific (C-527/17)

Boston Scientific’s SPC application related to paclitaxel for the treatment of restenosis.  Instead of an MA for paclitaxel itself, the application was based on an MA granted under the Medical Devices Directive for a stent incorporating paclitaxel (TAXUS Express2 Paclitaxel-Eluting Coronary Stent System).

Strictly speaking, the SPC Regulation requires an MA under one of the Medicinal Products Directives. Hence, authorised medical devicesper seare not considered eligible for SPC protection. With their SPC application, Boston Scientific sought to protect the active ingredient paclitaxel incorporatedwithinthe medical device, arguing that the MA should be considered equivalent to those required by the SPC Regulation because of the analogous requirement for quality, safety and usefulness data.

Until recently, there was uncertainty whether an MA granted under the Medical Device Directive for a medical device that comprises a medicinal product could provide basis for an SPC.

In its October 2018 judgment, the CJEU ruled that an MA granted in accordance with the Medical Devices Directive for a device incorporating a medicinal product as an integral part,cannotbe treated in the same way as an MA for that medicinal product granted under the Human Medicinal Products Directive, even if there was a similar quality, safety and usefulness assessment.

The CJEU emphasised that the two types of products (medical devices and medicinal products) are mutually exclusive and their authorisation processes are not cross-applicable. Products which are combinations of a medical device and medicinal product are either considered a medical device authorised under the Medical Devices Directiveora medicinal product authorised under the Human Medicinal Products Directive. Competent authorities must categorise (and then assess) products as one or the other, taking into account the “principal mode of action of the product” as set out in the Medical Devices Directive.

Categorisation depends on whether the combination medical device and medicinal product is intended to be used exclusively in that combination in a non-reusable way (conclusion: a medicinal product) or whether the medicinal product component acts on the human body by an action ancillary to that of the medical device itself (conclusion: a medical device).

Thus it is not possible to classify the medicinal product independently from the device. Once a product is assigned a definition (medical device or medicinal product), that definition automatically determines theprima facieeligibility of the product for any corresponding SPC application.

The ruling will be a disappointment for innovators who were hoping to rely on the SPC regime to extend the exclusivity for medical devices in Europe.

Abraxis (C-443/13)

Abraxis filed an SPC application for “paclitaxel formulated as albumin bound nanoparticles” covering its product ‘nab-paclitaxel’ (Abraxane).

Article 3(d) of the SPC Regulation requires the MA to be thefirstauthorisation to place the product on the market as a medicinal product.

Since in the context of the SPC Regulation the term “product” means only “the active ingredient or combination of active ingredients of a medicinal product” and not any non-active ingredients such as excipients or adjuvants, Abraxis’ application was refused because there was an earlier MA for the active ingredient, paclitaxel.

However, Abraxis argued that the CJEU’s July 2012 judgment inNeurim(C-130/11) had ruled that:

the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal productdoes not preclude the grant of [an SPC] for adifferent application of the same product for which [an MA] 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 [SPC]”.

Neurim’s SPC for melatonin (under the brand Circadin) for use in treating insomnia in humans was accordingly allowable despite there being a previous MA covering melatonin (under the brand Regulin) for use in regulating fertility in sheep.

The question grappled with by patent professionals ever since has been how broadly the term “different application” inNeurim can be interpreted.

During Abraxis’ High Court appeal of the refusal of its SPC application, the firm argued thatNeurimpermits an SPC to be granted for a “different application” of a previously-authorised product and that “different application” encompasses a newformulationof a known active ingredient, such as Abraxane.

In view of the uncertain scope ofNeurim, Arnold J referred the following question to the CJEU:

Is Article 3(d)… to be interpreted as permitting the grant of an SPC where the [MA] is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?

In its March 2019 judgment, the CJEU decided that SPCscannotbe granted for new formulations of previously-authorised active ingredients, even if the MA for the new formulation is the first one that falls within the scope of the basic patent relied on for the SPC.

The Court endorsed a narrow interpretation of Article 3(d), drawing support from Recital 10 of the SPC Regulation and the Explanatory Memorandum to say that, taking into account the interests of all stakeholders, including those of public health, the intention of the legislature was:

to protect not all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients of a medicinal product.

Allowing SPCs for new formulations of previously-authorised drugs would allegedly jeopardise this objective and lead to legal uncertainties and inconsistencies.

A future for Neurim?

The CJEU’s narrow literal interpretation of Article 3(d) inAbraxiswill be a blow to innovators and is difficult to square with the more liberal interpretation adopted inNeurim. While the Court did recogniseNeurim as an “exception”, it failed to offer definitive guidance on its scope, beyond “new formulations” being unallowable.

Even if the CJEU had decided differently inBoston Scientificand allowed Medical Device MAs to support SPCs, Boston Scientific would still have faced the hurdle of Article 3(d).  Whereas Abraxis’ formulation of paclitaxel was for use for a previously-authorised indication (cancer), Boston Scientific’s use of paclitaxel in the treatment ofrestenosismay otherwise have been considered a “different application”.

The hope is that the CJEU will decide on a clear approach toNeurimin its forthcoming decision inSanten(C-673/18).  We will see whether the CJEU will continue its trend of squeezing the SPC provision towards more restricted rewards, or else support innovators working on new applications of existing active ingredients.

Joel Beevers is an assistant and Michael Pears is a partner and patent attorney at IP firm Potter Clarkson