CJEU puts further brakes on SPCs

The Court of Justice of the European Union (CJEU) yesterday, March 21, handed down a supplementary protection certificate (SPC) decision referred to it by the English High Court.

In the decision, the court held that marketing authorisations (MA) of new formulations of ‘old’ active ingredients don’t qualify for first marketing authorisations under the SPC regulation, indicating the adoption of a narrower approach in future.

SPCs provide an additional period of protection for a product that is subject to a valid MA when the SPC is applied for. Under article 3(d), the MA must be the first authorisation to place the product on the market as a medicinal product.

Abraxis applied for an SPC for “paclitaxel formulated as albumin bound nanoparticles”, covering its drug Abraxane (nab-paclitaxel) for the treatment of certain cancers.

In 2016, the UK Intellectual Property Office (IPO) refused to grant the SPC, finding that the combination of paclitaxel and albumin as ‘nab-paclitaxel’ didn’t constitute a new singular active ingredient, so it didn’t satisfy article 3(d).

According to the IPO, while article 3(d) permits the grant of an SPC for a new and inventive therapeutic use of an old active ingredient, its scope doesn’t extend to a new and inventive formulation of an old active ingredient.

Abraxis had previously been granted an MA for nab-paclitaxel in 2008 by the European Medicines Agency and before this, other companies had marketed paclitaxel in another form under previous MAs.

The drugmaker appealed against the IPO’s decision to the English High Court, arguing that the CJEU judgment in Neurim allowed an SPC to be granted for a “different application” of a previously authorised product.

In January 2017, Justice Richard Arnold, concluding that there Neurim had an uncertain scope, referred the following question to the CJEU:

‘Is article 3(d) to be interpreted as permitting the grant of an SPC where the [MA] referred to in article 3(b) is the first [MA] 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?’

Yesterday, the CJEU handed down its decision.

The court said that where an SPC application for a new formulation of an old active ingredient relies on an MA, that MA can’t be regarded as the first authorisation where the active ingredient has already been the subject of an MA as an active ingredient.

In its decision, the court interpreted article 3(d) in conjunction with article 1(b), which states that “product” means the active ingredient or combination of active ingredients of a medicinal product.

“A new formulation of an old active ingredient, which, such as nab-paclitaxel, consists of that active ingredient and a carrier which has no therapeutic effect on its own linked together in the form of nanoparticles, cannot be regarded as being a product distinct from the product consisting solely of that active ingredient even if such a formulation allows that active ingredient to exercise its therapeutic effect with increased efficacy,” said the court.

Finally, the CJEU cited the advocate general’s observation (in an opinon on the case) that, in establishing the SPC regime, the legislature did not intend to protect all pharmaceutical research which gives rise to the grant of a patent and the marketing of a new medicinal product.

The legislature, according to the court, intended to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product.

The CJEU concluded: “Such an objective would be jeopardised if, in order to fulfil the condition set out in article 3(d), it were possible to take into account, in respect of a new formulation of an old active ingredient, solely the first MA to be covered by the scope of the basic patent protecting that new formulation and to disregard an MA which had been granted previously in respect of the same active ingredient in another formulation.”

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