Questions on Neurim scope remain post-SPC ruling, say lawyers
The Court of Justice of the European Union’s (CJEU) recent refusal to provide further guidance on the full scope of Neurim in a case involving supplementary protection certificates (SPC) last week has left some big questions unanswered.
On Thursday, March 21, the CJEU concluded that marketing authorisations (MA) for new formulations of ‘old’ active ingredients don’t qualify as first MAs under the SPC regulation.
SPCs provide an additional period of protection for a product that is subject to a valid MA when the SPC is applied for and, under article 3(d), the MA must be the first authorisation to place the product on the market as a medicinal product.
“Interestingly, although the court recognises Neurim as an ‘exception’, it has avoided commenting on the rationale behind the exception and does not explain why the rationale does not apply to new formulations,” said Micheal Pears, partner in the Nottingham, UK office of Potter Clarkson.
Back in 2012, the CJEU in Neurim allowed an SPC to cover a ‘different application’ of a previously authorised product. In Neurim, an SPC was allowed for Circadin (melatonin) for use to treat insomnia in humans despite a previous MA for Regulin covering melatonin for use in regulating fertility in sheep.
Pears added that the CJEU simply stated that Neurim didn’t refer to a case of a new formulation, and offered “no further guidance as to how broadly Neurim can be interpreted beyond its facts, if at all”.
In January 2017, Justice Richard Arnold, concluded that Neurim had an uncertain scope, and referred a question to the CJEU regarding article 3(d).
Mike Gilbert, a London-based Marks & Clerk partner, suggests that the CJEU’s decision in Neurim had “cast some doubts” on the idea that an MA for a new formulation of old active ingredient would not, and should not, be considered to be the first MA.
“However, any such doubts have now been resolved and Neurim, whilst not expressly overturned, has been placed in a special category of cases that were decided on their own peculiar facts,” says Gilbert.
Andrew Hutchinson, partner at Simmons & Simmons in London, adds that the court doesn’t comment on whether Neurim only creates an exception where a veterinary drug is developed for human use.
“This leaves open the question of whether SPC applicants will be able to obtain SPCs in respect of second or further medical uses of known drugs in humans,” says Hutchinson, who adds that the industry will be avidly awaiting the CJEU’s answer to the questions referred from the French courts at the end of 2018 in Santen (C-673/18).
In agreement with Hutchinson is Glyn Truscott, partner at Elkington + Fife and based in London, who adds that the impact of last week’s decision may be “tempered to some extent” by the Santen referral.
According to Truscott, the CJEU’s ruling puts a limit on the situations in which the reasoning in Neurim can be applied, but only as far as the facts that were before it.
“Given that the CJEU chose not to follow the advocate general’s more significant suggestions to depart wholesale from the reasoning of Neurim, I would be wary of predicting what the CJEU will decide in other fact patterns,” he notes.
Pears concludes that the ruling will no doubt be a disappointment for innovators who were relying on a broad interpretation of Neurim to support their SPCs, a sentiment Gilbert agrees with.
Hutchinson sums up: “In the seven years since Neurim, SPC applicants (like Abraxis) will have considered its scope and relied on its principles to invest in research and development and developing strategies to bring ‘different applications’ of existing drugs to market. This decision means that a number of those strategies will need to be revisited.”
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