Background
Merck Serono applied for a supplementary protection certificate (SPC) for Mavenclad, an oral cladribine treatment for relapsing-remitting multiple sclerosis. Its basic patent protected the treatment’s particular pulsed dosage regimen, rather than cladribine as such. Mavenclad received an EU marketing authorisation in 2017.
Cladribine had, however, already received an EU marketing authorisation in 2004 in Litak, a different company’s medicine for hairy cell leukaemia. The Controller of Intellectual Property refused Merck’s 2018 SPC application because the Mavenclad authorisation was not the first marketing authorisation for cladribine as required by Article 3(d) of Regulation (EC) No 469/2009.
The Court’s Holding
On a full rehearing, the High Court dismissed Merck’s statutory appeal. Applying the CJEU Grand Chamber’s decision in Santen, it held that the Regulation defines a “product” strictly as the active ingredient or combination of active ingredients. A new therapeutic application or dosage regimen does not make the same active ingredient a distinct product for Article 3(d).
There was no dispute that Mavenclad was protected by Merck’s basic patent and met the other Article 3 conditions. But Article 3(a), which concerns patent protection, and Article 3(d), which asks whether the relevant authorisation is the first for the active ingredient, require separate analyses. Because cladribine had already been authorised in Litak, Mavenclad’s 2017 authorisation could not be the first authorisation for the product. The court also rejected Merck’s argument that Mavenclad’s distinct pharmacological and therapeutic effects made its cladribine a different active ingredient, and declined to refer questions to the CJEU.
Key Takeaways
- For an SPC, a new therapeutic use or dosage regimen does not create a new “product” where the active ingredient was previously authorised.
- Article 3(a)’s patent-protection inquiry does not alter Article 3(d)’s first-marketing-authorisation test.
- The court treated Santen as clear and binding, substantially displacing the broader approach associated with Neurim.
Why It Matters
The decision confirms that, in Ireland, second-medical-use patents cannot obtain an SPC merely because the patented use required a new marketing authorisation. Where the same active ingredient was already authorised for another therapeutic application, Article 3(d) bars the certificate.
The court acknowledged the resulting policy concern for innovators who invest in new uses of known medicines, but held that any change must come from the EU legislature rather than a different judicial interpretation of the Regulation.