CJEU opinion on SPC referral is ‘overdue’, say lawyers
An opinion on whether a supplementary protection certificate can be granted to an owner of a drug patent when the marketing authorisation is held by a third party is overdue, lawyers told LSIPR.
On Friday, March 1 the patents division of the English High Court ruled that a patent owned by Genentech was invalid and denied the company’s application for a supplementary protection certificate (SPC).
While Justice Arnold found the patent and SPC application to be invalid, he made a referral to the Court of Justice of the European Union to answer whether an SPC can be filed based on an unrelated third-party marketing authorisation.
Glyn Truscott, a partner at Elkington and Fife in London, said it was interesting that the referral was made directly from the High Court.
“In the usual way of things, this case would be appealed and a referral, if needed, typically made from the Court of Appeal,” Truscott said.
“However, Arnold notes that there is a very real possibility that the UK courts will lose their jurisdiction to make references to the CJEU on March 29, and that the question of third Party
SPCs is in any event of general interest across Europe,” he added.
Sally Shorthose, a partner at Bird and Bird in London, said there was “sufficient ambiguity in existing case law and uncertainty regarding Genentech’s likelihood of appealing Arnold’s conclusion of invalidity”, to justify the referral to the CJEU.
“As far as the substance of the question is concerned, an opinion on ‘squatting’ on SPCs—that is the use of a third party’s marketing authorisation without that third party’s consent—is overdue,” she said.
Jin Ooi, an associate at Kirkland & Elis in London, said national patent offices, including the UK Intellectual Property Office, typically allow an SPC to be filed based on an unrelated third-party marketing authorisation.
“But it is widely debated that this standing practice sits uncomfortable with public policy arguments,” Ooi said.
Ooi said that this, coupled with the fact that the question has not been clearly answered by the CJEU, is probably what led to Arnold making a reference.
According to Ooi, Arnold has previously commented that “the most significant effect Brexit will have on his role as a judge is losing the ability to make a reference to the CJEU”.
Therefore, it is of “no surprise that he is keen to squeeze in just one more in the hope of having the law clarified,” Ooi said.
He added that Arnold is “no stranger to referring questions to the CJEU”, and has made at least five referrals on the topic of SPCs.
Trevor Cook, a partner at WilmerHale in New York, echoed this. Cook said he finds “nothing surprising in Arnold making such a reference to the CJEU”.
He added that it makes sense for first instance judges to avoid the delay of an appeal when the appeal courts “would only do the same thing, but at least a year later”.
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