LSPN Europe 2018: SPCs—important but ‘phenomenally complicated’, say lawyers
Supplementary protection certificates (SPCs) are hugely important to MSD’s business, according to Elena Böhles, assistant counsel at the pharmaceutical company, based in Hertfordshire, UK.
However, Böhles, who was speaking on a panel at LSPN Europe 2018 in London yesterday, November 15, added that the SPC system can also be a source of frustration.
Mike Gilbert, partner at Marks & Clerk in London and moderator of the panel, added that SPCs are an “incredibly important IP right” which come into force after a patent has expired.
However, the panel—which also featured Steven Ward, lead patent attorney at Syngenta in Reading, and Andy Porter, director and chief technical officer at Elasmogen in Aberdeen,—also shared some of the challenges surrounding SPCs.
For something which in principle is so simple, the SPC system is “phenomenally complicated”, claimed Ward.
“The saving grace is that it’s not too expensive [to file for an SPC], but then you don’t get much for your money,” he said.
Porter agreed that the process can be complex, before adding that he would like to see external counsel assist with the process more; particularly as many in in-house positions start with just a “modest experience of the SPC process”.
And Böhles said that a further challenge can be the process of explaining to US colleagues what an SPC is and the restrictions it comes with.
Gilbert added that not all of the current frustrations are necessarily with the SPC system, but rather the court’s interpretation of it.
“The Court of Justice of the European Union’s (CJEU) decisions seem to add extra layers of complexity,” Ward said. “I thought judges were here to make things clearer, and they definitely don’t.”
Böhles added that, in her experience, the CJEU seems to “work on the principle that whoever puts the word ‘patent’ in more times, wins”.
She said that in an ideal world, there would be a “unitary SPC”, allowing patent/SPC owners to “get rid” of dealing with numerous IP offices and different decisions.
Porter noted that SPCs are about building asset value and generating finance, and “anything that allows increased flexibility around the SPC system to allow that to happen would be a good thing”.
Finally, Böhles said that she would like the incoming SPC manufacturing waiver to “go away”.
The European Commission proposed the waiver in May with the intention that it would be implemented by 2019, though it has not yet completed the legislative process.
The waiver would allow EU companies to make generic/biosimilar versions of an SPC-protected medicine during the term of the certificate if the manufacture is done exclusively for export to a non-EU market where protection has expired or never existed.
Reception to the proposal was mixed, with the European Federation of Pharmaceutical Industries and Associations claiming that it would reduce IP rights, and Medicines for Europe calling the proposal essential for patient access.
Yesterday, Böhles expressed concerns about how the waiver will—or even can be—governed in such a way that protects the rights of SPC owners.
“It’s going to be a headache for us,” she said. “If that could go away, that would be great!”
Also at the LSPN event yesterday, Oliver Kingsbury, partner at Elkington + Fife in Kent, UK, spoke about the “tricky” nature of filing SPC applications.
He advised applicants to set out a strategy at the beginning of the patent filing process, to ensure that no opportunities are missed later down the line.
The LSPN Europe 2018 event took place yesterday, November 15 at the Bloomsbury Hotel in London.
