* Maria Isabel Manley (Head of Bristows’ Regulatory Practice)
“So far the approach to negative/zero SPCs has been very fragmented across the EU and, in this sense, the AG’s opinion is to be welcomed by the innovative pharmaceutical industry. For the first time, the CJEU will have the opportunity to look into this crucial area of negative SPCs and to harmonise the contradictory national interpretations. It will be great news for the industry if the CJEU decides to follow the AG’s opinion (which is usually the case) and rules in favour of the grant of SPCs with a negative term.* Gareth Williams (Partner, Marks & Clerk LLP)
This outcome will also be beneficial to the paediatric population as there is no doubt that it will encourage bio/pharma companies to invest in the conduct of paediatric studies. Indeed, the reward consisting of a 6-month extension to the SPC is an absolutely necessary incentive, as it will assist in partially recouping the investment made by the industry in generating the paediatric data which is so important to the paediatric population.”
“This is a slightly surprising Opinion, given that the notion of a negative term right goes against legal convention in general. However the Advocate General’s logic makes good sense, and this solution is in both the commercial and public interest in this particular case. The whole point of the Paediatric Extension is to incentivise R&D into drugs for use with children. This aim is compromised if we punish companies for marketing to children simply because the adult version of their drug went through marketing approval quickly, which is what would happen if we were to insist that SPCs should have a positive term. On the other hand, the Advocate General is right to reject zero term SPCs as compromising the public interest, as this approach incentivises companies to delay marketing approval for their products in order to get the extra six months protection, effectively encouraging companies to withhold treatments from the needy.
Importantly, Europe needs a harmonious approach, and the ECJ ruling – if it follows today’s Opinion – will provide the basis for that.
However, the concept of a negative term SPC is still rather odd, and one wonders whether this whole issue wouldn’t be better dealt with by simply separating the two rights, so that Paediatric Extensions can be applied for separately without having to be bolted onto an existing SPC.”This weblog would be delighted to hear what other comments have been received, including from different countries and industrial sectors around Europe and beyond. Do let us know.
Incidentally, voting was close in the opinion poll: 26 respondents said "yes", there could be negative term SPCs; 25 said "no" and a very small number answered "it all depends".