Historic court of appeal hearing in SPC case

United KingdomScotland

Lord Justice Floyd described the appeal hearing on 26 March as - so far as he knew - a first for the Court of Appeal. It took place, not in the Royal Courts of Justice, but in the homes and offices of the three judges, the advocates, and the solicitors by live video link. One member of the public was “present“, a journalist also on video link and with a set of papers. The rest of us interested bystanders had the benefit of a running transcript on screen courtesy of Marten Walsh Cherer.

Floyd LJ was joined on the panel by Lady Justice Davies and Lord Justice Arnold. The hearing started at 10 am and went through to close on 4 30 pm with a short morning break and the usual adjournment over lunchtime. There was another unscheduled 15 minute pause when Floyd LJ’s connection went down and he had to rejoin for half an hour on the telephone. Generally howeverit worked pretty well, with a high standard of courtesy, as one would expect, coming from the top, with everyone helping one another with document references and such (including a couple of interventions from Colin Birss J from off stage somewhere!). In reality, it must have been stressful for those working from one screen, as at least one QC was, needing to keep an eye on the bench and on the documents electronically. Two screens each in future would be an undoubted assistance.

So what merited such an unprecedented event? Well, Genentech was at risk, come next Thursday, 2 April of having its Supplementary Protection Certificate (“SPC”) (extending the life of its patent on its RANIBIZUMAB monoclonal antibody treatment for age-related vision loss) cut short by two years of its expected expiry in 2022. Worse, it had the consequence of preventing Genentech from benefiting from a paediatric extension to that SPC. A lot was at stake commercially, Many millions apparently,although the amount was not vouchsafed to us bystanders.

Recorder Douglas Campbell had two weeks previously upheld the Comptroller-General of the UK Patent Office’s decision not to allow the Appellants, the pharma global player Genentech, and its agent Master Data Centre, to rectify the latter’s mistake in filling out the SPC form incorrectly. This has resulted in Genentech having just a two year term rather than the four it had instructed MDC to obtain. MDC had paid a lower fee. The trouble was MDC had done something similar twice before.

MDC complained that the UKPTO could and should have reminded them at the two years' stage to pay more fees if they wanted the full four years but had apparently decided not to do so. MDC argue that this is discriminatory.

The controversy then continued in a deluge of references to the relevant EU Regulation (EC 469/2009) and the latest Patents Act(particularly Schedule 4A), and the Rules made under it, and explanations of them and complaints by the Appellants about them and especially the troublesome layout of Form SP2. Nothing could be done about the latter, it was said on behalf of the Comptroller - until it emerged after 4 pm that it could be amended by the Comptroller himself.

A lot could turn on discretion: whether the Court of Appeal has any at this relatively late stage, sufficient to change the exercise of his by Recorder Campbell. If so, they may think, it was put to the appeal judges, that they would want to take into account the Comptroller’s conduct (which it was alleged Recorder Campbell had not) and this to be set against the repeated mistakes of MDC - the advocate for Genentech maintained they were blameless, since they received no information which would have allowed them to spot the mistake until it was too late. He said that a separate discretion should be exercised in Genentech’s favour, separate from that to be considered in relation to the erring MDC. A potentially tricky agency point lurking here: whether the actions of an agent can be distinguished from its principal. It seems that MDC could have helped themselves more if they had put in more detailed evidence of why they had filled in the form as they did, how the error had occurred, and what steps they had taken to ensure it did not happen again; and the context of it all, for example how many such administrative actions they do a year - presumably a whole lot.

But the Court does not even reach the discretion point, unless the panel decides that one of the Appellants, and especially Genentech, has made out at least one of its grounds of appeal. The judges were keeping quiet about what they thought of it all. Indeed, Floyd LJ announced at the end that, while they were aware of the urgency, they did not want to be rushed. So quite a bit to ponder on they must have thought. They would publish their decision as soon as possible and their reasons for it afterwards.

Watch this space!

Article co-authored by Shirin Shah.