Updated 29 June 2020
The Court of Appeal dealt with Neurim's appeal against the refusal of an interim injunction on an expedited basis. Whilst it refused Neurim's appeal, finding that damages would be an adequate remedy, it stressed the fact sensitive nature of the assessment and the particular facts in this case. See here for our article on the Court of Appeal's decision.
The Patents Court has refused an interim injunction sought by Neurim (and Flynn Pharma claiming as exclusive licensee) against Mylan in relation to its planned launch of a generic competitor product to Circadin. This is a potentially positive development for generic firms seeking to launch at risk (i.e. where it has not "cleared the way"). The patent is due to expire in August 2022, and an expedited trial will take place at the end of October 2020. The European Patent Office has found the patent invalid on the grounds of anticipation but that decision is under appeal and may not be heard for some time.
Whilst the Judge referred to the 'well-established' line of cases where interim injunctions have been granted because damages are not an adequate remedy due to irretrievable price depression, he stressed that the legal principles are clear, and each case must turn on its own facts. In the present action the Judge held that damages would be an adequate remedy for Neurim/Flynn, even where there may be irretrievable harm, because there was no reason why those losses could not properly be calculated based on information held by Neurim/Flynn (with Mylan also being required to produce certain records). The added complication of other generics potentially entering the market did not change this conclusion. The Court also rejected Neurim/Flynn's reliance on other 'consequential effects', such as the impact on investment in research and development, manufacturing and distribution networks, educational programs, clinical trials and the prospect of redundancies, as Neurim was 'sitting on significant cash' and these losses would arise in any event after patent expiry in a couple of years.
That conclusion therefore disposed of the claim for an interim injunction but, if he had had to consider it, the Judge noted that it would have been considerably more difficult and uncertain to assess Mylan's losses. The Court also did not have to consider arguments about Mylan not having cleared the way, in circumstances where it had opposed the patent at the EPO and been 'assiduous' in obtaining a marketing authorisation. The Judge said this would be a factor to take into account in the assessment of whether damages were an adequate remedy for Mylan, but made no difference to the outcome here as damages would be an adequate remedy for Neurim/Flynn.
This decision (albeit, by a non-specialist patent judge) may signal a new approach to generic launches in the UK, giving greater confidence to generic firms to launch at risk, i.e., when they have not "cleared the way", and even where their launch will cause price depression (the latter being a factor which the Court has typically said will cause the patentee the serious irreparable harm which justifies the injunction).
Of course, a generic firm will still want to think carefully about launching during the period of patent protection: if it avoids an interim injunction and launches at risk it will be exposed to paying damages at the lost (monopoly) margin of the patentee if it loses at trial.