On 10 November 2017, Henry Carr J in the English Patents Court delivered a significant decision Actavis & Ors –v- ICOS & Lilly  EWHC 2880 (Pat) which will be of great interest to litigants in the field of generic pharmaceuticals. The decision was on an interim application by which ICOS sought an interim injunction to restrain launch of generic TADALAFIL pending ICOS' application for leave to appeal and further, if leave were granted, pending the subsequent appeal decision of the Supreme Court. Henry Carr J refused the injunction.
The application for an interim injunction related to main proceedings between ICOS and three generic pharma companies: Actavis, Mylan and Teva (the "Claimants"). The main proceedings involved a revocation action commenced as a "path-clearing" exercise by the Claimants in 2014/15 seeking revocation of two ICOS patents covering Tadalafil dosing regimens. At trial in June 2016 ( EWHC 1955 (Pat)), the validity of the key ICOS patent was upheld. The Claimants' appeal was heard in July 2017 and the Court of Appeal ("CA") delivered its judgment on 1 November 2017 ( EWCA Civ 1671), overturning the trial Judge and thereby revoking the ICOS patent in suit. The CA decision was itself significant in that it involved three experienced patent appeal judges (Kitchin, Floyd & Lewison LJJ) who overturned Birss J's decision and held the patent invalid on grounds of obviousness and each gave a judgment which refused leave to appeal to the Supreme Court in robust terms.
The relevant SPC for Tadalafil was due to expire at midnight on Monday 13 November 2017. ICOS however convinced the CA to stay the order revoking the patent in order to allow for an urgent application in the Patents Court for an interim injunction pending leave to appeal to the Supreme Court. In the event, the application was heard urgently on Friday 10 November.
The Judge considered the principles governing interim injunctive relief pending appeal which had been decided by the CA in Novartis v Hospira ( EWCA Civ 583). It was the Novartis decision which gave guidance that a generic pharma company's path clearing exercise would be well-advised to commence in sufficient time, prior to any product launch, to obtain a decision not only at first instance, but also on appeal. This time is roughly 2½ years before launch (and the Claimants had met this deadline in the main action). Success for ICOS in this injunction application could have effectively meant this period extending back by an additional 2½ years to allow for a typically slow-moving Supreme Court appeal.
The Judge considered the first question: whether ICOS' application for permission to appeal, and any subsequent appeal to the Supreme Court had real prospects of success. ICOS argued that the CA had fallen into error on an important point of law - whether a route could be obvious to try even where there was no reasonable expectation of success. The CA had held that even where the results of an entirely routine test were unpredictable, nonetheless there may be a finding of obviousness because it was not inventive to carry out a routine test even if the test resulted in an unexpected bonus. The Judge held that the CA had merely applied the facts as found by the trial judge, to existing and settled principles of law. In addition, the Judge observed that unlike the appellant's situation in Novartis, here ICOS had been refused leave to appeal to the Supreme Court with three CA judges finding that the case raised no point of law of general public importance (a key threshold for Supreme Court appeals). As a result, Henry Carr J held that ICOS had not even overcome the first hurdle of a realistic prospect of success.
In case he was wrong on that, the Judge went on to consider unquantifiable harm and the balance of convenience. He held that ICOS had not shown that it would suffer unquantifiable damage if the injunction were refused and later reinstated. The Judge relied on three factors. First, following any Supreme Court appeal the patent in suit would only have a few months of life remaining before it expired. As such, any future enquiry as to damages would involve entirely historical sales data. Second, the ICOS branded product essentially had a fixed list price and ICOS had not suggested that it would reduce the price in the face of generic competition. Finally, ICOS' evidence indicated that the market for Tadalafil was essentially flat. All this led the Judge to find that any damage that ICOS might suffer would be readily quantifiable.
The Judge then considered, if this were wrong, and ICOS did suffer some unquantifiable damage, whether such damage would outweigh any unquantifiable damage which would be suffered by the Claimants if the injunction were granted but later dismissed. He found that any such loss by ICOS would be significantly outweighed by the Claimants' unquantifiable losses. The Judge relied on the fact that the Claimants would be the "first movers" in the market for generic Tadalafil. After any appeal, it was foreseeable that there were likely to be many other generic companies ready to enter the market and as such, the market conditions would be entirely different at that time and sales would be very difficult to quantify.
ICOS had therefore failed to overcome any of the required American Cyanamid hurdles – serious issue to be tried on appeal, unquantifiable damage and balance of convenience. After such a robust decision by Henry Carr J (albeit on its own facts), it seems doubtful that we will see many future applications for grant of an interim injunction pending appeal to the Supreme Court.