2015 has seen a series of preliminary judgments from the High Court and one from the Court of Appeal concerning a dispute between Actavis and Warner-Lambert (part of the Pfizer group) over the drug pregabalin. Warner-Lambert sought to enforce against Actavis a patent with a Swiss-style second medical use claim directed to the use of pregabalin in treating pain. This dispute and the resulting judgments have attracted a huge amount of interest, since the courts are expected to give definitive guidance as to the types of act that infringe a Swiss-style second medical use claim in the United Kingdom.
Following the various preliminary judgements earlier this year, a full trial was held before the High Court in June and July 2015. The judgment from Mr Justice Arnold is now available here. It is a lengthy judgment (727 paragraphs!), but the upshot is that the relevant claims of Warner-Lambert 's patent were held to be insufficient. Mr Justice Arnold further held that even if he was wrong on validity, Actavis did not infringe those claims either directly or indirectly.
In coming to this conclusion Mr Justice Arnold applied the preliminary judgment of the Court of Appeal, despite concluding that he was not obliged to do so and questioning its correctness. The Court of Appeal had earlier held that infringement would arise if Actavis knew or could foresee that their generic pregabalin would be administered intentionally for pain. Mr Justice Arnold held on the facts that the conduct of Actavis and the other parties involved was such that it was not foreseeable to Actavis that the generic pregabalin would be administered intentionally for pain by doctors and pharmacists, save for a small number of exceptional cases that he considered de minimis. This outcome suggests that in cases where adequate measures have been taken to minimise the risk of intentional administration of a generic drug for a patented indication, it may be difficult for patentees to establish that infringement of Swiss-style second medical use claims has occurred.
Unless the parties settle, this judgment is unlikely to be the final word on this matter. We would expect an appeal to the Court of Appeal in due course, and the case could well end up eventually being considered by the Supreme Court.
Our full analysis of this judgment and the dispute over pregabalin will be available soon. If you would like to receive our briefing on this topic, or have any questions in the meantime, please contact us here.