Court of Appeal: High Court ruling in drug patent dispute failed to make findings of fact or to give reasons for decision

About this case:

• Citation:
  [2024] IECA 287
• Judgment:
  External link
• Court:
  Court of Appeal
• Judge:
  Ms Justice Caroline Costello

Delivering judgment for the Court of Appeal, Ms Justice Caroline Costello explained: “Simply put, neither the parties nor this Court can know why this case was rejected. The authorities make absolutely clear that in such circumstances the case should be remitted for rehearing: it cannot be upheld on appeal.”

Background

The appellant, BMS, held an Irish patent for a compound ‘Lactam’ (the 415 patent) and a Supplementary Protection Certificate (SPC) for the anticoagulant drug ‘Eliquis’ which expires on 19 May 2026.

The validity of the patent was challenged by the respondent, Teva, on grounds of priority and plausibility. Mr Justice Max Barrett in the High court rejected the case based upon priority but held that the 415 patent failed the test for plausibility and accordingly was invalid. 

BMS appealed the court’s finding of invalidity of its patent.

The Court of Appeal

Ms Justice Costello noted at the outset that the High Court made no findings of fact or failed to explain any such findings that it did make.

The court considered the extensive jurisprudence on the duties of a trial judge to give reasons for their decision, noting the statement of Ms Justice Mary Faherty in Butler v. Regan [2024] IECA 52 and Action Alarms Limited v. O’ Rafferty [2024] IECA 117 to the effect that the quid pro quo for an appellate court’s self-restraint is that the trial judge must make a clear statement of his findings, the inferences to be drawn, and the conclusions to be drawn.

Ms Justice Costello explained that if a judgment fails to make key findings of fact or fails to explain why the evidence of one witness is preferred over another and why the key or core elements of a party’s case is rejected (and it thereby loses its case) it cannot stand and falls to be overturned on appeal.

The court highlighted: “The judgment of the High Court inclusive of appendices runs to in excess of 900 pages. It is undoubtedly the longest in the experience of any member of the Court. It is replete with very lengthy extracts from the evidence of all of the witnesses; set out either from their witness statements or the transcript of their evidence. It is extremely regrettable that notwithstanding this conscientious and exhaustive exercise, the trial judge failed to a very large extent to make essential findings of fact. Indeed the parties could not even agree whether certain passages of the judgment represented findings of the trial judge or not.”

Recognising that the parties could not agree whether certain passages of the judgment represented the trial judge’s findings, Ms Justice Costello considered that insofar as it could have been inferred that the trial judge preferred the evidence of one witness over another he had failed to give any or any adequate reasons why he rejected the evidence of one witness and preferred the evidence of another.

The Court also found inter alia that the trial judge had identified the applicable test for plausibility as being that in Norton (Waterford) Limited t/a Teva Pharmaceuticals Ireland v. Boehringer Ingelheim Pharma GmbH & Co. KG [2022] IECA 58 (i.e. whether there is a real reason for supposing that the claimed invention will indeed have the promised technical effect) but then simply stated that there was no such reason without analysing the evidence and the arguments of BMS to the effect that there was a real reason to think that apixaban was plausible.

The president continued: “Simply put, BMS does not know why it lost in the High Court and this Court cannot properly assess whether or not the High Court was correct to conclude that the 415 patent was invalid. This means, in my view, that the judgment cannot stand and that the case must be remitted to the High Court for rehearing.”

Conclusion

Accordingly, the Court of Appeal allowed the appeal as to the plausibility of the patent and remitted for the case for rehearing to the High Court by reference to the test propounded by the Enlarged Board of Appeal in G2/21 Sumitomo instead of Boehringer as the former represented the definitive view of the highest authority on the interpretation of the European Patent Convention.

Bristol-Myers Squibb Holdings Ireland Unlimited v. Norton (Waterford) Limited t/a Teva Pharmaceuticals Ireland [2024] IECA 287