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The Irish Court of Appeal has allowed BMS to challenge a High Court ruling that the patent for its anticoagulant drug “Eliquis” is invalid. It was determined that the High Court “trial judge failed to a very large extent to make essential findings of fact” despite handing down a judgment which ran to more than 900 pages. Our Intellectual Property team considers the impact of the decision.


The case at issue concerns Bristol-Myers Squibb's (BMS) appeal against a High Court ruling handed down in December 2023. The High Court had found that Irish patent number EP (IE) 1 427 415[1], also known as the 415 patent, was invalid and should be revoked.

Teva challenged the 415 patent on the grounds of priority and plausibility. The challenge centred on whether the patent contained enough information to make it credible that the invention would provide the technical effect it claims. While the priority challenge was rejected, the High Court held that the patent was invalid because it failed the plausibility test. A similar invalidity decision was made relating to Supplementary Protection Certificate (SPC) No. 2011/032 for products containing the active ingredient apixaban. An example of a product containing apixaban is BMS’ Eliquis product. Apixaban is a form of factor Xa inhibitor and is listed in the 415 patent.

Duties of a trial judge to give reasons for their decision

At the beginning of the Court of Appeal judgment, Ms. Justice Costello stated that the High Court “either made no findings of fact or failed to explain such findings that it did make”. Ms. Justice Costello went on to detail the Common General Knowledge, or CGK, and witness statements of two medical chemists. The witness chemists were Dr. Young for BMS, and Dr. Edwards for Teva. It was held that the High Court trial judge failed to decide on the differences between the statements and to make findings of fact on their differences, “one of the most important tasks of the trial judge”. In addition, the Court of Appeal judgment stated that the trial judge:

“failed to give any reasons, or any adequate reasons, why he rejected the evidence of one witness and preferred the evidence of another.”

Considering the relevant case law concerning the duties of trial judges, the Court of Appeal referred to the statement in Doyle v Banville[2]. The statement referenced that “the judgement must analyse the case made for the competing versions of those facts and come to a reasoned conclusion as to why one version of those facts is to be preferred.”

Ms. Justice Costello also referred to the 2024 cases of Butler v Regan[3] and Action Alarms Limited v O’Rafferty[4]. Both cases reiterated the Doyle rationale that the appeal court should exercise self-restraint in overturning decisions so long as the trial judge makes clear statements in his or her findings. As a result, the Court of Appeal resolved that the inferences and conclusions to be drawn were that “if a judgment fails to make key findings of fact…it cannot stand and falls to be overturned on appeal.”

The Court of Appeal found that the trial judge “failed to a very large extent to make essential findings of fact” to the extent that the parties were unable to agree “whether certain passages of the judgment represented findings of the trial judge or not.”. Accordingly, the Court of Appeal found that the case must be reheard in the High Court.

Test for plausibility

The Court of Appeal also considered the legal test for plausibility adopted by the High Court. In its decision, the trial judge applied the plausibility test in Norton (Waterford) Limited t/a Teva Pharmaceuticals Ireland v Boehringer Ingelheim Pharma GmbH & Co. KG[5]. However, the High Court judge had failed to pay heed to the test for plausibility in the decision of the Enlarged Board of Appeal in Case G2/21 involving Sumitomo.

In the current case, BMS had put forward Sumitomo as the appropriate test. The Boehringer test focuses on the technical contribution to solve the problem addressed by the patent and whether there is a real reason for supposing that the patent provides a sufficient technical contribution to make it plausible. Without having regard to the evidence, the trial judge decided that the patent did not provide a reason to suppose that apixaban was plausible as a factor Xa inhibitor, seemingly ignoring BMS’ arguments to the contrary.

The Court of Appeal ruled that the case should be reheard by the High Court before a different judge. It added that validity would be assessed by reference to the plausibility test in Sumitomo which is:

“the definitive view of the highest authority on the interpretation of the EPC”.

Judicial comity

The Court of Appeal also considered that the trial judge had made errors in its approach to the doctrine of comity. The doctrine of comity is the legal doctrine under which courts recognise and enforce each other’s legal decisions as a matter of courtesy but not necessarily as a matter of law. Teva had brought similar validity challenges in the UK, France, Norway, and Sweden. These were unsuccessful everywhere except the UK. The trial judge in this case appeared to rely heavily on the UK decision, often referencing it throughout the judgment. However, the judge failed to account for the clear differences between the technical evidence and arguments presented in this case and those considered in the UK. While the Court of Appeal refrained from commenting as to what regard the High Court should have to the various foreign judgments on the issue, it did note that further judgments had been handed down and would need to be considered by the High Court judge tasked with rehearing the case.

Comment

The judgment is significant for several reasons, particularly its detailed analysis of a judge's duty to provide reasons for their decisions. It also underscores that an appellate court should not hesitate to grant an appeal if a judgment fails to address key findings of fact. The consequence is that “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.” The judgment also clarifies that the relevant test for plausibility is the one established in Sumitomo. While the Boehringer test remains valid and relevant, Sumitomo should be the primary reference when evaluating plausibility.

For more information and expert legal advice on how best to protect your intellectual property rights, please contact a member of our award-winning Intellectual Property team.


People also ask

What is patent plausibility?
Plausibility is the requirement for the technical effect of the invention disclosed in the patent is “plausible” from the outset i.e. that the patent contains enough information to make it credible that the invention will provide the technical effect alleged.
What are the duties of a trial judge?
A key duty of a trial judge is to analyse the case made for the competing versions of the facts presented to them and come to a reasoned conclusion as to why one version of those facts is to be preferred. The case of Doyle v. Banville [2018] 1 I.R. 505 provided guidance on such a principle.
What is judicial comity?
Judicial comity refers to the mutual respect which judges have for each other’s opinions. Judicial comity may lead a judge to agree with another judge even though he has doubts as to the correctness of the decision with which he is agreeing.

[1] Entitled “Lactam containing compounds and derivatives thereof as factor Xa inhibitors

[2] [2018] 1 I.R. 505

[3] [2024] IECA 52

[4] [2024] IECA 117

[5] [2022] IECA 58

The content of this article is provided for information purposes only and does not constitute legal or other advice.



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