UK appeals court upholds cancellation of AstraZeneca’s diabetes SPC and patent

In the dispute between AstraZeneca and generics manufacturers Viatris, Teva and Glenmark, the UK Court of Appeal has upheld a High Court decision invalidating AstraZeneca's patent, agreeing with the application of the concept of plausibility. According to JUVE Patent sources, AstraZeneca will appeal to the Supreme Court.

The UK Court of Appeal has dismissed AstraZeneca’s appeal and upheld the UK High Court judgment, ruling that the patent is invalid for both lack of inventive step and insufficient disclosure (case ID: CA-2025-001040, [2025] EWHC 1012 (Pat)).

At issue is AstraZeneca’s EP 1 506 211, which expired on 14 May 2023. The company is also the proprietor of UK SPCs SPC/GB13/021 and SPC/GB14/050 based on the patent, which expire on 13 and 14 May 2028. The patent claims relate to dapagliflozin, marketed by AstraZeneca under the brand Forxiga pursuant to a marketing authorisation granted on 14 November 2012. The drug treats diabetes.

In their ruling the judges expressly referred to the decisions Sandoz vs BMS concerning apixaban, the Supreme Court decision on Warner-Lambert, and the Enlarged Board of Appeal decision G2/21.

The judgment primarily concerns the interpretation of plausibility when determining patent validity. However, the court also addressed the concept of arbitrary selection from prior art.

Regrettable decision

The court, led by Richard Arnold, rejected AstraZeneca’s appeal, stating that, in applying Sandoz vs BMS, the High Court judge “correctly concluded that the patent did not make it plausible that dapagliflozin would be useful for the treatment of diabetes, and therefore both claims 2 and 15 were invalid for both lack of inventive step and insufficient disclosure”.

The court thus upheld the first-instance decision. Arnold noted that “the judge made it clear that he reached his decision with regret given that dapagliflozin had proven to be successful”. Neverthless, “later findings about dapagliflozin do not enter the picture” and the judge’s main task was to “assess the validity of the patent based on its disclosure”.

Arnold writes, “The judge went on to observe that it was not for him to speculate about why the Patent was drafted in the way that it was, and in particular why it contained no data about the performance of dapagliflozin.” However, Arnold noted that the timing of BMS’s patent application coincided with that of apixaban.

“In the apixaban litigation courts of other EPC Contracting States have accepted that, at the time of filing the application for that patent, BMS had data in respect of apixaban which it did not include in the application,” writes Arnold. But, while “there is no evidence before this Court as to whether the same was true of dapagliflozin and the application for the patent”, Arnold emphasises, patent applicants “should not be permitted to rely upon data which they choose to keep secret when filing their applications”. Arnold details the reasons for this in the judgment.

The UK court thus confirms the case law on lack of plausibility as set out in the High Court’s decision and the Warner-Lambert case. This constitutes a continuation of case law that is not in line with the EPO.