CA-2025-001040 - [2025] EWCA Civ 903

Conclusion

For the reasons given above I would dismiss the appeal. In summary, the judge correctly interpreted the Patent. Applying Sandoz v BMS, as he was bound to do, he 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. Even if the standard applicable when considering inventive step for claim 2 is whether the skilled team would have legitimate reason to doubt that dapagliflozin would be useful for the treatment of diabetes, on the judge’s findings the skilled team would have legitimate reason to doubt this. Turning to arbitrary selection, the judge was correct to hold that the Patent claims a compound arbitrarily selected from the genus disclosed in Formula IB of WO 128 because the Patent makes no technical contribution compared to WO 128: the disclosure with respect to the assay is identical, and AstraZeneca does not even argue for this purpose that dapagliflozin is in fact superior in any of its properties to any of the compounds disclosed in WO 128, and in particular the compound of Example 12.

The judge made it clear that he reached his decision with regret given that dapagliflozin had proved to be successful, but as he rightly said at [281] “later findings about dapagliflozin do not enter the picture and my task has been to assess the validity of the Patent based on its disclosure”. 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. It may be no coincidence, however, that the application for the Patent was filed by BMS at around the same time as the apixaban application. As discussed above, 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. There is no evidence before this Court as to whether the same was true of dapagliflozin and the application for the Patent. Even if that were the case, I have explained above why applicants for patents should not be permitted to rely upon data which they choose to keep secret when filing their applications.

Lord Justice Stuart-Smith:

I agree.

Lord Justice Peter Jackson:

I also agree.