UK Supreme Court to assess plausibility of anaemia patents

The UK Supreme Court has just confirmed that it will hear the appeal in FibroGen Inc v Akebia Therapeutics concerning patents for treating anaemia and whether they lacked plausibility.

Green light for appeal

Perhaps buried by Christmas cards in the past week is news that the Supreme Court has given permission for the appeal in FibroGen Inc v Akebia Therapeutics to proceed. (The court granted leave on 3 October 2022, although this was not publicised on its website until 16 December 2022.)

Court of Appeal’s ruling: quick recap

In August 2021, the Court of Appeal reversed the decision of the Patents Court that patent claims for a broad class of compounds, defined by structure and function, to be used for treating specified types of anaemia were invalid for insufficiency as lacking plausibility and imposing an undue burden. FibroGen owned the patents and Akebia had applied to invalidate them to clear the way for their product, which was undergoing clinical trials. Arnold LJ had sat as the Patents Court judge.

Birss LJ who gave the principal judgment in the Court of Appeal analysed the case law on plausibility, which he preferred to call “reasonable prediction”. He concluded that there were three sequential steps to be followed, but the Patents Court judge had only applied a single test. When the three-step test was applied, there was no insufficiency on the basis of reasonable prediction.

Sir Christopher Floyd, who agreed with the decision of Birss LJ, gave his own judgment on sufficiency because they were “… differing from a patent judge of enormous experience and distinction, and the issues addressed in this case are of…