Irides: Weekly patent litigation update (via Passle)

This edition features updates from: the United Kingdom (UK), France, India, the Unified Patent Court (UPC) and the European Union (EU).

The Irides Weekly Update is our round-up of patent litigation news highlights from around the world. Taking its name from the plural of “iris” - a nod to the ability of Irides to see what’s happening around the world.

As previously reported here, at first instance Deputy High Court Judge Michael Tappin KC found AstraZeneca’s (AZ) patent and corresponding SPCs to the SGLT-2 inhibitor dapagliflozin invalid for both lack of plausibility and a lack of technical contribution of the basic patent. On 16 July, Arnold LJ, with whom the other Lord Justices agreed, upheld the judgment of Dr Tappin KC at first instance and dismissed all of AZ’s grounds of appeal.

A key disclosure of the patent in suit was an assay to measure SGLT2 activity of the compounds of the invention. At first instance, the trial judge found that the disclosure of the patent did not comprise a verbal statement of an experimental result in relation to dapagliflozin and therefore the claimed inventions to dapagliflozin (or its medical use) lacked plausibility. Arnold LJ agreed.

Further, even if the skilled person considered that dapagliflozin had been tested in the assay and some degree of SGLT2 inhibition found, they would not know the level of potency and whether that potency was sufficient to confer therapeutic utility in the treatment of diabetes. Arnold LJ was not persuaded that the trial judge had erred in reaching this conclusion.

AZ argued that the Court should depart from its decision in the Apixaban case (Sandoz v BMS), which applied the Warner-Lambert standard of plausibility to product claims, on the basis of G 2/21 and the subsequent decisions of the EPO Boards of Appeal (BoA) and national courts across Europe. It was not disputed that the Warner-Lambert Supreme Court judgment was binding on the Court in relation to second medical use claims.