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UK – Sandoz v. Bayer / Xarelto Appeal

02 Jul 2024

Jack Lawrence

Simmons & Simmons LLP

Bryan Tan

Simmons & Simmons LLP

Amy Crouch

Simmons & Simmons LLP

Sandoz AG & Ors v. Bayer Intellectual Property GmbH & Ors [2024] EWCA Civ 562

Introduction / Summary

The Court of Appeal dismissed Bayer’s appeal against the order of the Patents Court revoking European Patent (UK) No. 1 845 961 (“EP’961” or “the Patent”) on 12 April 2024. EP’961, a medical use patent for the thromboembolic disorder drug Rivaroxaban (market name “Xarelto”), was solely owned and exclusively licensed by Bayer.

The Patents Court Decision

At first instance, HHJ Hacon (sitting as a High Court Judge) had found EP’961 to be invalid for lack of inventive step over two pieces of prior art: “Harder” and “the Kubitza posters”.

The principal issue was “whether the skilled team would have had a reasonable expectation of success with respect to once daily administration”. The Harder prior art indicated that the once-daily 30mg dosage of Xarelto was already considered appropriate, and therefore the skilled team would have found it obvious to conduct a Phase II trial that included such a regime.

The judge reasoned that the skilled team would have been aware of the clinical advantages and the potential financial benefit of a once-daily tablet. Where the prior art had raised the possibility of including a once daily regimen in a Phase II trial, that possibility would have been given serious consideration, and would not have been considered to have an unacceptable level of risk.

The judge noted that he had been referred to a number of decisions by foreign courts in parallel cases (as well as the EPO Board of Appeal, which had maintained the patent as granted) but expressed the view that the decisions were of little assistance because they were based on different evidence and arguments. Nevertheless, the judge recorded that the Claimants had submitted that the courts which had found the parallel patents valid had been influenced by Bayer’s “invention story”, which Bayer had not adduced evidence on in the UK case.

Having come to the decision that the Patent was obvious over the two pieces of prior art, the Judge added that it was clear that Bayer had carried out a single Phase II trial with a once-daily dosage regimen and that no convincing reason was advanced as to why the skilled team would not have reached the same conclusion and done exactly as Bayer did.

The Appeal

Bayer was given permission to appeal against the first instance decision of obviousness on two grounds (ground 1, which included three sub-grounds, and ground 5). Arnold LJ delivered the judgment of the Court of Appeal.

– Ground 1(1)

Bayer argued that the judge erred in law or principle by failing to consider important factors that contributed to the decision on obviousness reached. There were two stages to Bayer’s argument. The first stage focussed on the judge’s statement that “there was no perceived technical barrier to the claimed invention on the part of the skilled team” being inconsistent with his later statements regarding the difficulty of determining a therapeutic window. Arnold LJ considered this argument to be predicated on a “misreading” of the first instance decision, and explained in detail his understanding of what would be technically obvious to the skilled team.

The second stage of Bayer’s argument was based on the judge’s comments that “the real or key criterion was whether the skilled team would have thought that it was worth applying to

the relevant ethics committee for permission to conduct a Phase II trial which included a once daily regimen with a reasonable expectation that the committee would give permission and whether it was likely that the committee would have given permission”. Bayer argued that this criterion is “legally irrelevant” because the issue with regards to obviousness should be a solely technical one.

Arnold LJ agreed with Bayer that “on a strict legal analysis this is irrelevant” but that the comments by the judge did not “undermine his evaluation of obviousness”, as the correct legal criterion was repeatedly identified and the correct questions considered.

– Grounds 1(2) and (3)

Grounds 1(2) and (3) were based on a single point; that the judge had “erred in placing weight on Bayer’s decision not to adduce “invention story” evidence in this jurisdiction”. Bayer submitted that this prevented the question of obviousness from being objectively assessed from the perspective of the skilled team.

Arnold LJ disagreed that the judge had placed any weight on the absence of “invention story” evidence. He noted that the “invention story” evidence had only been considered relevant when evaluating why the decisions of foreign courts and tribunals that were favourable to Bayer should not be persuasive on the UK decision.

– Ground 5

The second ground of appeal was that “the judge failed to grapple with the key question of whether the skilled team would have a reasonable expectation, based on Harder and the Kubitza posters, that a once daily 30 mg dose of rivaroxaban would have a therapeutically useful effect for 24 hours”. It was Bayer’s contention that, if the judge had grappled with this principal question properly, he would have answered it in the negative.

Arnold LJ found this ground to be unsupported and considered Bayer’s arguments to be based on “no more than a series of disagreements with the judge’s reasoning”. He explained that “careful consideration” was given to these arguments at first instance, and that a detailed explanation was given as to why the judge took a different view.

The Court of Appeal Decision

The Court of Appeal finally found that:

“The judge made no error of principle in his assessment of obviousness. His conclusion was grounded in the expert evidence. Nor, standing back, is that conclusion at all surprising. Harder expressly suggests that rivaroxaban is suitable for once daily administration. Harder and the Kubitza posters contain some data to support that statement, at least in the case of a 30 mg dose. It was therefore obvious to try including a once daily regimen in the Phase II trial, and the skilled team would have had a reasonable expectation that a 30 mg once daily dose would be efficacious and safe”.

The Court of Appeal therefore dismissed the appeal.

The full judgment can be accessed here.