Irides: Weekly patent litigation update

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.

Our latest edition - 31 May 2024 - is below:

UK

Court of Appeal dismisses appeal in Rivaroxaban litigation.

As reported in Irides Weekly Update 20/2024, on 16 May 2024 the Court of Appeal gave a short oral judgment dismissing Bayer’s appeal against the decision of HHJ Hacon which had found EP (UK) 1 845 961 (the Patent) to be invalid for obviousness (as reported in Irides Weekly Update 16/2024). On 24 May 2024, the Court handed down its full decision, with Arnold LJ writing the lead judgment. Decision here.

The Patent (claimed a once-daily dosing regimen for rivaroxaban (a blockbuster anticoagulant drug). At first instance, HHJ Hacon had held that the key criterion for obviousness was whether the skilled team would have thought it was worth applying to an ethics committee to carry out a Phase II trial including a once-daily dosing regimen, and whether it was likely that the committee would have given permission. HHJ Hacon also acknowledged that this criterion would be the same question as to whether the skilled team would have a reasonable expectation that a one-daily dose would be safe and effective.

Bayer sought to appeal on five grounds, of which permission to appeal was granted in relation to two. Bayer subsequently sought permission to amend their grounds of appeal to introduce a further ground, and went on to advance a further unpleaded ground in oral argument (though the Court of Appeal refused permission to raise this unpleaded ground).

In its application to amend its grounds of appeal, Bayer had sought to challenge the first instance finding that the authors of one of the conference posters were either “distinguished clinicians” or “leaders in the field”. The Court of Appeal dismissed the application, noting that such a finding could only be overturned if it were “rationally insupportable”, and held that the finding was not just rationally supportable, but substantially correct.

Bayer submitted that the trial Judge had erred in suggesting that the key criterion for obviousness was whether the skilled team would think it worth applying to the ethics committee. The Court of Appeal dismissed this ground, noting that, even though the Judge’s reference to the need for ethics committee approval was unnecessary, he had repeatedly identified the correct legal criterion in his judgment and that his question of whether the skilled team would have had a reasonable expectation that a one-daily dose would be safe and effective was the correct one.

The Court of Appeal also dismissed as “no more than a series of disagreements… without identifying any error of principle” Bayer’s submission that the trial Judge had failed to assess whether the skilled team, in light of the prior art, would have had a reasonable expectation that a 30 mg dose of rivaroxaban once a day would have been considered to have a therapeutically useful effect for long enough, thus justifying its inclusion as one of the regimens in a Phase II trial.

Finally, the Court of Appeal rejected Bayer’s contention that the trial Judge had erred in placing weight on Bayer’s decision not to adduce “invention story” evidence in the UK Proceedings. The Court of Appeal found that there was no weight given to the lack of such evidence in the trial Judge’s decision on obviousness – the lack of such evidence was relevant principally in explaining why the trial Judge had not found the decisions of foreign courts and tribunals in favour of Bayer to be persuasive.

Bayer’s appeal therefore failed on all grounds.

In a postscript, the Court of Appeal noted that although the TBA of the EPO had upheld the validity of the Patent in October 2021, the respondents (a number of generic drug manufacturers, including Sandoz, Teva and others) had not filed a claim seeking revocation of the UK designation of the Patent until a full year later despite knowing that the rivaroxaban compound patent would expire on 1 April 2024. Although the trial had taken place in February 2024, the Court of Appeal noted that the trial Judge had not been sufficiently informed of the potential consequences if he failed to deliver a judgment by 1 April 2024. This resulted in the need for an urgent interim injunction (as reported in Irides Weekly Update 13/2024) – which the Court of Appeal considered was not a sensible use of the parties’ and the court’s resources. The Court of Appeal judgment was handed down within 6 weeks of the first instance decision.

UK

MHRA outlines proposals for international recognition of medical devices.

On 21 May 2024, the MHRA issued a Statement Of Policy Intent as regards a new approach to the regulation of medical devices (including in-vitro diagnostic medical devices (IVDs)).

The proposal would allow many medical devices to be placed on the GB market if the device has been “approved” in a trusted Comparable Regulator Country (CRC). The CRCs are Australia, Canada, EU and the USA.

The stated rationale is that the MHRA should be able to rely on the work of trusted regulators to allow access for devices approved in CRCs as this:

• represents “smarter” regulatory oversight, resulting in more predictable, faster approvals to improve access to quality-assured medical devices for patients; and
• reduces duplication of assessments conducted by trusted regulators that, in turn, will focus resources (regulators and manufacturers) on more innovative products for the benefit of patients.

Some lower-risk devices (most class I devices and all Class A IVDs ) will get automatic access to the GB market – this route is known as Recognition.

Not unsurprisingly given the MHRA’s familiarity with the EU systems, the proposal would give near-automatic access (known as Reliance) to virtually all devices “approved” in the EU. There is a slightly enhanced version of Reliance for most general medical devices approved in Australia or under the US Pre-Market Approval process.

The most onerous route is an “abridged” review by the MHRA. This applies to virtually all:

• general medical devices approved in Canada or “approved” under the US 510k or DeNovo processes; and
• IVDs: approvals from Australia, Canada or the US.

Even this most onerous process does not entail a review of the dossier or clinical data. Of course, the MHRA retains right to reject any application if evidence is “insufficiently robust”.

Certain devices are excluded. By way of example, this would not apply to (a) companion diagnostics or (b) combination products, where the companion or combined medicine is yet approved in the UK.

This development has been expected for several years and reflects a new reality post-Brexit and a post-pandemic enthusiasm for focusing the MHRA’s efforts on facilitating market access for innovative devices.

This pragmatic approach could allow certain devices avoid current backlogs for “approvals” and to get to the market in Great Britain months or years earlier than might otherwise have been the case.

CN

China joins Patent Prosecution Highway Improvement Initiative.

The China National Intellectual Property Administration (CNIPA) has announced that it will join the Patent Prosecution Highway (PPH) Improvement Initiative. The PPH is a programme designed to fast-track patent examination. It enables patentees to request accelerated processing of an application if the claims have been deemed patentable by another IPO and allows IPOs to maximise efficiency by sharing work.

This PPH Improvement Initiative involves five IPOs known as IP5: China, the United States, Europe, Japan, and the Republic of Korea. Under this initiative, the IP5 has set a target processing time of three months from the request for accelerated processing under the PPH to issue of the first office action. Additionally, the initiative aims to reduce the average examiner response time, providing users with a more predictable examination cycle.

UPC

UPC announces Judge appointments, and further German local division panels formed.

Mr Andrea Postiglione, Ms Anna-Lena Klein and Ms Marije Knijff have been appointed as Judges of the future section of the central division in Milan, due to open its doors on 26 June 2024.

The UPC also announced the appointment of Ms Ulrike Voß (Presiding Judge) and Mr Daniel Voβ (Judge), who will form an additional panel at the local Munich division.

Further, Mr Dirk Böttcher (Judge) has been appointed to the local division of Mannheim and will form a second panel presided by Mr Peter Tochtermann. Mr Tochtermann will continue to preside over the panel comprising Mr Holger Kircher (Judge).

Additionally, Emmanuel Gougé will replace Françoise Barutel as a Judge in the Court of Appeal starting 9 September 2024. Mr Gougé has given up his private practice role to take up the position.