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 - 19 April 2024 - is below:

UK

High Court finds Bayer's rivaroxaban patent obvious, but grants preliminary injunction pending permission to appeal application.

Following on from Irides Weekly Update 13 2024, on 12 April 2024, His Honour Judge Hacon revoked as obvious Bayer’s once-daily dosing regimen patent for rivaroxaban, EP (UK) 1 845 961 (EP 961). The validity of Bayer’s patent had been challenged by numerous generic companies, including Teva, STADA, Sandoz/Accord, Hetero/Amarox, Cipla and Viatris. Between the expiry of the SPC for Bayer’s compound patent on 1 April 2024 and the hand down of judgment in the EP 961 validity proceedings on 12 April 2024, the generics had been subject to a “holding the ring” interim injunction preventing offers, sale or supply of their once-daily generic rivaroxaban products, ordered by HHJ Hacon following a hearing on 27 March 2024.

In the decision on merits, HHJ Hacon considered that it was appropriate to mosaic documents expressly referred to in the cited prior art; in this case additional conference posters which had previously been made available to the public, but which it was common ground would not have been located by the skilled team at the priority date. HHJ Hacon considered the relevant question for assessing inventive step over the posters to be whether, in light of the prior art, the skilled team would have thought that it was worth applying to the ethics committee for permission to conduct a phase II trial which included a once-daily dosing arm, and whether it was likely that permission would be granted. HHJ Hacon acknowledged that this might amount to the same thing as a reasonable expectation on the part of the skilled team that a once-daily dose would be both safe and effective. HHJ Hacon held that the skilled person would have considered such trials to represent an acceptable level of risk.

At the Form of Order hearing immediately following hand down on 12 April 2024, HHJ Hacon refused to grant Bayer permission to appeal on the basis that it would have no reasonable prospect of success. However, since Bayer expressed an intention to make an application to the Court of Appeal, HHJ Hacon considered the authority of Skatteforvaltningen v Solo Capital Partners LLP which emphasised the need to ensure that the Court of Appeal should be put in a position that allowed it to be best able to do justice between the parties. As such, HHJ Hacon again injuncted the generic companies until 29 April 2024, thereby maintaining the status quo while imposing a deadline of 22 April 2024 for Bayer to apply to the Court of Appeal for permission to appeal.

FR

Allergan patent for glaucoma treatment declared invalid for lack of inventive step after PI was refused.

On 29 March 2024, the Paris Judicial Court handed down its judgment in case no. RG 21/02570 invalidating Allergan’s patent for an eye-drop treatment for glaucoma on the grounds of lack of inventive step.

Allergan is the proprietor of patent EP (FR)1 753 434 (the Patent) which discloses a solution comprising a specific concentration of the active ingredient bimatoprost and a preservative benzalkonium chloride (BAK) to treat glaucoma or intraocular hypertension. Bimatoprost, a prostaglandin analogue, was already marketed at the priority date in an eye drop for glaucoma called Lumigan 0.3 mg/ml, which contained 0.03% bimatoprost and 0.005% BAK (i.e. 50 parts per million or ‘ppm’). The Patent claimed a composition containing between 0.005% and 0.02% of bimatoprost and between 100 and 250 ppm of BAK. Viatris started marketing a glaucoma eye drop solution in France in February 2020. Allergan’s application for a PI against Viatris was refused by the interim judge and Court of Appeal on the grounds that the validity of the Patent was seriously challenged, Allergan then brought infringement proceedings against Viatris, and Viatris counterclaimed for invalidity.

The Paris Judicial Court adopted the problem-solution approach to its assessment of inventive step. The court considered the skilled team, comprising an ophthalmologist (specialising in glaucoma treatment) and a pharmaceutical formulator, would understand the objective technical problem the Patent addressed to be the formulation of a bimatoprost composition which reduces the hyperaemia (redness of the eye) caused by bimatoprost, whilst maintaining the same therapeutic effect. Claim 1 also implicitly teaches that increasing the concentration of BAK increases the efficacy of bimatoprost.

By the priority date, 16 March 2005, it was known that bimatoprost causes hyperaemia in a dose-dependent manner, and so it was obvious to the skilled team that hyperaemia could be reduced by reducing the concentration of bimatoprost in the solution, including to the claimed concentration of between 0.005% and 0.02%. A known corollary of this approach, however, was a corresponding decrease in therapeutic efficacy.

Another known issue with topical ophthalmic drugs was that they have low bioavailability, due to the difficulty for the active substances to pass through the wall of the eye, in particular the cornea, which was the preferred route of entry. It was taught in the prior art that certain preservatives, in particular BAK, had the effect of increasing the permeability of these membranes, and therefore play an important role in the bioavailability of drugs and may maintain efficacy.

The prior art therefore suggested to the skilled team to lower the concentration of bimatoprost to reduce the severity of hyperaemia, and increase the bioavailability of bimatoprost by using a higher concentration of BAK. The known toxicity of BAK would not dissuade the skilled team from checking its effect at the claimed doses, particularly since BAK was already widely used by the priority date including at concentrations of up to 200 ppm. The court noted that the availability of a large number of possible solutions at the priority date has no effect in itself on the obviousness of each solution, which must be assessed individually. The invention was therefore obvious and claims 1, 5 and 12 of the Patent declared invalid.

UPC

Time period for filing an appeal to a procedural order. The UPC Court of Appeal takes a pragmatic approach.

In a decision handed down on 11 April 2024, in Neo Wireless GmbH & Co KG v Toyota Motor Europe NV/SA (UPC_CoA_79), the Court of Appeal of the Unified Patent Court (UPC) has interpreted the provisions in Rule 220 of the Rules of Procedure (RoP) on the time period for filing an appeal and provided clarity on this subject.

Background

This case involved a decision dated 9 February 2024, of Judge-Rapporteur Maximilian Haedicke of the Court of First Instance (CFI) Paris Division. Toyota had brought a revocation action against Neo’s patent EP 3 876 490 (EP 490). Neo objected to the UPC having jurisdiction, and requested the claim be dismissed for lack of competence, EP 490 having been opted-out of the UPC on 30 March 2023. The Judge-Rapporteur rejected the objection to jurisdiction by Neo, in an order dated 9 February 2024.

Neo requested permission to appeal on 22 February 2024 which was granted the next day. Neo’s Statement of Appeal was lodged on 8 March 2024. Toyota argued that this was out of time as it was not filed within 15 days of the order being appealed (dated 9 February 2024), and therefore Toyota requested a decision by default.

Decision

The Court of Appeal held that Toyota had misinterpreted the RoP provisions. R.220.2 deals with appeals other than those listed in R.220.1. The orders covered by R.220.2 are known as “procedural orders”, whereas R.220.1 covers appeals against decisions and certain specifically named orders.

Procedural orders under R.220.2 can be appealed either:

• together with the final decision in the proceedings in which the order is given – the time limit for lodging the appeal is then within 15 days of service of this decision; or
• with permission of the CFI – when appealing an order with leave, the deadline for filing an appeal is within 15 days of service of the Court’s decision to that effect.

The Court considered that the wording in R.224.1(b), which specifically states that a Statement of Appeal must be filed “within 15 days of a decision referred to in 220.2” and does not refer to the impugned order itself, was intentional. Had it been intended to relate to the original order being appealed, the RoP would have expressly stated so. In addition, the words “the Court’s decision to that effect” in R.220.2 clearly refer to permission itself being granted. An order that does not already contain permission to appeal therefore cannot be ”a decision to that effect”.

Conclusions

If an appeal is lodged under Rule 220.2 and permission to appeal is granted within the order which is to be challenged itself, the Statement of Appeal must be lodged within 15 days of service of that order.

However, decisions to grant leave to appeal can be contained in separate orders. If this is the case, the Statement of Appeal instead has to be lodged within 15 days from the date of service of this further and separate order.

As here Neo was granted permission to appeal on 23 February 2024, the 15 day period ran from this date. A Statement of Appeal lodged on 8 March 2024 was therefore within this time period. Toyota’s request was therefore rejected.

Miscellaneous

A minor point was also considered in relation to the correction of formal deficiencies under R.229.2, as Neo were requested to make corrections to their submission on 13 March 2024, which they did on 26 March 2024 (namely, changing details of their representative), but due to a CMS malfunction, the formality checks were only finalised on 9 April 2024. Toyota requested a decision by default on the grounds that Neo had not provided their correction after notification on 13 March 2024. However this was held to be incorrect and it was held that the corrections had been lodged on 26 March 2024 i.e. within the time period of 14 days of service of notification of the correction. Toyota therefore did not succeed on this ground either.