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 - 20 October 2023 - is below:
Patents Court considers plausibility and obviousness in relation to formulation patent for mirbegron
On 17 October 2023, Mr Justice Mellor handed down his long-awaited decision in an action in which Astellas alleged infringement by Teva and Sandoz of its European Patent (UK) 2 345 410 B1 (the “Patent”) for a “pharmaceutical composition for modified release” which concerns a modified release pharmaceutical composition containing mirabegron as an active ingredient. The Defendants’ counterclaimed for revocation of the patent on the basis of insufficiency, obviousness, and added matter. The correct construction of the main claim of the Patent was also heavily contested. Teva admitted infringement in relation to its original product but also brought a declaration of non-infringement in relation to a new product. However, there was insufficient time at trial to consider this. This decision follows the Court of Appeal’s decision on a related patent for the use in the treatment of overactive bladder (“OAB”) in which the Court of Appeal upheld Meade J’s decision finding the patent to be valid and infringed. See Irides Weekly Update 31 2023 for our report on this decision.
It was common ground before Mellor J that a skilled pharmacokineticist (“PK”) should be part of the team with PK expertise. However, the level of that expertise was in dispute. Astellas submitted that a skilled formulator with PK knowledge would be sufficient and that to the extent that a Skilled PK might be involved in the Skilled Team, it would only be at a stage well after the decision had been taken as to what type of formulation to take forward, when developing clinical trials and analysing the results. The CGK of the Skilled Team was not affected by whether the PK expert was part of the Skilled Team. The Judge held that the Skilled PK would be an integral member of the team.
Turning to construction, the debate between the parties was whether the words in the claim “pharmaceutical composition for modified release…” meant: (i) simply that the formulation should have the composition stated in the claims and satisfy the stated dissolution test (Astellas’ construction) or whether (ii) there was a requirement that food effects were reduced (the Defendants’ construction). Ultimately, the Judge held that over-meticulousness was not to be confused with carefulness and the Defendants were correct. This finding influenced much of the remainder of judgment.
On validity, the Defendants first sought to argue that the Patent was insufficient due to excessive claim breadth and ambiguity, alleging, among other things, that the Skilled Team would be unable to make a reasonable prediction that the invention would work with substantially all products falling within the scope of at least claim 1. Astellas sought to remedy this by applying for three conditional amendments to the Patent which were opposed by the Defendants on the basis of adding matter. The Judge considered the case law in this area, including the Court of Appeal judgments in Regeneron v Genentech  and FibroGen v Akebia . In the latter case, it was held that it can be helpful to analyse the question of reasonable prediction by asking 3 questions: (1) what is the scope of the claimed class? (2) what does it mean to say that the invention works? And (3) is it possible to make a reasonable prediction that the invention will work with substantially everything falling within the scope of the claim? After a detailed analysis, Mellor J considered that the invention's "working" meant the formulation's ability to reduce a food effect and that, based on the teaching in the Patent, it was possible to make a reasonable prediction that such an effect would be achievable across the scope of the claims.
The Court went on to consider obviousness, noting from the long-established case-law that a holistic assessment was required. Overall, based on the construction of the claim that Mellor J had adopted, it was held that it was not predictable that a reduced food effect would be achieved, and the Patent was accordingly held to be inventive over the cited prior art. The Judge noted that had the food effect not been imported into the claims, they would have been obvious.
On infringement, the construction of the claims again played an important role. Having found that a reduced food effect was part of the claim, the Court concluded that there was no evidence before the Court on whether Sandoz’ product exerted such effects. Astellas were therefore held not to have made out their case on infringement.
German Court confirms that orphan drug market exclusivity right can be enforced against competitors in civil courts
As an incentive for pharmaceutical companies to develop orphan drugs that treat rare diseases, EU laws give the marketing authorisation holder (MAH) of an orphan drug 10 years of market exclusivity.
Previously, enforcement actions relating to this market exclusivity right have only been filed against regulatory authorities, to prevent marketing authorisations from being granted to competitors. However, in a decision (21 O 6235/23) on 4 August 2023 confirming a preliminary injunction, the Munich Regional Court found that this market exclusivity right also gives the MAH of the orphan drug the right to sue competitors for infringement of market exclusivity before civil courts.
The claimant marketed an orphan drug, Soliris, with four approved indications. Three of these indications still benefited from orphan drug market exclusivity in the EU but market exclusivity had expired for the fourth indication. In April 2023, the defendant was granted a marketing authorisation for a new biosimilar medicinal product for the fourth, expired, indication but not for the other three indications. The claimant filed an action against the defendant due to concerns regarding the defendant’s promotion of the biosimilar product, which included references to cross-label use of the biosimilar drug for the three indications that were still under market exclusivity.
In May 2023, the claimant obtained a preliminary injunction ordering the defendant to cease distributing its biosimilar product without taking specific precautions to protect the remaining orphan drug market exclusivity of Soliris. The preliminary injunction was appealed by the defendant.
The injunction was upheld. The court found that the market exclusivity for orphan drugs gives an absolute, subjective right to the MAH, which can enforce this against competitors. The defendant argued that the Orphan Drug Regulation only applies under public law, to prohibit regulatory agencies from authorizing a competitor product and that the regulation does not grant the MAH a claim under civil law against competitors. However, the court found that the market exclusivity right is intended to grant protection against infringements of the market exclusivity by other competitors. The court emphasised that the market exclusivity right is the decisive incentive for companies to invest in the development of orphan drugs and that this is only possible if the MAH is given the possibility to take individual action against infringements of its rights, even after a marketing authorisation has been granted.
Despite art. 8 of the Orphan Drug Regulation making no reference to the possibility of infringement of market exclusivity through advertising activities by a competitor, the court confirmed that infringement of the market exclusivity right of an orphan drug can also be committed if a competitor distributes promotional material that suggests use of a product for an indication that is still subject to market exclusivity.
This is the first time a court in Europe has ruled on the question of whether market exclusivity of orphan drugs can be enforced against competitors. Therefore, this decision strengthens the legal status of orphan drug market exclusivity.
UPC issues two preliminary injunction decisions on related patents in 10x Genomics, Inc. & others v NanoString Technologies Inc.
As noted in the Irides Weekly Update 38 2023, the Munich Local Division issued preliminary injunction judgments in relation to alleged infringement by NanoString of two of 10x Genomics’ patents: EP 4 108 782 (EP 782) and its parent EP 2 794 928 (EP 928). The same panel of the Local Division ordered an injunction to be granted restricting infringement of EP 782, but denied an injunction in relation to EP 928. An official translation of the EP 782 translation can be accessed here.
EP 782 – The Divisional
The Local Division began by finding that it had jurisdiction and that the application was admissible. It then considered in some detail questions of validity and infringement, finding with sufficient certainty that EP 782 was valid and infringed.
Following this finding, the Division went onto consider the necessity of ordering provisional measures. In terms of urgency, it was ruled, noting that EP 782 is a unitary patent, that enforcement measures before national courts are not equivalent to those before the UPC. Therefore, in this case unreasonable delay should be evaluated from 1 June 2023. Regarding harm, it was ruled that NanoString’s market entry would cause 10x Genomics significant, long-lasting harm.
Finally, the Local Division balanced the parties’ interests and found that 10x Genomics’ interests were more pertinent. An important factor in this assessment was the fact that there was a high likelihood of the patent being found valid and infringed at trial. A preliminary injunction was therefore granted to 10x Genomics without provision for security.
EP 928 – The Parent
In contrast to its finding for EP 782, the same panel of the Munich Local Division dismissed the application for a preliminary injunction in relation to EP 928.
The Munich Local Division was found to have jurisdiction, notwithstanding ongoing litigation relating to EP 928 in Germany. However, the Division was not convinced that EP 928 was valid and infringed. 10x Genomics was seeking to rely on the patent claim being interpreted with an obvious error corrected. However, the Local Division deemed assessing validity in such circumstances beyond the scope of provisional proceedings and asserted that it had to consider the patent as granted.
Further, in terms of urgency, it was noted that EP 782 is a European patent granted since early 2019. Therefore, provisional measures could have been sought in the countries in which the patent was granted prior to 1 June 2023. The necessity requirements were therefore not satisfied.
Finally, balancing the interests of the parties, the Division ruled that an injunction should not be granted. Again, a key factor in its decision making was the finding in relation to validity and infringement of the patent at issue.