In an appeal of a PI decision, the Danish Eastern High Court has ruled to uphold the dismissal of Novartis’ application for a preliminary injunction against Glenmark, Zentiva, and Viatris, based on the European patent application 2 959 894. In its decision, the Court firmly stated that a preliminary injunction can only be issued based on a patent in effect.
In the first instance decision, The Maritime and Commercial High Court had decided to try the issue of the applicant’s cause of action/legal interest separately (review of the ruling can be read here). As stated, the Maritime and Commercial High Court dismissed the application due to insufficient legal interest and noted that no formal decision to grant had been issued by the EPO. By this, the Maritime and Commercial High Court only rejected enforcement prior to a ‘decision to grant’ yet left open the possibility of enforcement after a ‘decision to grant’ – but before the grant of a patent. Thus, the ruling left it unresolved when sufficient cause of action is present in cases of PI proceedings based on patent applications.
With reference to case law of the Danish Supreme Court, the Eastern High Court started off by noting that a patent cannot be subject to judicial review before it becomes effective. In keeping with this, a patent application cannot serve as the basis for a preliminary injunction, as i) a patent right is neither substantiated nor made probable with an application. Consequently, the first criterion for a preliminary injunction is not met, cf. section 413(1)(1) of the Danish Administration of Justice Act. As a preliminary injunction cannot be issued, an applicant for a patent has ii) no legal interest in cases concerning the patent applied for, as there is no cause of action. Accordingly, the legal outcome of an application for a preliminary injunction on the basis of a patent application must be dismissal of the case.
In its decision, the Court noted in an obiter dictum that the question concerned ought to have been considered up front by the Maritime & Commercial High Court and not made the subject of a separate hearing and the High Court seems to indicate that this should have been obvious.
With the High Court’s decision, the state of the law has by this decision been laid down definitively: Only a granted patent with effect in Denmark may form the basis of judicial proceedings in Denmark, including preliminary injunctions. In this interim period, Danish utility models may, however, in some cases offer protection, as a quickly granted utility model registration may be used as the basis for an application for a preliminary injunction concerning an invention, for which a patent application is pending.
Zentiva and Glenmark were represented by BUGGE VALENTIN
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The patent has been granted on 12.10.2022, Bulletin 2022/41. The filing date is 25.06.2007.
The patent relates to an S1P receptor modulator for use in the treatment of relapsing-remitting multiple sclerosis.
The patent is the result of divisional applications EP 13186359.9 / 2 698 154 and EP 07764828.5 / 2 037 906.
The patent has given itself raise to a further divisional application EP 20208442.2 / 3 797 765.
In view of the eagerness with which Novartis has sued for infringement no less than 5 oppositions have been filed on 12.10.2022! The opponents are: Pharmathen, Zentiva, Generics (UK) Ltd, Teva, and Glenmark Pharmaceutical Europe. On 20.10.2022 a further opposition has been filed by Elpen Pharmaceutical. And the time limit for filing oppositions is not even a month old.
On the front page there is the following statement: “The file contains technical information submitted after the application was filed and not included in this specification”. As the question of sufficiency was an important aspect during the grant procedure, G 2/21 could lead to a stay of the opposition procedure.
This does not take away the rightfulness or not (cf. Art 67) of the decision of the Danish Eastern High Court. It means that we have not finished hearing about this case.
The same patent EP 2 959 894 has been subject to a publication on FPC Review
https://www.patentlitigation.ch/its-official-now-the-effect-of-email-newsletter-fizzles-out-quickly/
“Only a granted patent with effect in Denmark may form the basis of judicial proceedings in Denmark”.
A reasonable statement. Why is it, then, that anyone looking to file an opt-out filed in respect of a granted EP that does NOT have effect in Denmark might nevertheless need to obtain authorisation from the “proprietor” of the Danish designation of the patent?
Alternatively, if authorisation from a non-existent proprietor of a non-existent patent right (in Denmark) is NOT required in order to file an opt-out, then does the UPC’s administrative committee need to clarify the opt-out rules?
Rule 5(1)(b) reads as follows:
“The Application to opt out shall be made in respect of all of the states for which the European patent has been granted or which have been designated in the application”.
If not the states listed on the front page of the granted patent, what else are we to understand by “all of the states for which the European patent has been granted”? This language does not appear to require the patent to actually be in force in those states, or even to have legal effect there.
https://ipcopy.blog/2022/10/24/are-the-upc-rules-on-opt-out-flawed/
I can only support the comment and concerns raised by Concerned observer about the amendment of R 5(1,b) RPUPC.
I have raised the problem of the amended R 5(1,b) RPUPC relating to the opt-out possibility shortly after it came out.
I refer to the following link:
https://blog.ipappify.de/new-r-51b-rpupc-why-has-the-opt-out-to-be-so-complicated-zombie-states-automatic-opt-out/
Up to this amendment opt-out was only required for UPC contracting states which is normal.
Pretexting the “long-arm jurisdiction” of the UPC, all states which have been designated in the granted patent have to be opted-out, that is not only UPC or EU contracting states but all EPC contracting states.
Opt-out has to be declared even for contracting states for which the proprietor will not or has no reason to validate his granted EP. This anything but reasonable as the time limit for validation is three months and the opt-out has to be declared within one month.
Why should an opt-out be necessary when no UP patent can be requested, for instance if the designation of one UPC contracting state or a different set of claims for a UPC state has been filed and granted by the EPO?
At least during the transitional phase in such a situation the opt-out should be automatic!
The aim of the amendment of R 5(1,b) RPUPC is see-through: artificially increase the number of patents dealt with by the UPC during the transitional phase. R 5(1,b) RPUPC is no more than a mechanism introducing a forced opt-in!
It shows clearly that the possibility given to the Administrative Committee of the UPC, that is by the governments of the contracting states, to indirectly amend the UPC by amending the RPUPC is lacking any democratic justification.
One aspect is best illustrated by the status of assistants of representatives before the UPC:
According to Art 48(4) UPCA representatives of the parties may be assisted by “patent attorneys”, who shall be allowed to speak at hearings of the Court in accordance with the Rules of Procedure.
According to R 287(7) UPC the expression “patent attorney” also includes professional representatives before the EPO pursuant to Art 134 (1) EPC.
According to R 292(3) UPCA the “patent attorneys” shall be allowed to speak at hearings of the Court
– at the discretion of the Court and
– subject to the representative’s responsibility to coordinate the presentation of a party’s case.
The same applies mutatis mutandis to representatives allowed to represent a party before a national patent office.
In other words, qualified representatives may at best have a position similar to that of accompanying persons in the meaning of G 4/95, i.e. they have no procedural right to speak before the Court.
If it was the intention of the legislator to also allow representatives under Art 134 EPC or nationally qualified representatives to be allowed, under condition, to address the UPC, this intention is clearly counteracted by the RPUPC!