Mylan AB prevails in lifting of preliminary injunctions and orders against its medicinal product Copemyl

In March 2019, the Danish Maritime and Commercial High Court issued preliminary injunctions and orders ("the Injunction") against Mylan AB's ("Mylan") use, offer for sale, sale etc. of its medicinal product Copemyl.

The Injunction was based on three patents, EP335, EP962 and EP172 (the "Patents"), which Teva Pharmaceutical Industries Ltd. and Teva Denmark A/S ("Teva") had enforced against Mylan during the preliminary injunction proceedings. The Patents all concern a specific dosage regimen for use in treating a human patient suffering from a relapsing form of multiple sclerosis, where the treatment is carried out with 40 mg glatiramer acetate administered by subcutaneous injections three times a week.

The Patents bear significant similarities which, inter alia, is illustrated by the fact that, apart from a few minor deviations, claim 1 of the three patents have the same content and the Patents all solve the same technical problem. Accordingly, during the preliminary injunction proceedings, the parties agreed that the dispute applied for all three patents, and consequently agreed to consider the Patents together as a whole, such that the parties and the Court, during the oral hearing, based their assessment on EP335, exclusively.

On 10 September 2020, i.e., approx. 18 months after the Injunction was granted, EPO's Technical Board of Appeal ("TBA") ruled in the opposition proceedings concerning EP335. The TBA found that EP335 lacked inventive step and therefore revoked the patent with effect ex tunc. As a result of TBA's decision, EP335 should be regarded as never to have existed.

It was against this background that Mylan decided to file a request for a lift of the Injunction arguing that the conditions for the Injunction were no longer fulfilled, cf. Section 426 (2)(1) of the Danish Administration of Justice Act.

During the lifting proceedings, Teva acknowledged and admitted Mylan's request in relation to a lift of the Injunction ordered on the basis of EP335 and EP962. However, Teva did not agree to a lift of the Injunction based on EP172 which, Teva argued, was still formally in force. More specifically, Teva argued that dependent claim 8 (as dependent on claims 7 and 1) and/or dependent claim 9 (as dependent on claims 7 and 1) of EP172 were valid and infringed. Teva did not argue that the Injunction should remain in place based on claim 1 as granted of EP172. In effect, this meant that the Court was left to assess whether the Injunction could be upheld based on an amended version of EP172 (i.e. a new claim set with an independent claim 1 consisting of a compilation of claims 1, 7 and 8 and/or a compilation of claims 1, 7 and 9) and not EP172 as granted.

"Substantial and concrete doubts"

The Court accepted Mylan's request and consequently lifted the Injunction. In its reasoning and result, The Court based its decision on various factual circumstances that all contributed to raise doubts about EP172's validity.

In this regard, the Court noted, inter alia, that there are currently oppositions proceedings pending before the EPO Opposition Division concerning the validity of both EP962 and EP172. In an updated preliminary opinion from February 2021 concerning EP172, the Opposition Division had stated that they are of the preliminary opinion that EP172, in the light of TBA's decision regarding EP335, lacks inventive step.

In addition, the Court noted that numerous decisions from foreign courts have found one or more of the Patents invalid, including Oslo District Court, which found the Norwegian counterparts of the Patents invalid due to lack of inventive step. The District Court's decision is final, since Teva withdrew the entire appeal of the decision.

Further, the Court dismissed Teva's argument that the Injunction should remain in force based on an amended version of EP172 and noted that because the dependent claims of EP172 had not been assessed by neither the EPO nor the Court during the preliminary injunction proceedings, no presumption of validity existed for these claims. As the case had been presented, the Court found that Teva had not rendered it likely that a valid right existed based on the compilation of the dependent claims of EP172 that Teva had asserted.

In conclusion, the Court found, in light of the above-mentioned circumstances, that such "substantial and concrete doubts" about the right according to EP172 had been raised, that the conditions for upholding the Injunction were no longer fulfilled.

Landmark decision

Danish caselaw concerning lifting of preliminary injunctions and orders in patent cases is scarce. The case law that does exist has established that a subsequent lift of the preliminary injunction is the exception and only available in very special cases. For instance,  it is not in itself sufficient that the patent, on which the injunction is based, has been revoked in a first instance decision on the merits (or in administrative proceedings) if such decision has been appealed and thus is not final.

Thus, existing case law explicitly states that the provision regulating the possibility of having injunctions and orders lifted, i.e., Section 426 of the Administration of Justice Act, should not be regarded as creating a general access for enjoined parties to have the courts assess whether the conditions, on which the preliminary injunctions and orders have been issued, are still fulfilled, indicating that special circumstances must occur before requests for lift of injunctions and orders can be expected to be successful. Consequently, Danish courts have generally been reluctant to lift preliminary injunctions and orders and enjoined parties therefore typically face a challenging task when initiating lifting proceedings.

The Maritime and Commercial High Courts' decision in this case is thus a fairly rare example of a decision where the court has found that the conditions for upholding a preliminary injunction are no longer fulfilled, and, accordingly, the decision adds to the limited, yet growing, bulk of caselaw in the area.

Notably, the decision confirms that it is possible for an enjoined party to have a preliminary injunction lifted, even if the right, on which the preliminary injunction is based, is still (formally) in effect, e.g., the patent-in-suit has not been revoked by a final decision. The decisive criterion in such cases is whether the enjoined party has been able to raise "substantial and concrete doubts" about the validity of the right on which the injunction is based. When assessing whether this criterion is satisfied, the courts will, inter alia, look at the factual circumstances in the specific case, including possible foreign decisions invalidating the patent-in-suit.

Kromann Reumert (Nicolaj Bording) represented Mylan AB in the case.