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DE – Teva Pharmaceutical Industries v. Mylan dura

16 Oct 2019

Regional Court Düsseldorf (docket no. 4c O 22/19) and Higher Regional Court Düsseldorf (docket no. I-2 U 28/19)

The Higher Regional Court Düsseldorf recently confirmed on appeal that Teva Pharmaceutical Industries Ltd. (“Teva”) is entitled to a preliminary injunction (“PI”) against Mylan dura GmbH (“Mylan”) in Germany. This PI relates to Mylan’s product CLIFT 40 mg/ml, a glatiramer acetate product infringing patent EP 2 949 335.

The decisions concern the following important topics:

• Can a PI be denied in case of a positive decision on validity? In particular: what is the standard when it comes to arguing that the validity decision is evidently wrong?

• Can a PI be denied due to deviating (foreign) decisions?

• Can the withdrawal of a parent/ parallel patent be considered an abusive behavior and hinder the grant of a PI?

Facts and Background of the Case
Teva is the exclusive licensee of patent EP 2 949 335, owned by Yeda Research and Development Company, Ltd. It inter alia distributes the original product Copaxone® 40 mg/ml in Germany. The patent concerns a low frequency glatiramer acetate therapy with a specific dosage regime for 40 mg glatiramer acetate. On March 28, 2019 said patent was upheld by the Opposition Division of the European Patent Office in slightly amended form (this decision is under appeal). Mylan’s product, CLIFT 40 mg/ml infringes upheld claims 1 and 2 of said patent, which remained undisputed between the parties throughout the course of the proceedings.

Already in December of 2015, another Opposition Division of the European Patent Office had upheld the parent patent EP 2 405 749. Said patent was withdrawn in February 2017.

Mylan’s CLIFT 40 mg/ml was made available in Germany as of December 15, 2017. Teva had already tried to obtain a PI against Mylan before the Munich Courts back then. However, the request was rejected in both instances as the judges had doubts regarding the validity of the patent EP 2 949 335 – despite the positive decision regarding the parent patent. In this respect, the judges strongly relied on a deviating decision of the UK High Court of Justice.

Course of the Düsseldorf Proceedings
Following the positive validity decision of the Opposition Division regarding EP 2 949 335, Teva requested a PI before the Regional Court Düsseldorf.

Mylan tried to convince the judges that the decision of the Opposition Division was evidently wrong. It tried to establish a contradiction between the assessment of plausibility and inventive step and focused on one piece of prior art (which had already been assessed in the opposition proceedings). In addition, Mylan tried to refer to foreign decisions, including the decision in the UK, arguing that a PI would be barred in this scenario and accused Teva of an abusive behavior in light of the withdrawal of the parent patent.

The Regional Court Düsseldorf was not persuaded by Mylan’s line of argumentation and granted a PI on June 14, 2019 (docket no. 4c O 22/19). Teva is enforcing said decision. Mylan’s request to preliminarily stay enforcement of the decision was also rejected by the Higher Regional Court.

Mylan appealed the decision of the Regional Court to the Higher Regional Court Düsseldorf, which heard the case on September 26, 2019. Mylan’s appeal was, however, dismissed on the same day (docket no. I-2 U 28/19).

Take-Home Messages

Evident incorrectness of validity decision remains a high hurdle
The decisions of the Regional Court and Higher Regional Court Düsseldorf are characteristic for the increasing attempts of parties to argue that an “unpleasant” validity decision is evidently wrong and should thus be disregarded. For instance, Applicants have (unsuccessfully) tried to argue in the cases re Fulvestrant, Dexmedetomidin, Pregabalin and recently Pemetrexed that respective invalidity decisions of the Federal Patent Court were evidently wrong. The two decisions from Düsseldorf underline that this is a high hurdle.

The positive validity decision may be disregarded in case it is not at all tenable or if there are arguments, which have not been considered by the validity instance (e.g. in case passages of a document have been overlooked by the validity instance). In this regard the Higher Regional Court stresses that the infringement Courts are not the right forum to address (let alone “correct”) technically complex issues. Only if an injunction entailed far-reaching consequences for the party or the general public, an exception could be made in the context of the weighing of interests.

This standard was not met in the case at hand. In this regard, both Courts reviewed the decision of the Opposition Division in detail and concluded that an evident error can certainly not be assumed.

Deviating decisions can hinder a PI when they are part of the legal instance train
Mylan had also heavily relied on case law, according to which a PI may be barred in case of deviating decisions from equally or higher ranked panels regarding the identical facts (unless said decisions are untenable themselves). In this regard, Mylan focused on the deviating assessment of foreign Courts, particularly of the UK High Court of Justice.

In its decision, the Higher Regional Court inter alia clarified that not every deviating decision (even including technical participants) can hinder the grant of a PI. Rather only decisions from a panel, which has access to the respective protective right by being part of the legal instance train, are considered relevant (e.g.: Opposition Division –> Technical Board of Appeal). The assumption of validity would cease to apply, if it is to be expected that the decision will likely be amended in the following instance.

Consequently, this exception was not met in the case at hand. Especially, the Higher Regional Court pointed out that respective competent Opposition Division confirmed the validity of the parent patent EP 2 405 749 as well as the validity of the injunction patent.

Abusive behavior can be considered – but timing is of essence
Furthermore, the Higher Regional Court Düsseldorf dismissed Mylan’s allegation of an abusive behavior in view of the withdrawal of the parent patent EP 2 405 749.

The Higher Regional Court stated that an abusive behavior could generally be taken into consideration in the overall weighing of interests. However, according to the judges, the timing of the withdrawal is of essence:

• In case a parent or parallel patent is waived after a negative preliminary opinion of the competent panel (e.g. Technical Board of Appeal), the secured validity of the asserted injunction patent would generally have to be denied. The reason for this would however rather be the indication of the lacking validity by the technical competent authority and not so much a possibly tactical maneuver.

• In case a parent or parallel patent is waived before a preliminary opinion of the respective panel, one can only speculate about the reasons for doing so. For instance, one may assume that the patentee has negatively assessed its chances of success. However, an “ill will” that is merely based on a subjective assessment/fear, can alone not be sufficient to refuse a PI (if there is a positive validity decision regarding the injunction patent).

As no preliminary opinion had been issued in the appeal proceedings re EP 2 405 749 at the time of the withdrawal of the patent, an abusive behavior (or lacking assumption of validity) could not be assumed here.

A copy of the judgment can be found here (German).

Reported by Oliver Jan Jüngst, LL.M., Dr. Anna Wolters-Höhne and Dr. Annika Lückemann, LL.M. (all Bird & Bird LLP).