On September 26, 2019, the Higher Regional Court of Düsseldorf confirmed on appeal that Teva Pharmaceutical Industries Ltd. (“Teva”) – one of Bird & Bird’s key clients – is entitled to a preliminary injunction against Mylan dura GmbH (“Mylan”) in Germany. This preliminary injunction relates to Mylan’s product CLIFT 40 mg/ml, a glatiramer acetate product which infringes patent EP 2 949 335.
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 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 the patent was upheld by the Opposition Division of the European Patent Office in a slightly amended form (this decision is under appeal). Mylan’s product, CLIFT 40 mg/ml infringes upheld claims 1 and 2 of the patent, which remained undisputed between the parties throughout the course of the proceedings.
In December 2015, another Opposition Division of the European Patent Office upheld the parent patent EP 2 405 749. This patent was withdrawn in February 2017.
Mylan’s CLIFT 40 mg/ml was made available in Germany on December 15, 2017. Consequently, Teva tried to obtain a preliminary injunction against Mylan before the Munich Courts. 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 instance, the judges strongly relied on a deviating decision of the UK High Court of Justice.
Course of the Proceedings
Following the positive validity decision of the Opposition Division regarding EP 2 949 335, Teva requested a preliminary injunction before the Regional Court of Düsseldorf. Before issuing a decision, the Regional Court of Düsseldorf wanted to wait for the grounds of the Opposition Division decision, as Mylan had already indicated in its protective letter that it held the validity decision of the Opposition Division to be evidently wrong. Once the decision grounds were available (May 13, 2019), the Regional Court Düsseldorf scheduled the oral hearing for May 28, 2019.
During the course of the proceedings, 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), based on which it continued to argue that the patent would lack inventive step. In addition, Mylan tried to refer to foreign decisions, including the decision in the UK, arguing that a preliminary injunction 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 of Düsseldorf was not persuaded by Mylan’s line of argument and granted the preliminary injunction on June 14, 2019 (docket no. 4c O 22/19). Teva is enforcing the 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 of 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).
Lessons to be Learned
Unsuccessful attempt to argue evident incorrectness of validity decision
The decisions of the Regional Court and Higher Regional Court of Düsseldorf are characteristic of the increasing attempts by parties to argue that an “unpleasant” validity decision is evidently wrong and should therefore be disregarded. For instance, Applicants have (unsuccessfully) tried to argue in cases such as 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:
- Under the Düsseldorf legal practice, a preliminary injunction can usually only be granted if the injunction patent has survived validity proceedings.
- If there is a positive validity decision, this also means that the validity of the injunction patent is considered to be sufficiently secured and that the grant of an injunction is generally indicated.
- 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.
Preliminary injunction despite deviating decisions
Mylan had also heavily relied on case law from the Higher Regional Court of Düsseldorf, according to which a preliminary injunction may be barred in case of deviating decisions from equally or higher ranked panels regarding the identical facts (unless the 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 clarified its jurisprudence as follows:
- First of all, the Higher Regional Court only took decisions into account, which were issued after the decision of the Opposition Division. According to the Higher Regional Court of Düsseldorf, the respective panels would need to have the chance to review and consider the Opposition Division’s argument.
- Secondly, the Higher Regional Court stressed that not every deviating decision (even including technical participants) could hinder the grant of a preliminary injunction. 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. 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. In concreto:
European Patent Office: Opposition Division - Technical Board of Appeal
Germany: Federal Patent Court - Federal Supreme Court
- With respect to foreign decisions, the Higher Regional Court of Düsseldorf stresses that these are merely indications, which the Infringement Court has to consider without being bound. A different assessment could hinder an effective legal protection for Applicants, as deviating decisions in different countries are common.
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.
No abusive behavior
Furthermore, the Higher Regional Court of Düsseldorf dismissed Mylan’s allegation of 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, this could not be determined in the present case, particularly as the timing of the withdrawal was of the essence here:
- 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 be the indication of the lacking validity by the technical competent authority and not so much a tactical maneuver.
- In case a parent or parallel patent is waived before a preliminary opinion of the respective panel, we can only speculate about the reasons for doing so. For instance, we 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 not be solely sufficient to refuse a preliminary injunction (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, abusive behavior (or lacking assumption of validity) cannot be assumed here.
If you have questions regarding this case or a similar matter, including strategic advice for future cases, feel free to contact Oliver Jan Jüngst, Dr. Anna Wolters-Höhne and Dr. Annika Lückemann.