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 This patent was withdrawn in February 2017.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