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30 April 2012
In a landmark decision of January 5 2012 the Supreme Court firmly asserted the prima facie validity and enforceability of granted European patents which are subject to opposition proceedings before the European Patent Office (EPO).
Swiss pharmaceutical company Novartis was the holder of a European patent that granted protection for sustained-release formulations of fluvastatin. While protection for immediate release fluvastatin marketed under the name LESCOL had expired, this new patent granted Novartis exclusivity for its sustained-release product, marketed under the name LESCOL EXEL.
Novartis had applied to the president of the Brussels Commercial Court for a preliminary injunction against a local subsidiary of Mylan, which had threatened to launch its own generic sustained-release fluvastatin product on the Belgian market.
These proceedings were still pending when Novartis's patent, having initially been upheld with some limitations, was revoked for lack of clarity (under Article 84 of the European Patent Convention) by the Opposition Division of the EPO, to which the case had been remanded by the EPO Technical Board of Appeal. Novartis appealed against this revocation and invoked the suspensive effect of its appeal, in accordance with Article 106(1) of the convention, before the Brussels Commercial Court, which was considering its application for an injunction in summary proceedings.
The president of the court rejected Novartis's application for a preliminary injunction, considering that the invoked patent was too uncertain to justify the injunction.
Novartis appealed to the Brussels Court of Appeal. Reversing the lower court's decision, the appellate court considered that the Belgian tier of Novartis's patent should be presumed to be valid for the purpose of obtaining a preliminary injunction. It held that the prima facie validity of this title was unaffected by the decision of the Opposition Division, against which an appeal had been lodged, even though the patent had previously been entirely revoked by the Opposition Division. The court further held that the suspensive effect of an appeal pursuant to Article 106(1) of the convention must be interpreted as meaning that a decision to revoke the patent should be without legal effect; therefore, the patent should be deemed valid and enforceable.
A preliminary injunction was granted against Mylan for as long as the patent was not revoked by the Technical Board of Appeal.
Mylan appealed to Supreme Court. Among other things, it claimed that Novartis's patent could not be considered valid prima facie because it had been revoked by the Opposition Division.
The court rejected Mylan's appeal and held that according to Article 106(1) of the convention, the Opposition Division's decision, against which an appeal had been lodged, did not affect the prima facie validity of the patentee's rights, as a final decision had not been rendered in the opposition proceedings. In so doing, it explicitly confirmed the following points of the appeal court's reasoning:
In upholding the Brussels Court of Appeal's decision to grant a preliminary injunction, the Supreme Court has reconfirmed the principle - applied for more than 20 years by the Belgian courts - that a European patent is presumed to be valid for the purpose of obtaining an interim injunction, irrespective of whether it is the object of opposition or invalidation proceedings before the EPO or a competent Belgian court.
This decision is particularly significant in light of the underlying facts, in particular the fact that the patent had already been revoked by the Opposition Division. In view of the general wording of Article 106 (1) EPC, the Supreme Court held this circumstance to be irrelevant. for the purpose of the granting of injunctive relief. This situation must be contrasted with the situation where the (Belgian tier of a) European patent is invalidated by a competent Belgian court. Under the principles of Belgian procedural law, an invalidation decision by a Belgian court has the authority of res iudicata (ie, a matter already having been decided) in respect of the patentee, which is prevented from enforcing its patent, even if an appeal against the invalidation decision is pending. It appears from the Supreme Court's ruling that such authority of res iudicata cannot be granted to a revocation decision of the Opposition Division, which will thus not constitute a barrier to the continued enforcement of the patent in the Belgian legal order.
The decision highlights the need for alleged patent infringers to clear the way for their allegedly infringing product or process by seeking the invalidation of any relevant contested patent rights before the competent Belgian courts.
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