SPCs: Questions of validity

Over the years, there have been numerous requests to the Court of Justice of the European Union (CJEU) to issue preliminary rulings in relation to the EU regulation (469/2009) concerning supplementary protection certificates (SPCs) for medicinal products. So far, Danish courts have not engaged in this move to the CJEU, but in a pending court case between Teva and Amgen concerning an SPC that Amgen obtained for lipegfilgrastim (the active ingredient of neutropenia treatment Lonquex) based on Teva’s marketing authorisation (MA) for Lonquex, the issue of a reference to the CJEU has been raised.

The proceedings pending before the Danish Maritime and Commercial Court (Denmark’s specialist IP court) are part of a larger dispute over SPCs between the two companies. In the autumn of 2013, Teva filed the case against Amgen before the court (in Copenhagen) and requested the revocation of Amgen’s Danish SPC, CR 2013 00044.

Teva initially relied on two arguments. It argued that Amgen’s SPC was invalid because: a) it is based on a MA not belonging to Amgen, but in fact belonging to Teva; and b) the compound lipegfilgrastim, with which Amgen’s SPC is concerned, is not covered by one of Teva’s European patents. Further, Teva claimed that the Danish part of Amgen’s European patent EP 1482046 is invalid; it has subsequently raised a revocation claim within the same action.

According to Teva, the Maritime and Commercial Court should request a preliminary CJEU ruling on the interpretation of article 3(b), regulation 469/2009. This concerns the granting of an SPC based on an MA issued under EU Directive, 2001/83/EF, to a third party with no relation to the patentee (third party SPC). The initial oral hearing between the parties related only to the question of whether the Danish court should make such a reference to the CJEU.

Amgen claimed that the request for a preliminary ruling from the CJEU should be dismissed or, alternatively, that it was premature and the issue should be postponed. This was because, Amgen claimed, the factual circumstances in which the question to the CJEU should be based were disputed. Amgen argued that, on the basis of the existing CJEU case law, including the decision inBiogen v SmithKline Beecham Biologicals, and (indirectly) Eli Lilly v Human Genome Sciences, the question of admissibility of third party SPCs should be considered acte clair. Amgen also argued that it was evident from case law that third party SPCs were recognised by the CJEU and were compliant with the SPC regulation.

The Danish Maritime and Commercial Court decided in a ruling on April 3 last year that a reference to the CJEU for a preliminary ruling presupposes that the questions are decisive for the outcome of the dispute, that there is no uncertainty concerning the factual circumstances, and that it is reasonable to question the proper understanding of the community law provision at issue.

The court stated in its ruling that Teva had so far not given a binding undertaking that it would not challenge the validity of the basic patent and furthermore, it was not clear whether Teva would argue that it was the rightful owner of Amgen’s Danish SPC, as it had done in other jurisdictions.

"IT WAS NOT CLEAR WHETHER TEVA WOULD ARGUE THAT IT WAS THE RIGHTFUL OWNER OF AMGEN’S DANISH SPC, AS IT HAD DONE IN OTHER JURISDICTIONS."

If a validity challenge to the basic patent were to become relevant in Denmark, the outcome of that issue is of such fundamental importance that the issue of third party SPCs may become redundant. Furthermore, there is doubt about the history of the basic patent, the parties’ contribution to research relating to the grant of an SPC based on the MA for lipegfilgrastim, and the content of Teva’s European patent.

In light of the current stage of proceedings, including that the facts were not yet sufficiently established, the court held that there was, at least at that time, no basis for referring questions to the CJEU relating to the interpretation of article 3(b) of the SPC regulation. The court did not further comment on the question of whether it was reasonable to question the Community law provision at issue or whether the provision was sufficiently clear.

The decision of the court was not appealed against and so far the question of a reference to the CJEU regarding third party SPCs has been postponed.

Understanding the regulation

Despite a reference to the CJEU not being made, the interpretation of the SPC regulation, and also the CJEU decision in Eli Lilly, continue to be relevant to the case, based on the CJEU’s statements regarding the understanding of article 3(a) of the SPC regulation.

In the pending proceedings between Teva and Amgen, Teva has submitted that lipegfilgrastim is not specified in claim one of the ‘046 patent, and therefore Amgen’s SPC is invalid.

According to article 3(a) of the regulation, it is a condition for obtaining SPC protection that “the product is protected by a basic patent in force”. As is well known, the interpretation of article 3(a) has been the subject of a number of decisions by the CJEU. The most recent CJEU decision interpreting article 3(a) is the Eli Lilly decision.

So far, neither the Danish courts nor Denmark’s Board of Appeal for Patents and Trademarks has rendered any decisions applying the test set out in Eli Lilly. The test is: “Where the active ingredient is covered by a functional formula in the claims of a patent issued by the European Patent Office, article 3(a) of that regulation does not, in principle, preclude the grant of an SPC for that active ingredient, on condition that it is possible to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by article 69 of the Convention on the Grant of European Patents and the Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question.”

It will be interesting to see how the Danish Maritime and Commercial Court, provided that it does not invalidate the basic patent, will apply the test set out in Eli Lilly. The court may choose to look to the UK, where the conditions set out by the CJEU have been interpreted by the English High Court in the underlying case between Eli Lilly and Human Genome Sciences.

The pending matter between Teva and Amgen is currently progressing and, depending on whether the basic patent is held to be invalid, it may be relevant for the Danish Maritime and Commercial Court to rule both on the article 3(b)/third party SPC issue and on article 3(a), on the application of the test set out in the Eli Lilly decision.

Michael Pitzner-Bruun is a partner at Kromann Reumert. He can be contacted at: mpb@kromannreumert.com.