"The Court of Appeal for England and Wales (CA) has referred questions to the Court of Justice of the European Union (ECJ) on whether a supplementary protection certificate (SPC) can be obtained for active ingredients which have previously been authorized for a different use. Although the ECJ may well feel that it has considered this issue previously, the case again highlights weaknesses of the legislation governing SPCs, and has even prompted the CA to question whether it is fit for purpose.
The precise questions referred by the CA have not previously been considered by the ECJ. However, similar factual situations have been the background to earlier references to the ECJ in respect of Pharmacia Italia, MIT and Yissum cases (cases C-31/03, C-431/04 and C-202/05, respectively).
In particular, the Pharmacia Italia case led to the ECJ deciding that an earlier veterinary MA for a formulation containing cabergoline was prejudicial to the grant of a SPC based upon the first MA for a human use of cabergoline. Although the decision in Pharmacia Italia related specifically to the transitional provisions of the legislation (Article 19(1) of Regulation 1768/92), another ECJ decision (case C-127/00, Hässle) has made it clear that the words “first marketing authorisation” must take the same interpretation for all provisions of the SPC legislation.
Underlying referral of questions in Neurim appears to be the CA’s perception that there is an injustice in not awarding an SPC to the holder of a patent for a new (and non-obvious) use of a previously authorized substance which is the subject of a new MA. In this respect, it will be interesting to see how the ECJ answers the questions referred. To date, the ECJ has interpreted Article 3(d) in a manner that takes no account of the perceived injustices outlined by the CA. Instead, it has simply adopted a ‘one bite of the cherry’ approach, in which the availability and term of all SPC protection for an active agent is based upon the first MA issued for that active agent (for any human or veterinary use).
If Neurim succeeds in persuading the ECJ that Article 4 should be taken into account when interpreting the term ‘first marketing authorization’ in Article 3(d) of Regulation 469/2009, this would significantly increase the number of patents to (approved) second medical uses that might qualify for SPC protection.
Success for Neurim based only on its potentially most persuasive arguments (relating to the regulatory burden faced by those seeking the first ever authorization for a human use of an active agent) would have a more limited impact: the relevance of the decision might be restricted to only those factual situations where the existence of one or more earlier MAs for certain uses does not in any way reduce the regulatory burden for the sponsor of (pre-)clinical trials for a different, separately patented use.
However, it is far from certain that Neurim will succeed in relation to any of its arguments. Success depends upon persuading the ECJ to depart completely from the logic applied in previous ECJ decisions relating to Article 3(d).
In any event, the case will be watched closely by SPC aficionados, as a decision completely adverse to Neurim could lead to questioning whether the legislation is fit for purpose, or even to calls for its complete overhaul".
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