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Does A also include A + B?

December 2011 - Intellectual Property. Legal Developments by Norrbom Vinding Law Firm, member of ius laboris.

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A German state court recently held that a supplementary protection certificate granted for the substance A also protected the combination of A+B. This may benefit a Swiss pharmaceutical company.
The EU regulation on supplementary protection certificates for pharmaceutical products raises a lot of questions. For instance, is it possible to obtain an SPC for a combination product – that is, a product with more than one active ingredient? The answer is yes, in certain circumstances. This was recently established by the EU Court in Medeva, a case we have commented on here.
Another question is whether an SPC granted for a product with a single active ingredient (A) also protects a product containing A in combination with one or more other active ingredients (B, C, etc.). This was the issue before the German Oberlandesgericht in DĂĽsseldorf in this case.
Combination or no combination
A Swiss pharmaceutical company held an SPC for a product containing the substance valsartan, which is primarily used for the treatment of hypertension. But the Swiss company also marketed a product containing valsartan in combination with other active ingredients, including a diuretic called hydrochlorothiazide.
When a competitor was granted a marketing authorisation for a product containing valsartan in combination with hydrochlorothiazide, the Swiss company went to court. There it claimed that the competitor’s product fell within the scope of its own SPC for valsartan-containing products. The competitor, on the other hand, argued that the Swiss company’s SPC only prevented it from marketing products containing valsartan – no more and no less. Therefore, its competing combination product did not fall within the scope of the SPC.
On appeal to the German Oberlandesgericht in DĂĽsseldorf, it was held that the competing combination product fell within the scope of the SPC. The Court based its decision on the premise that an SPC should give the holder the same rights as a patent would. And there was no doubt that a patent on a valsartan-containing product would have prevented the competitor from marketing its combination product.
But the Court decided to seek guidance from the EU Court since it was not quite sure how to interpret the relevant EU regulation.
Norrbom Vinding notes:
  • that a similar question was referred to the EU Court earlier this year in a case currently pending before the High Court of England and Wales; and

  • that, in its judgment of 24 November 2011 in Medeva, the EU Court may have hinted that it will rule in favour of the Swiss SPC holder in the German case.
Norrbom Vinding will follow the case closely and comment on the EU Court’s judgment when it is available.
The above does not constitute legal advice and should not be relied upon as such

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