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SPCs and combination products

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

More articles by this firm.

Patents
All active ingredients in a pharmaceutical product must be specified in the patent claims to extend patent protection by means of a supplementary protection certificate.
The patent authorities in some member countries have adopted a narrow interpretation of the EU regulation on supplementary protection certificates for pharmaceutical products. As a result, they have only granted SPCs for combination products if all of the active ingredients in the product are mentioned in the claims of the underlying patent which protected the product in the first place. In other member states, the patent authorities have granted SPCs for combination products in which the combination was only implied in the description of the underlying patent.
The EU Court recently ruled on the question of whether and how the exact combination of active ingredients in a combination product should be specified in the underlying patent.
 
Five in one
In 2009, Medeva applied to the British patent authorities for five SPCs for vaccines with each their own combination of active ingredients. The application was rejected.
For four of the vaccines, the application was rejected because Medeva wanted to include more active ingredients in the SPC than claimed in the underlying patent. For the fifth vaccine, the problem was that the marketing authorisation covered more active ingredients than claimed in the underlying patent.
Medeva thought the practice of the British patent authorities was too restrictive in relation to the requirements of the EU regulation. It therefore brought proceedings against the patent authorities. But the Court of Appeal (England and Wales) had to seek guidance from the EU Court.
In August 2011, the Advocate General gave her opinion in the matter. She believed that the question of whether a given combination of active ingredients was sufficiently described in the underlying patent was basically an issue that should be left to the national courts.
 
Almost clear
But the EU Court did not follow the Advocate General’s opinion. Instead, the EU Court ruled that the relevant EU regulation requires that the combination of active ingredients in a product for which an SPC is sought must be specified in the wording of at least one of the claims in the underlying patent.
On the other hand, the EU Court said there was no requirement in the EU regulation for the marketing authorisation to mention the exact combination of active ingredients in the product for which an SPC is sought. As a result, it is not a problem if the marketing authorisation mentions multiple active ingredients so long as the applicant is only applying for an SPC for the combination which is indicated in the claims of the underlying patent.
 
Norrbom Vinding notes:
  • that the EU Court has still not set out in detail the meaning of the requirement that a combination of active ingredients must be specified in the wording of a patent claim;

  • that the pharmaceutical industry is concerned that the EU Court has apparently used this opportunity to cement its judgment in Biogen, which held that only one SPC can be granted for each basic patent – a principle that has been far from consistently applied in subsequent administrative practice; and 

  • that, against this background, this will not be the last case we will see about SPCs for combination products and possibly not the last reference to the EU Court on that subject, either.
The above does not constitute legal advice and should not be relied upon as such

For more information please visit www.norrbomvinding.com