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SPC update – further question referred to CJEU regarding meaning of “protected”

6 April 2018

One of the requirements for obtaining SPC protection for a product is that the product must be subject to a marketing authorisation and the product must also be “protected” by a patent.  The CJEU ruled that the meaning of “protected” is narrower than simply infringing the claim, without saying where exactly the boundary between protected and not protected might lie.

It is perhaps unsurprising that yet another referral has been made to the CJEU on this point, meaning there are now three pending referrals attempting to get to the bottom of what “protected” means.

The latest referral relates to a compound that falls within the scope of a Markush definition, but the compound is not an individualised embodiment in the application.  The High Court case was reported on earlier here, where Mr Justice Arnold proposed a seemingly sensible test based around the compound embodying the inventive advance.  Unfortunately, this decision has been overturned by the Court of Appeal.

The question referred to the CJEU is copied below.  To paraphrase, the Court of Appeal is seeking to find out if the compound merely needs to fall within a Markush definition or if the specific substituents must be derivable from the patent claims.

This question joins pending referrals from the UK High Court (Teva v Gilead) and the German Federal Patent Court (Royalty Pharma).  We will be keeping a close watch as this law develops, with the Advocate General opinion on the first of these referrals due on 25 April 2018.

Where the sole active ingredient the subject of a supplementary protection certificate issued under [the SPC Regulation] is a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of the SPC Regulation that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims?” (See here, section 115)

 

Andrew Evitt
Life Sciences & Chemistry group

If you require further information on anything covered in this briefing, please contact Andrew Evitt (aevitt@withersrogers.com; 44 20 7940 3600) or your usual contact at the firm. This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.

© Withers & Rogers LLP, April 2018