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23 May 2017
Please note: This High Court decision has been overturned and referred to the CJEU. Click here to read our latest update.
In good news for pharmaceutical patent owners, the England and Wales High Court has confirmed here that an SPC is allowable for a compound that is not specifically identified in a patent but (a) where there is a generic claim that covers the product and (b) where the product embodies the technical advance of the claim.
One of the requirements for obtaining an SPC is that the product, subject to the market authorisation, must be “protected” by the patent.
In considering what “protected” means, the CJEU stated in Medeva that more than a simple “is the product within the scope of the claim” is required. The CJEU added that “protected” means “specified in the claims”. In Queensland, the CJEU used the word “identified” rather than “specified”. This created confusion. Could a claim with a generic formula (widely known as a Markush formula) or functional definition be seen to “specify” all possible compounds within the claim scope?
Subsequently, in Lilly, the CJEU added that the product does not need to be identified in the claims, as long as the claim clearly relates to the product.
Hoping to capitalise on some of the uncertainty in this area, Sandoz and Hexal attacked the validity of a Searle SPC. Claim 1 was a generic formula which allegedly only covered darunavir due to its immense breadth. Darunavir was not specifically referred to by structure or chemical name anywhere in the patent and, allegedly, the patent did not even guide the reader towards the darunavir structure.
Turning to the present High Court case, Mr Justice Arnold criticised the CJEU tests as being unclear and applied some much needed common sense to the situation. He used a simple and sensible two-part test that still falls within the CJEU’s rules:
(a) the product must fall within the scope of the claim, and
(b) the product must embody the inventive advance of the claim.
Essentially, this rules out SPC protection for any compounds within the scope of the claim that do not actually work. This does not appear to be a great loss.
Pharmaceutical patents often use generic structures as a way of protecting a whole area of chemical space that is showing activity against any given target. Such patent owners can now take comfort in that if one particular compound in that space is later identified as particularly effective, but it was not specifically identified by name or structure in the patent, such a compound can still be the subject of an SPC.
Life Sciences & Chemistry group
If you require further information on anything covered in this briefing, please contact Richard Worthington (+44 1179 253 030) 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, May 2017