SPC update – further insight to the meaning of “protected”
25 April 2018
For a product to qualify for SPC protection, the product must be “protected” by a basic patent in force. The CJEU has previously stated that “protected” means something more than simply falling within the granted claim scope. In a referral from the High Court of England and Wales in Teva v Gilead (C-121/17), Mr Justice Arnold asked the CJEU what the criteria are for determining this “something more”. Advocate General Wathelet handed down his preliminary opinion this morning (25 April 2018).
Previous CJEU case law has laid out that the product must be “specified” or “identified” in the patent claims. Being specifically named, however, is not necessarily essential as long as the claims relate “implicitly, but necessarily and specifically, to the active ingredient in question”.
Mr Justice Arnold suggested that a “core inventive advance” test could make a good replacement test, with certain countries suggesting both tests should be used together. The AG rejected the core inventive advance test as running the risk of confusion with patentability criteria. The AG then neatly summarised the problem at hand as “the real question which arises in the present case is with what degree of specificity or abstraction a product is ‘specified’ in the claims of the basic patent“. To answer this question in respect of products with a single active ingredient, the AG suggested that:
“A product is protected by a patent … if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent.”
The word “precisely” is the progression proposed by the AG, but it is not immediately apparent how much clarity (if any) this brings to the test. The general impression is that if the product is not explicitly named then the space for arguing implicit protection may be tightening up. More information on this should be provided when the CJEU hands down its opinion in Sandoz v Searle, relating to SPC protection for a compound that is within the scope of a Markush definition but is not individualised anywhere in the application.
The AG also provided guidance on combinations of active ingredients, adding the further requirement that each active ingredient must be “individually identifiable” in the wording of the claims. This is where the SPC in question allegedly falls down, as the claim in question covered the active ingredient tenofovir disoproxil together with ‘optionally other therapeutic ingredients’. The ‘other therapeutic ingredient’ of the SPC was emtricitabine, which was not mentioned anywhere in the application. The AG summarises:
“the active ingredient emtricitabine is claimed solely through the use of completely indeterminate expressions such as ‘comprising’ and ‘optionally other therapeutic ingredients’, terms which may cover multiple substances that are not specifically and precisely identifiable on the priority date of the patent”
There is a clear concern with the vagueness of the reference in the claim.
The AG also brings assessment at the priority date to the test, seemingly because emtricitabine was not known to be efficacious on the priority date and this would presumably be the only way the skilled person could have thought to include it. Given the AG assigns importance to the priority date, it would be interesting to know the AG’s thoughts in the hypothetical situation that emtricitabine was known to be efficacious as an antiretroviral at the priority date, and the claim language stated a combination with other retrovirals but without any reference to emtricitabine anywhere in the application.
We will be keeping a watch for the full CJEU decision, and will report on this as soon as possible.
Life Sciences & Chemistry group
If you require further information on anything covered in this briefing, please contact Andrew Evitt (email@example.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