SUPPLEMENTARY PROTECTION CERTIFICATES: SOME FURTHER TWISTS
05 January 2012
Queensland, Daiichi and Yeda: references by the UK courts
In Queensland (C-630/10), Daiichi (C-6/11) and Yeda (C-518/10) further clarity on aspects of SPC law was sought. The cases were referred after the Medeva and Georgetown references but before the respective decisions, and related to similar issues of interpretation. In addition to the more general questions posed in Medeva, each case involved specific questions unique to its facts.
The University of Queensland's SPC applications related to vaccines comprising multiple antigens: Is it permissible for a Product comprising multiple active ingredients to be protected by a basic patent if those actives were protected across a family of patents derived from the same application? When the basic patent claims a process for making a Product, does that Product needed to be obtained directly by means of that process in order to be considered protected?
Daiichi's SPC application related to an anti-hypertensive combination therapy. The issue was whether the ‘infringement test' is the correct test for assessing whether a Product is protected by a basic patent, or whether it is necessary to have some degree of specification of the Product's active ingredients in the claims.
Yeda's SPC applications concerned the monoclonal antibody cetuximab: If the infringement test is the correct test to decide whether a Product is protected by a basic patent, does it extend to contributory infringement (i.e. where a Product only infringes by virtue of its supply to a third party to make what is actually claimed)? The question goes to whether claims that specify two active ingredients can be used to obtain an SPC for only one of those active ingredients.
CJEU's reasoned orders
Following the rulings in Medeva and Georgetown, the CJEU decided not to wait for hearings in Queensland, Daiichi and Yeda but has instead issued reasoned orders. The orders largely refer back to the Medeva and Georgetown decisions and, in line with them, conclude that the infringement test is not the correct test to decide whether a Product is protected by a basic patent. However, there are some additional points worth highlighting.
First, all three cases express the test for assessing protection of a Product by a patent in terms of what is "identified" in the wording of the claims of the basic patent, rather than what is "specified". It is doubtful, however, that there is intended to be any difference in meaning.
Second, the Yeda order appears to provide some insight into what is meant by "specified" or "identified" in the wording of the claims. In particular, in the answer given, and in paragraph 33 of the order, the Court appears to consider that the single active ingredient of one of Yeda's SPC applications, cetuximab, is "identified" in the wording of the claims. The relevant claim, Claim 1 of Yeda's basic patent, reads:
"A therapeutic composition comprising:
- a monoclonal antibody which inhibits the growth of human tumor cells by said antibody binding to the extra-cellular domain of the human EGF receptors of said tumor cells in an antigen-antibody complex, said tumor cells being characterized by their expression of human EGF receptors and mitogenic stimulation by human EGF; and
- an anti-neoplastic agent....."
No mention is made of cetuximab in the wording of the claim although the definition provided in part (a) would encompass cetuximab. Thus, the decision could be interpreted as meaning that the active ingredient(s) of a Product may be sufficiently "specified" (or "identified") in the claims of a basic patent without having to be named explicitly as individual compounds.
Third, the order in Queensland confirms that SPCs may be granted based on process claims but only if the Product is identified in the wording of the claims as deriving from that process. For the purpose of granting an SPC, it does not matter whether the Product is obtained directly as a result of that process.
Conclusions and potential further action
The reasoned orders essentially confirm that, to secure SPC protection for a Product, the active ingredient(s) of that Product must be ‘specified' or ‘identified' in the wording of the claims of one basic patent. The order in Queensland also highlights the importance of contemplating downstream products of claimed processes and ensuring that they feature in the wording of the claims.
There remains uncertainty as to what degree of ‘specification' or ‘identification' of each active ingredient is required. The test may be broad, requiring merely a positive recitation of claim features that read on each active ingredient. It may be a narrow test, requiring unambiguous individualisation of each active ingredient; or it may instead be something in between. However, Yeda could be interpreted to suggest that explicit naming of active ingredients in the claims is not necessary to satisfy the test.
In view of this uncertainty, possibly one or more further references to the CJEU will be needed to determine the level of ‘specification' or ‘identification' in the wording of the claims that is required for a patent to protect a Product.
Please contact us if you have any queries regarding the scope and/or validity of SPC protection that you may wish to seek, or that is associated with the granted SPCs of others.
If you require any further information, please contact John Miles, Mike Snodin or Michael Pears of our SPC & Regulatory group.