The CJEU recently handed down its guidance in the case of Eli Lilly v Human Genome Science (HGS) which seeks to clarify the level of specificity required to define a medicinal product in a patent claim in order to meet one of the requirements of the SPC Regulation; namely that "the product is protected by a basic patent".
In its previous judgement in Medeva the CJEU held that the SPC Regulation precluded the grant of an SPC for a medicinal product which was not "specified" in the wording of the claims. However, uncertainty has arisen as to the extent to which that test ought to be applied.
HGS holds a European patent which has claims to an antibody defined functionally by reference to its ability to bind to neutrokine-alpha. In effect, the claims cover numerous antibodies but the specification contains no examples of an antibody having been made or tested, or any structural description of such antibodies.
Eli Lilly brought an action before the UK Patents Court seeking a declaration that any SPC based on the antibody claims contained in HGS's patent would be invalid as the claims were too broadly drafted for the antibody to be sufficiently "specified". Essentially, Eli Lilly believed that the claims needed to define the antibody structurally in order to meet the requirement that "the product is protected by a basic patent".
The UK Patents Court sought clarification from the CJEU as to whether an SPC could be granted on the basis of a patent claim which defines a medicinal product in functional terms only.
The CJEU ruled that it is not necessary for the medicinal product to be identified in the claims by a structural formula. It further noted that the SPC Regulation does not, in principle, preclude the grant of an SPC for a medicinal product defined functionally in the claims so long as the skilled person would understand that the claims relate "implicitly but necessarily and specifically" to the medicinal product in question. Such matters are to be determined by the referring court by interpreting the claims in the usual way in light of the description.
Whilst the CJEU's guidance clarifies that claims which define a medicinal product functionally may, in principle, from the basis for grant of an SPC, it is not clear as to what criteria ought to be applied to determine whether a claim "implicitly but necessarily and specifically" relates to the medicinal product. The CJEU's guidance does, however, highlight the importance of providing sufficient basis in patent applications for defining a medicinal product in narrower dependent claims. This is so particularly if the independent claim to the medicinal product is drafted broadly by reference to functional features, and the functional features might not pass the "implicitly but necessarily and specifically" test.
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