Unresolved legal issues concerning when a pharmaceutical patent owner can claim the extended protection of a Supplementary Protection Certificate (SPC) continue to cause much uncertainty. In this decision[i], handed down on 19 December 2019, the Court of Appeal clarifies that an SPC for a ‘combination’ medical product can only be obtained if the relevant patent claim requires the presence of both compounds, but, frustratingly, it leaves some other issues unresolved.
More than infringement
An SPC offers up to five years’ extra patent protection for an authorised medical product, so it is an extremely valuable prize. In order to obtain one, the patent owner must show that its patent ‘protects’ the authorised product within the meaning of the EU SPC Regulation[ii]. At first sight, this might suggest simply that the product must come within the scope of the patent in the sense that it would infringe if produced without the patent owner’s consent. A string of Court of Justice cases have, however, established that this is not enough - the test is narrower.
Truvada is an anti-retroviral medicine for the treatment of HIV containing two active ingredients, Tenofovir disproxil (TD) and emtricitabine. Whereas TD was mentioned expressly in Gilead’s patent, emtricitabine was not. This would not necessarily be fatal to obtaining an SPC. However, the Court of Justice had laid down two conditions: first, based on the description and drawings in the patent, the combination must “necessarily” fall under the patented invention and secondly, both (or all) the active ingredients in the combination must be “specifically identifiable” from the information disclosed in the patent, even if they are not expressly mentioned. (See our previous note on the CJEU decision here.)
Second ingredient cannot be optional
The relevant claim in Gilead’s patent referred to certain claimed compounds being administered “as pharmaceutical formulations with optionally other therapeutic ingredients”. The Court of Appeal held that optional inclusion was inconsistent with the idea that the combination must “necessarily” fall under the patented invention. A patent claim to compound A where compound B is optional was not enough for an SPC on of A+B. As a result, Gilead’s SPC on Truvada was invalid.
Having come to this conclusion the Court of Appeal did not need to go further and define what was meant by the Court of Justice’s second requirement – that all the active ingredients in the combination must be specifically identifiable in the light of the information in the patent. Unfortunately, it decided not to do so, as a result of which further references to the CJEU on this point are likely to be necessary. The Court even seemed to suggest some of the questions that will require further clarification. These included what type of knowledge could be relied on to make ingredients “specifically identifiable”, for example, would these need to form part of the common general knowledge, and whether the reference to “other therapeutic agents” was too broad to be regarded as ‘specifically identifying’ particular ingredients.
The future – Brexit
The SPC regime is an EU law regime which applies directly in the UK under the SPC Regulation. This is expected to continue during a transition period after which the UK Government has stated its intention to set up an equivalent UK regime to enable SPCs to be applied for in the UK in much the same way as before. It remains to be seen whether at that point the UK Courts, which have expressed considerable frustration with the approach so far taken by the CJEU under the SPC Regulation, may begin to diverge from CJEU case law. A disadvantage of this for global business is arguably the loss of harmonisation of the criteria for SPCs across Europe. On the other hand, in practice, European patent offices and courts often take differing views on how the CJEU case law on SPCs should be implemented in any event.