SPCs to combinations of active ingredients available only if the combination constitutes the “subject matter of the invention” in the patent
27 March 2015
Boehringer was granted an SPC for the single active ingredient, telmisartan, which is used in the treatment of high blood pressure. On the basis of the same patent and a subsequent marketing authorisation, Boehringer was granted a further SPC for the combination of telmisartan and the diuretic, hydrochlorothiazide (HCTZ). In obtaining this “combination SPC”, a new claim was added to Boehringer’s granted patent, which claim recited both active ingredients explicitly.
Actavis brought the validity of the “combination SPC” into contention during proceedings before the UK High Court. To be able to decide the case, the High Court sought clarification from the CJEU on two main issues:
(i) to what extent does Article 3(c) of the SPC Regulation preclude the grant of
multiple SPCs based on the same basic patent, and
(ii) is it allowable to amend the basic patent after grant in order to satisfy Article 3(a)?
The first issue, (i), was the subject of an earlier Actavis case (C-443/12; see our previous report here), where the CJEU ruled that, if an SPC has already been granted to the active ingredient, A, that is the core inventive advance of the patent, the grant of an SPC for the combination of A with another active ingredient, B, which is not protected as such by the basic patent, based on a subsequent marketing authorisation for A+B and the same basic patent, is precluded.
The second issue, (ii), had not previously been brought before the CJEU.
Decision and commentary
In relation to (i), the CJEU has decided that it is not possible under Article 3(c) to get an SPC for a combination of active ingredients, A+B, based on a marketing authorisation for A+B, when an SPC has already been granted for the active ingredient that was the sole subject matter of the invention, A, based on the same basic patent and a marketing authorisation for A.
This essentially reaffirms the position that the CJEU took in the earlier Actavis case.
Although both Actavis and Boehringer seemingly agreed that telmisartan was the sole subject matter of the invention, Boehringer had argued that since both A and B were specified in the wording of the claims, they were both independently protected as such by the basic patent. Based on this interpretation, Boehringer presumably believed that its facts were distinguishable from the earlier Actavis case such that it was entitled to the “combination SPC”. In other words, the combination A+B was not one where B was not protected as such by the basic patent. However, the CJEU decided that, for a basic patent to protect “as such” an active ingredient, that active ingredient must constitute the subject matter of the invention covered by the patent. Thus, the CJEU has ruled that, whenever an SPC has been granted for an active ingredient that constitutes the sole subject matter of the invention, an SPC for a combination comprising that active ingredient is precluded, based on the same basic patent. If, however, the combination of active ingredients can be said to be “the subject matter of the invention” it would appear to follow that an SPC would be allowable for that combination.
Frustratingly, there was no discussion in the judgement on what is meant by “constitutes the subject matter of the invention”. Perhaps this is because it was apparently common ground between the parties that telmisartan was the sole subject matter of the invention. However, we can expect further references on this point. For example, for a combination of active ingredients, A+B, to be considered the subject matter of “the invention”, is it sufficient for that combination to be specifically mentioned in the wording of the claims, or is something else required? If something else is required, exactly what is required? Does the combination of A+B need to be patentable over and above A alone, for example? Until these issues are resolved, it seems likely that patent filing strategies which place claims to the combination of active ingredients in a separate patent will be adopted by applicants.
Also, the decision does not say how the “subject matter of the invention” test is intended to be related to the “core inventive advance” test described in the earlier Actavis case, if at all. If the CJEU intended the same test to be applied, it has been rather unhelpful in using different language. If a different test is intended, then by virtue of the concept of “subject matter” being probably broader than “core inventive advance”, perhaps the test embodied in the first Actavis case has been liberalised.
With regard to (ii), the CJEU did not answer the question, given its answer to (i). Thus, the still very important issue of whether post-grant amendments are allowable for the purposes of securing an SPC remains open. Again, we can expect further references on this issue.
Please contact us if you are interested in products or patents that are or may be the subject of SPCs, even if the patent or regulatory approval process is at an early stage.
If you require any further information, please contact Michael Pears, John Miles, Stephanie Pilkington or David Carling of our SPC and Regulatory group.