The European Court of Justice (ECJ) has ruled that a product composed of several active ingredients with a combined effect may be protected by a basic patent in force under the Supplementary Protection Certificate (SPC) Regulation (469/2009/EC) (2009 Regulation) even if the combination is not expressly mentioned in the claims of the basic patent.
The purpose of an SPC is to re-establish a sufficient period of effective protection of the basic patent by permitting the holder to enjoy an additional period of exclusivity on the expiry of that patent. This is intended to compensate, partly, for the delay to the commercial exploitation of their invention by reason of the time elapsed between the date on which the application for the patent was filed and the date on which the first marketing authorisation in the EU was granted. The additional period of exclusivity is to encourage research by ensuring that the investments put into such research are covered (recital 4, 2009 Regulation).
The grant of an SPC is governed by the 2009 Regulation. Article 1(b) of the 2009 Regulation defines "product" as the active ingredient or combination of active ingredients of a medicinal product. "Basic patent" means a patent which protects a product, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate.
Article 3 of the 2009 Regulation (Article 3) provides that a certificate shall be granted if, in the EU member state in which the application is submitted and at the date of that application the product is protected by a basic patent in force.
T challenged the validity of G's SPC for a product marketed by G on the ground that it did not comply with Article 3(a) of the 200 Regulation. G's product, an anti-retroviral medication used in the treatment of human immunodeficiency virus (HIV), is a combination product consisting of two active ingredients. The claims in G's basic patent mention expressly only the first of those two active ingredients, and the second can only be covered by the phrase ‘other therapeutic ingredients’ in the relevant claim of that patent.
The Patents Court referred to the ECJ the question of:
- What criteria decide whether the product is protected by a basic patent in force under Article 3.
- What the applicable rules of patent law were for this purpose.
- Whether satisfaction of that test was sufficient to establish that a product was protected by a basic patent for the purposes of the 2009 Regulation or whether something more was required, and if so, what.
The ECJ held that Article 3 must be interpreted as meaning that a product composed of several active ingredients with a combined effect is protected by a basic patent in force where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:
- The combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent.
- Each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.
Where the products which were the subject of an SPC were composed of several active ingredients which had a combined effect, the question whether a claim of the basic patent in fact covered a combination that was the subject of the SPC, had to be determined by the referring court by considering whether, for a person skilled in the art, the general expression "other therapeutic ingredients", associated with the term "optionally", satisfied the requirement that the claims of the basic patent had to relate necessarily and specifically to the product.
Here the description of the basic patent contained no information as to the possibility that the invention covered by that patent could relate specifically to a combined effect of the two active ingredients for the purposes of the treatment of HIV. So, it did not seem possible that a person skilled in the art, on the basis of the prior art at the filing date or priority date of that patent, would be able to understand how the combination necessarily fell under the invention covered by that patent. However, it was for the referring court to check whether this was indeed the case, and to establish whether each of those active ingredients was specifically identifiable by the person skilled in the art in the light of all the information contained in that patent, on the basis of the prior art at the filing date or priority date of the patent in question.
The ECJ answered only the first of the referred questions, and was silent on the second question, whether there were any additional requirements. While the emphasis on what the skilled person would understand is consistent with patent law, it could present problems to a patent office which has to decide on an application for an SPC based on a marketing authorisation for a combination of the main product with other active ingredients where that combination is not expressly claimed. An opposition to the grant of the SPC, or challenge to its validity, will likely produce conflicting expert reports.
While English patent courts are experienced in dealing with this, based on the testing of these reports by cross-examination of the experts by experienced advocates, most patent office procedures do not allow for this type of detailed examination of evidence.
Case: Teva UK Ltd and others v Gilead Sciences Inc C-121/17.
First published in the September 2018 issue of PLC Magazine and reproduced with the kind permission of the publishers. Subscription enquiries 020 7202 1200.