The Patents Court has held that a Supplementary Protection Certificate (SPC) for a combination product was invalid, following a ruling from the European Court of Justice (ECJ) on the meaning of Article 3 of the Supplementary Protection Certificate Regulation (469/2009/EC) (2009 Regulation) (Article 3).
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 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.
G produced a medicine which consisted of two active ingredients. The claims in G's basic patent mentioned expressly only the first of those two active ingredients, and the second was only covered by the phrase "other therapeutic ingredients".
T challenged the validity of G's SPC on the ground that it did not comply with Article 3.
The Patents Court referred questions to the ECJ on the interpretation of Article 3.
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 (www.practicallaw.com/w-016-3653).
Following the ECJ ruling, T applied for final judgment in its favour.
G applied for permission to adduce further expert evidence and directions for a second trial.
The court refused G's application and held that the SPC was invalid and had to be revoked.
The two-part test was not a pure extent of protection test. More was required than that the product fell within the scope of the claim. The claims of a patent, and the issue whether the product which was the subject of the SPC necessarily fell under the invention covered by that patent, had to be interpreted from the perspective of a person skilled in the art, on the basis of their general knowledge and in the light of the description and drawings of the invention in the basic patent.
In the case of a product consisting of a combination of active ingredients, the ECJ's two-part test (the two-part test) was:
• Whether the skilled person would understand that the product to which the claims of the basic patent related embodied the technical contribution of the patent.
• Whether each of those active ingredients was specifically identifiable by the person skilled in the art
In the light of the description and drawings and the prior art and their common general knowledge, as at the filing date or priority date of the patent, and not merely in the light of information which became available later.
Here, the combination of active ingredients was not one that the skilled person would understand, from the description and drawings and their common general knowledge, to embody the technical contribution made by the patent. One of the active ingredients was not specifically identifiable by the skilled person in the light of the information disclosed in the patent.
The starting point in considering G's application to serve a further expert report was that there had already been a trial of these claims, with both sides putting forward evidence. It was not appropriate to give the parties permission to adduce further evidence at this stage because it would require a second trial.
G's application was an abuse of process. It amounted to an attempt by G to amend its case and adduce fresh evidence after trial and judgment, and thereby get a second bite at the cherry, in circumstances where it could and should have brought its whole case, including any expert evidence, before the court at the trial. Even if the application did not amount to an abuse of process, it was not in accordance with the overriding objective to give G permission to adduce further evidence and direct a second trial at this stage, with the consequential expense and delay.
The decision that G's SPC was invalid, in view of the two-part test set out in the ECJ's ruling and its suggested application to the facts of the case, is unsurprising. The test for protection by a basic patent is more stringent for combination SPCs, since those applying for SPCs for combination products may require evidence to explain why the skilled person would consider both of the ECJ's criteria to be satisfied. Other references are pending before the ECJ and further developments are expected in this area of law.
As regards G's application to adduce further evidence, the court noted that this was analogous to an application by a patentee to amend the claims of its patent in an attempt to validate the claims after trial and judgment concluding that the existing claims were invalid. If this required a second trial, it would usually amount to an abuse of process and so would not be permitted. This issue is currently before the Supreme Court in Generics v Warner-Lambert.
Case: Teva UK Ltd and others v Gilead Sciences Inc  EWHC 2416 (Pat).
First published in the November 2018 issue of PLC Magazine and reproduced with the kind permission of the publishers. Subscription enquiries 020 7202 1200.