Astellas appeal dismissed, with no reference to ECJ

Mr Justice Arnold has just given his ruling this morning in Astellas Pharma Inc v Comptroller-General of Patents [2009] EWHC 1916 (Pat), an appeal against the decision of the Intellectual Property Office, United Kingdom. At the time of writing this post, the decision has not yet been added to the decisions freely available on the BAILII website, but you can read it in full here.

Arnold J dismissed the appeal, considering the hearing officer's decision to be correct. He did not feel that this was a matter that was appropriate to refer to the Court of Justice of the European Communities for a preliminary ruling:

31. ... Astellas contends that Takeda was wrongly decided and that the correct test to apply under Article 3(a) of the Regulation is the infringement test.

32. Counsel for Astellas supported the five reasons given by Kitchin J in Gilead [see SPC Blog here] for questioning the correctness of Takeda. In particular, he submitted that Takeda is inconsistent with the ECJ’s ruling on the second question in Farmitalia that to determine whether a product is protected by a basic patent reference must be made to the national law governing the patent. He argued that this must mean determining whether the product falls within the scope of protection of the patent in accordance with section 125 of the Patents Act 1977 and Article 69, and the Protocol on the Interpretation of Article 69, of the European Patents Convention. He also submitted that, in the light of Kitchin J’s judgment, it could not be said that it was acte clair that the infringement test was wrong and that this question should be referred to the ECJ.

33. Counsel for the Comptroller submitted that none of the five points identified by Kitchin J justified the conclusion that the infringement test was the right test. In particular, she submitted that there is a distinction between the scope of protection of a patent and infringement: the scope of protection is limited to that specified in the relevant claim properly construed, whereas infringement is not so limited. A product which includes all the elements of the claim infringes, but so does a product which also includes additional elements which are not specified in the claim at all. Accordingly, she argued, it is the scope of protection which matters, not whether a product infringes. She also submitted that consideration of the Opinion of Advocate General Fennelly in Farmitalia leads to the conclusion that the ECJ rejected the infringement test in that case. Finally, she submitted that the matter remained acte clair. She acknowledged, however, that it is the Comptroller’s understanding that at least one Member State of the Community, namely Norway, applies the infringement test.

34. I am not convinced that Takeda is wrong. To my mind, Jacob J’s reasoning remains persuasive. Furthermore, I agree that there is a distinction between the scope of protection and the question of infringement. As to Farmitalia, it is not clear to me that the ECJ either endorsed or rejected the infringement test in that case. Nevertheless, I agree with Kitchin J that there are arguments in favour of the infringement test which do not appear to have been considered in Takeda and which merit consideration by a higher court and perhaps the ECJ.

35. I have considered whether it is appropriate to refer this question to the ECJ. If I were confident that the Court of Appeal would refer it, I would avoid delay by making a reference now. I am not confident that the Court of Appeal will refer it, however. I conclude that the decision whether to refer should be left to that Court.

On the same basis, Arnold J decided not to to refer a question about the correct treatment of applications for SPCs for combination products to the ECJ.

The SPC Blog's note on the original decision can be read here.