Arrow Generics Ltd & Anor v Merck & Co, Inc

A European patent does not take effect for a designated state merely because the European Patent Bulletin mistakenly mentions that state. Where its designation was validly withdrawn before publication, no decision to grant for that state remains capable of taking effect.

The court may grant a negative declaration concerning a claimant’s own product where the issue is clearly defined, the declaration serves a useful commercial purpose and justice supports relief. Section 74 of the Patents Act 1977 does not bar a declaration that a specified product was obvious at the priority date of pending European patent applications. Such relief neither determines the validity of ungranted patents nor usurps the European Patent Office’s examination function.

The claimants marketed once-weekly 70 mg alendronate products after successfully challenging an earlier patent concerning that treatment. The defendant subsequently pursued several divisional European patent applications which might cover the claimants’ products.

The claimants sought declarations concerning EP (UK) 1 175 904 and declarations that their specified product was obvious at the priority date of the pending divisional applications. The first issue was whether an EP (UK) patent had existed where the Bulletin mentioned grant with a GB designation, although that designation had been withdrawn before publication. The second was whether the court could permit the product-focused declarations concerning pending applications to proceed.

1. The claims concerning EP (UK) 1 175 904 were struck out. The European Patent Office’s decision to grant could take effect only when mention of grant was published. Before publication, the proprietor remained entitled under article 79(3) of the European Patent Convention to withdraw a state designation. Once the GB designation was withdrawn, no decision to grant for the United Kingdom remained capable of taking effect. The erroneous mention of GB in the Bulletin did not create an EP (UK) patent. The later corrigendum recorded the correct position. The court therefore lacked jurisdiction to declare that supposed UK patent invalid or revoke it.

2. The jurisdiction to grant declaratory relief is discretionary. The court should consider whether the declaration would serve a useful purpose, whether it would advance the aims of justice, whether the underlying issue is sufficiently defined to be justiciable, fairness to both parties and any special circumstances. The principles in Messier-Dowty v Sabena [2001] 1 All ER 275, Financial Services Authority v Rourke [2002] C.P.Rep. 14 and Nokia Corporation v InterDigital Technology Corporation [2006] EWHC 802 (Pat) were applicable.

3. Section 74 of the Patents Act 1977 did not bar the proposed declarations. Clear words were required to exclude a person’s right to seek a declaration concerning its own product. Section 74 should extend no further than its purpose of ensuring that invalid granted patents are revoked rather than merely declared invalid. It did not expressly prohibit product-focused relief prompted by published patent applications. Organon Teknika v Hoffmann-La Roche [1996] FSR 383 concerned a granted patent whose validity was directly put in issue and was distinguishable.

4. The claimants did not seek a declaration that no valid patent could emerge from the pending applications. Such relief would anticipate and usurp the European Patent Office’s examination function. They instead sought a determination that a product with specified characteristics was obvious at the applications’ priority date. That was a clearly defined and conventionally justiciable issue.

5. The declarations had a real commercial purpose. The pending applications carried GB designations, some claims covered the specified product, conditional infringement rights were accruing under section 69 of the Patents Act 1977, and the defendant had not disclaimed enforcement. The product-focused claims therefore had a reasonable prospect of success and were allowed to proceed.

not stated in the judgment.