VIIV Healthcare UK Ltd v Teva UK Ltd

A reference to the CJEU must be necessary to enable the national court to give judgment. It is not enough that a reference would be desirable, convenient, commercially useful, or helpful in deciding whether to amend a patent. A reference should generally await findings on the facts and should be based on a sufficiently precise factual context. Where the validity of the patent, the allowability of proposed amendments, or other essential factual issues may dispose of the EU-law questions, referring those questions prematurely is inappropriate.

ViiV sought a declaration concerning the interpretation of Article 3(d) of Regulation (EC) No 469/2009 in relation to an SPC for a combination of abacavir and lamivudine. Teva opposed a reference to the CJEU, arguing that the proposed questions were acte clair and that essential facts had not yet been established.

The patent validity proceedings, including conditional amendment applications, were due to proceed to trial. The central issue was whether the proposed EU-law questions were necessary for the court to determine the dispute at that stage.

1. Application dismissed. The court declined to refer questions to the CJEU.
2. Article 267 TFEU requires a reference to be necessary to enable the national court to give judgment. The requirement is stronger than desirability or convenience. A reference should not be made merely to assist a party in deciding whether to pursue a conditional patent amendment.
3. The court applied the guidance in Bulmer v Bollinger [1975] RPC 321 and Eli Lilly v Human Genome Sciences [2012] EWHC 2290 (Pat): ordinarily, the national court should first establish the relevant facts and provide the CJEU with a sufficiently defined legal and factual context.
4. A reference was premature because several matters to be determined at trial could make the proposed questions irrelevant. These included revocation of the patent, the conventional allowability of amendments, whether the A+B combination was innovative over A+B+C, and whether any alleged synergy existed and had legal significance.
5. The draft statement of facts contained contentions and contingencies rather than established facts. The proposed reference therefore lacked a firm factual basis. The court did not need to decide whether the questions were acte clair, since they might never require determination.
6. The court also noted that in Actavis v Boehringer C-577/13 the CJEU had left fully argued but academic questions unanswered, illustrating the importance of referring only questions necessary to resolve the particular case.