Actavis Group PTC EHF & Anor v Boehringer Ingelheim Pharma GmbH & Co, KG

When deciding whether to extend a cross-undertaking in damages to third parties, the court must exercise its discretion to do justice generally. It should identify the relevant class with reasonable certainty and understand the nature of the potential loss. A class may nevertheless be defined functionally where its members and the loss they may suffer are sufficiently clear, even if the particular corporate entities are not yet known. A vague class of potential customers should not ordinarily be covered in advance where the court cannot identify either its membership or the relevant loss. Such persons may apply later for the benefit of the undertaking.

Agreed questions of European law should be referred before trial where they properly arise and early resolution may avoid substantial factual expense. Interim undertakings should not remain in force longer than necessary.

Actavis sought to clear the way for marketing a telmisartan and hydrochlorothiazide combination product, which would otherwise risk infringement of Boehringer’s combination supplementary protection certificate. The parties agreed to interim undertakings and agreed that questions concerning the interpretation of the SPC Regulation should be referred to the CJEU.

The court had to decide whether to make the reference before trial and the proper scope of Boehringer’s cross-undertaking in damages. Actavis sought protection for other companies in its group and for customers or potential customers. Boehringer objected that the proposed classes were too wide or uncertain.

1. The court referred four groups of questions to the CJEU. The questions properly arose in the action, and Question 2 might determine whether any substantial factual trial was necessary. It was therefore cost-efficient and in the interests of justice to refer all the questions immediately. There was no reason to await the outcome of Actavis v Sanofi [2012] EWHC 2545.

2. The court expressed preliminary views that a lawful amendment to a patent may be relevant to the Article 3(a) condition, that the timing of such amendment should not ordinarily matter, and that there appeared to be no basis in the Regulation for shortening an otherwise valid SPC. It expressed no preliminary view on whether the combination had to embody a separate inventive advance.

3. Paragraph 5.1A of the Practice Direction to CPR Part 25 applies where the court accepts undertakings in lieu of an injunction as well as where it makes an injunction. The discretion must be exercised with the aim of doing justice not only between the parties but generally.

4. The court should require a cross-undertaking for third parties where a class can be identified suitably and the potential loss or harm is sufficiently understood. The person giving the undertaking is entitled to know with reasonable certainty the price being paid for interim relief.

5. The undertaking was properly extended to companies in the Actavis Group. The relevant functions were clear, and corporate restructuring could otherwise require repeated applications. The undertaking could benefit companies not identified until after judgment.

6. The proposed reference to customers or potential customers was refused. The class was vague and the nature of the possible loss was unclear. A person not initially covered could later apply to be joined, or otherwise obtain the benefit of the undertaking, if the circumstances justified it.