Proceduralists will love the judgment of the General Court of 22 January 2015 in Teva Pharma BV v European Medicines Agency (EMA) and Commission, T-140/12, EU:T:2015:41. Two interesting procedural points came up:

1. when can a new plea be adduced by the Applicant in the course of the litigation, and
2. what sort of measures can be the subject of an objection of illegality pursuant to Article 277 TFEU.

The case was a about a rather complex medicinal products case. We’ll just concentrate on the more general procedural issues that the judgment deals with.

New plea during the procedure

The general rule is that the applicant must set out all pleas and supporting evidence in the application. According to Article 48(2) of the General Court’s Rules of Procedure no new plea in law may be introduced in the course of proceedings unless it is based on matters of law or of fact which come to light in the course of the procedure.

The Court recalls that according to case-law, the fact that a party became aware of a factual matter during the course of the procedure before the General Court does not mean that that element constitutes a matter of fact which came to light in the course of the procedure. A further requirement is that the party was not in a position to be aware of that matter previously (judgments of 6 July 2000 in ACIS v Parliament, T‑139/99, EU:T:2000:182, paragraph 62, and of 9 December 2010 in Tresplain Investments v OHIM — Hoo Hing (Golden Elephant Brand), T‑303/08, EU:T:2010:505, paragraph 167).

The Court points out that a plea which may be regarded as amplifying a plea put forward previously, whether directly or by implication, in the original application, and which is closely connected therewith, must be declared admissible (judgments of 19 September 2000 in Dürbeck v Commission, T‑252/97, EU:T:2000:210, paragraph 39; of 28 April 2010 in Gütermann and Zwicky v Commission, T‑456/05 and T‑457/05, EU:T:2010:168, paragraph 199; and of 10 July 2012 in TF1 and Others v Commission, T‑520/09, EU:T:2012:352, paragraph 185).

In this case, however, the Court held that the plea advanced by the applicants for the first time in their reply was not based on any matter of law or of fact which came to light during the procedure. Consequently, the General Court declared the new plea inadmissible.

The Court went on to consider, however, an objection of illegality advanced by the applicants as part of that plea.

The Court recalled that Article 277 TFEU permits any party to proceedings to challenge, as an incidental plea, with a view to obtaining the annulment of a decision of direct and individual concern to that party, the validity of an earlier act of the institutions of general application forming the legal basis of the decision that is being contested, if that party was not entitled under Article 263 TFEU to bring a direct action challenging such an act by which it was thus affected without having been in a position to ask that it be declared void (see, judgments of 6 March 1979 in Simmenthal v Commission, 92/78, EU:C:1979:53, paragraph 39; of 19 January 1984 in Andersen and Others v Parliament, 262/80, EU:C:1984:18, paragraph 6; and of 11 December 2012 in Sina Bank v Council, T‑15/11, EU:T:2012:661, paragraph 43).

The type of acts which can be the subject of an objection of illegality is viewed broadly. The Court recalls that the objection of illegality cannot be limited to acts in the form of a regulation for the purpose of Article 277 TFEU, in order to ensure that those persons who are precluded from instituting proceedings directly in respect of general acts of the institutions may obtain a genuine judicial review of such acts when they are affected by implementing decision which are of direct and individual concern to them (see, to that effect, judgment in Simmenthal, EU:C:1979:53, paragraphs 40 and 41, and judgment of 26 October 1993 in Reinarz v Commission, T‑6/92 and T‑52/92, EU:T:1993:89, paragraph 43).

There are certain limits, though. The Court states that according to case-law, the objection of illegality must be confined to what is essential for the resolution of the dispute and there must be a direct legal connection between the individual decision that is being contested and the general measure in question (see, to that effect, judgments of 31 March 1965 in Macchiorlati Dalmas v High Authority, 21/64, EU:C:1965:30, p. 227, 245; of 13 July 1966 in Italy v Council and Commission, 32/65, EU:C:1966:42, p. 563, 594; and of 21 February 1984 in Walzstahl-Vereinigung and Thyssen v Commission, 140/82, 146/82, 221/82 and 226/82, EU:C:1984:66, paragraph 20).

The Court found in this case that the measure that was the subject of the illegality plea – a Committee’s summary report – was a preparatory measure and was thus not a general act capable of forming the legal basis of the contested decision or had a direct link with the decision being challenged in such a way that its purported illegality may have any effect on the resolution of the dispute.

Consequently, the objection of illegality was declared inadmissible too.