Judgment of the General Court (Second Chamber) of 5 December 2018 –

Bristol-Myers Squibb Pharma v Commission and EMA

(Case T‑329/16)

(Medicinal products for human use — Orphan medicinal products — Decision withdrawing the designation of Elotuzumab as an orphan medicinal product — Decision that the designation criteria were no longer met — Marketing authorisation for the medicinal product for human use Empliciti (Elotuzumab) — Article 5(12)(b) of Regulation (EC) No 141/2000 — Article 5(8) of Regulation No 141/2000 — Obligation to state reasons)

1. Judicial proceedings — Application initiating proceedings — Formal requirements — Identification of the subject-matter of the dispute — Identification of the contested act — Designation implicit in the application — Admissibility (Art. 263 TFEU; Statute of the Court of Justice, Arts 21, first para. and 53; Rules of Procedure of the General Court, Art. 76(c)) (see paras 32-34, 40, 41)

2. Action for annulment — Actionable measures — Definition — Measures producing binding legal effects — Removal of medicine designated as orphan medicinal products from the Community Register of Orphan Medicinal Products — Not included (Art. 263 TFEU; European Parliament and Council Regulation No 141/2000, Art. 5(12)(b)) (see para. 38)

3. Action for annulment — Actionable measures — Definition — Measures producing binding legal effects — Taking account of the form of the act — Limits (Art. 263, first para. TFEU) (see para. 42)

4. Acts of the institutions — Statement of reasons — Obligation — Scope — Reference to the legal basis of a measure — Need for an express reference — None (Art. 296 TFEU) (see paras 50, 55)

5. Action for annulment — Pleas in law — Infringement of essential procedural requirements — Infringement of the duty to state reasons — To be considered of the Court’s own motion (Art. 263 TFEU) (see para. 51)

6. EU law — Interpretation — Acts of the institutions — Statement of reasons — To be taken into consideration — Decisions based on the opinion of a scientific authority — Incorporation of those opinions into the statement of reasons for such decisions (Art. 296 TFEU) (see paras 52-54)

7. Approximation of laws — Uniform legislation — Medicinal products for human use — Orphan medicinal products — Procedure for reviewing the designation of a medicinal product as an orphan medicinal product — Significant benefit — Criteria for assessment — Comparison between the evaluated medicine and previously authorised medicines — Limitation to medicinal products authorised only after the submission of the application for marketing authorisation of the evaluated medicinal product — Not included (European Parliament and Council Regulation No 141/2000, Arts 3(1)(b) and 5(12)(b); Commission Regulation No 847/2000, Art. 3(2)) (see paras 65-68)

8. Approximation of laws — Uniform legislation — Medicinal products for human use — Orphan medicinal products — Procedure for reviewing the designation of a medicinal product as an orphan medicinal product — Significant benefit — Failure to meet the criterion — Consequences — Removal of medicine from the Community Register of Orphan Medicinal Products — Breach of principle of proportionality — None (European Parliament and Council Regulation No 141/2000, Arts 3(1)(b) and 5(12)(b); Commission Regulation No 847/2000, Art. 3(2)) (see para. 74)

9. Approximation of laws — Uniform legislation — Medicinal products for human use — Orphan medicinal products — Procedure for reviewing the designation of a medicinal product as an orphan medicinal product — Significant benefit — Criteria for assessment — Verification by the Committee on Orphan Medicinal Products — Taking into account factors arising since the granting of the initial designation (European Parliament and Council Regulation No 141/2000, Arts 3(1)(b), 5(12)(b) and 7(3); Commission Regulation No 847/2000, Art. 3(2)) (see paras 82-84)

10. Approximation of laws — Uniform legislation — Medicinal products for human use — Orphan medicinal products — Procedure for reviewing the designation of a medicinal product as an orphan medicinal product — Opinion of the Committee on Orphan Medicinal Products — Discretion of the Commission — Judicial review — Limits (European Parliament and Council Regulation No 141/2000, Art. 5) (see paras 95-97, 99)

11. Approximation of laws — Uniform legislation — Medicinal products for human use — Orphan medicinal products — Withdrawing the designation of a medicinal product as an orphan medicinal product where the criteria for granting are no longer met — Commission decision — Requirement of an express measure — Non-compliance — Consequences — Annulment — Conditions (European Parliament and Council Regulation No 141/2000, Arts 3 and 5(8); Commission Regulation No 2003/C 178/02) (see paras 115-120, 123-125)

12. Judicial proceedings — Costs — Order that the successful party bear its own costs and pay those of the applicant (Rules of Procedure of the General Court, Art. 135(2)) (see paras 128, 129)

Re:

Application pursuant to Article 263 TFEU for annulment of an act adopted by the Commission removing Elotuzumab from the Community Register of orphan medicinal products for human use and/or of a possible act adopted by the Commission or the EMA determining that Elotuzumab no longer met the criteria for designation as an orphan medicinal product when the marketing authorisation was granted for the medicinal product Empliciti (Elotuzumab) under Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1).

Operative part

The Court:

1. Dismisses the action;