EU Judgment in Case C-237/22 P Mylan IRE Healthcare v Commission

Friday 4th October 2024

EU Judgment in Case C-237/22 P Mylan IRE Healthcare v Commission

(Public health)

From the Opinion of AG Emiliou

‘Orphan medicinal products’ are medicinal products for the treatment of diseases that are relatively uncommon (also known as rare diseases), which makes it difficult to develop and market them profitably.

To address the concerns that arise from the restricted availability of medicinal products to patients suffering from such diseases, the EU legislature has adopted a legislative framework to encourage production of those medicinal products. That framework, comprising in particular Regulation (EC) No 141/2000 and Regulation (EC) No 847/2000, offers several incentives to the pharmaceutical industry, including a ‘reward’ in the form of several years of market exclusivity.

To obtain designation as an orphan medicinal product (also referred to as ‘OMP’), and benefit from such exclusivity, the product must provide, inter alia, a significant benefit compared to other authorised treatments.

At the same time, the marketing exclusivity is not absolute. A derogation can be granted when, inter alia, a similar medicinal product is safer, more effective or otherwise clinically superior to the designated OMP.

The present case primarily concerns two medicinal products: ‘Tobi Podhaler – Tobramycin’ (‘Tobi Podhaler’) and ‘Tobramycin VVB and associated names’ (‘Tobramycin VVB’). Both products are indicated for the treatment of pulmonary infection caused by the bacterium Pseudomonas aeruginosa in cystic fibrosis patients aged six years and older.

More specifically, Tobi Podhaler was designated as an OMP and was subsequently granted a marketing authorisation (‘MA’) and, therefore, market exclusivity. Mylan IRE Healthcare Ltd (‘Mylan’) subsequently became the holder of that MA.

However, during the period of that market exclusivity, another company, UAB VVB (‘VVB’), obtained an MA for Tobramycin VVB, a product similar to Tobi Podhaler. To that end, VVB applied for, and was granted by the European Commission, a derogation from Tobi Podhaler’s market exclusivity.

That decision was challenged before the General Court, but the action was dismissed.

By the present appeal, Mylan seeks to challenge what it claims is an erroneous interpretation of the criteria permitting a derogation from the OMP-related market exclusivity.

Background Documents C-237/22 P