Dublin firm can market drug in most of Europe after Dutch firm's injunction bid

High Court reporters

An Irish company which developed a drug used to treat low blood pressure can market the product in most European countries after a Dutch company failed to get a High Court injunction restraining the full termination of a commercialisation agreement between the two firms.

Dublin-registered pharmaceutical developer Brepco Biopharma Ltd is a small private limited company engaged in the development of pharmaceutical products, but its business is focused on the production and sale of a single product called Neoatricon.

The product, developed over 15 years of research, is used for the treatment of hypotension in seriously ill neonates, infants and older children up to 18.

In October 2022, Brepco entered a licence agreement with Netherlands-registered Piramal Critical Care BV to commercialise and market the product in 29 countries comprising the EU, the UK and Norway.

However, Brepco claimed Piramal did not launch the product, as required by the agreement within a certain timescale in most countries, save for German, the UK and Italy.

As a result, Brepco moved to terminate the agreement.

Piramal then brought High Court proceedings including seeking an injunction restraining termination of the agreement.

Brepco, which opposed the proceedings, said Piramal’s performance had been disastrous.

Rather than launching in 29 countries within 18 months of authorisation, they said that Piramal launched in only three countries and in at least 23 out of 29 countries, Piramal had taken either no steps, or minimal steps, to prepare for launch of the product.

In the three countries where it did launch, Brepco said sales were dismal.

Piramal said, among other things, that its commercialisation strategy was a phased EU launch under which the five largest markets, Germany, the UK, Italy, Spain, and France were prioritised before expansion into smaller markets.

This was both commercially rational and consistent with standard industry practice and allowed it to focus its resources initially on the largest and most established pharmaceutical markets, where the potential for uptake and return was greatest, it said.

Following a two-day hearing, Ms Justice Eileen Roberts granted the injunction in relation to the UK, Germany, and Italy.

However, she refused the injunction in relation to the remaining countries.

The judge said it meant Piramal could continue to exclusively commercialise the product in the three countries where it was already launched, but otherwise its exclusivity for the other countries was terminated.

The balance of justice appeared to favour permitting Brepco to now make its own arrangements to launch in those countries, she said. Brepco may be unsuccessful or only moderately successful in doing so – but that will be a matter for Brepco, she said.