Launch at risk

A launch at risk is the marketing of a generic medicinal product or a biosimilar while a patent or a supplementary protection certificate is still in force, the manufacturer considering that the title is invalid or not infringed and accepting the risk of an infringement action. It stands in contrast to the strategy of having the title revoked before any launch. The launch at risk is an economic choice: the first months of marketing a generic are the most profitable, and waiting for a final decision can take years.

The risks of a launch at risk

First, interim relief: the holder may obtain, before the Paris Judicial Court or the Unified Patent Court, a preliminary injunction within weeks if it shows that the infringement of its right is likely, which requires the withdrawal of the products and the recall of stocks. Next, damages: if infringement is upheld on the merits, the manufacturer must compensate the originator’s lost profits, which may be considerable because of the price drop caused by the arrival of the generic, and hand over its profits. Finally, the effect on the market: the administered price drop and substitution are not easily reversed, which fuels the debate on the originator’s loss and on the generic manufacturer’s liability where an injunction is later overturned.

The parties’ strategies

The generic manufacturer prepares the launch with a freedom-to-operate study, a révocation action or an opposition brought in advance, and sometimes an action for a declaration of non-infringement. The holder monitors marketing authorisations, entries in the generics register and pricing applications, sends a warning letter and prepares an application for a preliminary injunction. The Unified Patent Court has specified that an application for provisional measures must be made without unreasonable delay after becoming aware of the launch or its preparation. A holder whose injunction is later overturned may be ordered to compensate the generic manufacturer’s loss.

Key points

In practice, a launch at risk is decided on a solid validity and infringement analysis, on a quantified assessment of the scenarios and on the preparation of the security the judge might require. The firm assists originators and generic manufacturers in these strategies and in urgent proceedings, as presented on the pages pharmaceutical patents and regulation and provisional measures and interim relief.