Launch at risk

A launch at risk is the commercial launch of a generic or biosimilar while a potentially relevant patent or SPC remains in force and infringement risk has not been definitively resolved. The manufacturer may argue that the right is invalid, not infringed or unenforceable in the circumstances. Launching does not itself establish infringement.

Align three timelines

• IP: claims, territories, expiry dates, SPCs, any paediatric extension and pending proceedings.
• Regulatory: marketing authorisation, authorised indications, regulatory exclusivities, pricing and reimbursement in the relevant country.
• Commercial: manufacture, imports, stocks, tenders, commercial offers, deliveries and intended launch date.

Marketing authorisation does not provide patent clearance. Conversely, a regulatory step is not necessarily infringement or proof of imminent launch. Acts require precise legal assessment, including any applicable Bolar exemption.

Imminence: examine dated evidence together

A firm offer, scheduled delivery, specific launch announcement or documented commercial preparations may carry different weight from a project or administrative authorisation. Identify the product, country, date, author and reliability of each item. No universal score turns an authorisation, price or stock into an automatic injunction.

Provisional relief is distinct from the merits

In France, Article L.615-3 requires evidence making infringement or its imminence sufficiently plausible. Procedure, challenges to the right, requested measures and security require assessment. Before the UPC, Article 62 UPCA provides for provisional relief and balancing the parties’ interests. Jurisdiction and territorial scope must be checked for the right concerned.

An approaching launch does not dispense with examining validity, claim scope, infringement, evidence and proportionality. A provisional decision does not finally determine the merits. Timing and outcome cannot be guaranteed.

Assess the cost of both scenarios

For the manufacturer: interrupted sales, inventory, launch adjustments, litigation costs, security and potential compensation. For the owner: launch consequences, evidence of loss and possible liability where unjustified measures are later revoked under the applicable rules.

In France, Article L.615-7 requires separate consideration of economic harm, moral prejudice and the infringer’s profits. It does not mandate automatically adding the owner’s entire lost profits to disgorgement of all the defendant’s profits.

Prepare the record

Gather current rights, claim analysis with technical specialists, relevant regulatory materials, dated commercial documents, correspondence and alternative launch schedules. Compare an early validity challenge, negotiation and a launch with litigation preparation. Suitability depends on country, evidence and budget.

Sources

French IP Code, Article L.615-3. Article L.615-7 (French). UPCA, Articles 60(9) and 62.

Related concepts

Second medical use · Plausibility