Second medical use

A second medical use is a new specific medical use of a known substance or composition. A patent may protect that use if patentability requirements are met. It does not automatically renew protection for the molecule across every use.

Subject matter of protection

Article 54(5) EPC allows a specific medical use of a known substance to provide novelty. Novelty alone is insufficient: inventive step, sufficiency and other requirements must also be assessed. A claim may cover a particular indication. Treatment parameters must be read in the actual granted wording.

A purpose-limited product claim, such as “substance X for use in treatment Y”, differs from the older Swiss-type claim concerning manufacture of a medicament for a specified use. Claim format and date matter when assessing scope.

Skinny label and carve-out

Here, a carve-out means removing an indication from regulatory product information. A skinny label is the resulting limited presentation. This may permit targeting unprotected indications, subject to applicable regulatory requirements. It does not automatically determine patent infringement.

Examine claims, the summary of product characteristics and patient leaflet, as well as offers, tenders, communications to healthcare professionals, prescribing and substitution arrangements, and evidence of targeted uses. Any required knowledge or intention depends on the cause of action and jurisdiction: there is no worldwide rule that a skinny label is always, or never, sufficient.

A case illustrating why automatic rules mislead

In Warner-Lambert v Generics ([2018] UKSC 56, paragraph 15), the majority found certain pregabalin claims insufficient. The judges also discussed infringement of Swiss-type claims on the hypothetical assumption that the claims were valid. Their reasoning differed, notably on product presentation and intention. Describing the judgment simply as a “green light for skinny labelling” would be misleading.

Four checks before launch

• The right: claim version, countries, expiry dates and validity proceedings.
• The product: authorised indications, product information, leaflet, packaging and doses.
• The market: customers, volumes, offers and concrete measures addressing protected uses.
• The procedure: available evidence, alleged urgency, competent forum and scope of requested relief.

Patent validity, infringement and provisional-injunction requirements need separate analysis. Marketing authorisation is not patent clearance.

Sources

EPC, Article 54(4) and (5). Warner-Lambert v Generics, [2018] UKSC 56, paragraphs 14 and 15.

Related concepts

Plausibility · Launch at risk