Skinny labelling in the Australian context: an overview

This article was first published in the 2023 Pharmaceutical Patent Review.

Key takeaways

• In Australia, new indications for known pharmaceuticals may be protected by several different patent claim formats, including method of treatment claims, Swiss type claims and EPC 2000 claims.
• Various forms of "skinny labelling" may be adopted by suppliers of generic and biosimilar medicines in an attempt to avoid infringement of second medical use patents when supplying a known pharmaceutical product for an off patent indication in Australia.
• Typically, skinny labelling involves omitting patented indications from the prescribing information (i.e., label) for a generic or biosimilar product, with or without an express statement that the product is not supplied for use in any patented indications. Such measures require regulatory approval. Sponsors of generics and biosimilars may also communicate directly with prescribers and pharmacists regarding the permissible use