Skinny Labelling – A “Loophole” Under Pressure?

Considerations from an IP perspective

During the development of a branded product, the aspirations for its use are often large and always hold great potential. Then reality and resources hit, and focus on one, potentially two indications is the outcome. Once proven effective in one indication, leading to a Marketing Authorisation (MA) with a specific label (e.g., paracetamol for the treatment of headache), other marketing authorisations for the same branded product may be obtained later.

The Patent Departments in pharmaceutical companies are always (or should be) part of the whole development process. I.e., from the discovery of the active ingredient to the specific uses of the active ingredient – and even post-launch!