Part 1: Patenting orphan drugs

Collectively, rare diseases impact approximately 8% of the Australian population, or around 2 million people. Orphan drugs are pharmaceutical products developed to treat rare diseases, however with each drug involving small patient populations and high development costs, these therapies require carefully crafted patent and regulatory strategies to be commercially viable.

In the first of our two part series on orphan drug development, we look at some of the key patenting considerations. In the second article, we examine how orphan drugs are defined and the regulatory considerations for them.

Patent strategies for orphan drugs: Start early, think long

A robust patent strategy for orphan drugs, as with other drugs, generally involves both primary patents, covering the substance, and often including claims to method of manufacture, formulation and the like, and secondary patents covering other key aspects of the substance, such as newer methods of manufacture,