Biosimilars: The Challenges of Novelty, Inventive Step and Sufficiency.

In order to understand the relationship between patents and biosimilars in Australia better, this article examines whether, and in what circumstances, biosimilars can be patented under the Patents Act 1990 (Cth). Part II provides the necessary background in discussing the structure and function of biosimilars as well as the regulation of, and key arguments for, biosimilars in Australia. Part III explores the key challenges faced in patenting biosimilars in Australia, particularly the requirements of novelty, inventive step and sufficiency of description. In so doing, the recent case of Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017] FCA 285 provides some guidance and is discussed. The article concludes in Part IV with consideration of the implications of biosimilar patents for manufacturers, as well as access and affordability of treatment to the community and the interaction between government subsidy through the Pharmaceutical Benefits Scheme, and biosimilars.