Biopharma IP Trends Across the Atlantic
The law around biosimilars and patent term extensions is rapidly evolving in both Europe and the United States. On October 4, 2017, attorneys from Harrison Goddard Foote and Wolf Greenfield shared their perspectives on these issues from both sides of the pond.
Kate Taylor, HGF | Biosimilars in Europe
2016 saw the approval of four additional biosimilars by the European Medicines Agency (EMA), including a biosimilar of Enbrel® and two biosimilars of Clexane®. As the European biosimilars market continues to expand, we will discuss the different strategies available for building up and chopping down biosimilar patent thickets in Europe.
Oona Johnstone, Wolf Greenfield | Biosimilars in the US
Biosimilars, which are approved under the Biologics Price Competition and Innovation Act (BPCIA), represent a new and rapidly evolving field in the US, with five biosimilars having now obtained Food and Drug Administration (FDA) approval. A recent Supreme Court case and an increase in post-grant proceedings are shaping the patent landscape. We will discuss strategic considerations in navigating this landscape for both patent holders and biosimilar developers.
Andrew Wells, HGF | Patent Term Extensions — A European Perspective
Patent term extensions for pharmaceutical and agrochemical products are available in Europe in the form of Supplementary Protection Certificates (SPCs). The law relating to SPCs has been continuously evolving over the last few decades, and continues to do so as new case law appears on a regular basis. We will provide an overview of the SPC system in Europe and outline some key strategic considerations for patent holders.
Jeff Hsi, Wolf Greenfield | Patent Term Extensions — A US Perspective
Patent term extensions (PTEs) for pharmaceutical and veterinary products are available in the US under the 1984 Drug Price Competition and Patent Term Restoration Act (also known as the Hatch–Waxman Act). While the law is reasonably established, the interplay of factors in PTE calculation presents a complex web of strategic planning considerations to navigate in order to maximize advantage. We will provide an overview of the system in the US and outline some key considerations for patent holders.