Fitzpatrick, Cella, Harper & Scinto, US
Title: “Why so serious?” – The increasing impact of post grant challenges to biologics and biosimilars in the US
Biography: Ha Kung Wong
Biologics and biosimilar products are the fastest growing pharmaceutical products in the US, being 3 of the top 5 best selling pharmaceutical products in the US in 2018. As such, it has become even more important to companies in both the biologics and biosimilars space to acquire and protect related intellectual property, as well as conduct a thorough analysis concerning potential infringement and validity issues of competitor intellectual property. The supreme court has now upheld the constitutionality of inter partes review and post grant review as viable avenues for challenging patentability and recent developments with the federal circuit have potentially increased the likelihood of challenges, particularly with respect to the very important area of biologics. We will take a look at the IPR and PGR processes, discuss strategies for filing and responding to these petitions, consider recent case law and it impacts on these processes and provides insight as to what steps to take to prepare for a potential future challenge.