Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars

Patent thickets, patent litigation, patent dances—all of these legal terms have plagued the biosimilar space, causing many biosimilar products to launch well after the originator's market exclusivity was supposed to expire. A perfect example of this is the Stelara (ustekinumab) space, where patent litigation settlements have led to delayed market access for ustekinumab biosimilars from late 2023 to early 2025. Additionally, congressional leaders have had to investigate AbbVie for potentially abusing the patent system to stall biosimilar competition for Humira (adalimumab).

But why does the system work like this? What can be done to improve it? What actions can be taken to ensure the patent system doesn't hinder competition and innovation?

On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.

Show notes

To read more of Ha Kung's thoughts on the US patent system and its role in the biosimilar landscape, click here.

To learn more about Congress' role in addressing AbbVie's alleged anticompetitive practices regarding adalimumab products, click here.

To learn more about the suit filed by CareFirst BlueCross BlueShield regarding ustekinumab biosimilar delays, click here.

To learn more about the settlements that have resulted in the market delay of ustekinumab biosimilars, click here.

To learn more about lawsuits involving AbbVie that led to the delayed market entrance of adalimumab biosimilars, click here.

To learn more about what types of patents are at most to blame for biosimilar market delays, click here.