June 04, 2020

Center for Biosimilars Features Q&A with Ha Kung Wong on Pending Biosimilars Legislation

2 min

On June 4, 2020, Ha Kung Wong was featured in an extended Q&A with The Center for Biosimilars regarding pending biosimilars legislation. The following is an excerpt:

CfB: The Biologic Patent Transparency Act would force innovator companies to make public the patents protecting their products and is intended to limit the filing of patents to block ongoing biologic product applications. Ha Kung, why has patent transparency become a problem?

Wong: Biologic drugs are very scientifically complex, as most come from living organisms and aren't as simple as small molecule drugs, where everything is essentially just a handful of carbons, oxygen, and hydrogen. There are often many more patents filed on each biologic drug because of this complexity, including composition of matter, formulation, methods of use, and most important, manufacturing patents, something that might not have been as important for the small molecule space. So, some innovator biologic drug manufacturers, because of this, have identified over 100 patents that potentially cover aspects of the drug.

With all the scientific and manufacturing complexity, it can be difficult for an innovator to determine exactly which patents cover which aspects of the product, which means it can be even more difficult for a biosimilar manufacturer to identify all of the potential patents that may cover its biosimilar product. As a result of this, biosimilar manufacturers may not have a complete understanding of what patent issues they may face in the future prior to committing resources to development.

Click here to view the article.