September 6, 2023

Harness IP’s Kisuk Lee Answers Questions for Bio Pharm International Regarding SCOTUS’ Amgen v. Sanofi Patent Decision

Harness IP principal Kisuk Lee was interviewed by Bio Pharm International regarding the implications of a recent U.S. Supreme Court patent decision. An article recapping the interview, “Unpacking Amgen v. Sanofi,” was recently published.

Lee, questioned by Bio Pharma associate editor Grant Playter, gives an overview of the state of pharmaceutical patents in the wake of the Supreme Court’s decision in favor of Sanofi: “In this case the issue was, how much information is enough to enable full scope of the claimed invention?”

In the in-depth Q&A piece, Lee outlines the decision’s effect on pharmaceutical research and patents, what it means for research institutions, and potential next steps for pharmaceutical companies. “Innovators will have to file more applications to cover a broad scope,” Lee writes. “That’s a higher cost because of filing costs, preparation costs, prosecution costs and maintenance costs.”

Lee predicts significant impact on the biologics segment of the industry, in particular: “Innovators need to identify a pathway as well as the certain messenger molecules involved in that pathway. Then they have to show what happens when that pathway is inhibited to demonstrate how that kind of modulation is necessary for biologic inventions. Thus, functional language and broad coverage are necessary.”

The article can be accessed on Bio Pharma International’s website.