Harness patent attorney Kisuk Lee was quoted in an article published by PharmTech and BioPharm, “US Supreme Court Weighs Biologics Patents in Amgen vs. Sanofi Case.”
On March 27, 2023, the United States Supreme Court heard oral arguments from Amgen and Sanofi in a case that could have broad ramifications on the state of patents in the United States.
The crux of the case concerns the enablement requirement, and whether “genus claims” (i.e., patents that cover various structurally and functionally related chemicals) satisfy it. If Amgen wins the case, the victory would allow the company to claim all antibodies that use this mechanism of action shared by evolocumab and alirocumab and would extend to other patents, which has left some companies worried about their intellectual properties. Conversely, if Sanofi wins the case, the outcome would likely result in the death of broad genus claims.
Some, including Lee, feel that a Sanofi win could depress innovation. According to Lee, while it requires billions in R&D to bring a molecule to market, it is not incredibly difficult to extrapolate research concerning one molecule to similar ones.
“Nowadays, antibody production is quite automated,” says Lee, a principal in the St. Louis Metro Office. “If you have the roadmap as described in Amgen’s specification, with computer modeling anybody can quickly produce antibodies.”
“If [the Supreme Court] decision only focuses on functional language, there will still be a good outcome for industry,” says Lee. “But if they say broad patent claims hinder competition and follow-on inventions, and you need to provide enabling disclosure for all variants falling within the scope, then it will be really damaging for our industry.”
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