BPI Labs has announced its collaboration with Empower Pharmacy to challenge Eli Lilly's patent on tirzepatide. The two companies have filed a petition with the U.S. Patent Trial and Appeal Board, presenting additional prior art to support claims of the patent's invalidity.
According to Forbes, compounding pharmacies such as Empower Pharmacy and BPI Labs are increasingly challenging Eli Lilly’s exclusivity over tirzepatide, marketed as Mounjaro. Their efforts are driven by patient advocacy, access constraints following shortages, and the demand for more affordable treatment options. Forbes describes these petitions as "a dose of disruption" for Big Pharma’s intellectual property hold on weight-loss injectables, highlighting increased scrutiny on the validity of Lilly’s ‘780 patent.
The official petition filed by BPI Labs with the U.S. Patent Trial and Appeal Board initiated an inter partes review (IPR2025-01346) against Eli Lilly’s U.S. Patent No. 9,474,780 on August 4, 2025. The filing argues that Lilly’s claims were obvious based on prior publications by Alsina-Fernandez, DiMarchi, and Lau. BPI's argument expands upon Empower Pharmacy’s earlier challenge by introducing new prior art related to peptide design techniques that improve stability and reduce immunogenicity—factors they claim were already known before Lilly’s filing.
Eli Lilly previously sued Empower Pharmacy in federal court in early 2024, alleging infringement of the '780 patent through compounded tirzepatide products. Lilly maintains that Empower’s operations unlawfully "copy" Mounjaro despite FDA restrictions on compounding clinically available drugs. In response, Empower contends that its formulations serve patients unable to access the branded version due to cost or shortage and argues that Lilly’s patent is invalid due to prior art and obviousness.
BPI Labs operates from Largo, Florida as both an FDA-registered drug manufacturer and a 503B outsourcing facility. It specializes in sterile and non-sterile compounded medications using robotic isolator systems for injectable production. The company services hospitals, clinics, and telehealth platforms across the U.S., positioning itself as a high-capacity alternative to traditional compounders.
Empower Pharmacy is a licensed 503B outsourcing facility and 503A compounding pharmacy headquartered in Houston, Texas. It operates a 503B FDA-registered manufacturing facility built to current Good Manufacturing Practice (cGMP) standards, supplying sterile and non-sterile medications nationwide. Empower emphasizes its role in addressing medication shortages and reducing costs through compounded alternatives in areas like hormone therapy, weight management, and chronic disease care.
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