Empower Clinic Services LLC, a compounding pharmacy based in Houston, has petitioned the U.S. Patent Trial and Appeal Board (PTAB) to invalidate Eli Lilly & Co.'s patent on the peptide tirzepatide. The company filed this request with the board, arguing that the scientific methods used to develop tirzepatide were already known before Eli Lilly's patent application.
According to Empower, several scientific publications serve as prior art, describing similar compounds and techniques. The company claims these developments would have been routine knowledge for experts in the field at the time, suggesting that the patent lacks originality.
In its submission, Empower argues that Lilly’s peptide is "an obvious variant of a prior art peptide" and claims that its creation was "a simple matter of routine synthesis." Empower seeks cancellation of multiple claims of U.S. Patent No. 9,474,780 on grounds of obviousness and lack of novelty, citing three earlier international publications that allegedly describe every element of Lilly’s molecule.
Amidst ongoing disputes with compounding pharmacies, Eli Lilly has taken legal action against firms including Empower for producing unapproved tirzepatide drugs like Mounjaro and Zepbound without FDA approval. According to the Houston Chronicle, Empower Pharmacy CEO Shaun Noorian said, "Empower will not be bullied. We’ll continue doing what we do best, serving patients with integrity, quality, and relentless commitment to access." Noorian added that they operate within federal and state laws and aim to provide affordable alternatives for patients who cannot access or afford name-brand therapies.
The filing coincides with increased scrutiny over industry influence on public health policy. A recent White House assessment highlighted that from 1999 to 2018, the pharmaceutical industry spent $4.7 billion on federal lobbying expenditures—more than any other industry—and noted that nine out of ten former Food and Drug Administration commissioners later worked for drugmakers.
Empower Pharmacy is recognized as one of the largest 503A compounding facilities in the United States. It specializes in providing personalized medications tailored to individual patient needs across the nation.
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