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# Provide Consistent Info to FDA and USPTO: Attorneys
- URL: https://www.fdaweb.com/provide-consistent-info-to-fda-and-uspto-attorneys/
- Published: 2021-09-15T12:00:00.000Z
- Updated: 2026-09-14T17:14:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150145

A 9/1 decision by the U.S. Court of Appeals for the Federal Circuit highlights the potential impact of contradictory positions taken before FDA and the U.S. Patent and Trademark Office (USPTO). That’s the view of three Cooley attorneys in an online [analysis](https://www.lexology.com/library/detail.aspx?g=29bffc00-4e27-4cf0-bc09-7a424fb64518&ref=fdaweb.com) of *Belcher Pharmaceuticals v. Hospira*.

The appeals court upheld a Delaware federal court decision that the Belcher patent for epinephrine was unenforceable because the company had withheld material information from the USPTO with malicious intent.

The attorneys write that patent applicants must disclose to the USPTO any information material to patentability. In *Belcher*, they write, the material information included a journal article and knowledge of two other companies’ prior similar formulations of epinephrine. Evidence was admitted at trial showing that the company told FDA that racemization of the drug was a “well-known process,” citing the journal article that it withheld from the USPTO. Belcher also reportedly characterized an in-process pH change as a “very minor change” compared to the manufacturing process for one of the two formulations not disclosed to the patent examiner.

The appeals court agreed with the district court that the withheld information was material to patentability because it “would have blocked the issuance of a patent.”

The appeals court also found that Belcher’s chief scientific officer had acted with deceptive intent because he was “an active participant in the FDA approval process” in which the company represented that a key feature of the claimed drug formulation was “old,” but also in dealing with the USPTO when the same feature was described as a “critical” innovation.

“FDA and the USPTO do not coordinate their respective drug approval and patent examination processes,” the lawyers conclude…. “Without due caution, innovator companies can undermine their own patents.” To avoid such a scenario, the lawyers say, companies should consider: 

- if the regulatory process causes company employees to identify any information material to patentability, the company patent counsel should be promptly informed, so any appropriate disclosure to the USPTO can be arranged; and
- the company’s scientific, product development, regulatory, and legal teams should coordinate to avoid inconsistency in arguments made before FDA and the USPTO.