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Friday, December 8, 2023 | Back issues
Courthouse News Service Courthouse News Service

No Patent Adjustment for Bacteria Treatment

WASHINGTON (CN) - The U.S. Patent and Trademark Office was justified in refusing to adjust the patent term of antibodies that kill stomach bacteria, a federal judge ruled.

The University of Massachusetts and Medarex sued Patent and Trademark Office Director David Kappos, claiming the office wrongfully denied them a patent term adjustment for "Antibodies Against Clostridium Difficile Toxins and Uses Thereof."

Clostridium difficile is a species of bacteria that causes severe diarrhea when other stomach bacteria get wiped out by antibiotics. It can cause pseudomembranous colitis, and a condition known as toxic megacolon.

The University and Medarex patented monoclonal antibodies that bind to the bacteria, submitting their first patent application in 2006.

The PTO agreed to adjust the patent, but not enough to the liking of the school and Medarex. The PTO adjusted the patent term by 434 days instead of the 1,255 days requested by the antigen makers.

"Under the (Administrative Procedure Act), the court functions as an appellate authority addressing legal questions ... and only in rare circumstances, not present here, will the court disturb the agency's factual findings," U.S. District Judge Ellen Huvelle ruled. She said her ruling was cemented in the clear wording of federal patent term adjustment statute.

Under federal law, a patentee can get a one-day adjustment for every day from the end of a 14-month period until the first PTO action is issued. The University and Medarex unsuccessfully argued that various problems arising after the first PTO action was issued should lengthen the patent.

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