The FDA’s acting commissioner Janet Woodcock clarified the agency’s concerns around patents and competition via a letter.
The letter addressed to Andrew Hirshfield, director of the U.S. Patent & Trademark (PTO), said the FDA is concerned that some companies are filing so-called “continuation” patent applications, which can allow a filer to pile on follow-on patents on one drug, creating a thicket of patents to block competition.
“The existence of multiple patents increases litigation burdens and potentially delays the approval of generics and the launch of generics and biosimilar and interchangeable biological products,” she wrote.
Concerns also have been raised about patent changes to approved drugs such as formulation changes, new delivery systems, or patents claiming additional methods of use should also come under scrutiny, wrote Woodcock.
She pointed to a study published in the Journal of Law and the Biosciences that found 78% of drugs for which new patents were listed in the Orange Book from 2005-2015 were for existing drugs, not new drugs.
Product hopping was her other concern. Woodcock pointed out how some companies switched one drug’s entire market to a new dosing regimen (e.g., twice daily to once per day) before competition is set to start.
Woodcock said product hopping “has the practical effect of forestalling competition although the prior product (for which generic, biosimilar or interchangeable competition has become available) remains safe and effective.”
Woodcock offered up opportunities for PTO examiners and staffers to learn the ways of the FDA’s databases and other expertise to support their “ability to accurately and fairly grant patent term extensions.”
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