FDA commissioner urges US to crack down on drugmakers' patent abuse

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Acting FDA Commissioner Janet Woodcock, MD, wrote a letter to the U.S. Patent and Trademark Office Sept. 10, in which she urged the agency to provide more intervention in drugmakers' anti-competition patent practices.

Dr. Woodcock said that litigation increases when drugmakers have multiple patents on a drug, which could delay the approval and subsequent launches of cheaper generics. 

She also criticized the practice of patenting slight changes to a new drug, such as new formulations or delivery systems, saying it should be regulated more. She cited a study showing that 78 percent of drugs for which new patents were listed from 2005-2015 were for existing drugs, not new ones.

Product hopping, which occurs when drugmakers force patients to switch to a new formulation of a drug to get new patents, was another area of concern detailed in Dr. Woodcock's letter. She said the practice "has the practical effect of forestalling competition notwithstanding the fact that the prior product (for which generic, biosimilar or interchangeable competition has become available) remains safe and effective."

Dr. Woodcock ended the letter by saying the FDA and USPTO must "address the need for an appropriate balance between innovation and patient access to medicines."

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