Patent Rigging: FDA Commissioner Urges USPTO to Act
For decades, Americans have been wailing over the exorbitant price of prescription medicines which the drug companies have linked to the huge cost of research and development of new medications. But it appears that beyond the issue of price and the huge profit the big pharmaceutical companies are raking in, some drug companies are also rigging the patent process to elongate their patents according to the acting FDA Commissioner Janet Woodcock, MD.
Woodcock recently wrote a letter to the U.S. Patent and Trademark Office, 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.”
Studies have also shown that Per capita prescription drug spending in the United States exceeds that in all other countries, largely driven by brand-name drug prices that have been increasing in recent years at rates far beyond the consumer price index. The United States Department of Health and Human Services, recently introduced a plan with which it aims to reduce the cost of prescription medicine in the US, but many have expressed doubt about the plan which some describe as weak.