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.”
Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit
