Half of drug patent applications are continuations on existing patents to stop generic entry
Robertson 23. Rachael Robertson (Craig Newmark Graduate School of Journalism at CUNY, where she focused on health and science reporting. She got her bachelor’s degree in Communication Arts with a minor in Global Health Studies from Allegheny College.) Aug 1 2023. MegPageToday “Continuation Patents Have Surged, Disrupting Generic Competition, Study Shows” https://www.medpagetoday.com/special-reports/features/105720 ///MSU///QLC///*Brackets inserted by author, not QLC
Continuation patents on FDA-approved drugs skyrocketed by 200% from 2000 to 2015, likely putting off generic competition, researchers found. Over this time period, the ratio of continuation patents increased from 0.6 for drugs approved in 2000 to 1.8 for drugs approved in 2015, while the ratio of the number of original patents per FDA approval increased by 15%, from 1.3 to 1.5, respectively, reported S. Sean Tu, JD, PhD, of West Virginia University College of Law in Morgantown, and colleagues. Overall, the ratio of the number of FDA-listed patents per drug increased by a relative 68%, they noted in a research letter in JAMA. Among 3,967 distinct patents on these drugs through 2021 listed in the FDA's "Orange Book," also known as the "Approved Drug Products with Therapeutic Equivalence Evaluations," 53% were original patents and 47% were continuation patents. While the ratio of the number of litigated original patents per approval increased by 63%, from 0.38 for drugs approved in 2000 to 0.62 for drugs approved in 2015, the ratio of litigated continuation patents increased 213%, from 0.22 to 0.69, respectively. Companies apply to the U.S. Patent and Trademark Office for a continuation, which is when the "patent holder adds new applications to a prior submission by offering minor clarifications or additions without substantial change to the underlying invention," the authors explained. Tu told MedPage Today that continuation patents are a pervasive legal strategy increasingly used in patent thicketing and are designed to increase costs for competitors and make it harder for generics to hit the market. "Not only are [companies]* filing and getting more continuation patents, they're [are] actually litigating these patents," Tu said. Of the 1,936 litigated patents in total, the number of original and continuation patents was similar: 985 and 951, respectively. "More continuation patents mean that generic firms seeking to challenge existing protections on brand-name drugs must contest and potentially litigate more patents," Tu and team noted.