America’s Priciest Drugs Protected by Post-Approval Patent Thickets, Study Says

More than 1,400 patents and patent applications — most filed years after drug approval — protect the US’ 10 top-selling drugs, heading off competition from generics or biosimilars for decades, a new study has found. 

“Regardless of the validity of each patent, the overall density of patent thickets can deter competition by raising the perceived cost of market entry,” Aaron S. Kesselheim of Brigham and Women’s Hospital, Boston, and colleagues wrote in JAMA Internal Medicine. “Competitors will have to predict the probability that each patent will be found valid, enforceable, and infringed, and weigh the costs of challenging administratively or in litigation.”

More than a third of the patents on small-molecule drugs weren’t listed in the Orange Book, the authors said, and 19 percent of the biologic patents weren’t listed in the Purple Book. A dozen of the unlisted Orange Book patents and 56 of the unlisted Purple Book patents have been the subject of legal challenges since 2000.

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