Paucity of intellectual property rights information in the US biologics system a decade after passage of the Biosimilars Act

The Food and Drug Administration (FDA) maintains 2 lists of drugs approved in the United States-the Orange Book for small-molecule drugs and the Purple Book for large-molecule drugs.• US law requires that each application for approval of a small-molecule drug disclose the patents protecting the drug and mandates publication of the information in the Orange Book.• US law, however, imposes no patent-disclosure requirement on any application for approval of a large-molecule drug.Instead, US law requires that a brand biologic company disclose its patents-and that those patents are published in the Purple Book-only after a biosimilar applies for approval, and even then, only if rights negotiations between the brand and biosimilar reach a certain stage.• This legal regime for large-molecule drugs has led to remarkably little patent disclosure in the Purple Book: Only approximately 2% of the brand biologic listings in the Purple Book contain patent information.In comparison, the percentage of small-molecule drugs disclosing patent information in the Orange Book is 21 times greater.• Given that the Purple Book lists so little patent information about brand biologic drugs, a prospective biosimilar maker cannot readily assess its risk of patent infringement litigation, and so must make investment and manufacturing decisions blindly.