Open Secrets

Patents and trade secrets were never intended to meet, but in the world of biologic drugs, they’ve become as thick as thieves. Patent law’s disclosure requirement has demanded far too little of biologics manufacturers—allowing them to keep vital manufacturing details under trade secret lock and key. This intellectual property patchwork has been devastating for drug affordability: Because the most critical manufacturing information remains hidden, makers of follow-on biologics (called biosimilars) are often stuck reinventing the wheel, even after the original patents have expired. This Article makes two principal contributions to illuminating this problem.

First, it presents, for the first time in legal literature, an in-depth examination of the typical life cycle of a biosimilar drug, assessing precisely where original biologics manufacturers use insufficient disclosure and trade secrets to gain more market protection than they are rightfully entitled to. Second, it charts a path toward a solution. Through either congressional action or the agency’s own licensing authority, the Food and Drug Administration should facilitate the disclosure of manufacturing information currently protected as trade secrets. Part VI outlines both the congressional and regulatory route for implementing this plan, placing particular emphasis on the latter, given the highly polarized state of Congress today.

More generally, this Article demonstrates why the Food and Drug Administration is in a perfect position to release––or to require the release of––this crucial information and how such action would have a profound effect on the access and affordability of biologics.