Improving Access to Emerging Lifesaving Drugs: Solving the Disclosure Problem Within the Patent Dance

Biologics are a growing class of pharmaceutical drugs and are associated with a significant portion of major medical breakthroughs over the past fifty years. However, in comparison with traditional small-molecule drugs, biologics are vastly more complex, more difficult to manufacture, and extremely expensive. Congress passed the Biologics Price Competition and Innovation Act (BPCIA) in an effort to increase the availability of biosimilars—the generic versions of biologic drugs—but the BPCIA has been largely ineffective. This is due, in part, to the lack of a standard regarding initial information disclosures required at the outset of the BPCIA process, leading to a cumbersome and inefficient process that is mired in disputes over the adequacy of initial disclosures. Rulings by the Supreme Court in Sandoz Inc. v. Amgen Inc. and the Federal Circuit in Amgen Inc. v. Hospira, Inc. have further complicated the issue and cemented several problematic practices. This article examines the impact of the current lack of a disclosure standard within the BPCIA and proposes that the adoption of the enablement standard from patent law would reduce unnecessary litigation, provide a more streamlined process, and bring some much-needed balance to follow-on competition. Such a change is likely to increase the number of biosimilars entering the market, leading to decreased patient costs and increased accessibility for millions of patients whose lives may depend on access to this critical class of drugs