In 2010, Congress fundamentally changed how federal law encourages the discovery and development of certain new medicines and for the first time authorized less expensive “duplicates” of these medicines to be approved and compete in the marketplace. The medicines at issue are biological medicines—generally, medicines made from, or grown in, living systems. Many of the world’s most important and most expensive medicines for serious and life-threatening diseases are biological medicines. Today, that law is beginning to bear fruit; FDA has begun to approve the first of these duplicates, called “biosimilars,” and the products have begun to enter the marketplace.
We have a profound interest in understanding and evaluating the impact of this legislation on innovation and competition in medicine. Scholars and courts considering this question may be tempted to reason from, or analogize to, experience with generic drugs. The generic drug statute, which applies to ordinary drugs, most of which are small and chemically synthesized, is thirty years old. It has yielded a rich field of scholarship and jurisprudence relating to innovation and competition. The 2010 biosimilar law was similar to the 1984 generic drug statute in basic purpose and structure. But the biologic framework as a whole—the complete landscape within which innovation and competition in biological medicines take place—is profoundly different from anything that scholars and courts have seen before. We are in uncharted waters.
This Article is the first piece of legal scholarship to offer a high-level map to those waters, organized around the characteristics that define the biologic framework and distinguish it from the thirty-year-old conventional drug framework. It makes two claims. First, the pathway to market, the competitive landscape, and the means and extent of market penetration for biosimilars are likely to vary from product to product and maybe even from company to company. They are also likely to evolve over time. The variability and dynamic nature of the biosimilar pathway and market penetration distinguish the biologic frame-work from the drug framework. Second, biologic patents have been severed from the regulatory paradigm. Patents are more clearly distinguished, in purpose and function, from the primary regulatory device designed to reward preclinical and clinical research—data exclusivity. The regulatory scheme does not reinforce biologic innovator patents the way the drug regulatory scheme reinforces drug patents. And, although the biologic framework makes premarket patent litigation possible, it omits the regulatory incentives to achieving premarket resolution of patent disputes that have been a hallmark of the drug scheme for more than thirty years.
Although scholars and policymakers focusing on innovation and competition with respect to medicine have decades of experience with the generic drug paradigm, this experience may be mostly irrelevant when it comes to biologics. The specific differences between the two frameworks, and the broader thematic divergence at play in the biologic framework, have profound implications for analysis of the marketplace. This Article fills a needed gap, by providing a basis for understanding how fundamentally the biologics framework differs and, in the final Section, precisely how these differences may matter.
The Uncharted Waters of Competition and Innovation in Biological Medicines,
44 Fla. St. U. L. Rev.