A Solution in Search of a Problem at the Biologics Frontier
17 Pages Posted: 30 Nov 2017 Last revised: 6 Feb 2018
Date Written: November 27, 2017
This short paper comments on Professor Carrier's new article, Biologics: The New Antitrust Frontier. His article makes a profound initial contribution to a new area of scholarship, based on a large body of prior work considering antitrust issues relating to small molecule drugs. But Professor Carrier’s article, like my own forthcoming piece on innovation and competition in the biologics marketplace, is inherently speculative. We are making our best judgments about the nature of a still emerging marketplace and likely conduct in that marketplace, based on our understandings of a new regulatory framework that is itself still emerging, the broader legal landscape that includes reimbursement law and state law (among other things), and intellectual property law. We disagree about the likelihood of particular fact patterns arising in the first instance, and where we agree our explanations for their emergence are sometimes different. It may be premature to offer antitrust assessments about those fact patterns, particularly when the nature of the marketplace itself remains so profoundly uncertain. To illustrate this point, I discuss three factors that may merit greater attention than they receive in Professor Carrier’s article -- FDA’s existing regulatory authorities, the means by which biosimilar companies will compete and achieve market share, and the stacking of the premarket patent litigation scheme against innovative companies. Disparagement, product hopping, and patent scheme manipulation -- three of the seven topics tackled by Professor Carrier -- take on a different light when these factors are considered. I suggest we focus on a different issue: the possibility that the new scheme may harm incentives for innovation.
Keywords: Antitrust, Competition, Generic Drugs, Biosimilars, Patents, Exclusivity, Product Hopping, Incremental Innovation, Competition, Innovation
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