Exclusivity's benefits

In her Oct. 7 Point of View article, Laura Musselwhite complained that 12 years of data exclusivity for biotech medicines is too long and costly. Note that data exclusivity refers to the Food and Drug Administration keeping private the data supplied to it when a firm applies for FDA approval. Why should biologics get 12 years when pharmaceuticals receive only five?

First, pharmaceuticals patents protect them from copycats for approximately 12 years, while biologic patents provide much less. Why? Because biologic molecules, unlike pharmaceutical molecules, are large and very complex; they can be altered slightly to produce a new patentable biosimilar medicine that also works. Generic pharmaceuticals are chemically identical and outlawed by patents. Give biotech generic firms data on a new biologic and they can quickly engineer a slightly different biologic to sell.

For this reason, innovator biologics need longer data exclusivity to protect the economic incentives for firms to undertake their long (15 years), costly ($1.5 billion), and risky R&D efforts.

Shorter data exclusivity provides benefits of lower prices for current biotech medicines, but at the expense of significantly reduced R&D and fewer future biotech breakthroughs. Where do the benefits and costs equate? Musselwhite says five years, but we believe that is much too short.

John A. Vernon

Professor, Department of Health Policy and Management

UNC-Chapel Hill

Chapel Hill