Adopt IP Protections to Ensure Regulatory Exclusivity for Orphan Drugs
Bringing a drug to market requires an extraordinary investment. In-house counsel at biotech and pharmaceutical companies routinely face the challenge of developing an IP strategy that maximizes an investment’s return. This is especially difficult when the market for approval of a drug is relatively small. This article provides an overview of the regulatory frameworks for orphan drugs in the United States and other developed and emerging markets.