Adopt IP Protections to ensure Regulatory exclusivity for Orphan Drugs

orphan drugs present unique risks — the potential return on investment is inherently constrained by small patient populations and attendant reimbursement challenges. recognizing these challenges, some countries have passed laws designed to make the economic model associated with developing treatments for orphan diseases more attractive. the most meaningful incentive provided by the various orphan drug statutes is the period of market exclusivity available for qualifying drugs; however, there are still limitations. a comprehensive patent strategy provides a key complement to orphan exclusivity by buffering against the exceptions to orphan protection and extending the period of exclusivity to a point that better ensures a sufficient return on investment.