Replies to post #3146 on Bio Path Holdings Inc (BPTH)

[Pat Torney]

Patent protection and Orphan Drug Exclusivity (ODE) are not directly related. Getting ODE provides a 7-year period when the FDA will apply certain delays and prohibitions on approval of competitor drugs. Patent rights are a property right whereby the company could keep any competitor from even making or using the drug for experimental purposes. Under ODE, competitors can make and use the technology for experimentation and development, but they won't be able to get FDA approval until the 7-year period expires. Hopefully that makes sense.

Here is a link with more information
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm