What is the difference between drug patents and exclusivity?

Protecting the intellectual property of new drugs is complicated but essential for drug companies. Patents and exclusivity create time-periods during which a new drug is protected from competition.

“Patents and exclusivity work in a similar fashion but are distinct from one another and governed by different statutes” (@US_FDA).

A patent is a property right issued by the United States Patent and Trademark Office (USPTO). Generally, the term of a new patent is 20 years from the date the patent was filed. Patents are not associated with FDA approvals. Patents can expired before a drug is approved, issued after drug approval and anywhere in between.

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent (or not). Some drugs have both patent and exclusivity protection. Some neither. Designed to promote a balance between new drug innovation and generic drug competition, exclusivity is based on FDA approvals and granted on the basis of the type of drug. Exclusivity is not added to the patent life.

Intellectual property is often recognized as more valuable than any physical asset in the BioPharma world. Market exclusivity is one of the reasons why drugmakers rush to introduce their products in the U.S. first and why patients access new drugs faster than elsewhere | @heatinformatics