WORLD OF GENERIC DRUGS MODULE

Patent Protection

Patent protection is awarded by the U.S. Patent and Trademark Office. There is virtually no communication between FDA and the Patent and Trademark Office.

Some countries take on the responsibility of determining patents and setting prices. When the generic program was created in the mid-1980s, FDA installed a process by which the generic companies police the patents and in exchange receive a 180-day exclusivity.

Drug companies, as part of the new drug approval, provide FDA with a list of relevant patents. FDA publishes the patent information and refers generic companies to review patents as part of the research and development process.