The dangers of letting prescription drug patents expire

Glenn W. Peterson

California prescription drug companies have to protect their drug inventions from competitors in order to be able to make a profit from them. There are two main protections available: patents and exclusivity. However, expired patents or exclusivity rights can lead to many legal issues and fights over ownership, making it important for a company to stay current on what protection is available and keeping that protection valid, if possible.

It is important to understand that the longest length of any patent is 20 years from the date the application is filed. According to the Houston Chronicle, within this time limit, though, patents can expire in other ways.

Maintenance fees are generally due at regular intervals, and if they are not paid, the patent will expire. A petition can be filed with the U.S. Patent and Trademark Office to reinstate the patent. However, the USPTO will charge a fee and will require a solid explanation as to why the patent should be reinstated. Abandoning an application also voids a patent and can happen if requests from the USPTO are not recognized. If this happens, a fee can be paid within two months to revive the application.

Patents are not the only protection a company has for prescription drugs, though. There is also something called exclusivity. The U.S. Food and Drug Administration provides the company with the exclusive rights to market the drug through this provision. The length of exclusivity is based upon the type of drug and can range from 180 days to seven years. It can be in effect during, before or after the product is patented. It is completely separate from the patent protection.