Chemical formulations used to manufacture prescription drugs are much like other trade secrets in that they can also be patented. Two different concepts comprise this process: Patent and exclusivity. It’s important that you understand how both work in terms of medications.
A patent is a property right granted by the United States Patent and Trademark Office. The patent holder can file claims against anyone who steals or otherwise violates their intellectual property. The concept of exclusivity applies to the drug industry. It’s the amount of time that competitors must wait before introducing their competing drugs to the market.
Patents generally last for 20 years from the application date. Chemical or drug exclusivity periods last for a much shorter time, however.
The Orphan Drug exclusivity period lasts seven years whereas the Chemical Entities and Generating Antibiotic Incentives Now ones only remain in effect for only five years. All New Clinical Investigation Exclusivity periods last for three years. Pediatric Exclusivity lasts for six months. Both Patent Challenges and Competitive Generic Therapy exclusivity periods each last for 180 days.
The fact that someone holds a patent doesn’t also mean that the drug has been approved for use. The exclusivity period doesn’t begin tolling until regulators have issued a public usage approval for a drug. Patent holders can find out what exclusivity period if any, applies to their application by consulting The Orange Book.
All manufacturers are required to submit their new drug applications (NDAs) and associated patent information to the U.S. Food and Drug Administration (FDA). The manufacturer must then submit all patent information from the Orange Book within 30 days of the NDA having been approved. The patent submission date is considered to be the date the FDA receives the patent information from the NDA holder.
Filing a patent can be a complicated process. If the right forms are not filed at the correct time, then it can result in delays or even a possible loss in one’s rights. Consult with a patent law attorney here in Roseville and make sure that your application is filed correctly so that your rights are fully protected.