New US Law Extends Drug Patents Slightly
US President Barack Obama has signed into law a Congressional bill extending exclusivity periods for new drugs and biologics containing a controlled substance. The extension will be achieved by changing the date they are considered to have been approved.
Under the current procedure, patent protection begins when the Food and Drug Administration (FDA) approves the product. In future it will apply from the date the US Drug Enforcement Agency (DEA) schedules it for sale.
The Improving Regulatory Transparency for New Medical Therapies Act was passed by Congress in response to drugmakers’ complaints that they had lost exclusivity rights while waiting for DEA to give the marketing green light.
At the same time, the legislation allows a controlled drug or biologic to be marketed for an interim period before the DEA assigns it to a controlled substance schedule.
The agency will be required to issue an interim final rule to place a product in a Controlled Substances Act schedule within 90 days of its approval by the FDA or when the US Department of Health and Human Services (HHS) sends a scheduling recommendation to the DEA, whichever comes later.
The legislation signed by the president also contains provisions amending the US Controlled Substances Import and Export Act to remove regulatory barriers to the re-exportation of controlled substances among members of the European Economic Area.