Counterfeit medications are drugs that are deliberately and fraudulently mislabeled. Their quality is unpredictable because they might be made with the correct formulations, or with the wrong formulations, or without the active ingredients, or with insufficient amounts of the active ingredients, or any combination of the aforementioned.
All counterfeit drugs are 100% illegal, whether they are “harmless” or not. It is a criminal offense to manufacture, process, pack, or otherwise distribute counterfeit pharmaceuticals or medical devices.
The prevalence of counterfeit drugs is a problem. As the world’s population grows, more people are suffering from different ailments and demand for drugs is increasing. Sick people tend to have an inelastic demand for drugs and medical devices. Counterfeiters are well aware of this and take advantage of the situation to traffic in fakes. The enormous market, and a huge profit margin creates opportunities for easy money that entice criminals to pursue the production of counterfeit drugs. They cut corners in essential aspects of drug production and offer counterfeit products at significantly lower prices.
To combat the trafficking in counterfeit medicines, the USPTO tracks relevant domestic and international legislation and works with foreign governments, law enforcement agencies, regulatory bodies, and IP offices to (a) raise awareness about the dangers of counterfeit pharmaceuticals and (b) train inspectors, agents, regulatory, and legislative officers to better identify, seize, investigate, prosecute, and deter the consumption and sales of these illicit products.
Upcoming events and resources
- The U.S. Patent and Trademark Office’s COVID-19 Response Resource Center includes links to information about combatting COVID-19–related counterfeiting and fraud.