Criminal intellectual property cases are unique and challenging. There are a few different kinds of intellectual property crimes that fall under this umbrella. Probably the most commonly prosecuted intellectual property crimes these days are criminal counterfeiting and FDA important and mislabeling cases.
Criminal intellectual property investigations target a variety of people. Criminal counterfeit prosecutions often involve online retailers, people who run flea markets, people selling tickets to sports events, and store owners.
Criminal Food and Drug Act prosecutions – like importing or using non-FDA-approved medicines or devices – target doctors, pharmacists, pharmacologists, and online pharmacies.
The federal government has gotten very aggressive about criminal intellectual property cases. Big corporations that own the right to sell something exclusively have a strong interest in using every weapon at their disposal to crack down on competition. These companies can be very effective in getting the federal government to investigate and prosecute the people who sell things that these companies think they alone have the right to sell.
Criminal intellectual property crimes – like criminal copyright charges, importation of misbranded or non-FDA-approved medicines or devices, and using misbranded medicines or devices – are taken very seriously by the federal government.
KNOWLEDGE IS OFTEN IMPORTANT
The most serious charges in this area often turn on whether the person who is accused of selling the things that are alleged to be counterfeit or illegitimate knew that they weren't the real thing. If a doctor is using a medical device that looks a whole lot like the FDA-approved device, then it can be hard to show, unless there's other evidence, that the doctor knew the device was mislabeled.
If you can show that the doctor didn't know that the drug was not FDA-approved, he can normally avoid felony charges. Unfortunately, there are some misdemeanors that don't depend on whether the doctor – or other person – knew that the products were misbranded. As long as the doctor used the non-FDA-approved device, that's enough for a misdemeanor conviction. In addition to a conviction, this can have serious effects on the doctor's medical license.
FEDERAL EFFORTS ON THESE CASES
There is a national office – the National Intellectual Property Rights Coordination Center – that helps federal law enforcement investigate and prosecute people who it thinks have violated some criminal intellectual property law.
The federal government puts out guidance for federal prosecutors who are prosecuting intellectual property crimes. This manual tells prosecutors what to look for in these cases and how to bring them.
In the cases we've seen, the primary law enforcement agency investigating these cases is ICE – Immigration and Customs Enforcement. Because so many of these cases involve cross-border transactions, Customs officers have access to a lot of information about the shipping aspects of these cases.
