According to the National Law Review, the number of patent infringement disputes filed annually at the U.S. International Trade Commission (ITC) has more than tripled over the last 20 years. While this is not limited to medical devices, it certainly contains a good number of them. In a field where new innovations bring plenty of recognition, praise and good money, it is important to keep intellectual property safely under wraps. Medical device patents are not a new phenomenon, but with the growing number of suits, it is important to protect medical technology from the beginning.
According to Section 337 of the Tariff Act of 1930, U.S. intellectual property owners can seek exclusion orders that do not allow the importation of articles that infringe their patents or other intellectual property rights. If the case is won, the infringing product will not be allowed to cross the border into U.S. territory.
In order to prove a patent suit, the complaint must contain four things, according to the International Trade Commission Trail Lawyers Association:
- That articles are being imported into the United States
- That those articles infringe complainant’s patent or patents
- That the complaining company or its licensee has made sufficient economic investments in exploiting its patent in the United States to satisfy section 337’s definition of a “domestic industry”
- That the alleged unfair act has caused or threatens to cause injury