Legal professionals practicing in corporate environments and international law firms must be wary of the recent policy statement issued by the US Federal Trade Commission (FTC). In view of an escalating drive against anticompetitive practices, the FTC has made its intentions clear towards those entities that improperly enlist patents in the Orange Book.
As outlined by Cooley LLP, the recent FTC policy statement serves a dual purpose. Firstly, it provides relevant market players a cautionary warning that the FTC is approaching Orange Book listings with an added level of scrutiny. Secondly, the FTC confirmed that it won’t hesitate from taking appropriate measures against companies and individuals who manipulate the Orange Book listings in a malintended fashion. Read the full discussion on JDSupra.
The Orange Book, officially known as Approved Drug Products with Therapeutic Equivalence Evaluations, is crucial for pharmaceutical companies. The book not only lists every drug that the US Food and Drug Administration believes to be safe and effective but also enlists patent information associated with these drugs. Improper exploitation of these listings could have far-reaching consequences on competition and the wider economy.
The FTC has been progressively active in its fight against antitrust violations. The recent policy statement can be seen as a further attempt to highlight its commitment towards minimising uncompetitive business practices and maintaining a healthy competitive landscape.
This active approach towards antitrust law enforcement might translate into a stepping-up of scrutiny for both domestic and international companies, and it is advisable that legal professionals dealing with intellectual property rights and antitrust law remain cognizant of these developments to anticipate any potential legal actions and adjust strategies as necessary.