In a significant move that could potentially impact the patent landscape in the United States, the Federal Trade Commission (FTC) has issued a policy statement regarding the listing of pharmaceutical patents in the Food and Drug Administration (FDA)’s Orange Book. The statement suggests that even in cases where there is no ongoing litigation over patent infringement, the FTC could still conduct inquiries into the listing of patents.
As outlined in the policy statement, the FTC’s new focus areas seem to be particularly geared towards enhancing competitive practices in the pharmaceutical industry. This could imply more rigorous scrutiny on the part of the FTC when pharmaceutical patents are listed in the FDA’s Orange Book, a move that could impact both patent holders as well as generics manufacturers.
While the specifics of this policy statement are yet to be analysed in depth, it is clear that FTC is keen to proactively address instances of potential anti-competitive behaviour in the pharmaceutical sector.
Legal professionals across corporations and law firms specializing in patent and competition law will need to adjust to this shift in policy to ensure compliance and mitigate potential risks.
Further information and analysis on the FTC’s policy statement can be found here.
This article is based on information provided by Dechert LLP.