In Law360, Attorneys Examine FTC’s Criticism of “Junk” Orange Book Filings

In a Law360 article, attorneys examined the Federal Trade Commission criticism of so-called “junk” Orange Book listings as a way to focus on regulating drug prices. Over the past nine months the FTC has filed amicus briefs in numerous private litigations, asserting that improper Orange Book listings thwart competition, including one in support of Amneal Pharmaceuticals in the Teva Pharmaceutical litigation. The FTC also has issued ‘warning letters’ against over 400 patents that the agency disputes as improperly listed in the Orange Book.

The authors note that during this time of heightened FTC scrutiny on perceived high drug prices, pharmaceutical companies should assess potential risk posed by their listed patents, and if possible from a legal or commercial perspective, take steps to mitigate attendant risks.

Beyond the risk of an FTC dispute or investigation of an Orange Book listing, the FTC warning letters have prompted Congressional inquiries and inspired private action relating to these allegedly improper listings. Given high stakes on this issue, branded manufacturers should pay particular attention to auditing current and future statutory compliance of their Orange Book listings, particularly those relating to medical devices.

The article was authored by life sciences and IP transactions partner David McIntosh, antitrust partner Jacqueline Grise, IP litigation counsel Rachael Bacha and IP transactions associate Lauren Kimmel.