This browser is not actively supported anymore. For the best passle experience, we strongly recommend you upgrade your browser.
| 2 minutes read

FTC's New Orange Book Listing Complaints Target Drug Delivery Device Patent Issue That FDA Has Ignored For Years

The Federal Trade Commission (FTC) is at it again, jumping into the Food and Drug Administration's sandbox with a splashy press release announcing a volley of letters to ten pharma companies and a notice to the FDA, accusing the companies of illegally listing more than 100 pharmaceutical patents in the FDA's Orange Book. 

Some readers may understandably be scratching their heads about what business FTC thinks it has in policing FDA's Orange Book patent listing issues, especially in light of the Commission's prior failure to persuade the Supreme Court that “reverse payment” settlements involving Orange Book listed patents were presumptively unlawful (FTC v. Actavis, Inc. (2013)).  However, a closer look at the specific patents that FTC has challenged reveals a fascinating plot twist: all of the patents identified by FTC relate to drug delivery devices for products such as asthma inhalers, eyedrops, and auto-injector products. 

As Hatch-Waxman practitioners may recall, this particular issue of listing patents on drug delivery devices is one where industry has, for nearly 20 years, genuinely, meaningfully, and repeatedly sought clarity and guidance from the FDA, but to no avail. Indeed, multiple drug companies, as early as 2005, have filed Requests for Advisory Opinions with FDA, respecting the listing of patents that claim a pre-filled drug delivery device or components thereof. Given the complexity and uncertainty of the issue, some of the requesters specifically informed FDA that they would continue to list such patents “unless the company receives guidance from FDA that such listings are improper.”  This disclaimer approach has been used by other pharma companies in specific patent listing submissions for many years.

However, those industry requests for guidance went unanswered by FDA until 2020, when FDA finally issued a consolidated response letter that did not actually address or resolve the substantive questions. Rather, the FDA stated that it had “determined that the issues raised should be examined as part of a broader effort to seek comment on the subject of patent listings in the Orange Book,” and thus opened a new public docket for comments on these and other issues. Then, in 2021, the President signed the Orange Book Transparency Act, which requires FDA “to solicit public comments regarding the types of patent information that should be included in, or removed from, the Orange Book.” Thus, FDA re-opened its 2020 docket, received additional public comments, and in a 25-page report to Congress announced that after nearly 20 years of uncertainty and lack of FDA policy on Orange Book listing of drug delivery patents, the agency determined that – it will keep thinking about it! Specifically, FDA told Congress that it "will create a multidisciplinary working group within the Agency. This working group will evaluate whether additional clarity is needed regarding the types of patents, patent information, or other patent-related information that should be included in, or removed from, the Orange Book.” 

In light of the foregoing, it would be Kafka-esque for FTC to seriously seek to take enforcement action against companies that, in light of longstanding regulatory uncertainty, have in good faith listed drug delivery device patents in the Orange Book. Thus, rather than a direct attack on the drug industry, FTC's latest action can arguably be seen as a sign of internecine warfare between agencies -- a shot across the bow of FDA telling it that two decades of dawdling on this issue is long enough, and if something isn't done soon, FTC may take steps that would force the courts to intervene and make the decision for them. 






life sciences, fda regulatory & compliance, patents