The Orange Book Transparency Act (the Act), signed into law on January 5, 2021, was intended to help ensure that the Orange Book–the resource managed by FDA that provides information to the public on certain patents and regulatory exclusivities for approved pharmaceuticals—is accurate and up-to-date. Among other things, the Act specifies what information must be submitted to the FDA, what patent information should be listed and when patents should be delisted—most particularly after a determination they are invalid. The Act largely codifies existing regulations but, despite its name, fails to provide certainty as to whether device patents should be submitted for listing in the Orange Book.
Types of Patents to be Listed:
The Act makes clear that the only types of patents that are to be listed in the Orange Book are drug substance (active ingredient) patents, drug compound (formulation or composition) patents and approved methods of use patents. Although these requirements are not new, the Act affirmatively states that patents that are not drug substance patents, drug compound patents and approved methods of use patents should not be listed. To date, FDA’s role has always been ministerial as it does not independently evaluate whether the patents submitted by the NDA applicant are properly listed and relies solely on the NDA applicant’s submission. Nonetheless, the best practice for applicants is to comply with the statutory mandate when identifying patents to be submitted.
Patents that Must be Timely Delisted:
The Act further codifies FDA regulations regarding the delisting of patents. In particular, the Act requires NDA applicants to amend or withdraw within 14 days any claim of a patent that has “been cancelled or invalidated pursuant to a final decision issued by the [PTAB] or by a court, from which no appeal has been, or can be taken.” While this has always been the case, numerous litigants have had to deal with an NDA/patent holder who fails or refuses to delist patents found invalid. The expectation is that this codification will bolster any challenges that need be made to ensure timely delisting. Of note, however, this provision of the Act only applies to invalidity decisions issued after the date of enactment.
Uncertainty as to Device Patents:
The Act fails to provide certainty as to whether device patents that are associated with approved pharmaceuticals should be listed in the Orange Book. In the past, where a delivery device is relied upon to administer a drug substance to a patient, questions have arisen as to what patents are appropriate for listing in the Orange Book. Often if a delivery device patent also includes as part of its claims the drug substance (e.g., “A metered dose inhaler including drug substance X”), the patent is listed in the Orange Book as the patent being submitted claims the finished dosage form of the approved product. Some NDA applicants have also listed patents in the Orange Book that protect the drug delivery device, per se, where the patent is silent on the drug being delivered.
However, the Act fails to address the question of whether a patent that cannot easily be classified as a drug substance, drug product or a method of use should be listed in the Orange Book. Prior to enactment of the Act, FDA failed to provide clear direction and, as a result, NDA applicants often took the position that the law required the submission of such ambiguous patents for listing. As a matter of practice, NDA applicants commonly submitted device patents for listing in the Orange Book.
Accordingly, NDA applicants are likely to continue to exercise their own discretion on whether to submit device patents for listing in the Orange Book. As a general guideline, a patent claim that has specific language linking the device to the approved drug substance is more likely to accord with the statutory mandate. By comparison, a patent claim that only protects the device or its components without any linkage to the drug substance or drug product is less likely to fall within the scope of patents that are permitted to be listed.
Subsequent Review and Reporting:
Implicitly acknowledging the uncertain status of device patents, the Act requires the FDA within one year of enactment to solicit public comments on the types of patent information that should be included (or removed) and to report to Congress a summary of such comments and actions the FDA is considering taking in response to the public comments. The Act further requires the Comptroller General of the United States to issue a report within two years of enactment on drug/device patents, including recommendations on what types of drug/device patents should be listed and which ones should not be listed. While the FDA’s report and the Comptroller General’s findings remain to be seen, further legislation in this area is possible. Pharmaceutical companies with products that utilize device would be well served to monitor the situation for further developments.
For more information about the status of pending legislation and how it may affect business opportunities for pharmaceutical companies, please contact the authors or your Polsinelli attorney.