As rising medication costs continue to burden patients and our healthcare system, the Food and Drug Administration (FDA) has undertaken a Drug Competition Action Plan[1] to streamline the Abbreviated New Drug Application (ANDA) process and encourage generic competition. As part of that initiative to facilitate utilization by ANDA applicants and application holders, FDA has issued a new Q&A Guidance regarding the Orange Book (OB) (Approved Drug Products with Therapeutic Equivalence Evaluations).[2] The Guidance addresses the content and format of the OB, petitioned ANDAs, product and patent listings and handling of discontinued products.
In addition to the Guidance, FDA has opened two dockets to solicit comments from healthcare providers, drug manufacturers, Federal and State health agencies, individuals involved in patent litigation (e.g., patent counsel), and any other interested parties, on how the OB, and specifically, the listing of patents can be improved.[3],[4] One docket poses a series of questions aimed at OB users and focuses on therapeutic equivalence information and its role in drug competition. The second docket focuses on whether the FDA should further evaluate or provide clarity on the types of patents which should be listed in the OB.
While NDA applicants file patent number and expiration dates with their applications and must keep the list current if additional patents are issued, FDA has not examined those patents but rather has played a ministerial role. After passage of the Hatch-Waxman Amendments, FDA indicated that only ingredient, formulation, certain NDA supplement, polymorph patents and method of use patents should be included in the OB. Process patents, method of use (non-FDA approved indications), packaging, metabolite/intermediate patents have been excluded.
Increasing complexities in NDA applications (e.g., drug-device combination products, complex delivery systems, associated digital applications such as clinical decision support software, REMS patents), have resulted in a lack of clarity and litigation as to the types of patents which should be listed in the OB. Where there is lack of clarity, the courts have filled the void. In Re Lantus Direct Purchase Antitrust Litigation[5], the court ruled that because of the FDA’s patent listing ambiguities, the patent for an insulin pen component was improperly listed. The improper listing will now be litigated in Federal District Court to determine if such listing, which restricted competition, ran afoul of antitrust scrutiny.
How Frier Levitt Can Help
Frier Levitt FDA attorneys have provided comments for FDA’s proposed Guidances, drafted legislation and filed Citizen Petitions to assist our industry, trade organization and pharmacy clients to amend FDA’s authorities. Comments on the Guidance and the two public dockets are due by August 31, 2020.
[1] https://www.fda.gov/drugs/guidance-compliance-regulatory-information/fda-drug-competition-action-plan.
[2] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orange-book-questions-and-answers-guidance-industry.
[3] 85 FR 33165-33167.
[4] 85 FR 33169-33173.
[5] No. 18-2086 (1st Cir. 2020).
