Earlier this month, the FDA published a final rule that updates the requirements for ANDA submissions under section 505(j) of the Food, Drug, and Cosmetic Act (“FDCA”) and NDA submissions under section 505(b)(2) of the FDCA. The new rule takes effect on December 5, 2016, and the following is an overview of the most important takeaways.
Timing of Paragraph IV Certification Notice: Under the new rule, ANDA applicants may not provide notice of a paragraph IV certification to the NDA holder until “the first working day after the day the patent is published in the Orange Book.” The FDA reasoned that “serial submissions” of paragraph IV certifications to secure ANDA first-filer status and the associated 180-day marketing exclusivity are overly burdensome to the FDA and NDA holders. According to the FDA, limiting the notice period in this manner creates a level playing field for all ANDA applicants.
Further, the FDA specified that paragraph IV certification notice must be sent no later than twenty days after the postmarked date of the paragraph IV acknowledgment letter.
Supplemental Patent Certifications: The new rule requires unapproved follow-on applicants to submit a patent certification or recertification for an amendment to its application for any amendment (1) to add a new indication or other condition of use; (2) to add a new strength; (3) to make other than minor changes in product formulation; or (4) to change the physical form or crystalline structure of the active ingredient.” The new rule does not apply to approved follow-on applicants.
“Relied Upon” Drugs: The new rule clarifies that a follow-on applicant must identify a pharmaceutically equivalent drug product approved in an NDA as a “relied upon” drug if the drug product was approved before the date of the submission of the original 505(b)(2) application. If more than one drug product meets this criterion, the follow-on applicant need only identify one pharmaceutically equivalent drug product as relied upon.
Use Code Submissions and Amendments: In the preamble of the new rule, the FDA clarified that NDA holders must identify individual patent claims for method-of-use patents in order to assist follow-on applicants in determining whether a listed patent claims a use for which a follow-on applicant is seeking approval. Thus, each claim of a pending or approved method-of-use patent must be separately identified on the submission form.
The new rule further requires that “if the scope of the method-of-use claim(s) of a patent does not cover an indication or other approved condition, of use in its entirety, then the applicant must describe only the specific approved method of use claimed by the patent for which a claim of patent infringement could reasonably be asserted.” This provision leaves open for interpretation the extent of the NDA holder’s responsibility to predict the patent infringement claims a follow-on applicant could reasonably assert.
The FDA also clarified the timing of submission of use code amendments. Under the new rule, an NDA holder’s amendment to the description of the approved method(s) of use claimed by a patent will be considered untimely filed if it is submitted (1) more than 30 days after patent issuance and it is not related to a corresponding change in approved product labeling or (2) more than 30 days after a corresponding change in approved product labeling.
Use Code Disputes: The FDA declined to adopt new regulations for resolving disputes between NDA holders and follow-on applicants regarding Orange Book use codes of method-of-use patents. The proposed rule outlined a process by which follow-on applicants could dispute a use code by contacting the FDA with the grounds for disagreement. The NDA holder could then argue the correctness of the code. Additionally, if there was insufficient evidence to support the correctness of the code, the FDA would review any proposed labeling carve-outs with deference to the follow-on applicants.
In the final rule, however, the FDA explained it would “take a stepwise approach and evaluate whether [its] revisions to the regulations on . . . patent listing dispute procedures adequately address the problem of overbroad and ambiguous use codes before [it] establish[es] a process to review a proposed labeling carve-out with deference to the [follow-on applicants’] interpretation of the scope of the patent.”
Effective Date: These rule changes go into effect on December 5, 2016.