FDA recently issued a draft guidance clarifying its interpretation of certain Hatch-Waxman provisions that were enacted as part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (the “MMA”). Among the most important of the “clarifications” are the following:

1. the availability of a 30-month stay of approval on an ANDA or 505(b)(2) application;
2. notice requirements pertaining to a paragraph IV certification; and
3. the 180-day exclusivity period awarded to the first submitter of a substantially complete ANDA containing a paragraph IV certification.

Each of these provisions is discussed below.

Applicability of 30-Month Stay. In the MMA, Congress required FDA to define the term “listed drug” for purposes of the MMA provisions prohibiting an applicant from amending or supplementing an ANDA to seek approval of a drug referring to a different listed drug from that identified in the original application.

FDA notes that where the Orange Book identifies a separate listed drug with the characteristics for which the applicant is seeking approval, the applicant should submit a separate ANDA for that product. Thus, where an ANDA applicant makes changes to its product that cause it to differ from the original listed drug (e.g., different active ingredient, dosage form, route of administration), such a change triggers the requirement for submission of a new ANDA rather than an amendment or supplement. The sole exception noted is that a new ANDA is not required for approval of a strength different from that covered in the initially submitted ANDA.

This clarification became necessary because the MMA amendments limited the 30-month stay to only those “patents submitted to FDA before the date on which the ANDA [or 505(b)(2)] (excluding an amendment or supplement to the application) was submitted.”

Notice of Paragraph IV Certifications. The guidance also clarifies that all Paragraph IV certifications must comply with notice provisions, regardless of whether the ANDA is eligible for a 30-month stay. The MMA requires that if the certification is included in the original ANDA, notice must be provided not later than 20 days after the date of the postmark on the notice from FDA confirming that the application has been filed. If the Paragraph IV certification is contained in an amendment or supplement to an application, the applicant must provide notice at the time of the submission of such amendment or supplement.

Triggers for 180-day Exclusivity. Prior to the passage of the MMA, the 180-day exclusivity period awarded to the first to file a substantially complete ANDA containing a Paragraph IV Certification was triggered by the earlier of the first commercial marketing of the ANDA drug or a court decision finding the patent at issue to be invalid or not infringed. The FDA guidance clarifies the MMA changes to this as follows:

1. Paragraph IV ANDAs. For ANDAs filed after December 8, 2003, if no other ANDAs containing a paragraph IV certification for that listed drug were filed prior to December 8, 2003, a court decision no longer triggers the 180-day exclusivity period. Instead, the exclusivity period does not begin until the commercial marketing of the drug.
2. All other ANDAs. For ANDAs other than those described above, the 180-day exclusivity period can still be triggered by the earlier of commercial marketing or a court decision. However, if the exclusivity was not triggered prior to December 8, 2003, then the only type of court decision that can trigger the exclusivity is one from which no appeal has been or can be taken.

FDA is accepting written comments on the draft guidance until February 2, 2005.