Yesterday, the FDA published a draft guidance titled New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers (here). The guidance goes over the basics that we pretty much all know, like:

“An application may qualify for 3-year exclusivity if it is a 505(b) application or supplement to a 505(b) application:

  • for a drug, which includes an active moiety that has been approved in another 505(b) application (or, for a fixed-combination drug product where each of the active moieties were previously approved in another 505(b) application); and
  • that contains reports of new clinical investigations that are:

i. Not bioavailability studies;
ii. Essential to the approval of the application (or supplement); and
iii. Conducted or sponsored by the applicant.”

However, it also describes some scenarios with fact-specific issues that have evolved the FDA’s thinking over the course of almost forty-two years since the passage of Hatch-Waxman in 1984. The draft contains eighteen questions and answers on clarifying issues that fall into the following categories:

  • General Eligibility for 3-Year Exclusivity
  • New Clinical Investigations
  • Essential to Approval
  • Conducted or Sponsored by the Applicant
  • Process for Requesting 3-Year Exclusivity
  • Exclusivity Determination by FDA

 

It also includes an appendix titled New Clinical Investigation Exclusivity Request: Representative Language, which provides examples of the language that the FDA wants to see in an application when requesting three-year market exclusivity and where in the application it should go. The draft guidance opens the kimono on the who and how of the FDA making decisions on the award of three-year exclusivity and also when you can expect a decision to be made.

While we all likely have good general working knowledge regarding three-year Hatch-Waxman market exclusivity, there are a number of issues identified in the guidance that have developed over time, based on either court decisions or unique situations that have informed the FDA’s policy in this arena, some of which are discussed in the section on New Clinical Investigations. For instance, the following questions provide insight into the current FDA thinking on two rather esoteric issues and they are fact-specific:

  • QB.5: “Could an investigation assessing both PK/bioavailability and clinical safety and/or effectiveness qualify as a clinical investigation for 3-year exclusivity?
  • QB.8: “When a study involves multiple cohorts or treatment arms, could an investigation of a cohort or treatment arm qualify as a new clinical investigation when the results of at least one different cohort or treatment arm were previously relied on for approval of an application?”

 

The Hatch-Waxman exclusivity draft guidance thus provides both a general tutorial on three-year market exclusivity as well as an outline of other complex scenarios that impact the award of this form of exclusivity. Please pay particular attention to the footnotes in the document as they provide some insight into how three-year Hatch-Waxman exclusivity policy has evolved. This is an important read and worth the time spent. I bet that everyone, including those who have a healthy understanding of Hatch-Waxman’s three-year market exclusivity provisions, will have a moment while reading the document when they say, “Well, I didn’t know that!”