Enhancements

Enhancement to the Paragraph IV Database to Aid Generic Applicants and Provide Greater Transparency

Having lived through the days at FDA when sponsors called the FDA asking if anyone had submitted a Paragraph IV patent challenge for a specific drug and was thus potentially eligible for 180-day exclusivity as being a first-to-file applicant, the move to the PIV database was a godsend as it took the pressure off us FDAers having to skirt the answers to these inquiries for fear of providing confidential information about an ANDA submission.  Finally, the PIV database provided industry a place where they could see the date upon which the first ANDA with a PIV certification was submitted.  While it did not tell who or how many ANDAs were submitted on that prized first day, it let folks know that at least someone was
in-house and the date after which eligibility no longer could be gained.

In an FDA announcement issued yesterday (here) the FDA announced some enhancements to the PIV database to make it more transparent and provide additional information that could aid future applicants make submission and filing decisions.

The notice states:

One area we have identified to help spur investment in generic drug development is the availability of resources that may help applicants predict when their application may be able to receive final approval and when they may begin marketing their product ‒ providing patients timelier access to high-quality, lower-cost medicines.  As a result, today we are enhancing one of the Agency’s most viewed databases for industry, the Paragraph IV Patent Certifications List, which provides information about exclusivity related to generic challenges of patents on “brand” drug products (180-day exclusivity).

So here are the enhancements.  The FDA will be:

  • “sharing the number of applicants that are potentially eligible for 180-day exclusivity. This information may inform other generic manufacturers’ decisions on whether to develop a generic drug for that product.  These new data fields will be included for any drug products that are the subject of ANDAs with Paragraph IV patent certifications, beginning today.”
  • providing the dates that 180-day exclusivity has expired or has been forfeited.
  • providing information about the dates of first approval, marketing status and expiration dates of blocking patents.

FDA notes that “[O]ne area we have identified to help spur investment in generic drug development is the availability of resources that may help applicants predict when their application may be able to receive final approval and when they may begin marketing their product ‒ providing patients timelier access to high-quality, lower-cost medicines.”  These enhancements are designed to further that goal by providing additional information to factor into industry decisions.

FDA also noted that they will, in the near future, further outline the process by which they deal with a first applicant’s final approvals where a subsequent court action finds the patent is infringed by the applicant.  This typically occurs in a post-30-month clock period after which the Agency may approve an ANDA while the litigation continues but before a final court decision is made on the infringement issue.  The Agency plans to clarify the process where it rescinds approval and converts the application to tentative approval status until the patent expires.

These enhancements will permit the industry to make more informed submission and marketing decisions.