Have You Finished Reading the Proposed 505(b)(2) / ANDA Rule? Yeah, Right!

Just to help you out a bit, here are some additional issues to pay attention to in the Proposed Rule. It may be time for your firm to comment, especially if you don’t like them.

Amending a Paragraph III or IV Certification After Patent Expiry

FDA explains that applicants have (in many instances) failed to revise their patent certification after the patent on a product has expired.  The FDA expectation is that the applicant will amend the certification to a Paragraph II certification, indicating that the patent has expired.  Historically, in many instances, FDA has requested the applicant to amend its certification. “Accordingly, we [FDA]are proposing to codify our longstanding position that if an applicant that previously submitted a paragraph III certification, a paragraph IV certification, or a statement under section 505(b)(2)(B) or (j)(2)(A)(viii) of the FD&C Act with respect to a listed patent fails to amend its patent certification to a paragraph II certification upon patent expiration, the Agency will consider the 505(b)(2) or ANDA applicant to have constructively changed its patent certification to a paragraph II certification.”

No Requirements to Amend Patent Certification After Approval of (b)(2) or ANDA

FDA is “proposing to revise §§ 314.50(i)(6)(iii) and 314.94(a)(12)(viii)(C) to technically correct, but not substantively change, the reference to the lack of a requirement to “amend” a submitted patent certification after approval of a 505(b)(2) application or ANDA, respectively.  We are proposing to correct this statement to indicate that an applicant is not required to submit a supplement solely to change a submitted patent certification after approval of the application.  This revision also reflects that any changes to an application after approval would be made in a supplement to the application and not in an amendment, as the current regulation describes.”

Patent Certifications in Amendments and Supplements to (b)(2) or ANDA Applications

Applicants are required to submit new patent certifications in amendments for the following changes to applications:

  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.

“If an applicant submits an amendment to a 505(b)(2) application or ANDA for any of the categories of changes described in these provisions and does not submit a new patent certification, the applicant will be required to verify that the proposed change described in the amendment is not the type of change for which a new patent certification is required (e.g., the proposed formulation change meets the criteria for a “minor” formulation change).” FDA is requesting comments on this proposal.

As far as patent certifications for supplements, FDA is requiring applicants to make a new patent certification to:

  1. To add a new indication or other condition of use or
  2. To add a new strength.

“FDA is not proposing to require a patent certification with a supplement to change the formulation or to change the physical form or crystalline structure of the active ingredient of a product approved in a 505(b)(2) application or ANDA. It is not necessary for FDA to use its limited resources to require patent certifications under these circumstances because the NDA holder for a listed drug and any patent owner can monitor postapproval changes in the formulation or active ingredient of a marketed drug product and address any patent-related concerns without the involvement of FDA. With respect to NDA supplements, it should be noted that these patent certification requirements apply to 505(b)(2) supplements, irrespective of whether the original application to which the supplement was submitted was approved as a stand-alone 505(b)(1) application or a 505(b)(2) application.”

Well, hold on to your hats on this provision as I am certain we will see a number of comments on this proposal.

Keep watching for additional posts on the Proposed Rule.  We are a little over halfway through the document.  It sure makes for good reading and it will likely make for some interesting industry comments once its provisions are fully realized.