For years, the debate as to when an amendment to an ANDA or a 505(b)(2) application had to include a new patent certification raged on, and, at times, was handled on a case-by-case situation if it was noticed at all. Even when I was at the Agency – when dinosaurs walked the face of the earth- there was disagreement among staff as the when such amendments required new patent certifications or little viii statement. But now, as explained in a great post by Kurt Karst, Director, at Hyman, Phelps & McNamara (here), the requirements are clear, the December 5, 2016 effective date of the FDA’s Final Rule of October 6, 2016 implementing certain provisions of the Medicare Modernization Act have kicked in and FDA is watching closely for compliance.
I won’t get into any of the fine detail because Kurt has laid it all out very well in his blog post, but only to say that even if a new patent certification or little viii statement is not required, FDA demands that each amendment must contain a verification statement (which can be in the cover letter) that the amendment is not one of the four types of amendments (see below) which require a new certification or little viii statement
(i) To add a new indication or other condition of use;
(ii) To add a new strength;
(iii) To make other than minor changes in product formulation; or
(iv) To change the physical form or crystalline structure of the active ingredient
Please read Kurt’s post carefully and be certain to follow the advice provided therein – “Remember to incorporate the verification in any template correspondence for an ANDA amendment” – to avoid any delay in the review or acceptability of the amendment.