Summary of the changes

On October 6, 2016, FDA published a Final Rule in the Federal Register to implement and amend certain regulations regarding the MMA. These changes will go into effect on December 5, 2016. In addition to proposed definitional changes, the FDA’s summary of major provisions highlights revisions of requirements to submit patent information regarding (1) patents that claim the drug substance and/or drug product and meet the requirements for patent listing on that basis; (2) drug substance patents that claim only a polymorph of the active ingredient; and (3) certain NDA supplements.

This client alert discusses certain aspects of FDA’s Final Rule, but is not intended to be a discussion of all of the rule’s changes. Clients should consult counsel with any particular questions or circumstances and how the new rules impact those issues.

Executive Summary

The Final Rule implements portions of Title XI of the MMA and revises FDA’s regulations relating to the requirements for submission and approval of 505(b)(2) applications and Abbreviated New Drug Applications (“ANDA”). FDA has been implementing the MMA directly from the statute and now FDA is revising its regulations to implement portions of the MMA that relate to 30-month stays and other matters not related to forfeiture of 180-day exclusivity. FDA currently implements the 180-day exclusivity provisions of the MMA directly from the statute and will continue to do so. FDA will determine at a later time whether additional rulemaking is necessary with respect to the 180-day exclusivity provisions of the MMA.

The Final Rule codifies many FDA policies and current practices developed while implementing the MMA. For example, FDA is revising the regulations (i) codifying the types of court decisions and other actions that will terminate a 30-month stay of approval on a 505(b)(2) application or ANDA, (ii) codifying its longstanding requirement that the NDA holder’s description of the patented method of use required for publication in the Orange Book must contain adequate information to assist FDA and 505(b)(2) and ANDA applicants in determining whether a listed method-of-use patent claims a use for which the 505(b)(2) or ANDA applicant is not seeking approval, (iii) codifying its current interpretation of the MMA’s prohibition on submitting an amendment or a supplement to seek approval of: (1) “[A] drug that is a different drug” than the drug identified in the original 505(b)(2) application; or (2) “a drug referring to a different listed drug” than the drug cited as the basis for ANDA submission, (iv) codifying its practice that permits an applicant to amend or supplement an ANDA to seek approval of a different strength of the drug, (v) codifying its current practice of considering the nature (e.g., major or minor) of the deficiencies, including the number of deficiencies in the ANDA, in determining whether an ANDA is incomplete on its face, and (vi) codifying existing practice permitting the use of scientifically valid methods for assessing bioavailability and bioequivalence.

Other provisions clarify the requirements for submission dates of patent information provided by an NDA holder, amendments to patent information, patent listing disputes, timing and submission of paragraph IV certifications, methods of sending notice of paragraph IV certifications, amending a paragraph IV certification, amending and supplementing an ANDA, and commercial marketing.

By implementing the Final Rule, the FDA intends to reduce unnecessary litigation, reduce delays in the approval of 505(b)(2) applications and ANDAs that are otherwise ready to be approved, and provide business certainty to both brand name and generic drug manufacturers.

Impact of the Final Rule

The Final Rule streamlines requirements relating to the content and timing of the submission of patent information as well as the timeframe for providing notice of a paragraph IV certification. Although the Final Rule codifies many existing FDA policies, both NDA holders and ANDA applicants should review the rules closely to make sure they are in compliance with the new provisions.

For example, an NDA holder must make sure its use codes describe only the specific approved method of use claimed by the patent. Untimely filed patent information such as untimely filed patents and certain amendments to the NDA holder’s description of the approved method(s) of use claimed by the patent will not delay approval of a pending 505(b)(2) application or ANDA until patent expiration. Thus, NDA holders must make sure they are in compliance with the rules and file required patent information (1) within 30 days of patent issuance; (2) within 30 days of approval of a corresponding change to product labeling; or (3) within 30 days of a decision by the U.S. Patent and Trademark Office (USPTO) or a Federal court that is specific to the patent and alters the construction of a method-of-use claim(s) of the patent. These revisions are intended to reduce delays in approval related to overbroad or ambiguous patent use codes.

ANDA applicants will have an improved mechanism to challenge the accuracy or relevance of the NDA holder’s submission of patent information. The Final Rule allows an ANDA applicant to request that an NDA holder confirm that a previously submitted use code complies with current requirements. An NDA holder has a 30-day timeframe in which it will be required to substantively respond to the patent listing dispute and verify the accuracy and completeness of the response. NDA holders will also be required to correct or change patent information if (1) the patent or patent claim no longer meets the statutory requirements for listing; (2) the NDA holder is required by court order to amend patent information or withdraw a patent from the list; or (3) the term of a listed patent is extended under patent term restoration provisions.

ANDA applicants must also make sure they are in compliance with the revised regulation concerning the timeframe within which notice of a paragraph IV certification can be provided to the NDA holder and each patent owner. An ANDA applicant cannot send valid notice of a paragraph IV certification before the NDA holder’s patent is listed in the Orange Book. Notice of a paragraph IV certification that has been sent prematurely is invalid. This provision is intended to promote equity among ANDA applicants seeking eligibility for 180-day exclusivity.

The Final Rule also clarifies that the statutory 30-month stay begins on the later of the date of receipt of notice of paragraph IV certification by any owner of the listed patent or by the NDA holder. This codifies FDA’s current practice and will ensure that each patent owner or NDA holder will receive the full statutory 30-month stay.