289 Pages of Pure Hatch-Waxman Joy

The FDA pre-published a Final Rule (here) today implementing Title XI of the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003.  FDA has been regulating directly from the statute since 2003 and now (based on various court decisions and FDA’s experience) has finalized implementing regulations for portions of the Act some 13 years after passage.

FDA goes on to say “[T]his final rule implements portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. This final rule also amends certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.”

The Regulations will become effective 60 days from date of publication in the Federal Register (FR) which should be October 6, 2016.

The Rule addresses, among other things, limits on 30-month stays, provides direction relative to NDA holder’s description of the use codes they list in the Orange Book to help prevent overly broad descriptions that have a tendency to delay approval of generics by unnecessary litigation, and will help facilitate implementation of the “carve out” provisions of the regulations that permit a 505(b)(2) applicant or ANDA applicant to carve out certain protected uses of a product from its approved labeling.

Some of the Final Rules major provisions include:

  • “Expanding the category of untimely filed patent information to include certain amendments to the NDA holder’s description of the approved method(s) of use claimed by the patent, if such changes are not submitted: (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. This revision to our regulations is intended to reduce delays in approval related to overbroad or ambiguous patent use codes.” This is a big change and may ultimately be challenged in court.
  • FDA is “clarifying and improving the procedures that govern challenges to the accuracy or relevance of the NDA holder’s submission of patent information to the Agency. These procedures allow a person (including a 505(b)(2) or ANDA applicant) to request, for example, that an NDA holder confirm that a previously submitted use code complies with current requirements. We are establishing a 30-day timeframe in which the NDA holder will be required to substantively respond to the patent listing dispute and verify the accuracy and completeness of the response.”
  • FDA is “revising our regulations to clearly delineate the two limitations on the timeframe within which notice of a paragraph IV certification can be provided to the NDA holder and each patent owner: (1) The date before which notice may not be given (reflecting FDA’s longstanding practice regarding premature notice) and (2) the date, established by MMA, by which notice must be given to be considered timely.” 505(b)(2) applicants must send notice on or after the date upon which NDA has been filed and ANDA holders must file notice on or after the date that FDA has officially “received” the ANDA acknowledgement that the application is sufficiently complete to permit a substantive review.
  • FDA is “establishing a date (the first working day after the day the patent is published in the Orange Book) before which an ANDA applicant cannot send valid notice of a paragraph IV certification to a newly listed patent. Notice of a paragraph IV certification that has been sent prematurely is invalid, and will not be considered to comply with the FD&C Act’s notice requirement. This approach is intended to promote equity among ANDA applicants seeking eligibility for 180-day exclusivity and to reduce the burden on industry and FDA associated with serial submissions and multiple notices of paragraph IV certifications related to a newly issued patent.”
  • FDA is codifying and “expanding the acceptable methods of sending notice of a paragraph IV certification beyond registered or certified mail to include “designated delivery services.” This reduces the burden on 505(b)(2) and ANDA applicants who currently must submit requests to the Agency to send notice by common alternate delivery methods.”
  • FDA is “clarifying and augmenting the patent certification requirements for amendments to 505(b)(2) applications and ANDAs to ensure that certain types of changes to the drug product are accompanied by an appropriate patent certification (or recertification) or statement. An appropriate patent certification (or recertification) or statement is required to accompany an amendment to add a new indication or other condition of use, to add a new strength, to make other-than-minor changes in product formulation, or to change the physical form or crystalline structure of the active ingredient.”
  • FDA is “requiring a 505(b)(2) applicant to identify one pharmaceutically equivalent drug product approved in an NDA, if one or more is approved before the original 505(b)(2) application is submitted, as a listed drug relied upon, and comply with applicable regulatory requirements. This is intended to help ensure that the 505(b)(2) pathway is not used to circumvent the statutory patent certification obligations that would have applied if the proposed product could have been approved in an ANDA.”

There are lots more where this comes from but I think this is enough for one day. Enjoy and if you need to make engrossing party conversation this weekend, be sure to print out a copy of the Final Rule and take it with you – you will be the hit of the party, for sure!