United States: FDA Issues Final Hatch-Waxman Regulations

The U.S. Food and Drug Administration (FDA) on October 6, 2016, finally issued a Final Rule to implement provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), entitled "Abbreviated New Drug Applications and 505(b)(2) Applications." A preliminary review of the Final Rule shows that it relates primarily to (1) patent certification notices to the patent owners and new drug application (NDA) holders of certain patent certifications by applicants submitting either abbreviated new drug applications (ANDA) or 505(b)(2) applications; (2) availability of 30-month stays of approval for ANDAs and 505(b)(2) applications that are otherwise ready for approval; (3) submission of amendments and supplements to ANDAs and 505(b)(2) applications; (4) notification of court actions or written consent to approval; and (5) notification of commercial marketing. The purpose of the Final Rule is to "reduce unnecessary litigation, reduce delays in 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 manufacturers." The Final Rule is meant to clarify and update the regulations based on recent court decisions and the FDA's own experience in implementing the statutory provisions related to approval of ANDAs and 505(b)(2) applications. The Final Rule is effective on December 5, 2016. We discuss key provisions below.

Patent Certifications and Notices

Patent Information Submissions

The Final Rule revises and streamlines requirements for submitting patent information on the patents relating to drug substances and/or drug products, relating only to a polymorph of an active ingredient and relating to NDA supplements.

More significantly, the Final Rule codifies the FDA's "longstanding requirement" that NDA holders publish method-of-use descriptions in the Orange Book that 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) and ANDA applicant is not seeking approval." Specifically, the Final Rule addresses overbroad and ambiguous use codes, requiring that where a patent claims methods of use that do not cover an approved indication or condition of use in its entirety, the NDA holder's use code relates only to the "specific approved method of use" for which a patent infringement claim could be asserted against the 505(b)(2) or ANDA applicant.

Timing of Patent Information Submissions

The FDA does not require an applicant with a pending ANDA or 505(b)(2) application to provide a patent certification to patents whose information is untimely filed with the FDA (i.e, patent information that has not been submitted to the FDA within 30 days of the issuance of the patent). The Final Rule expands the category of untimely filed patent information to include amendments to the NDA's description of approved method(s) of use if they are not submitted:

  1. within 30 days of the patent issuance;
  2. within 30 days of approval or 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 of the patent.

The Final Rule establishes that the submission date of patent information after approval "will be the earlier of the date on which Form FDA 3542 is date-stamped by the Central Document Room or officially received by FDA in an electronic format."

Correction or Change of Patent Information

With respect to requests that an NDA holder confirm that a use code complies with current requirements, the Final Rule establishes a 30-day period for the NDA holder to (1) substantively respond to the request and (2) "verify the accuracy and completeness of the response." For the time being, the FDA will "take an incremental approach and evaluate" whether these revisions to the regulations are sufficient to address overly broad and ambiguous use codes before determining "whether a process to review a proposed labeling carve-out with deference to the 505(b)(2) and/or ANDA applicant(s)' interpretation of the scope of the patent is also needed."

The Final Rule will also require correction or change of 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.

Timing of Notice of Paragraph IV Certifications

The Final Rule provides two limitations on the timing of Paragraph IV certifications.

First, a 505(b)(2) application must send notice of a Paragraph IV certification on or after the date on which the application is filed, but not later than 20 days after the date of the "postmark" on the Paragraph IV acknowledgement letter. An ANDA applicant must send notice of a paragraph IV certification on or after the date on which it receives a "[P]aragraph IV acknowledgement letter" from the FDA that its application is sufficiently complete to begin substantive review, but not later than 20 days after the date of the "postmark" on the Paragraph IV acknowledgement letter.

Second, the Final Rule establishes that an ANDA applicant may not send a valid notice of a Paragraph IV certification to a newly listed patent before the "first working day after the day the patent is published in the Orange Book." FDA will consider any notice sent prior to this date invalid and not in compliance with the notice requirement.

Content of Notice of Paragraph IV Certifications

Notice of a Paragraph IV certification must include at least:

  1. A statement that data from any required bioavailability or bioequivalence studies have been submitted;
  2. A statement that:

    1. the ANDA applicant has received the Paragraph IV acknowledgment letter for its ANDA; or
    2. the FDA has filed the 505(b)(2) applicant's NDA;
  3. the patent number and expiration date of each patent listed in the Orange Book that is the subject of the Paragraph IV certification; and
  4. an offer of confidential access, if the applicant seeks to preserve the option to file a civil action for declaratory judgment in accordance with section 505(c)(3)(D) and (j)(5)(C) of the Food, Drug, and Cosmetic Act (FD&C Act) (see proposed §§ 314.52(c) and 314.95(c)).

The notice must also cite section 505(b)(3)(D) and (j)(2)(B)(iv) of the FD&C Act, respectively, as amended by the MMA and include information described in section 314.52(c)(1) through (8) and section 314.95(c)(1) through (9).

Method of Notice of Patent Certifications

The Final Rule expands the acceptable methods of sending a notice of patent certification beyond registered or certified mail to include "designated delivery services," which include:

a delivery service provided by a trade or business that FDA determines: (1) Is available to the general public throughout the United States; (2) records electronically to its database, kept in the regular course of its business, or marks on the cover in which any item referred to in this section is to be delivered, the date on which the item was given to the trade or business for delivery; and (3) provides overnight or 2-day delivery service throughout the United States (see §§ 314.52(g)(1) and 314.95(g)(1)).

Therefore, ANDA and 505(b)(2) applicants are no longer required to submit requests to the FDA to send notice "by common alternate delivery methods."

Amended Patent Certification

The Final Rule requires that an ANDA or 505(b)(2) applicant submit an amendment to change its Paragraph IV certification to a Paragraph III certification or to a statement under section 505(b)(2)(B) or (j)(2)(A)(viii) if (1) a court enters a final decision of infringement from which no appeal has been or can be taken irrespective of whether the infringement action was brought within 45 days of receipt of a notice of Paragraph IV certification or (2) a court signs a settlement order or consent decree that includes a finding that the patent is valid and infringed, unless the final decision, settlement order or consent decree also finds the patent invalid. However, if settlement is reached without a finding of infringement or invalidity, then the Paragraph IV certification may be maintained.

When an NDA holder requests the removal of a patent or patent information from the Orange Book, an ANDA or 505(b)(2) applicant must submit an amendment to its application to withdraw certification to that patent upon removal of the patent or patent information from the list. However, the patent information will remain in the Orange Book until any 180-day exclusivity based on that patent has expired or been extinguished.

With respect to reissue patents, the FDA "now consider[s] reissued patents as separate and distinct from the original patent for purposes of administering the patent certification requirements of the FD&C Act and any 30-month stay approval or 180-day exclusivity." Therefore, "the date on which patent information on the reissued patent (and not the original patent) is submitted to the FDA determines whether a paragraph IV certification to the reissue patent could give rise to a 30-month stay if other criteria are met" and the "FDA evaluates eligibility for 180-day exclusivity based on whether the criteria are met for an original patent (irrespective of whether it subsequently is reissued) or for a reissued patent."

Patent Certification Requirements for Amendments

The Final Rule requires an appropriate patent certification/recertification or statement to accompany an amendment to (1) add a new indication or other condition of use; (2) add a new strength; (3) make other-than-minor changes in product formulation; or (4) change the physical form or crystalline structure of the active ingredient. At any time before approval, amendment to a patent certification is required if the applicant learns that previously submitted certification or statement is no longer accurate.

30-Month Stays of Approval

When the 30-Month Stay Begins

The Final Rule reflects the MMA's limitation on multiple 30-month stays for ANDA and 505(b)(2) applications. Specifically, the Final Rule clarifies that "the statutory 30-month stay begins on the later date of receipt of notice of paragraph IV certification by any owner of the listed patent or by the NDA holder (or its representative(s))."

Federal District Court Decisions and 30-Month Stay

The Final Rule also provides that if a federal district court decides a patent is invalid, unenforceable or not infringed (including a finding that there is no cause of action for patent infringement or invalidity) before the expiration of the 30-month stay, the ANDA or 505(b)(2) application "may be approved on the date on which the court enters judgment reflecting the decision pursuant to Federal Rule of Civil Procedure (Fed. R. Civ. P.) Rule 58. An ANDA or 505(b)(2) application may also be approved on "the date of a settlement order or consent decree signed and entered by the court stating that the patent that is the subject of the certification is invalid or not infringed." In addition, a federal district court's finding that a patent is unenforceable may terminate a 30-month stay.

However, if the federal district court's decision of infringement is appealed before the expiration of the 30-month stay, an ANDA or 505(b)(2) application may be approved on:

(1) The date on which the mandate is issued by the court of appeals entering judgment that the patent is invalid or not infringed or (2) the date of a settlement order or consent decree signed and entered by the court of appeals stating that the patent that is the subject of the certification is invalid or not infringed.

If a federal district court's decision of infringement is not appealed or is affirmed on appeal before the expiration of the 30-month stay, an ANDA or 505(b)(2) application "may be approved no earlier than the date specified by the district court in an order under 35 U.S.C. 271(e)(4)(A)."

If a preliminary injunction is entered before the expiration of the 30-month stay, the stay is extended until the court decides whether the patent is valid and/or infringed. With respect to timing of approval:

  • If a preliminary injunction is entered before the expiration of a 30-month stay (or 7˝ years where applicable) and the Federal district court later decides that the patent is invalid, unenforceable or not infringed, the 505(b)(2) application or ANDA may be approved as provided in § 314.107(b)(3)(ii) (see § 314.107(b)(3)(v)(A) and section 505(c)(3)(C)(iii) and (j)(5)(B)(iii)(III) of the FD&C Act).
  • If a preliminary injunction is entered before the expiration of a 30-month stay (or 7˝ years where applicable) and the Federal district court later decides that the patent is infringed, the 505(b)(2) application or ANDA may be approved as provided in § 314.107(b)(3)(iii) or (iv), whichever is applicable (see § 314.107(b)(3)(v)(B) and section 505(c)(3)(C)(iv) and (j)(5)(B)(iii)(IV) of the FD&C Act).

If a court order is issued terminating the 30-month stay, the ANDA or 505(b)(2) application may be approved in accordance with the court's order.

Additionally, the 30-month stay "will be terminated if the court(s) enter(s) an order of dismissal without a finding of infringement in each pending suit for patent infringement brought within 45 days of receipt of the notice of paragraph IV certification sent by the 505(b)(2) or ANDA applicant."

Written Consent to Approval by Patent Owner or Exclusive Licensee

Should the patent owner or the exclusive patent licensee agree in writing that the ANDA or 505(b)(2) application be approved, the 30-month stay would be terminated and the application may be approved on or after the date of consent.

Amendments and Supplements

The Final Rule prohibits submitting an amendment or supplement for: "(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." Parallel restrictions are also provided on submission of certain types of changes in an amendment or supplement to an ANDA or 505(b)(2) application.

Notification of Court Actions or Written Consent to Approval

The Final Rule expands the scope of documents that must be submitted to the FDA regarding court actions and settlements. Specifically, the FDA requires the ANDA or 505(b)(2) applicant to submit a copy of any judgment by a court either finding the patent invalid, unenforceable or not infringed or finding that the patent is valid and infringed. Additionally, an ANDA or 505(b)(2) applicant must provide the FDA with a copy of any written consent of approval by the patent owner or exclusive licensee (e.g., a letter to the FDA from patent owners or exclusive licensee providing consent to approve the application after the date of consent) or any court order terminating the 30-month stay. These documents must be provided to the applicant's NDA or ANDA "within 14 calendar days of the date of entry by the court, the date of appeal or expiration of the time for appeal, or the date of documented agreement, as applicable."

Notification of Commercial Marketing

The Final Rule requires a first applicant to notify the FDA within 30 days of the date of first commercial marketing of the drug product. If this is not done within 30 days, then the FDA is deeming the date of first commercial marketing to be the date of the drug product's approval.

If you have any questions about this Alert, please contact Frederick (Rick) R. Ball, Carolyn A. Alenci, any member of the Pharmaceutical, Medical Device, Pharmacy and Food industry group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.

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