Exclusivity Provisions in the 21st Century Cures Act

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On May 21, 2015, the Energy and Commerce Committee voted unanimously to advance the 21st Century Cures Act, which the Committee has presented as “a bill to help modernize and personalize health care, encourage greater innovation, support research, and streamline the system.”

The legislative text of the proposed bill spans over 300 pages in its current form (as of June 1, 2015), and consists of four titles:

  • Title I—Discovery,
  • Title II—Development,
  • Title III—Delivery,
  • Title IV—Medicaid, Medicare, and Other Reforms.

The fourth title appears to have been added after the bill was introduced in the House on May 19, 2015.

There’s much to discuss about this bill, but in this post we want to highlight one subsection of the Act that might be of particular interest to readers of this blog: Subtitle I of Title II, entitled “Orphan Product Extensions Now; Incentives for Certain Products for Limited Populations.” Subtitle I, the “OPEN Act,” would amend the Federal Food, Drug, and Cosmetic Act (“FDCA”) by adding proposed Section 505G, which would extend by six months the exclusivity periods for a drug approved for a new indication for a rare disease or condition.

Proposed subsection (b) provides:

(b) Extension.—If the Secretary designates a drug as a drug approved for a new indication for a rare disease or condition, as described in subsection (a)(1)—

“(1)(A) the 4-, 5-, and 7 ½-year periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 3-year periods described in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of section 505, and the 7-year period described in section 527, as applicable, shall be extended by 6 months; or

“(B) the 4- and 12-year periods described in subparagraphs (A) and (B) of section 351(k)(7) of the Public Health Service Act and the 7-year period described in section 527, as applicable, shall be extended by 6 months; and

“(2)(A) if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505 or a listed patent for which a certification has been submitted under subsections (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 505, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B) shall be extended by a period of 6 months after the date the patent expires (including any patent extensions); or

“(B) if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B) shall be extended by a period of 6 months after the date the patent expires (including any patent extensions).

The proposed provisions would extend by 6 months the regulatory exclusivity and/or patent protection periods for any drug designated and approved “for a new indication to prevent, diagnose, or treat a rare disease or condition.”

Subsection (b)(1) of the proposal would add six months of regulatory exclusivity to existing periods of regulatory exclusivity available under the FDCA (5-year new chemical entity exclusivity, 3-year new clinical study exclusivity, 7-year orphan drug exclusivity) and BPCIA (12-year new biologic exclusivity).

Subsection (b)(2) of the proposal would extend by 6 months any patents protecting the designated drug for which a certification has been submitted under the FDCA provisions, unless a generic drug applicant succeeds in litigation to show that the patents are invalid or would not be infringed. The text of subsection (b)(2) does not appear to cover patents protecting products governed by the BPCIA.

Proposed subsection (c) also provides:

(c) Relation To Pediatric And Qualified Infectious Disease Product Exclusivity.—Any extension under subsection (b) of a period shall be in addition to any extension of the periods under sections 505A and 505E of this Act and section 351(m) of the Public Health Service Act, as applicable, with respect to the drug.

There has been no major action reported on the bill since May 21, 2015. We will be tracking updates on this and other proposed legislation, and will be sure to post any updates here on the Big Molecule Watch.

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