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  • Four currently pending bills – each complex, each different First – Waxman Senate bill 1695 bipartisan effort led by HELP, Senate committee on Health Education Labor and pensions 4 th Eshoo house bill is least complicated Bills have similarities and differences
  • Previously proposed legislation differed on whether to amend the FDCA or PHSA …and away we go
  • Not interchangeable means new active ingredient
  • Peds extension: House version, extension is in the legislation Senate version amends subsection (a)(1) of 409I of PHSA and § 505A(p) of FDCA
  • FOB market exclusivity provided in the legislation – varies HW - 180 days from first commercial marketing differs when litigation ensues Inslee, like EP provides not FOB exclulsivity; Others require interchangable label.. None yet
  • Each of the new bills varies the HW model of generics; but there is no plan for an ORANGE book. Instead, parties will exchange patent information and be provided with access to confidential information as needed to determine infringement. Only HR5629 addresses the rights of third parties, e.g., Universities and other parties that may have an interest in the patents. None provides for an automatic stay of approval for patent litigation, nor provides for control of patent litigation
  • Senate—20 days; House—30 days Senate also requires identification of the patents on the list that the RPS would be prepared to license to the applicant
  • House is 45 days for RPS or 3d party, Senate is 60 days House version does not require (i) or that (ii) is on a claim by claim basis
  • (iv) Same as (A)(iii) – if new patent then must furnish within 30 days

Transcript

  • 1. H.R. 3962 (House version)
    • Affordable Health Care for America Act passed 220-215 on Nov. 7, 2009
    • Division C, Title V, Subtitle C (Food and Drug Administration, Part 2 (Biosimilars): pages 1528 to 1560
  • 2. H.R. 3590 (Senate version)
    • Patient Protection and Affordable Care Act passed U.S. Senate 60-39 on Dec. 24, 2009
    • Title VII, Subtitle A (Biologics Price Competition and Innovation Act of 2009); pages 1823-1869
  • 3. Legislation – PHSA
    • § 351 of PHSA (42 U.S.C. § 262) is amended in subsection (a)(1)A) by inserting “under this subsection or subsection (k)” after “biologics license” and by adding at the end the following “(k) Licensure of Biological Products as Biosimilar or Interchangeable—”
  • 4. “ Biosimilar” Defined
    • “ Biosimilar” or “biosimilarity” means
    • (A) highly similar notwithstanding minor differences in clinically inactive components; and
    • (B) No clinically meaningful differences in terms of safety , purity, and potency
  • 5. Interchangeable
    • “ Interchangeable” or “Interchangeability”
    • Meets the standards described in subsection (k)(4)
    • =the risk in terms of safety or diminished efficacy of alternating or switching is not > the risk of using the reference product without alternation or switching
    • May be substituted without intervention of the health care provider
  • 6. Required Information (k)(2)(A)(i)
    • An application shall include information demonstrating that—
    • (I) the biological product is biosimilar to a reference product based upon data derived from--
    • (aa) Analytical studies demonstrating product is highly similar notwithstanding clinically inactive components;
  • 7. Required Information (k)(2)(A)(i)
    • (bb) Animal studies (including toxicity); and
    • (cc) Clinical studies (including immunogenicity and pharmacokinetics or pharmacodynamics) to demonstrate safety, purity, and potency;
    • (II) Utilize the same mechanism of action for the condition(s) of use;
    • (III) Condition(s) of use approved for reference product;
  • 8. Required Information (k)(2)(A)(i)
    • (IV) Route of administration, dosage form, and strength of product are the same as the reference product; and
    • (V) The facility of manufacture meets standards to assure that the product continues to be safe, pure, and potent.
  • 9. Reference Product Exclusivity
    • 4 years of data exclusivity
    • 12 years market exclusivity
    • +6 extra months pediatric
    • This is irrespective of patents, which are tied to a filing date and may expire prior to market exclusivity expiration
  • 10. FOB Market Exclusivity
    • No determination that 2 nd FOB is interchangeable until the earlier of:
    • (A) 1 year after 1 st commercial marketing after approval as interchangeable;
    • (B) 18 months after final court decision(s) or dismissal(s) on all patents in suit; or
  • 11. FOB Market Exclusivity
    • (C)
    • (i)42 months after approval of the 1 st FOB if 1 st applicant still has litigation pending; or
    • (ii) 18 months after approval of 1 st FOB if 1 st applicant has not been sued.
  • 12. Information Exchange COMPLICATED !
    • NO ORANGE BOOK!
      • Exchange of patent information
      • Access to confidential information needed to determine infringement
      • Sanctions
      • Tight Deadlines
    • Patent Litigation
      • No automatic stay of approval
      • Control?
  • 13. Exchanges with Reference Product Sponsor (RPS)
    • (A)(i) 20/30 days for Applicant to provide RPS with copy of application & info regarding biosimilar product & its production
    • (ii) 60 days from receipt of (i), RPS provides Applicant list of relevant patents owned or has right to commence infringement suit
    • (iii) If RPS has new patent issued or acquires interest in relevant patent after providing list in (ii), RPS shall identify patent to Applicant within 30 days of issue or acquisition
  • 14. Exchanges with Reference Product Sponsor (RPS)
    • Within 45/60 days of receiving list, Applicant
    • (i) may provide to RPS a list of patents that Applicant believes a claim of patent infringement could reasonably be asserted by RPS;
    • (ii) shall provide to RPS, with respect to each patent listed by RPS or Applicant, (I) a detailed statement that describes claim by claim the factual and legal basis of the opinion of the Applicant that such patent is invalid, unenforceable, or will not be infringed; or (II) a statement that Applicant does not intend to begin commercial marketing of the product prior to patent expiration
  • 15. Exchanges with Reference Product Sponsor (RPS) (Senate Only)
    • (C) Within 60 days, RPS shall provide Applicant with a statement on a claim by claim basis that details the factual and legal basis of the opinion of the RPS that Applicant’s product will infringe RPS’ patent(s)
  • 16. Exchanges with Third Parties (House Version)
    • (i) Any interested 3d party may provide notice to Applicant’s designated agents that 3d party owns or has rights under 1 or more patents that may be relevant
    • (ii) Within 30 days, Applicant provides 3d party with copy of application & info regarding biosimilar product & its production
    • (iii) Within 90 days, 3d party shall provide Applicant with a list of relevant patents