Hatch-Waxman and BPCIA Overview 2019-01-08آ  Hatch-Waxman Act . #FDABos Hatch-Waxman Compromise Facilitate

Embed Size (px)

Text of Hatch-Waxman and BPCIA Overview 2019-01-08آ  Hatch-Waxman Act . #FDABos Hatch-Waxman Compromise...

  • #FDABos

    ACI’s 23rd FDA Boot Camp Kurt Karst


    Hyman, Phelps and McNamara, PC

    Hatch-Waxman and BPCIA Overview

    September 18 - 19, 2014

    Christopher E. Jeffers, Ph.D.


    Womble Carlyle Sandridge and Rice, LLP

    Tweeting about this conference?

  • #FDABos

    • Thalidomide and the 1962 amendments to

    the Food and Drug Cosmetic Act

    • First attempt to pass patent restoration and language re: generics in 1978 by Carter

    • Debate Continued through 1983

    •Roche v. Bolar

    Roche v Bolar (1984)

  • #FDABos

    • Roche v. Bolar, 733 F.2nd 858 (1984)

    • Valium (diazepam)

    • Bolar pharma started testing generic version prior to expiration of patent

    • Bolar wanted to have their application for FDA approval ready when the patents expired

    • Roche sued for patent infringement.

    • CAFC found that Bolar’s manufacture and testing of diazepam was in infringement

    Roche v Bolar (1984)

  • #FDABos

    • “Uproar” over Bolar decision • De-facto extension of patent monopoly

    • Drug Price Competition and Patent Term Restoration Act of 1984 (“Hatch- Waxman Act”)

    • Statutory compromise • Provides an accelerated path for generic approval (ANDA)

    • Patent restoration for time spent by branded companies in clinical trials

    Hatch-Waxman Act

  • #FDABos

    Hatch-Waxman Compromise

    Facilitate Generic Entry

    • Regulatory exclusivities • 5 year exclusivity for NCE

    (FDA won’t accept a new application for same chemical entity until 4th year)

    • 3 year exclusivity for novel formulation / indication (FDA won’t APPROVE new application relying on branded data for 3 years)

    • Patent Term Extension for time spent in regulatory approval


    • Establishes ANDA pathway

    • Methods for challenging patents

    • 180-day exclusivity for first generic

    • “Orange Book” established to list all relevant patents (structure and methods of treatment)

  • #FDABos

    Hatch-Waxman Scheme (small molecule drugs)

    0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32




    Filed (Yr 1)

    Patent issues

    (yr. 6)

    IND Filed

    (yr. 9)

    NDA Filed

    (yr. 14)

    NDA Approved

    (yr. 15)






    Patent Term

    Restoration (1/2 trial period +

    Review period)

    Effective Exclusivity (~10 years in this example)

    Potential Generic


    ** 3 year exclusivity

    Is available for

    non-NCE’s w/ new Indications, formulations,


  • #FDABos •6

    •Generic Patent Certifications

    • Paragraph I certification: required patent information •has not been filed. 21 U.S.C. 355(j)(2)(A)(vii)(I).

    • Paragraph II certification: Orange Book-listed •patents have expired. 21 U.S.C. 355(j)(2)(A)(vii)(II).

    • Paragraph III certification: ANDA applicant will not •challenge listed patent(s), and FDA will not approve

    •the ANDA until patent expiration. 21 U.S.C.


  • #FDABos

    •Notice to the Brand Company of P-IV •Certification

    ANDA/505(b)(2) application must include a statement that the applicant will give notice of a P-IV certification to the patent holder and the owner of the approved application for the drug claimed by the patent. 21 U.S.C. 355(j)(2)(B)(i).

    Notice must be given:

    If the certification is in an original application, within 20 days of after notice to the applicant from FDA that the application is complete (21 U.S.C. 355(j)(2)(B)(ii)(I)); or

    If the certification is in a supplement to an application (i.e., for a later-listed patent), at the time the supplement is submitted to FDA. 21 U.S.C. 355(j)(2)(B)(ii)(II).

    Notice must include:

    notification of the filing of the ANDA seeking approval to sell the drug before expiration of the patent that is the subject of the P-IV (21 U.S.C. 355(j)(2)(B)(iv)(I)); and

    A detailed statement of the factual and legal basis for the certification.

    •21 U.S.C. 355(j)(2)(B)(iv)(II). 8

  • #FDABos

     NDA holder or patent owner, upon receiving notice of the P-IV certification, may sue the ANDA/505(b)(2) applicant for patent infringement.

     If patent infringement litigation is brought within 45 days of the receipt of notice, then FDA may not approve the ANDA/505(b)(2) application until the earlier of:

     The expiration of 30 months (the “30-month stay”) (FDA may grant “tentative approval”);

     The date on which a district court enters judgment for the defendant that the patent is invalid/unenforceable/uninfringed (or there is a settlement or consent decree to these effects); or

     If the district court rules for the plaintiff, and the court appeals reverses, the date of the appellate decision (or settlement/consent decree). 21 U.S.C. 355(j)(5)(B)(iii).

     Additional stay possible where ANDA/505(b)(2) applicant changes drug product formulation.

     Where suit is not brought by patent/approval holder, ANDA/505(b)(2) applicant may bring declaratory judgment action seeking a judgment of invalidity/unenforceability/noninfringement. 21 U.S.C. 355(j)(5)(C)(i).

     Generic/505(b)(2) applicant may also counterclaim against an infringement claim to force the NDA holder to correct or delete OB patent information because the patent does not claim the drug or an approved method of using the drug. 21 U.S.C. • 355(j)(5)(C)(ii). 9

    •Response to Notice of P-IV Certification

  • #FDABos •11

    •180-Day Exclusivity

    •The first generic applicant with a substantially complete application

    containing a P-IV certification that successfully challenges the certified patent

    is entitled to 180 days as the only generic version of the RLD on the market.

    21 U.S.C. 355(j)(5)(B)(iv).

    •Exclusivity is structured as a bar to other FDA approvals: FDA may not approve another ANDA for 180 days where an ANDA filer qualifies as a “first

    applicant” entitled to exclusivity.

    505(b)(2) applicant not eligible for 180-day exclusivity.

  • #FDABos

    New Drugs – Three

    Routes to Approval

  • #FDABos

  • #FDABos

  • #FDABos

  • #FDABos

  • #FDABos

    ANDA Review Process

  • #FDABos

    • Once an applicant submits an ANDA to FDA’s Office of Generic Drugs (“OGD”), the Office reviews the submission to determine whether the application is sufficiently complete to permit a substantive review. • See 21 C.F.R. § 314.101.

    • If so, OGD will “receive” the ANDA. • If not, OGD will “refuse to receive” the ANDA

    and the generic applicant must address the deficiencies noted by OGD before the Office will receive the ANDA.

    ANDA Review Process

  • #FDABos

    •OGD tries to review ANDA submissions within 60 days after they are submitted to determine whether to receive the ANDA. •OGD’s decision on whether or not to

    receive an ANDA often takes longer, due to scarce resources, a large number of submissions, and other issues.

    ANDA Review Process

  • #FDABos

    • OGD’s ANDA approval time has been on the rise over the past several years.

    • Today, the median ANDA approval time is reportedly about 36 months.

    • And there is a significant backlog of applications . . . .

    ANDA Review Process

  • #FDABos

    OGD Statistics

  • #FDABos

    •ANDAs are generally reviewed on a “first-in, first-reviewed” basis. • This assures fair and even-handed treatment of applicants.

    •OGD does not deviate from the “first- in, first-reviewed” approach unless there are specific reasons to expedite an ANDA.

    Expedited ANDA Review