Hatch-Waxman Counseling

Hatch-Waxman Counseling

Counseling pharmaceutical manufacturers on various aspects related to the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”)


The Generic Drug Industry

The Hatch-Waxman Act forms the basis for today’s generic drug industry in the United States. It provides an expedited Food and Drug Agency (FDA) approval process for generic drug applications as well as patent term extensions for drug-related patents due to regulatory approval delays. Both branded and generic drug companies also may benefit from certain data, marketing and patent exclusivities provided by the Hatch-Waxman Act.


Hatch-Waxman Basics

To market or sell a pharmaceutical product in the U.S., a company must obtain approval from the FDA:

  • Brand – apply for an NDA
  • Generic – apply for an ANDA

The 1984 Hatch Waxman Legislation

  • Compromise to reward innovation but allow for early and easier approval of lower cost generics
  • Public policy rationale to get multiple versions of drug on the market to enhance competition

The 2007 Amendments – Medicaid Modernization Act (MMA)

  • Limitation on 30 month stays and first-to-file exclusivities
  • Addition of Forfeiture provisions to limit FTF exclusivity
  • Applies to ANDAs filed after December 8, 2003

Hatch-Waxman Benefits

Benefits to the NDA Holder:

  • 5 years for NCE
  • 7 years for ODE (disease affects fewer than 200,000 people in US or no reasonable expectation that R&D costs of the drug can be recovered)
  • 3 years for NDA or NDA supplement conducted or sponsored by applicants that are essential to NDA approval
  • 6 months for PED
  • 30 month stay of FDA approval
  • Can obtain PTE to compensate for delay of FDA approval (either up to 5 yrs OR capped at 14 yrs from approval)

Benefits to ANDA Filer:

  • May file an Abbreviated New Drug Application (“ANDA”) relying on clinical studies of the NDA holder.
  • Provides exemption to conduct BE testing to submit ANDA to FDA
  • Ability to challenge validity of unexpired patent
  • Opportunity for 180 days exclusivity if ANDA holder is P4 FTF

Orange Book Patents

Permitted OB patents (21 CFR 314.53(b)(1)):

  • Drug substance (active ingredient) of the NDA
  • Drug product (formulation)
  • Method of Use
  • Different polymorphs that are the “same” (dissolution, solubility, bioavailability) as brand

Not permitted:

  • Process patents
  • Patents claiming packaging (but not drug delivery systems), metabolites, or intermediates (post-MMA)

ANDA Application Requirements

  • Generic drug: contains the same active ingredient as listed drug
  • Generic drug is bioequivalent to listed drug
  • Same conditions of use and same labeling as listed drug
  • Same route of administration, dosage form and strength as listed drug (unless suitability petition)
  • Application contains required patent certification:
    • (pI) No patents in the OB
    • (pII) OB patents expired
    • (pIII) Won’t market product until OB patents expired
    • (pIV) OB patents invalid or not infringed

Paragraph Four Challenge

FTF with P-IV gets 180 days market exclusivity if:

  • Notice to NDA holder and patentee sent no later than 20 days after postmark date of FDA filing receipt (post-MMA)
  • Letter containing detailed legal and factual bases for non-infringement and/or invalidity
  • Successful in P4 Challenge
  • NB: if all FTFs forfeit (post MMA), no other applicant eligible for 180 exclusivity

NDA Holder:

  • Has 45-day window to sue ANDA sponsor
  • Automatic 30-month stay of approval

Section viii Carveout

Besides p1-4 certifications under section viii, can also certify under section viii

  • Applies to method of use patents, may be able to carve-out indication
  • Can be used if applicant seeks approval for fewer than all of the approved indications for drug product
  • For generic, no notice required and no 180 day exclusivity
  • For brand, no 30 month stay

Forfeiture (post MMA)

FTF applicant can forfeit exclusivity when:

  1. Failure to market by LATER of:
    • (I) 30 months after filing ANDA [time to obtain timely TA is 40 months during the period from 7.9.12 to 9.30.15 and 36 months during the period from 10.1.15 to 9.30.16] or 75 days after final approval, whichever is earlier of these two; and
    • (II) 75 days after each of the patents against which FTF submitted a P-IV, at least one of the following has happened:
      • a final court decision of invalidity or non-infringement;
      • consent settlement/judgment that patent is invalid or not infringed;
      • patent is delisted
  2. FTF withdraws of ANDA
  3. FTF amends P4 certifications
  4. Failure to get tentative approval within 30 months of filing
  5. FTF enters into agreement with another ANDA applicant or brand that violates antitrust laws
  6. Expiration of all of FTFs P4’d patents

Forfeiture – FDA Letters

  • Pre-MMA, no forfeiture in ramipril even though Cobalt (FTF P4 applicant) had settled suit because no evidence that Cobalt had marketed drug (NO COMMERCIAL TRIGGER) or that Cobalt had conceded that P4’d patent was valid, enforceable and infringed (COURT DECISION TRIGGER).
  • Post-MMA, forfeiture in irinotecan by Watson because although eligible for 180 stay, no TA within 30 months
  • Post-MMA, no forfeiture in granisetron by Teva under failure to market provision because there was a continuing possibility of litigation (facts: p3, viii and p4, no suit filed against FTF Teva or any other app)

Case Analysis: Bristol-Myers Squibb v. Teva (entecavir): Is the Sky Falling on Chemical Compound Claims?

Abstract: The Federal Circuit’s decision to uphold the invalidity of the chemical compound claim to Bristol Myers Squibb’s anti-hepatitis B drug, entecavir (Baraclude®) as obvious, and its refusal to reconsider its decision en banc, has generated enormous attention within the pharmaceutical industry and other research-based industries. The widely varying opinions among the Federal Circuit judges about how the district court and appellate panel weighed the evidence presented, and even about what evidence was considered, demonstrate the need for further clarification of how to analyze obviousness under 35 U.S.C. § 103, particularly with regard to chemical compound claims.

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