VERY USEFUL PPT FOR UNDERSTANDING HACTH WAXMAN ACT AND CODE OF FEDERAL REGULATION. THIS PPT HAS BEEN PREPARED FROM VARIOUS SOURCES AVAILABLE ON INTERNET.

1. Yuvraj Regmi
M.Pharmacy, 1st Sem
Department of Pharmaceutics
Karnataka College of Pharmacy
8/31/20191
“Hatch-Waxman Act & Amendments”
REGULATORY AFFAIRS
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2. CONTENTS
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Introduction
Objectives
Provision of the Act
Types of Patent Certification
 Para IV filing Procedure
Exclusivity
Loopholes of the Act
Conclusion
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3. INTRODUCTION
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 In early 1980’s very few generics drug were
introduced to market after expiration of patent of brand
drugs.
 If drug was covered by patent, testing could not begin
until patent expires. If patent is expired also required to
submit their own comprehensive NDA.
 Innovators or Branded drug companies were also
facing some regulatory delay in marketing of drug
product.
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4. 8/31/20194
 In order to overcome the above problem an act was
needed to promote generic drug and innovators.
 In 1984, Two American politicians Orrin Grant
Hatch & Henry Arnold Waxman sponsored the
Official act “ The Drug Price Competition and Patent
Term Restoration” since then this Act was informally
known as Hatch-Waxman Act.
“AIM: To make available more low cost generic drugs”
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5. OBJECTIVES
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 To Motivate the generic drug manufacturers by providing
provision for the marketing of generic versions of patented
drugs on the day after patent expiry.
 To reduce the cost associated with the approval of a generic
drug by allowing the early experimental use of the
patented drug.
 To compensate for the time lost in the time-consuming
regulatory approvals for obtaining patent term by innovator
or branded drug manufacturers.
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6. PROVISION OF THE ACT:
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 Creation of section 505(j)
 This Section outlines the process of pharmaceutical
manufacturers to file a Abbreviated New Drug Application
(ANDA) for approval of generic drug manufacture.
 NDA must include any patent that claims the "drug" or a
"method of using [the] drug" for which a claim of patent
infringement could reasonably be asserted.
 On approval of NDA, FDA publishes patent information
for drug in Orange Book (“Approved Drug Products with
Therapeutic Equivalence Evaluations”).
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7. ORANGE BOOK
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 The orange book is a resource which identifies drug
products approved on the basis of safety and effectiveness
by the FDA and related patent and exclusivity information.
 The orange book is available on the internet and is updated
monthly.
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8. 8/31/20198
 An NDA applicant must submit the following information for
each patent:
Patent No. and date on which the patent will expire.
 Type of patent, i.e. drug, drug product, or method of use.
 Name of patent owner.
 Abbreviated applications may be submitted for:
* Drugs products that are the same as a listed drug in orange book
* Identical in active ingredient
* Identical in dosage form
* Identical in strength
* Identical in route of administration
* Identical in condition of use
* Bioequivalent
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9. TYPES OF PATENT CERTIFICATION
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10. PARAGRAPH I
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 States “Required patent information has not been
filed”.
 In this case, FDA may approve the ANDA
application immediately.
 In the ANDA application for Paragraph I certification
applicant must certify that such patent information
has not been submitted by the new drug
application(AND) holder for listing in the Orange
Book.

11. PARAGRAPH II
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 States that “Listed Patent has been expired”.
 In this case also, FDA may immediately approve the
ANDA application immediately.
 One or more applicant may enter in the market.
 In the ANDA application for Paragraph II certification,
applicants patent certification must state that such
patent has expired.
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12. PARAGRAPH III
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 In Paragraph III certification “The listed patent is not
expired and will be expired on a specific date”.
 In this case, FDA may approve the ANDA application
which is effective on the date of expiration of the
patent.
 One or more applicant may enter into the market.
 In the ANDA application for Paragraph III certification,
applicants patent certification must state the date on
which such patent will expire.
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13. PARAGRAPH IV
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 In PARA IV certification generic product applicant
does not infringe on the listed patent or that those
patent are not enforceable.
 In this case, Generic applicant (ANDA) provides
notice to innovator/patent holder.
 Entry of first to file in the market or may not occur.
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14. PARAGRAPH IV CERTIFICATION
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 When patent is not expired and ANDA applicant
intended to market its generic version prior to
expiration of the patent, ANDA applicant files the
application with P-IV certification.
 While making Para IV filing, ANDA applicant
proclaim either one of the following:
Not infringed Invalid Not enforceable
Patent is:
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15. PARA IV FILING PROCEDURE:
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ANDA application to USFDA with P-IV certification
By
ANDA
applican
t
Written notice to patent owner within 20 days of
acceptance of filing by FDA
By
ANDA
applican
t
To sue the ANDA applicant within 45 days of
receiving the notice.
By
Patent
Holder
No stay on ANDA application
FDA review the ANDA application and may Approve
or Disapprove the ANDA.
By
USFD
A
By
USFD
A
If ANDA application sued
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16. Contd..
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Litigation starts in Court.
 30 month stay on ANDA
approval by FDA
COURT DECISION
In favour of ANDA
applicant
In favour of Patent Holder
180 days exclusivity •Applicant can withdraw the application.
•Amend the application with Para III
certification.
After the expiry of 180 days exclusivity subsequent ANDA are granted.
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17. EXCLUSIVITY
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 The Patent holder may obtain exclusivity for a brand
name product, which essentially extend the time of
protection under certain circumstances. Exclusivity
also prevents the effective approval of ANDAs.
Types of Exclusivity:
Types Term
New chemical entity exclusivity(API) 5 Year
New clinical study exclusivity
(Formulation, Dose, Route)
3 Year
Orphan drug exclusivity 7 Year
Pediatric exclusivity 6 Months
180 day generic market exclusivity 180 Days
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18. LOOPHOLES OF THE ACT
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1. Authorized Generics:
 Authorized Generics is the brand company’s own
product repackaged and marketed as a generic drug
either through a subsidiary or a third party.
 Authorized generics provides consumers with brand
quality at generic price which would compensate the
loss after the patent expiry.
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19. Contd..
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2. Warehousing Patents:
 An innovator may patent multiple attributes of a
product (may be color, manufacturing process or the
chemicals produced when the drug is ingested in the
body) and keeps on adding patents in the Orange
Book. Which brings along the risks of litigation and
associated costs and delays in obtaining ANDA
approval.
 The provision of filing a patent infringement lawsuit
gives the brand name manufacturer at least an
additional two and a half years of product monopoly.
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20. CONCLUSION
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 The Hatch-Waxman act allows for a patent term
extension of a maximum of 5 years for the branded
drug manufacturer to compensate for the time lost
during the NDA approval by the USFDA.
 Permitted generic manufacturers to use safety and
effectiveness research performed by the brand name
pharmaceutical companies.
 Encouraged patent challenges by providing 180-day
market exclusivity for the first generic manufacturer
who files ANDA.
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21. Contd..
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 Finally Hatch-Waxman Act attempts to balance
between these two important contributors (Generic and
Brand) to health care essentially required in meeting
the goals of affordable health care and innovative
research.
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22. 8/31/201922 Regulatory Affairs

23. CFR
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 Code Of Federal Regulation is the codification of
the general and permanent rules and regulation
published in the federal register.
 Federal Register is the official journal of the
federal government of the United States that
contains government agency rules, proposed rules
and public notices.
 The first edition was published in 1938.
 50 Title of official CFR are revised once each
calendar year.
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24. LIST OF CFR TITLES
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 Divided into 50 titles:
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Title 1: General Provisions Title 2: Grants and Agreements
Title 3: The President Title 4: Accounts
Title 5: Administrative Personnel Title 6: Domestic Security
Title 7: Agriculture Title 8: Aliens and Nationality
Title 9: Animals and Animal Products Title 10: Energy
Title 11: Federal Elections Title 12: Banks and Banking
Title 13: Business Credit and Assistance Title 14: Aeronautics and Space
Title 15: Commerce and Foreign Trade Title 16: Commercial Practices
Title 17: Commodity and Securities Exchanges
Title 18: Conservation of Power and Water Resources
Title 19: Customs Duties Title 20: Employees' Benefits
Title 21: Food and Drugs Title 22: Foreign Relations
Title 23: Highways Title 24: Housing and Urban Development
Title 25: Indians Title 26: Internal Revenue
Title 27: Alcohol, Tobacco Products and Firearms
Title 28: Judicial Administration
Title 29: Labor
Title 30: Mineral Resources

25. 8/31/201925 Regulatory Affairs
Title 31: Money and Finance: Treasury
Title 32: National Defense
Title 33: Navigation and Navigable Waters
Title 34: Education
Title 35: Reserved (formerly Panama Canal)
Title 36: Parks, Forests, and Public Property
Title 37: Patents, Trademarks, and Copyrights
Title 38: Pensions, Bonuses, and Veterans' Relief
Title 39: Postal Service
Title 40: Protection of Environment
Title 41: Public Contracts and Property Management
Title 42: Public Health
Title 43: Public Lands: Interior
Title 44: Emergency Management and Assistance
Title 45: Public Welfare
Title 46: Shipping
Title 47: Telecommunication
Title 48: Federal Acquisition Regulations System
Title 49: Transportation
Title 50: Wildlife and Fisheries
Contd..

26. CITATION OF THE CFR
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 Each titles are broken down into chapters, parts, sections and
paragraph.
 For example:
42 CFR 260.11 (a) (1)
Title: Broad subject area of regulation
Part: Rules on a single program or function
Section: One provision of program/function rules
Paragraph: Detailed, Specific requirement
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TITLE PART SECTION PARAGRAPH

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28. CFR PUBLICATION TIMELINE
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 A full set of the C.F.R consists of approximately 200
volumes. The approximately 200 C.F.R volumes are revised
at least once a year on a quarterly basis as follows:
Titles 1 -- 16 as of January 1
Titles 17 -- 27 as of April 1
Titles 28 -- 41 as of July 1
Titles 42 -- 50 as of October 1
 The revision date of each volume is printed on the cover,
and at the top of every even-numbered page. Each year's
cover is a different color for quick reference.

29. FINDING REGULATION
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 If you know the agency you are interested in, there is an
alphabetical list of all agencies and corresponding C.F.R.
title, subtitle, or chapter at the back of each volume.
 Using e-CFR, westlaw, these database incorporates all the
changes to the code of regulation.
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30. 8/31/201930 Regulatory Affairs

31. REFERENCES
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 Subrahmanyam CVS, Thimmasetty J. Pharmaceutical
Regulatory Affairs,1st ed. MK Jain,Delhi.2012.
 Vyanwahare NS, CI Sachin,Drug Regulatory
Affairs.2nd ed.,pune:arihant,2011.
 https://en.wikipedia.org/wiki/Code_of_Federal_Regula
tions
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