hatchwaxmanact of generic product development

Also known as “The Drug Price Competition
and Patent Term Restoration Act”
Enacted in 1984
Amended the Patent laws
 Amended the Federal Food, Drug and
Cosmetic Act (F & D act)
Before 1962- New Drug Approval is based on
safety alone.
1962 - Proof of Efficacy made compulsory for marketing
approval of a new drug (Kefauver-Harris Amendments)
INTRODUCTION

Sunday, April 21, 2024 NNRG SCHOOL OF PHARMACY
The United States patent system is the driving force
behind pharmaceutical innovation in the United
States today.
i. Patent protection allows a research-based
pharmaceutical firm to use market exclusivity to
recover the tremendous investment necessary to
discover and develop new drugs.
ii. It also ensures the company's ability to further
profit from its innovations before generic drug
manufacturers can copy and market the drug at
a greatly reduced cost.

NNRG SCHOOL OF PHARMACY
Sunday, April 21, 2024
Sunday, April 21, 2024
 Without strong intellectual property rights,
innovation and pharmaceutical development in
research-based firms would deteriorate and
consumers might not have access to the
medicines they need.
 On the other hand, United States consumers often
do not want to pay the prices that these firms charge
for their patented products.
 Therefore, the work of generic firms in providing
lower-cost versions of off-patent drugs is crucial to
ensure that the American public is able to fully benefit
from the medical innovation and technology produced
by research-based firms.

 Unfortunately, in the past, Food and Drug
Administration (the "FDA") substantially many
generic firms from doing so…. (a).
 In addition to expediting the market entry of
generic drugs after patent expiration, Congress also
intended the Act to encourage generic firms to
challenge drug patents in the midst of their terms
 A generic firm successfully challenges a patent
when it creates a generic version of the patented
drug that does not infringe, or when it establishes
the patent's invalidity.

 This allows the generic firm to market its product
immediately (A), driving down drug prices for
consumers earlier than otherwise would have been
possible (B).
 Congress included the generic exclusivity
provision in the Act to provide an additional
incentive to encourage these patent challenges (i).
This quasi-monopoly (పాక్షిక-గుత్తా ధిపత్య ం) is
given in exchange for the important public benefit
produced by the efforts of those generic firms:
earlier consumer access to less expensive generic
versions of the drugs that are often essential to
consumers‘ well-being.

 However, the FDA and the courts have disagreed
on how to best implement the provision(i).
 When a generic firm challenges the pioneer's
patent as invalid or not infringed, the pioneer has
the ability to contest that challenge in court before
the generic product can enter the market(ii).
 Not surprisingly, in most cases the pioneer firm
sues to contest the generic firm's challenge and
preserve its patent term (I).
 However the generic exclusivity provision never
mentioned how this litigation might affect the award
of generic exclusivity (II).

 The provision simply prevents all generic
versions of a drug for which a previous application
has been submitted from entering the market until
the first-filer's exclusivity has expired.
 The FDA's initial regulations required that the
first-filer be sued by the patentee and successfully
defend itself in that lawsuit (the "successful defense
requirement"), before that first-filer could receive
generic exclusivity under the Act.

There was no provision for Patent Term Extension
Prior to enactment of the Hatch Waxman Act, to make
up for the time lost out of the total patent term during the
marketing approval process
Generic companies required to submit their own
comprehensive NDA
 Costly
 Time consuming
If drug was covered by patent
Testing could not begin until patent expired
To overcome the above problems an act was needed to
promote generic companies
INTRODUCTION Cont…

OBJECTIVES OF THE ACT
 Reducing the cost associated with the approval of a
generic drug
 Allowing Early-Experimental-Use
 Compensating the branded drugs manufacturers for the
time lost from the patent term because of the regulatory
approval formality.
 Motivating the generic drug manufacturers
“HWA strives to strike a balance between the
interests of branded drug manufacturers, generic
drug manufacturers and the consumers”

Creation of section 505(j) (a)
Section 505(j) established the ANDA approval process
The timing of an ANDA approval depends based on part
patent protections for the innovator drug
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”)
PROVISIONS OF THE ACT

PROVISIONS OF THE ACT
ORANGE BOOK
FDA publishes patent information on approved
drug products in the Orange Book.
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
 The name of an agent of the patent owner or
applicant

 Brand drugs listed for generics to compare with their
proposed products
Four Types of Patent Certifications
 When an applicant submits an ANDA to the FDA, the
applicant must certify one of four things under section
505(j)(2)(A)(vii):
 That the required patent information relating to such patent
has not been filed (Para I), the FDA may approve its ANDA
immediately
 That the patent will expire on a particular date ( Para III)
 That such patent has expired (Para II) the FDA may approve its
ANDA immediately
 That such patent is invalid or will not be infringed by the
drug, for which approval is being sought (Para IV – Patent
Challenge)

INCENTIVES AND PROTECTION
180 Day Market Exclusivity
 First applicant to submit a substantially complete
ANDA (first-to-file)
 May be shared by multiple applicants
 Subject to forfeiture
30-month stay of FDAApproval
 If patent owner or NDA holder sues the AND Applicant
for patent infringement within 45 days of receiving notice of
the Paragraph IV certification.
 Runs from date of notification or expiration of NCE
exclusivity
 May be lengthened or shortened by the court

PARA IV- PATENT CHALLENGE
GENERIC- PARA - IV FILING
GENERIC- PROVIDE NOTICE TO BRAND
WITHIN 20 DAYS OF ACCEPTANCE
BRAND- MUST BRING LAWSUIT
WITHIN 45 DAYS
GENERIC- IF SUED, AUTOMATIC
30 MONTH STAY GRANTED TO BRAND

Upon ANDA acceptance for filing, the applicant must
notify the NDA holder and patent owner of the NDA within
20 days. The notice must include a detailed statement of the
factual and legal basis of the opinion of the applicant that
the patent is invalid or will not be infringed
Upon notification, the NDA holder and patent owners
have 45 days to initiate an action for patent infringement.
If such an action is brought within 45 days, the ANDA is
subject to a 30-month stay of FDA approval beginning on
the date the notification letter was received
PARA - IV DEADLINES
NOTIFICATION LETTER:20 DAYS
LAWSUIT:45 DAYS

11
18 17
18 17
12 11
Drug approvals in US
2009 2010
19
15
ANDA APPROVAL & INDIAN COMPANIES
Indian companies bagged 33.17% or 139 of 419
original ANDA approvals from US FDA in 2010
Glenmark Aurobindo Sun Pharma Lupin DRL

The manufacture, use, or sale of a patented drug is
not an act of infringement, to the extent it is necessary
for the preparation and submission of an ANDA.
The Hatch-Waxman Act provides under 35 U.S.C. §
271(e)(1), generally that: “It shall not be an act of
infringement to make, use, or sell a patented invention
… solely for uses reasonably related to the
development and submission of information under a
Federal law which regulates the manufacture, use, or
sale of drugs.”
EXEMPT ACTS OF PATENT INFRINGEMENT
FOR FDA APPROVAL

BRANDS GENERICS
BRAND- 30 MONTH STAY GENERIC- 180 DAY EXCLUSIVITY
1st successful Para IV filer
A big head start on others
Automatic Injunction
Notice of generic competition
HATCHWAXMAN TRADE-OFF

BENEFITS FOR BRANDED MANUFACTURERS
Orange Book provides public notice of patents
Allows for resolution of patent disputes prior to generic
entry
30-month stay of FDA approval of generic drugs
Patent Term Restoration
Allows for Several Market Exclusivities:
 Data Exclusivity
5 years for New Chemical Entity (NCE) Drug
3 years for non-NCE Drug
 Orphan Drug (7 years)
 Pediatric (PEDS) (6 months)

BENEFITS FOR GENERIC MANUFACTURERS
180-day market exclusivity for first successful challenger
to Orange Book patent.
Allows generics to challenge Orange Book patents
without risk of damages.
“Safe Harbor” rule allows generics to perform
bioequivalence and other testing relating to regulatory
approval without risk of patent infringement.
“Dr Reddy’s was the first Indian company to get the 180-
day exclusivity for marketing Fluoxetine (Eli Lilly’s
Prozac) 40 mg capsule in August 2001”

Types Term
New Chemical Entity 5 years
New Clinical Study 3 years
Orphan Drug 7 years
Pediatric Exclusivity 6 months
180-day Generic Market
Exclusivity
180 days
NON-PATENT EXCLUSIVITY

 Hatch-Waxman Act, 1984
 Granted: To drug products containing a New
Chemical Entity
 Blocks: Submission of 505(b)(2) or ANDA
 Length: Five years (or four years if para. IV)
NEWCHEMICALENTITYEXCLUSIVITY

 New Chemical Entity : “A New Chemical Entity (NCE)
is a drug that does not contain any active moiety that has
been approved by the United States Food and Drug
Administration (USFDA) with any other application
submitted under section 505(b) of the act”
 Active Moiety: “the molecule or ion, excluding those
appended portions of the molecule that cause the drug to be
an ester, salt (including a salt with hydrogen or coordination
bonds), or other non-covalent derivative (such as a complex,
chelate, or clathrate) of the molecule, responsible for the
physiological or pharmacological action of the drug
substance”
NEWCHEMICAL ENTITY
DEFINITIONS

Federal Drug Administration Amendments Act,
2007(“FDAAA”)
Under strict conditions, an enantiomer can qualify as a
NCE:
–The single enantiomer has not been previously approved except
in the approved racemic drug
–The NDA includes full new clinical investigations
–The clinical studies were not used for the racemate
–The enantiomer indication is not in the same therapeutic category
as the racemate
Three-year exclusivity available:
e.g., Lexapro(escitalopram); Nexium (esomeprazole)
NCE EXCLUSIVITY FORENANTIOMERS

Hatch-Waxman Act, 1984
Granted: For submission of results of new
clinical studies
Blocks:Approval of 505(b)(2) or ANDA
Length:three years
NEWCLINICAL STUDY EXCLUSIVITY

Granted for submission of “reports of new
clinical investigations (other than biovailability
studies) essential to the approval of the application
[or the supplemental application] and conducted
or sponsored by the applicant”
Examples: New or changed formulations; salts;
indications; dosing regimens; patient populations;
OTC switches; or other label changes
 Opana ER (immediate release → extended
release)
 Caduet (atorvastatin/amlodipine combination)
NEW CLINICAL STUDY EXCLUSIVITY

Orphan Drug Act, 1983
Granted: to drugs intended for treatment of a “rare
disease or condition”
Affects < 200,000 people in the U.S., or
No reasonable expectation of recouping dev. costs
Blocks: approval of 505(b)(1), (b)(2), or ANDA
directed to the same drug, for same disease
Length: seven years
Additional rewards: tax credits; grants; fees
waived
ORPHAN DRUGEXCLUSIVITY

Food and Drug Administration Modernization Act, 1997
(“FDAMA”)
Granted: to applicants who successfully complete FDA-
requested clinical trials of a drug in a pediatric
population
Blocks: approval of 505(b)(2) or ANDA
Length: six months beyond any existing marketing or
patent exclusivity
Gov’t funding of pediatric studies if no exclusivity
PEDIATRIC EXCLUSIVITY

 Hatch-Waxman Act, 1984
 Granted: to first ANDA applicant who submits a
“substantially complete” ANDA containing a
paragraph IV certification
Substantially complete = sufficient to permit review
Blocks: approval of subsequently-filed ANDA
containing a paragraph IV certification
Length: 180 days, from commercial marketing
PATENT CHALLENGE /GENERIC DRUG
EXCLUSIVITY

Medicare Modernization Act, 2003 (“MMA”)
Six ways to forfeit:
1. Failure to market
2. Withdrawal of application
3. Amendment of certification
4. Failure to obtain tentative approval within 30
months.
5. Improper agreement with another applicant, the
listed drug application holder, or a patent owner
6. Expiration of all patents
180-DAY EXCLUSIVITY FORFEITURE

AGs are pharmaceutical products that are approved as
brand-name drugs but marketed as generic drugs.
AGs do not bear the brand-name or trademark of the
brand-name drug or manufacturer, but the brand-
name and AG products are manufactured to the brand’s
specifications
Authorized generics have a unique impact during the first
six months of generic competition
Competition from AGs during the 180 -day exclusivity
period has the potential to reduce both generic drug prices
and generic firm revenues
AUTHORIZED GENERICS(AG)

Drug: Nitrofurantoin
Innovator: P&G
AG: Watson
Generic: Mylan
Mylan lost about $30 mn of the revenue it was set to
realize under its 180-day exclusivity grant from FDA
AUTHORIZED GENERICS(AG)

The Hatch Waxman Act
– extended the life of the pharmaceutical patents up to 14 years from
the time the New Drug Application is approved by the FDA,
– provided additional market exclusivity for the new uses or new
formulations,
– allowed potential generic manufacturers to conduct work related to
marketing approval of the drug without the charge of patent
infringement,
–permitted generic manufacturers to use safety and effectiveness
research performed by the brand name pharmaceutical companies,
–introduced the concept of bioequivalence to obtain the approval of
generic drug, and simplified generic drug approval process by
introducing ANDA, and
–encouraged patent challenges by providing 180-day market
exclusivity for the first generic manufacturer who files ANDA
CONCLUSION

Hatch Waxman Act led to the birth of generic industry
It also gave protection to innovators in terms of 30 month stay,
market exclusivities and patent term extensions
But, the brand companies are taking advantage of the
loopholes of HWA in the form of authorized generics and reverse
payment agreements
Brand companies are also involved in sham litigations to take
advantage of 30 month stay provision
Role of both brand and generic companies are vital for US
healthcare system
Maintaining the balance between these two important
contributors to health care will be essential in meeting the goals of
affordable health care and innovative research
CONCLUSION CONTD…

hatchwaxmanact of generic product development

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