Dev Bhoomi Institute of Pharmacy and Research

(Dehradun)
Prepared by: ANIL KUMAR
Submitted to: Dr. SAYANTAN MUKHOPADHYAY

Drug price competition and patent term

Drug price competition and patent term
restoration act 1984: HATCH WAXMAN act
restoration act 1984: HATCH WAXMAN act

PRE-HATCH-WAXMAN ERA:
Before Hatch-Waxman era, the Food and Drug Administration’s
generic drug approval process required independent proof that a
new generic drug was safe and effective. The process was so
costly that few generic medicines were approved, and most
branded medicines enjoyed perpetual monopolies.
By 1979, legislation had been introduced to extend the life of
pharmaceutical patents by up to seven years. The pharmaceutical
industry argued that patents claiming a new drug were entitled to
longer life to compensate for the time lost in obtaining FDA
approval before a new drug could be sold. There was no legal
basis for that claim.
Roche Products, Inc. v. Bolar Pharmaceutical Co.
The Hatch-Waxman Act was created in response to a court case
called Roche Products, Inc. v. Bolar Pharmaceutical Co., which
involved a drug called flurazepam. Roche owned flurazepam, and
Bolar was seeking to sell a copy after Roche’s patents expired.
Bolar was hoping to time the approval with the expiration of the
patents, and began work on drug development activities while
Roche’s patents were still in force. The problem for Bolar was
that by doing so, it was legally infringing. Roche sued them for
infringement and ultimately won.
From a public policy perspective, this in effect extended the term
of the patent. That is, if another manufacturer can’t work on a
drug while the patent is still in force, that means it could only
work on it after the patent expired — and the approval process for
a drug is two to three years, so this would have the effect of
extending the life of the patent. Congress acted quickly
after Roche was decided to pass the Hatch-Waxman Act.
ENACTMENT OF THE HATCH- WAXMAN ACT:
Enactment of the Drug Price Competition and Patent Term
Restoration Act of 1984 signed into law on September 24, 1984,
that law has come to be known as the Hatch-Waxman Act. The
new law was subsequently codified in the Titles 15, 21, 28, and
35 of the U.S Code.
Although the Hatch-Waxman Act is a complex statute, observers
have frequently noted that it presents a fundamental trade-off: In
exchange for permitting manufacturers of generic drugs to gain
FDA marketing approval by relying on safety and efficacy data
from the brand-name firm's NDA, the brand-name firms receive
a period of regulatory exclusivity and patent term extension.
HATCH-WAXMAN ACT & ABBREVIATED NEW
DRUG APPLICATION (A.N.D.A)

Senators Orrin Hatch and Henry Waxman who introduced the Acts to
encourage generic drug price competition.

Prior to the introduction of the Hatch-Waxman Act, the federal

food and drug law contained no separate provisions addressing
generic versions of drugs that had previously been approved.
At times the FDA requested additional studies to address safety
and efficacy questions that arose from experience with the drug
following its initial approval. The result is that some generic
manufacturers were forced to prove independently that the drugs
were safe and effective, even though their products were
chemically identical to previously approved drugs.
The Hatch-Waxman Act created a new type of application for
market approval of a pharmaceutical. This application, termed an
"Abbreviated New Drug Application" (ANDA), may be filed at
the FDA. An ANDA may be filed if the active ingredient of the
generic drug is the bioequivalent of the approved drug. An ANDA
allows a generic drug manufacturer to rely upon the safety and
efficacy data developed by the original manufacturer.
ANDAs applications may allow a generic manufacturer to avoid
the costs and delays associated with filing a full-fledged NDA.
❖ Hatch-Waxman balance out between innovation and
affordability. The Act also offers incentives to drug
manufacturing companies for R&D of innovative medicines.
Moreover, Hatch-Waxman offers affordability by
developing an abbreviated path for generic drug developers
to bring pharmaceuticals to market at a lower cost.
BASICS OF HATCH-WAXMAN ACT:
The Hatch-Waxman Act regulates the approval procedure, along
with the marketing of generic drug. Under this Act, the marketing
authorization procedure for generic drugs is streamlined.
New drug manufacturers were given protections in two ways:
• By providing market exclusivity to the drug innovator-
With a five-year data exclusivity to a new chemical entity, a
new kind of market exclusivity was introduced. During the
exclusivity period, the Food and Drug Administration
 (FDA) cannot authorize a generic version of an innovative
drug.
• Extension in the life of patents- The Act allows an
extension in patents life, covering the time a drug is under
FDA regulatory review. This makes sure that regulatory
review will not consume the life of a patent.
KEY COMPONENT AND OBJECTIVES OF
HATCH-WAXMAN ACT:

➢ Creating a patent litigation framework.

➢ Allowing generic manufacturers to reference the brand
manufacturer’s data.
➢ Providing incentives to generic manufacturers to challenge
patents for brand.
➢ Provide 5-years exclusivity period to brand drug
manufacturers.
➢ Providing brand manufacturers incentives to develop new
pharmaceuticals.
OBJECTIVES:
 The original intent of the act was to increase generic
drug availability in the market and make drugs more
affordable.
 The act sought to achieve the objective of increasing
competition with the introduction of a greater number
of generic drugs in timely manner and rewards
innovators with increased patent terms during which
they enjoy market exclusivity.
 The Hatch-Waxman Act amended the FD&C Act and
created Abbreviated New Drug process to submit
generic drugs to the FDA for approval.
 It also compensates the branded drug manufacturers for
the time lost from the patent term because of the
regulatory approval formality.
 Motivating the generic drug manufacturers.
HATCH-WAXMAN AMENDMENTS BENEFITS:

➢ This Amendments tells that the innovator should be notified

of the generics intent to challenge the patent. Thus, it helps
innovator to take timely legal action.
➢ Both the generic companies and the innovator companies are
provided with certain benefits by virtue of the ANDA
notification system.
➢ For the generic companies, the Hatch-Waxman amendments
provide an inventive a 180-day exclusivity period in which
no other ANDA for that drug can be approved.
➢ The innovator company filing of an ANDA for a product that
is intended to be marketed before expiration of the orange
book patent is an act of patent infringement. So, if the
innovator drug company brings suit within 45 days, the
 approval of the generic company’s ANDA is delayed for up
to 30 months or until a court rules otherwise.
 Under these amendments polymorphs and novel product are
patentable, provided bioequivalent. However novel
processes of old product are not patentable.
CONCEPT OF PARAGRAPH I TO IV:
 For filing ANDA, generic company must include a patent
certification as per section 505(j) (2) (A) (vii) of the Hatch
Waxman Act. This certification has to make one of the
following statements:
I. No patent information on the drug product that is the
subject of the ANDA has been submitted to FDA
II. That such patent has expired
III. The date on which such patent expires
IV. That such patent is invalid or will not be infringed by
the manufacture, use, or sale of the drug product which
the ANDA is submitted.
  Paragraph IV certification generic drugs can be sold during
the term of the innovator’s patent protection. However, to
overrule this paragraph certification, if innovator brings suit
within 45 days for patent infringement, then the generic
company’s ANDA cannot be approved for 30 months unless:
a. The court decides that such patent is invalid or not infringed. In
this case ANDA approval is made effective on the date of the
court decision
b. The court decides that such patent has been infringed and sets
a date for approval of the ANDA as provided.
c. The court grants a preliminary injunction prohibiting the
ANDA applicant from engaging in the commercial manufacture
or sale of the drug until the court decides the issues of patent
validity and infringement.
➢ Under the proposed rule, only the applicant submitting the
first “Substantially complete ANDA” with a paragraph IV
certification with respect to patent in the Orange book for the
listed drug would be eligible for exclusivity.
➢ The application must contain all of the information required
like bioequivalence, etc.
➢ Another way to lose exclusivity is to withdraw paragraph IV
certification either voluntarily or as a result of a settlement
or defeat in patent litigation by first applicant.
➢ The FDA has provided an exception in its proposed rule with
respect to loss of exclusivity due to an ANDA being not
substantially complete.
REFERENCE:
1. https://www.statnews.com/2020/12/16/unaffordable-
prescription-drugs-real-legacy-hatch-waxman-act/

2. https://berksiplaw.com/2019/06/the-hatch-waxman-
act-simply-explained/

3. https://www.uspharmacist.com/article/breakthrough-
therapy-and-the-hatchwaxman-act

4. https://www.everycrsreport.com/reports/R44643.html

5. https://kalkinemedia.com/definition/h/hatch-waxman-
act

6. https://medium.com/@shenlin2/patent-protection-and-
drug-development-b9b826ca1914

7. www.drugs.com/new-drug-applications.html

8. www.fda.gov