Summary of ‘Hatch Waxman act and its amendments’

1. For innovator companies, the Act affords compensation for patent time lost in the
drug approval by granting up to five year extensions of the patent term.

2. For generic drug companies, the Act provides the incentive to challenge patents
by rewarding them with the so called ‘180 generic exclusivity’; if they are
successful in establishing that the patent is invalid or not infringed.

3. Every new drug approval requires the submission of the relavent patent
information to the FDA. The FDA publishes this information in the Orange Book.

4. A generic company seeking to enter the market must file an ANDA application
under the 505 (j) of the FDA. This patent must give one of four certifications/
statement to each patent listed in the Orange book.
(i) That such information has not been filed;
(ii) That such patent has expired;
(iii) The date on which such patent will expire; or
(iv) That such patent is invalid or will not be infringed by the manufacture,
use or sell of the generic drug.
viii Statement – The listed method of use patent does not claim the use for
which the applicant seeking approval (carve-out)
Limitation – Not permitted if renders generic less safe or effective than listed
drug for remaining non-patented condition of use.

5. An ANDA applicant making a paragraph four certification must provide notice to

the owner of the patent and holder of the listed drug. If, within 45 days of
receiving notice, the patent owner sues the ANDA applicant for patent
infringement, the ANDA approval is essentially stayed for 30 months.

6. Under the MMA, it is no longer possible for an NDA holder to “stack” 30-month
stays, i.e., obtain multiple 30-month stays by virtue of paragraph IV notifications
filed against later-listed patents.
 New rule only applies to patents submitted after 8/13/03.
Old rule if patent timely submitted ANDA would have to be amended if sued
triggered a new 30-month stay (FDA by regulation tried to limit through
notification)
 Multiple 30-month stays are possible if the paragraph III certification is amended
to a paragraph IV certification.
 Court may shorten or lengthen 30-month stay if either party to action fails to
reasonably cooperate in expediting action
 Court may issue an injunction against commercial marketing until decides thereby
effectively extending the 30-month stay
 Under the MMA, a 30-month stay will be terminated as of any of the
following:
(i) District Court decision that patent invalid, not infringed or not enforceable
(including any substantive determination that no cause of action)
(ii) Date of Settlement or Consent degree that patent invalid not infringed
(iii) Date of Court of Appeals decision reversing lower court decision of
infringement

7. 180-Day Exclusivity
 First to submit a substantially complete ANDA with Paragraph IV for listed patent.
 Prior to MMA (December 8, 2003) 180-day clock triggered by earlier of
commercial marketing or court decision.
 The Act clarified that the 180-day period starts upon marketing the ANDA
product, eliminating situations where the ANDA filer marketed the brand product
and the 180-day exclusivity period never began.
 Paragraph IV certification after MMA 180-day clock triggered by commercial
marketing, however subject to forfeiture.
 Forfeiture Events
(I)Failure to Market
(II)Withdrawal of Application
(III)Amendment of Certification
(IV)Failure to Obtain Tentative Approval Within 30 Mos.
(V)Agreement With Another Applicant, the Listed Drug
Application Holder, or a Patent Owner
(VI)Expiration of All Patents

8. There can be shared exclusivity is the case where more than one “substantially
complete” ANDA application is filed on the same day (by more than one ANDA
filer).
 First filers on subsequently (late) listed Orange Book patents do not have the
opportunity to gain shared exclusivity, in contrast to the situation under the old
rules.
 If the first applicant forfeits the 180-day generic exclusivity under any of these
specific forfeiture provisions of the MMA, no subsequent ANDA applicant will be
eligible for 180-day exclusivity.
 When FDA must make an approval decision for an ANDA, it will inform the
applicant that it is
(1) a first applicant and entitled to exclusivity
(2) a first applicant that has forfeited its exclusivity
(3) eligible only for TA due to another’s exclusivity
(4) eligible for FA because another forfeited exclusivity

9. MMA created a mechanism by which ANDA applicants can bring a declaratory

judgment action against the NDA holder if the NDA holder does not sue within its
45-day window after receiving notification of a paragraph IV certification.