By
Kevin E. Noonan —

Last
week, Senator Al Franken (D-MN) was joined by Senators David Vitter (R-LA),
Dick Durbin (D-IL), Jeanne Shaheen (D-NH), and Bernie Sanders (I-VT) in
introducing S. 504, the "Fair and Immediate Release of Generic Drugs Act."  Like many of its predecessors, it is aimed
at banning settlement agreements of ANDA litigation between innovator drug
companies and generic drug manufacturers.

The
bill contains provisions that preclude the 180-day exclusivity period granted
to the first ANDA filer from any party that has entered into a "disqualifying
agreement."  Another provision
limits agreements on deferring commercial marketing, which are defined as being
between a first ANDA filer and NDA holder (or owner of an Orange Book listed
patent that was the subject of a Paragraph IV certification) and wherein the
first filer agrees "not to seek an approval of its application that is
made effective on the earliest possible date" or "not to begin the
commercial marketing of its drug on the earliest possible date after receiving
an approval of its application" or both.  More specifically:

An agreement described in this subclause is an agreement between an applicant and
the holder of the application for the listed drug or an owner of one or more of
the patents as to which any applicant submitted a certification qualifying such
applicant for the 180-day exclusivity period whereby that applicant agrees,
directly or indirectly, not to seek an approval of its application or not to
begin the commercial marketing of its drug until a date that is after the
expiration of the 180-day exclusivity period awarded to another applicant with
respect to such drug (without regard to whether such 180-day exclusivity period
is awarded before or after the date of the agreement).

If
there is more than one possible date where an applicant can either "seek
an approval of its application or begin the commercial marketing of its drug,"
then the ANDA applicant can seek approval or begin commercial marketing on the
earlier of the latest date set forth in the agreement or 180 days after "another first applicant"
begins commercial marketing.  That latest
date in an agreement "shall be the date used to determine whether an
applicant is disqualified from first applicant status."

The
bill also contains a notice provision to the FDA that requires that the "text"
of any agreement "that has been reduced to writing" (or a "written
detailed description" of any agreement not reduced to writing) be
submitted to the Secretary of HHS "not more than 10 business days after
execution of the agreement."  And
the bill contains a confidentiality clause providing that "[a]ny information
or documentary material filed with the Secretary pursuant to this paragraph
shall be exempt from disclosure []and no such information or documentary material
may be made public, except as may be relevant to any administrative or
judicial action or proceeding (although another provision states that there is "nothing"
to prevent disclosure to either body of the Congress or to any duly authorized
committee or subcommittee of the Congress).

35
U.S.C. § 271(e) is also amended to
recite:

(7) The exclusive remedy under this section for an infringement of a patent
for which the Secretary of Health and Human Services has published information
pursuant to subsection (b)(1) or (c)(2) of section 505 of the Federal Food,
Drug, and Cosmetic Act shall be an action brought under this subsection within
the 45-day period described in subsection (j)(5)(B)(iii) or (c)(3)(C) of
section 505 of the Federal Food, Drug, and Cosmetic Act.

Application
of these provisions is limited to agreements subject to the amendments made by
the Medicare Prescription Drug, Improvement and Modernization Act of 2003.

It
is the responsibility of the prevailing party in the litigation to notify the
FDA.

For
those keeping track, the Supreme Court will decide FTC v. Activis this term, perhaps rendering the bill moot.  The proximity of the bill and the Court's
deliberations suggest that these Senators may be expressing their displeasure
with "pay for delay" agreements and that they recognize the political
capital that can be garnered by taking this stance.