The Supreme Court granted certiorari in Federal
Trade Commission v. Watson Pharmaceuticals, Inc., to address
whether and when "reverse payment" agreements made to
settle ANDA litigation violate antitrust laws. The Supreme Court
may decide whether such reverse payments should be evaluated under
the "scope of the patent" test (which upholds most
agreements) or the "quick look rule of reason" test
(which is more likely to find an antitrust violation). Oral
arguments are scheduled for March 25, 2013.
Reverse Payment Agreements
When a patented pharmaceutical product receives FDA approval,
any relevant patents are listed in the FDA "Orange Book."
When a would-be generic company files an Abbreviated New Drug
Application (ANDA) for approval of the same drug, it must make a
certification against each patent listed in the Orange Book.
Generic companies who want to enter the market before the patents
expire usually must make a "Paragraph IV certification,"
asserting that the
