The US Supreme Court shot down
requests to review a case that lawyers for
the generic drug industry hoped would
speed the marketing of lower-cost generic
pharmaceuticals. The case, filed by
Winnipeg, Canada-based Apotex Inc,
sought to invalidate Pfizer Inc's patent for
Zoloft (sertraline) on the grounds that the
brand name manufacturer refused to
bring legal action against Apotex during
the FDA approval process. A branded
manufacturer's refusal to sue a potential
generic competitor at this stage of the
process can create uncertainty for the
market because it leaves open the possibility
of a patent challenge after the generic
firm begins manufacturing its product.
In its unsuccessful appeal to the high
court, Apotex argued that the possibility
of litigation after distribution of its version
of Zoloft was under way would leave the
company facing "potentially crippling
patent liability." The Generic Pharmaceutical
Association, which had filed a
"friend of the court" brief in support of
Apotex'position, expressed disappointment
in the Supreme Court's action, noting
that the justices failed to seize the
opportunity "to improve consumers'
timely access to affordable medicine."