[Ip-health] NitroMed patent for preexisting drug for a new, race-specific indication

[Alexander Tsai]

The New England Journal of Medicine recently published the results of the
African-American Heart Failure Trial (AHeFT), in which they found that a
fixed dose of both isosorbide dinitrate and hydralazine benefited black
patients with advanced heart failure who were already receiving standard
therapy for heart failure.

The abstract can be found here:
http://content.nejm.org/cgi/content/short/351/20/2049

There is an accompanying commentary by Gregg Bloche (subscription required):
http://content.nejm.org/cgi/content/full/351/20/2035

"NitroMed's race-specific strategy promises another large business benefit.
Two years ago, NitroMed obtained a second patent, this one based on the use
of the formulation in blacks. This patent, the first ever granted to a
preexisting drug for a new, race-specific use, pushes back potential market
entry by generic sellers of the fixed-dose combination from 2007 to 2020."

"The ease with which race can be used as a crude marker for clinically
relevant biologic difference makes it attractive as a basis for bringing
pharmaceutical products to market. But once a pharmaceutical firm has
obtained patent protection and regulatory approval, it has little incentive
to sponsor research aimed at elucidating the relevant genetic variations and
their physiological manifestations. Indeed, such research risks shrinking
the demand for a drug, by subtracting patients who lack the genetic markers
that predict a good response. Such research is a classic "public good" in
the economic sense: absent government support (or state-imposed obligation),
it will tend to be undersupplied by market actors. And without the needed
follow-up science, racial categories are at heightened risk of being reified
as biologic."

--
Alexander C. Tsai
Case Western Reserve University