In the U. S.,
patent protection on a new drug expires after 20 years. Since the
clock starts ticking before clinical trials can begin, by the time a
drug gets Food and Drug Administration (FDA) approval, it typically
has seven to twelve years of patent protection. After that, other
companies are free to sell generic equivalents, which usually cost
less than half the price of the original. The goal of pharmaceutical
houses is to extend that patent protection as long as possible by
whatever means necessary.
Abbott did not do the research and
development that led to fenofibrate. They bought it from another
company. They marketed it as Tricor-1 in 1998. However, their
patent was about to expire, and in 2000, another company, Novapharm,
announced its intention to produce a generic version. Abbott then
filed suit for patent infringement. This was a frivolous lawsuit,
but such suits are routine because when they are filed, they
automatically result in an injunction against the generic company
which prevents them from marketing the generic for 30 months. Drug
companies almost always lose these infringement cases, but they file
them anyway because the amount of money they make during the 30 month
waiting period is far greater than the cost of the lawsuit.
The 30 months also gave Abbott time to
get a patent for Tricor-2 and introduce it to the market. Tricor-2
was identical to Tricor-1 except for the dosage. Because it was the
same, no new clinical trials were required. By the time the 30 month
period had expired, Tricor-1 was no longer available and Tricor-2 had
cornered 97% of the fenofibrate market. It was useless to produce
the generic version of Tricor-1 because Tricor-2 had different dosage
levels, and pharmacists can only substitute generics when the dosage
levels are the same.
So the generic company announced its
intention to produce a generic Tricor-2. At this point, the story
begins to resemble the plot of the film Groundhog Day.
New lawsuit by Abbott. Another 30 month wait. Abbott announces
Tricor-3. It captures 96% of the market. Generic company intends to
produce generic Tricor-3. New lawsuit. Another 30 month wait.
Abbott announces Filibrix. Filibrix is fenofibric acid rather than
fenofibrate, which requires new clinical trials, but gets them an
additional three years of patent protection extending it to 2012.
By
this time, the generic companies had noticed the futility of their
strategy, so they filed suit against Abbott for violation of the
Sherman Antitrust Act. Abbott eventually settled that suit for $300
million, which was about 4% of what they made selling various
versions of fenofibrate. The authors estimate that the cost
to the public of using Abbott's versions of fenofibrate rather than
their generic equivalents is $700 million a year.
This
is not an isolated incident. Several other drug companies have done
the same thing. When the patent is about to expire on one of their
lucrative drugs, they make a trivial change and market it under a new
name in order to extend their period of exclusivity. This common
practice is called “evergreening.” (Get it?) It succeeds in
part because doctors don't pay attention to what's going on.
However, even if they had known about Abbott's psychopathic behavior,
there was nothing doctors or pharmacists could do because no generic
equivalent of fenofibrate has yet made it to the market.
To add
insult to injury, a large outcome study published in 2005 showed that
fenofibrate was ineffective in reducing the risk of cardiovascular
disease. But apparently the doctors weren't paying attention to that
either, because as of 2010, fenofibrate sales were still increasing.
There
is a serious problem with the FDA's system of granting patents. They
only require clinical trials that compare the new drug with a
placebo—an inactive pill that supposedly controls for patient
expectations. This allows different drug companies to market nearly
identical drugs, none of which are more effective than the others.
It also allows companies like Abbott to “evergreen” by
relabeling old drugs under new names. A more sensible standard would
be to compare the proposed new drug to the best existing treatment
and only grant a patent if the new drug produces a significant
improvement in patient outcomes.
In our
capitalist wonderland, it's useless to urge “corporate persons”
such as Abbott to behave more responsibly. They will pursue profit
however they can. It's probably also unrealistic to expect doctors
to read medical journals or prescribe available generics. They get
their pharmaceutical information from drug salespersons bearing
gifts—everything from ballpoint pens to free trips to Las Vegas (to
attend a medical “seminar,” of course). It would be nice if
Congress would make this legalized bribery illegal, but since they're
doing the same thing, that's not likely to happen.
Downing and his colleagues only suggest one governmental remedy—elimination
of the 30 month hold on the generic during a lawsuit. Otherwise,
they just recommend consciousness raising among patients, doctors, and
pharmacists. Good luck with that.
