Patent reforms can shift research
Patent reforms can shift research
By Myrl Weinberg
August 2, 2008
Congress has a unique opportunity to help the millions of Americans afflicted by neglected diseases. The
Patent Reform Act, now being considered in the Senate, could rework the national patent system to
encourage breakthrough treatments for many chronic conditions that too often go unaddressed by drug
Currently, some federal lawmakers are pushing for broad "reforms” to either lengthen or shorten patents
across the board. This one-size-fits-all approach gives little consideration to how such changes to patent
law impact medical research and wastes a significant opportunity. This is the wrong approach.
History shows that strengthening patents in a strategic and targeted way is essential in the fight against
In 1983, Congress passed the Orphan Drug Act, extending the patent protections for drugs targeted
toward so-called "orphan” illnesses, which have low incidence rates and are therefore unlikely to be
profitable ventures for pharmaceutical firms.
The result was an unprecedented influx of drugs for previously ignored diseases.
Since the passage of the Orphan Drug Act, 282 new orphan drugs have been approved — compared with
just 10 in the 1970s.
The lesson learned is that even slight modifications to intellectual property rights can create powerful
incentives for new pharmaceutical research. Longer patents mean that firms have more time to recoup
their investment, providing an incentive for research aimed at developing drugs for long-ignored and often
It's a similar story for the Best Pharmaceuticals for Children Act, passed in 1998. The law added six
additional months to patents for drugs that had undergone safety tests specifically for children.
Previously, most drugs were tested only for adults, making their effects on children largely unknown.
Over the next three years, drug makers conducted more than 300 pediatric studies. That's 25 times more
pediatric studies than in the six years prior to the act's passage. The benefits to children's health have
For example, one study found that young patients routinely received an inadequate dosage of the
painkiller Neurontin. Many hospitals immediately adjusted their protocols accordingly, saving an untold
number of children from unnecessary suffering.
Congress should take its cue from history and use the Patent Reform Act to grant additional drug patent
extensions to reward research into today's neglected diseases, like autoimmune disease and neurological
With the Patent Reform Act, Congress can strategically alter patent law to direct research into areas that
have not been a priority for the pharmaceutical industry. It should seize this opportunity to modify patents
to improve the health of millions suffering from neglected diseases.
Weinberg is president of the National Health Council.
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