Patent reforms can shift research By Myrl Weinberg The Oklahoman 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 makers. 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 disease. 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 "unprofitable” diseases. 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 been profound. 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 degeneration. 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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