There is a movement afoot to reform the system enacted to address patent disputes between pioneer drug developers and their generic drug competitors. When this system, referred to as the Hatch-Waxman Act, was passed in 1984, it was intended to balance the competing interests of pioneer pharmaceutical manufacturers and the generic drug industry. Critics of the amendments say they have set the stage for near-obligatory litigation between pioneer pharmaceutical companies and generic drug companies before the launch of nearly every new generic drug. With the huge growth in the generic drug industry, the result is an intensely competitive pharmaceutical market where life and death battles are fought in the courts. Certain reforms will more equitably balance the policies of the patent system, and assist in…
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Barbara Carter is an Associate with Bromberg & Sunstein LLP, a Boston law firm concentrating in intellectual property, business, and litigation.