America Invents Act

Floor Speech

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Mr. GARRETT. Madam Chair, the Hatch-Waxman Act provides for the extension of patent terms covering drug products that must be approved by the FDA. And the extension that we're talking about here, while seemingly straightforward, the Patent Office and the FDA have interpreted it, as we have said, in two different ways, creating uncertainty that has led to miscalculations.

So our amendment, consistent with a court ruling, will clarify that when the FDA provides the final approval after normal business hours, the 60-day clock begins on the next business day. So by doing this, by ensuring that patent holders will not lose their rights prematurely, what this amendment does is it will not only resolve a longstanding problem but will encourage the development of innovative new drugs as well.

With that, I urge the adoption of this very commonsense amendment.

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