American Invents Act

Floor Speech

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Mr. GALLEGLY. Madam Chair, I rise in support of this amendment.

Development of new prescription drug therapies is critically important if we are to successfully treat--or even cure--diseases such as cancer, ALS and juvenile diabetes.

The problem is that medical research is expensive. A researcher can spend years trying various drug combinations before developing one that may be approved for testing in humans, and it can take even more years after that to get final Food and Drug Administration, FDA approval. If patent protection expires soon after the drug is approved, companies may not be able to recover their investment, which would lead to less research and development.

Congress recognized this problem when it passed the Hatch-Waxman Act in 1984. Hatch-Waxman provides for extended patent protection if the company applies within 60 days after the FDA approves a new drug.

Unfortunately, the FDA and the Patent and Trademark Office have different interpretations of when the company must file the application. The resulting confusion and uncertainty may be discouraging people from investing in life-saving medical research.

This amendment simply clarifies when the 60-day period begins. This is completely budget neutral and does not make any substantive change to the law.

I urge my colleagues to support this common sense amendment.

Mr. GALLEGLY. Madam Chair, I rise in strong support of this bill. First, I would like to recognize Chairman Smith's extraordinary work on behalf of American inventors. This bill is a well-crafted compromise that will streamline the patent process, while improving the quality of patents.

Although I do not support every single provision of this legislation, it is critical that the House of Representatives pass H.R. 1249.

I am especially pleased that Chairman Smith included a provision that helps many businesses in the United States, including several in my district, who have been forced to spend time and money to defend themselves against so-called ``false marking'' lawsuits.

By law, patent holders are required to place the patent number on their products. The problem is that after the patent expires, it may be very costly for a business to recall their products to change the label. Unfortunately, several law firms have discovered that suing these manufacturers can be lucrative, and we have seen a sharp increase in the number of these nuisance lawsuits.

This bill includes a common sense solution that will stop these lawsuits and allow employers to devote resources to developing new products and creating jobs.

I urge my colleagues to support this important legislation.

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