PATENT INTEGRITY FUELS AMERICAN PROSPERITY
By Reps. Ed Bryant and Jim McDermott

When we introduced the Patent Fairness Act of 1999, a measure to ensure patent equity for some brand name medicines, we were aware some might try to unfairly demagogue the issue. But we are disappointed that a recent report by the Washington Post's Charles Babcock included little recognition of the bill's goal of protecting the intellectual property rights guaranteed by the Constitution.

Few would dispute that innovation -- nourished by intellectual property protections -- has helped to forge our nation's economic success. Patent laws are a crucial part of this fabric, because they give innovators the chance to benefit from their ideas and labor. To keep American prosperity moving forward, it is imperative that the innovators - individuals and businesses - feel comfortable that their ideas and inventions will be protected.

That notion of fair reward for intellectual capital -- combined with the belief that hard work empowers individuals to build better lives for themselves and their families --> is the cornerstone of America's success. As we seek to expand prosperity, we must honor the benefits of innovation with policies that ensure the strongest protection for intellectual property.

Most people would be surprised to learn that there is only one "right" explicitly spelled out in the Constitution. It is a right to intellectual property:

"Congress shall have the power . . . to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries."

The message of the Founding Fathers was simple, straightforward and unmistakably clear that innovators should be able to benefit from their labors. This, in turn, provides the incentive to take the risks to create pioneering products that benefit us all.

Specifically, our legislation aims to encourage pharmaceutical companies to continue their efforts to discover and develop life-saving and life-enhancing drugs.

Pharmaceutical research and development is not a matter of simply walking into a laboratory one day, discovering a product, and putting it on the pharmacist's bench the next week. Sometimes, there are failures. Drug research is a marathon, not a sprint. It is expensive. And it is time-consuming. It costs more than $500 million to discover and develop one new medicine, and it can take 15 years between discovery and the time it is approved for sale by regulators.

Like the public, Congress has long recognized the value of this research. Fifteen years ago, in enacting the Hatch-Waxman Act, Congress acted to encourage pharmaceutical research by compensating drug companies for regulatory delays by providing additional patent protection.

But so-called "pipeline drugs" that were already in the Food and Drug Administration's approval process wound up getting shortchanged. Expecting quick approval of these drugs, Hatch-Waxman granted the pipeline drugs only two years of new patent coverage to account for the time they were expected to spend in the review process. But several drugs got stuck at FDA for five years or more, ending up with less patent coverage than anyone intended.

The loss of patent life is especially critical for pharmaceutical products because their patent life begins running out well before they get to market. While most products can be sold almost as soon as they receive patent coverage -- for effective patent exclusivity of up to 20 years -- pharmaceuticals typically are patented while still in the testing phase. By the time they receive regulatory approval, new drugs have lost six or seven years of patent life. The pipeline drugs covered by our bill lost even more -- and that costs revenues that could be used on new research.

H.R. 1598 provides a systematic way to redress this error by establishing an independent review process to consider each case on it merits.

In this context, it is vitally important to say what H.R. 1598 and similar Senate legislation S.1172 do not do. They do not extend a patent for any drug. Rather, they establish a fair and open process that will be conducted in a public forum. These bills would only apply to seven pipeline drugs that spent over 60 months in the FDA's New Drug Approval process. All affected parties would be able to make their case. All discussion would occur in the open, and the review would be bound by objective criteria. It's hard to see how anybody could be opposed to that.

It is the only fair solution. It reinforces our national heritage of intellectual property protection. It fuels the spirit of innovation that has made America a land of prosperity and economic opportunity. It provides patent integrity. And, in so doing, it specifically encourages research that leads to breakthrough drugs and other innovations that truly help people live longer and better lives.

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