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Christensen: Hatch-Waxman Act’s Interpretations Threaten Lives, Jobs

Congress is on the verge of approving a significant modernization of our patent laws. While many have heralded this effort as a major catalyst for our economy, innovation and job growth, I  — as a physician and as a Congresswoman — would like to highlight one provision upon which the health, and in many cases the lives, of millions of Americans depends.

This provision — Section 37 of the patent reform legislation recently passed by the House of Representatives — will promote research in lifesaving medical treatments and will keep alive the opportunity to make dramatic advances in our fight against the major causes of death and disability. Enactment of this provision is critical. Lives are at stake.

Before new drugs can be sold, they must be approved by the Food and Drug Administration. That process takes many years, during which the company seeking FDA approval receives no commercial benefit from its drug.

But during this FDA waiting period, the clock is ticking on the company’s patent. In 1984, Congress enacted a law called the Hatch-Waxman Act to address this problem. The act restores the patent term lost while awaiting FDA approval, giving drug companies a better opportunity to recoup their substantial research and development costs.

Unfortunately, inconsistent interpretations of the Hatch-Waxman Act by the Patent and Trademark Office and the FDA have threatened to undermine the purpose of the law. Correcting this problem is critical to fostering the research and investment necessary to develop new lifesaving medicines.

Take the example of the drug Angiomax: a synthetic blood thinner that was approved by the FDA in 2000 and has been shown to reduce bleeding, shorten patient recovery times and save hospitals money. The drug was developed after eight years and $200 million of investment and has benefited more than 1 million patients. Angiomax is an alternative to heparin, an animal-derived drug that can cause dangerous side effects in some patients and that we know has had contamination problems that have resulted in patient deaths.

Angiomax is already approved for use in angioplasties, and preliminary research indicates the drug also can be used in additional therapies and procedures, including open heart surgery and the treatment of stroke and peripheral artery disease. Permitting further research on these additional uses to go forward could lead to the saving of thousands of lives.

That research has not yet been completed, however, because of the inconsistent interpretations of the Hatch-Waxman Act, which Section 37 would address. The PTO initially took the position that the company that created Angiomax missed its patent term restoration deadline by one day. For 10 years, the company sought to obtain the patent restoration to which it was entitled.

Fortunately, Judge Claude M. Hilton recently set aside the PTO’s interpretation and found that the filing was timely. This decision benefited not only the Angiomax innovator but also another company with a lifesaving drug that this month applied for patent term restoration based on Hilton’s decision. Section 37 of the House-passed patent reform legislation would affirm Hilton’s decision, ensuring that it applies to all patent holders.

Further research on Angiomax would be of particular importance to groups such as African-Americans and senior citizens, which are disproportionately affected by heart disease and stroke. Indeed, studies have indicated that Angiomax offers even more positive results in African-Americans and in the elderly than in the general population. For this reason, members of the Congressional Black Caucus have strongly supported addressing this patent provision.

Our country’s patent laws should protect and promote lifesaving research, not thwart its development because of inconsistent interpretations by government agencies.

By acting to approve the House-passed patent reform bill, the Senate can ensure that investments are made in innovative, lifesaving drugs that will not only preserve and improve the health and well-being of millions of Americans who are afflicted with or at risk for so many diseases and conditions, but will also create jobs.

This legislation, therefore, not only is noncontroversial, but it makes great health, scientific and economic sense.

Del. Donna Christensen (D-Virgin Islands) is chairwoman of the Congressional Black Caucus Health Braintrust.

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