The importance of the biotech and pharmaceutical industries to our economy is indisputable. Even more important than the dollars and cents, are the life-saving medicines these companies are developing. Continued investment in drug development depends on a strong and clear patent regime. The House of Representatives recently expressed its support for clarity in our patent laws, passing a reform bill that would clarify the procedure for filing certain patent term extension applications with the Patent and Trademark Office.
A provision of the Hatch-Waxman Act, passed in 1984, allows for the extension of a patent term to make up for marketing time lost during the often-lengthy process of obtaining FDA approval for a new drug or medical device. Given the enormous costs of developing new drugs, this type of patent term extension is critical to continued investment in drug research and development. During my 14 years on the House Judiciary Committee, I repeatedly heard that if drug developers lose a portion of the patent protection to which they are entitled, they will need to cut back on the amount of research they are able to conduct and, as a result, will bring fewer drugs to market.
For the Hatch-Waxman system to work, drug developers and investors must be able rely on these extensions. However, there have been inconsistent and confusing interpretations of this extension provision. Recently, a federal judge concluded that the Patent and Trademark Office and the FDA were interpreting the statute inconsistently, resulting in confusion regarding how to calculate the due date for these extensions. The court held that the Patent and Trademark Office had acted arbitrarily in rejecting an application for extension by a New Jersey pharmaceutical company -- The Medicines Company -- that makes an important anti-clotting medicine currently used to treat patients undergoing coronary angioplasty procedures.
The recently-passed House reform bill would eliminate this confusion by clarifying the way in which the extension due date should be calculated. The bill interprets the provision the same way it was interpreted by the federal judge in the recent case.
The Medicines Company invested hundreds of millions of dollars on the development of its synthetic anti-clotting drug. This drug has already been used by millions of patients undergoing coronary angioplasty procedures and has the potential to save countless more lives if important additional research is conducted. But this research, which could lead to the treatment of additional diseases, including heart attacks, strokes and peripheral artery disease, has been stalled due to uncertainty about whether the company will actually receive the patent term extension to which it is entitled under the Hatch-Waxman Act.
If passed, the reform bill would provide drug developers and investors with needed certainty, by simply making clear that the recent court decision correctly states the law for all applicants. Many patent holders could benefit from this clarification and thousands of lives could be saved. In just the last month, two other companies have asked the Patent and Trademark Office to apply the same interpretation of the extension due date calculation that the reform bill, if approved, would confirm.
As patent reform moves to the Senate for final passage, the Senate should keep in mind the importance of this provision and make sure it remains part of the final legislation.