Commentary - Jeffrey Mazzella: Congressional solution for patent law’s unintended consequences

While this may seem far-fetched and unrealistic, an anomaly currently exists in our nation’s patent law that puts intellectual property — a driving force of the U.S. economy — at risk under scenarios similar to those outlined above.

In 1984, Congress passed the Hatch-Waxman Act, which among other things allows for an owner of a drug patent to seek restoration of the part of its patent term lost while awaiting Food and Drug Administration approval — which is usually a lengthy process. Under the act, owners of the drug patent must file for such patent-term restoration within 60 days of FDA approval.

Despite more than 30 instances in patent law and regulations in which the Patent and Trademark Office has discretion to excuse minor mistakes such as filing errors under Hatch-Waxman, an application unintentionally filed even one day late must be denied. The PTO director possesses absolutely no discretion.

Such a rigid command creates unfair outcomes, threatens innovation and arbitrarily jeopardizes enormously valuable property rights.

When years of patent protection must be forfeited because of minor filing errors, not only are millions of dollars lost by the patent holder, but significant benefits that might result from further development of a lifesaving drug are lost as well.

Take, for example, the drug Angiomax, marketed by The Medicines Company. According to reports, in 2001 the company filed its application for patent-term restoration one day late, and the application was denied on account of the strict Hatch-Waxman deadline.

Angiomax is now used as a blood thinner to prevent heart attacks in patients undergoing coronary artery stent procedures. But the drug also shows considerable promise protecting patients undergoing stent procedures against strokes.

Since stroke is the leading cause of disability and third-leading cause of death in the nation, and heart problems cause some 5 million Americans to be rushed to emergency rooms every year, it’s clear that Angiomax could be enormously important to millions of patients.

Yet, the extremely costly clinical trials needed to further test these new uses of an already approved drug are not feasible if years of earned patent protection are lost due to a minor filing error.

Recognizing the inequity of the rigid deadline in Hatch-Waxman, last year Congress considered narrowly tailored, bipartisan legislation to correct this unfair anomaly in patent law.

Specifically, the legislation would have granted PTO the discretion, whenever fair and appropriate, to accept patent term restoration applications within five days after the current 60-day deadline if the PTO found that the filing delay was unintentional.

The legislation passed the U.S. House of Representatives toward the end of the last session of Congress, but time ran out before it could be considered and acted upon in the Senate.

Given the substantial support in Congress, there is every reason to believe that bipartisan legislation to provide the PTO with much needed flexibility will be introduced in the 110th Congress.

As a matter of both intellectual property protection and public health, Congress has the opportunity to eliminate inequitably harsh provisions and provide important benefits to innovators and patients that are fully consistent with patent law and practices established under the Hatch-Waxman Act.

Just as it would be unfair and economically disastrous for the government to start seizing people’s homes for unintentionally filing their property taxes one day late, so too is it unfair and costly to public health and innovation for owners of drug patents to lose their hard-earned intellectual property for unintentional filing errors.

Jeffrey Mazzella is president of the Center for Individual Freedom.