Opinion

We Must Not Weaken the Patent Laws that Lead to Cures

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A pharmacy employee looks for medication as she works to fill a prescription while working at a pharmacy in New York on Dec. 23, 2009. Patent laws for medicine, which protect larger pharmaceutical companies from competition with knockoff versions of their medicines, could be harder to enforce under the Innovation Act. Lucas Jackson/Reuters

Last month, 17-year-old Johnny Escolero became one of the first Americans to undergo a newly approved epilepsy treatment. The revolutionary device implanted in his chest will reduce the frequency of his seizures, which, before the procedure, would occur up to 250 times a day.

Breakthroughs like this offer hope to the nearly 3 million Americans living with epilepsy—particularly the one-third who do not have their seizures under control with existing treatments.

At a time when we need to be creating incentives for investment in innovative therapies, Congress is considering epilepsy research that could make future advances in treating epilepsy all too rare. Lawmakers must rework the Innovation Act to avoid weakening the patents that sustain medical research.

When it comes to developing medical treatments, patents play an indispensible role. It takes an estimated $2.5 billion—and often longer than a decade—to bring a single new medicine to market, according to researchers at Tufts.

Investors are willing to shoulder this considerable cost because, once a drug is approved, they can recoup their money through exclusive sales of the medicine. This arrangement only works because of patent protections, which prevent a drug firm's competitors from releasing a knock-off version of the patented therapy.

The Innovation Act poses a threat to this drug discovery process. The bill creates a host of new administrative hassles for those defending their patents in court. New legal expenses and time burdens could deter researchers from pouring funds into drug development because the patents that make such development financially viable would be harder to enforce.

The Innovation Act would compound problems that have arisen since the 2012 creation of the Patent Trial and Appeal Board (PTAB), a panel of judges tasked with settling patent disputes out of court.

Congress formed the PTAB to review the overly broad patents used by patent trolls—businesses that use the threat of patent "infringement" lawsuits to shake down companies for licensing fees and settlement payouts. The PTAB has the power to evaluate the legitimacy of challenged patents and rule them invalid.

But the standard of evidence that the PTAB uses to determine illegitimacy is so low that the board has invalidated a large number of strong patents—even ones that were ruled legitimate by district courts.

This anti-patent bias harms patients by exposing drug developers to PTAB challenges launched by speculators and hedge fund managers who file PTAB challenges against pharmaceutical patents to drive down the value of pharmaceutical stocks they’ve bet against.

For drug makers, the Innovation Act and the PTAB add new hazards to already risky research and development endeavors. If investors lose confidence in the validity and enforceability of drug patents—which offer firms a chance to make back their investment—private funding for future therapies will evaporate. Drying up the drug development pipeline would dash the hopes of millions of Americans living with debilitating chronic conditions who are waiting for new treatments and cures.

This scenario is particularly troubling for patients with epilepsy—a condition that already receives scant attention. This year, the National Institutes for Health (NIH) committed $156 million to epilepsy research, but this is still a small fraction of what the federal government spends on other conditions with similar prevalence.

If the Innovation Act and the PTAB lead private firms to forgo investing in epilepsy therapies, some of the most promising areas of research may be abandoned. Lawmakers should protect such research by rejecting the Innovation Act and any other laws that make it more difficult to enforce patents in court. Congress should also exempt medical patents from the PTAB's biased review process.

By doing so, lawmakers will encourage continued research that provides life-changing treatment to millions of Americans with epilepsy and other chronic conditions.

Philip M. Gattone is president and CEO of the Epilepsy Foundation.

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