Tillis bill would protect health care innovation

Tillis bill would protect health care innovation

This Opinion Editorial by former Republican N.C. House member, Chris Malone appeared in the print edition of The Wake Forest Weekly on February 21, 2019.

In his State of the Union address, President Trump called on Congress to work with him on continuing to lower the cost of prescription drugs, drawing applause from both Republicans and Democrats in the audience. The president’s overall goal is correct – health care costs continue to rise in America. But the proposals put forth to address this problem are often a mixed bag. Thankfully, some in Congress are acting on a variety of unsexy, but important, measures to bring down drug prices and health care costs. Among them is Sen. Thom Tillis, who is leading the charge against patent abuse in the U.S. Senate.

Sen. Tillis’s bill, the Hatch-Waxman Integrity Act, would cease the practice of never-ending attacks on pharmaceutical patents; these frivolous challenges drive up the cost of medicines and disincentivize the creation of new drugs. Tillis’s work is a perfect example of putting action above rhetoric and tackling a specific cause of rising drug prices.

Intellectual property protection isn’t exactly an applause line in a State of the Union speech, but it’s important in incentivizing innovation. This is especially important in the pharmaceutical industry, where drug companies must spend billions of dollars to research and develop lifesaving drugs, many of which never successfully make it to market.

Our current drug patent system is stacked against those innovators whom invest so heavily in new medicines. Generic drug companies – those that copy the formulas of drugs invented by branded companies – are allowed multiple opportunities to challenge and overturn the patents of drugs they want to copy and produce, even if the patent in question has already been upheld by a federal judge.

There are two pathways in place for generic companies to challenge this IP, and if they fail at one, they simply try the other. This process forces branded pharmaceutical companies to defend themselves against multiple attacks, often completely without merit, spending time and money litigating legitimate patents. If the patents are overturned, thanks to the ongoing assault, the billions invested in research and development evaporates in the face of generic competition.

Competition is good, but so is an incentive to innovate. If branded pharmaceutical companies aren’t given patent protection – the exclusive right to market a product for a period of time – why would they spend billions to develop a drug, knowing someone will immediately copy it and sell it for pennies on the dollar?

That’s where Sen. Tillis’s Hatch-Waxman Integrity Act comes in. It still allows generic companies to challenge drug patents. Of course, where patents are invalid, we want to allow for competition in the drug market. But the Tillis bill only allows generics one shotat winning. If they challenge a patent under one of the two existing pathways and loses, that’s it. If they win, they get to enter the market immediately.

Generic drug companies are howling about the legislation, because that’s the way things work in Washington. Everything is a zero-sum game, where one industry benefits while the other thinks it gets a raw deal.

But how can anyone argue with such an incremental approach, that still allows generic competition without enriching lawyers to over-litigate? How can we ignore the chilling effect that nonstop litigation has on pharmaceutical innovation – which literally saves lives? Why do we give generics a free pass to gum up the drug approval system and raise health care costs in the process?

President Trump’s rhetoric during the State of the Union was completely on point. Congress needs to work with the White House to bring down health care costs. It looks like Sen. Tillis is the first Member of Congress to answer the call. The U.S. Senate should follow his lead.

– Chris Malone of Wake Forest is a Republican former N.C. House member.


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