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Patent abuse by Big Pharma must be confronted

by Rep. Ron Marshall
| September 12, 2023 12:00 AM

Pharmaceutical patents are a key instrument that promote innovation in America. They provide a financial incentive for pharmaceutical companies to invest in research and development, and allow them to recover costs and make a profit once their medication hits the market.

However, an alarming trend has emerged: companies are increasingly manipulating the patent system to create and extend monopolies on their drugs far beyond what is fair. This is not by any means what was intended when our patent system was created, and it has increasingly become one of the primary drivers of skyrocketing prescription drug costs.

Pharmaceutical manufacturers employ several tactics, including “product hopping,” “patent thicketing,” and “evergreening” to extend the amount of time their blockbuster drugs can be on the market without facing competition. Consequently, this patent abuse affects public health by forcing patients to pay higher prices for life-saving medications for longer. This problem is now pervasive — about 80% of the most commonly-prescribed drugs have had their patent protection extended at least once.

One of the most egregious examples of this practice is the case of Humira, AbbVie’s blockbuster Rheumatoid Arthritis drug. While Humira is facing competition for the first time ever this year, the drug remains a poster child for how Big Pharma has gamed the patent system to the detriment of patients. Over the course of its time on the market, AbbVie applied for 312 patents on Humira, securing 166 of those. Ninety-four percent these were filed after the drug was initially approved by the U.S. Food and Drug Administration, confirming that the brand name drug maker was seeking to extend the time the drug had on the market without facing competition.

The strategy has been more than successful for AbbVie. In Humira’s almost 20 years on the market without competition, the drug has brought in more than $200 billion for AbbVie. And just last year, the drug brought in more money for the Big Pharma company than all 32 teams in the NFL combined.

The pharmaceutical industry often claims their high prices and schemes to extend monopolies are justified by research and development (R&D) costs. But the facts don’t support their argument. Much of the R&D that results in new products is subsidized by U.S. taxpayers — and pharmaceutical companies often spend more on marketing and sales than on R&D.

Furthermore, the argument fails to address the morality of exploiting a system that denies millions of people access to essential medications.

Congress can make significant progress in addressing the pharmaceutical industry’s patent abuse by passing the Affordable Prescriptions for Patients Act, a bipartisan bill cosponsored by Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT). This bill would take steps to rein in some of the pharmaceutical industry’s more egregious abuses of the patent system while still allowing pharmaceutical companies reasonable patent protectionto recoup their R&D costs. No piece of legislation can solve every problem in a system as complex as healthcare, but it would be an important first step to address some of the industry’s most egregious abuses.

Patent abuse by Big Pharma is a critical challenge that we must confront for the sake of public health. It is time for policymakers, health advocates, and the public to intensify their scrutiny of this industry’s practices, demand accountability, and advocate for meaningful change. A balance must be found between encouraging innovation and ensuring access to essential medicines.

Rep. Ron Marshall serves House District 87 in the Bitterroot. He is a member of the House Human Service Committee.