Arrington Leads Bipartisan Effort to Address Patent Thickets and Increase Competition in the Prescription Drug Market

Representative Jodey Arrington (TX-19) led a bipartisan, bicameral group of lawmakers, including Representatives Doggett, Pfluger, Dingell, Issa and Jayapal and Senators Braun and Welch in introducing legislation to lower prescription drug costs by addressing patent gamesmanship. The U.S. patent system was designed to strike a balance between fostering innovation and encouraging competition. Protections around intellectual property (IP) are a cornerstone of American innovation and encourage companies to base their companies in the U.S. However, some companies have exploited this system by creating dense webs or “thickets” of patents around their most profitable drugs, blocking patients from accessing lower cost generic options.

New research shows that the thickets used by certain branded pharmaceutical companies are duplicative, and fail to make substantial improvements to the original drug. This practice delays competition and keeps drug prices high for hardworking American families. 

The newly introduced bill would curb the practice of patent thicketing, bringing much-needed competition to the domestic biosimilars market and increasing access to lower cost treatments and cures.

“America leads the world in medical innovation and Congress understands the necessity of strong IP protections. Groundbreaking research and development fuels our economy, improves quality of life for patients, and brings down healthcare costs – one of the drivers of our national debt,” said Rep. Arrington. “Unfortunately, loopholes in our current patent system allow manufacturers to file for duplicative patents that delay competition. I am proud to lead this legislation to ensure new patents include real innovation and bring additional value to patients.”

“I am excited to introduce bipartisan legislation alongside Congressman Jodey Arrington to eliminate patent thickets in the pharmaceutical industry—promoting fair competition and innovation. By allowing only one patent per terminally disclaimed group, we strike a balance to ensure every drug improvement receives proper protection without hindering innovation. Our goal is to lower drug costs for all Americans while fostering a competitive and inventive healthcare landscape. We invite our colleagues to join us in this crucial initiative," said Rep. Pfluger.

“The exceptionalism of America’s patent system is to be found in its commitment to protect our greatest innovations as well as promote the inventions and innovations that change the world,” said Rep. Issa. “But that system must also contain just as strong a commitment to fundamental fairness. This bill matters because it can deter gamesmanship in the patent system and streamline the process of determining when generic medicines can reach the market to provide the right treatment to the right patient at the right time,” said Rep. Issa.

“Creating a thicket of patents with multiple patent applications for the same idea is one tactic used by Big Pharma to block good ol’ fashioned American competition from generics. To encourage a healthy free market, this legislation ensures that when generic competitors successfully challenge one patent, the associated duplicates fall as well. This modest reform will encourage timely generic competition to drive down prices for patients and achieve savings for taxpayers. Much more is needed to combat Big Pharma’s monopoly pricing, but this bill represents a good step forward,” said Rep. Doggett.

“For far too long, Big Pharma has manipulated and abused the patent system to stifle competition and create monopolies on drugs. These practices raise prices for American families and too often put them out of reach of the patients who need them,” said Jayapal. “I’m so proud to join my colleagues in leading this bipartisan, bicameral bill to empower generic manufacturers to cut through ‘thickets’ and promote competition in the drug manufacturing market. This will be an important step to lower costs and ensure that hardworking Americans can afford lifesaving medications,” said Rep. Jayapal.

“Prescription drug costs continue to place an excessive burden on countless American families, and the misuse of our patent system by pharmaceutical companies is contributing to higher prices for consumers. This legislation will hold drug companies accountable for this unethical practice, help make prescriptions more affordable, and promote innovation and competition,” said Rep. Dingell.

“Protecting intellectual property is one of the things that makes the American economy so innovative, but often there are loopholes that allow the pharmaceutical industry to delay competition. Market competition is essential for keeping prices low, and this bill will go a long way to fixing one of those problems,” said Senator Braun.

“It’s egregious that because of Big Pharma’s greed, Vermonters pay three times more for prescription medications than people in other countries. For decades, Big Pharma has exploited U.S. courts and the patent system through anti-competitive practices that prevent generic and biosimilar competitors from entering the market, forcing Vermonters to pay more out of pocket for life-saving drugs,” said Senator Welch. “This bipartisan legislation will be a step forward in the fight to stop pharmaceutical companies from abusing the patent system. That will lead to fair competition and lower prescription drug prices. Congress needs to keep working together to cut drug costs for families and streamline access to care.”

“As the cost of delivering quality, affordable health benefits to workers and families continues to rise, ERIC appreciates the work of the bill sponsors to preserve and incentivize innovation in the life sciences sector by addressing patent thickets,” stated Melissa Bartlett, Senior Vice President of Health Policy at The ERISA Industry Committee (ERIC). “Employers support the careful balance between innovation and competition that Congress sought to create when passing the Hatch-Waxman Act in 1984 and the BPCIA in 2010. Practices like patent thickets can create barriers to competition, preventing employers and workers from unlocking drug savings. Congress should advance policies, like those in the bill, to help the more than 155 million Americans receiving health benefits through their employer continue to access innovative therapies while mitigating their out-of-pocket costs,” she added.

“Individuals living with Multiple Sclerosis (MS) rely on affordable access to life-changing medications to prevent disease progression, relapses, and irreversible damage. Patent system reform is necessary to protect innovation and prevent misuse of the patent system that delays generic and biosimilar competition. This legislation is an essential strategy to help people with MS and all who rely on expensive medications in gaining access to more affordable generic and biosimilar alternatives, said the MS Society.

“ACHP applauds the bipartisan commitment to addressing drug patent abuses. These gimmicks are used by drug manufacturers to simply make more money with no benefit to patients. Drug companies’ abuses of the patent system hinder the ability of lower cost generics or biosimilars to come to the market. This legislation is a necessary step to improving access and lowering costs of drugs for patients. ACHP looks forward to working with policymakers to see this legislation signed into law, and to continue working to ensure patients have access to lower cost drugs,” said Alliance of Community Health Plans (ACHP) President and CEO Ceci Connolly.

“Patent thickets impose a major barrier against patients who need high-quality and affordable generic drugs. Rep. Arrington’s commonsense proposal would ensure drug manufactures cannot game our patent system to artificially raise the cost of important medications. This will help put patients back in charge of their healthcare decisions,” said Governor Bobby Jindal, Chair of the Center for a Healthy America at The America First Policy Institute.

“As a researcher in the field of IP law, I applaud the sponsors of the bill for taking a narrow approach to combatting patent thickets by addressing the use of terminal disclaimers. This approach strikes a balance between fulfilling the public’s demand for cost effective and readily available medications, while also providing manufacturers with the incentives to foster innovation. Patents with terminal disclaimers are by definition non-patentably distinct from each other. Accordingly, it is likely unnecessary to assert multiple terminally disclaimed patents against a competitor.  More likely, manufacturers use these large patent families to unjustly delay or deter competitor market entry,” said Dr. Sean Tu, West Virginia University. “This bill will help drive competition. For generic and biosimilar firms the bill will help get lower cost drugs to market faster. For patients, the bill will promote better health outcomes. This legislation is also designed to avoid harming innovation because brand manufacturers will retain the ability to patent their inventions. However, they will be required to carefully select and enforce the most suitable patent.”

Bill Summary:

• This legislation rewards innovation by ensuring that every improvement to a drug gets the intellectual property protection it deserves.
• The bill does this by allowing a drug company to assert one patent per ‘terminally disclaimed group’ against a generic or biosimilar competitor, meaning if one patent in a family of duplicates is struck down by the courts, then all of its duplicates will also be invalidated.
• Very simply, a drug company can assert only one patent for each patentably-distinct improvement made on the drug. The more the drug is innovated, the more patents the innovator can assert against a generic or biosimilar manufacturer. 
• The bill applies only to patents asserted against generic and biosimilar drug manufacturers and does not impact other industries.

As authors of the bill, we are committed to working across the aisle to lower the cost of prescription drugs for our fellow Americans and generate savings for all patients, regardless of their healthcare coverage.