Big Pharma Drug Patent Abuses Cost Medicare Billions: Report

When the Inflation Reduction Act became law in 2022, it included a historic provision that gave the Centers for Medicare and Medicaid Services (CMS) the ability to negotiate maximum fair prices for select drugs. This means that CMS now has an important tool to resist high prices imposed by pharmaceutical companies and lower the cost that Medicare recipients pay for their drugs. So far, Medicare has negotiated the maximum fair prices for 10 drugs, which will go into effect January 1, 2026.

But according to a report released Wednesday by the watchdog group Public Citizen, the manufacturers behind these drugs are able to rely on another method to protect their profits: patent abuses and evergreening tactics.

The report defines "evergreening tactics" as the practice of "patenting trivial and/or obvious modifications of existing medications to lengthen exclusivity on branded medicines."

The makers of the drugs Eliquis, Imbruvica, Jardiance, Farxiga, and Entresto, for example, obtained patents on what constitute trivial or minor changes to earlier patent claims, "such as crystalline forms of drug compounds which would be discovered and managed during routine testing that is part of the drug approval process," according to Public Citizen. These new patents allow the manufacturers to extend their monopoly on these drugs.

"Big Pharma patent abuse is cheating Medicare enrollees of more affordable drugs and costing taxpayers billions," said Public Citizen Access to Medicines program researcher Jishian Ravinthiran in a statement.

"Patent abuses enable Big Pharma companies to unfairly extend their monopolies and keep prices artificially high. As CMS negotiates the prices Medicare will pay for top-selling drugs, it should take into account the billions we've already lost due to these patenting tactics," he added.

The report makes this same point, arguing that the agency's initial offers on pharmaceuticals should take into account how long-monopoly drugs have been able to obtain longtime exclusivities on medicines by manipulating patents.

This is paramount, Public Citizen argues, given the scope of lost savings. The group estimates that Medicare will lose somewhere between $4.9 and $5.4 billion in savings that should have accrued to taxpayers if four out of the 10 drugs did not take advantage of patenting tactics, and therefore would have faced greater competition prior to negotiation.

"These lost savings are nearly as much as what Medicare is expected to save if negotiated prices go into effect on all of the selected drugs in the first year of the program ($6 billion)," according to the report.

As an example, the drug etanercept, which is marketed as Enbrel, is on the list of 10 drugs that will be subject to a negotiated cap come January 2026. Etanercept's maker Amgen did not contribute to the original research and development of etanercept, per Public Citizen, it just acquired the original maker of the drug, Immunex, in 2002.

Immunex's patent of etanercept was set to expire in 2019, but "by using abusive patent practices" Amgen was able to extend the patent protections through 2029, according to Public Citizen. Amgen was able to evade competition of two potential "biosimilar" competitors, Erelzi and Eticovo, which received FDA approval in the 2010s.

Referencing analysis done in a separate report, Public Citizen estimated "that biosimilars could have entered the market after August 2019 were it not for Amgen's unwarranted patent exclusivities, and we calculated Medicare would have spent $1,891,500,836 less on a net basis had enrollees been able to use lower-cost alternatives by the time negotiated prices go into effect on January 1, 2026."