THEY SAID IT! “HOW PHARMA WEAPONIZES A WORD TO EXTEND MONOPOLIES”

Big Pharma Hides Behind False Innovation Rhetoric to Maintain Rampant Abuse of the U.S. Patent System, Block Competition and Keep Drug Prices High

In case you missed it, an op-ed published in STAT News authored by Tahir Amin, founder and CEO of the Initiative for Medicines, Access & Knowledge (I-MAK) and Rohit Malpani, consultant and former director of Policy for the Médecins Sans Frontières Access Campaign, details how Big Pharma deploys false innovation rhetoric to justify abuse of the patent system, extend monopoly pricing and block competition from more affordable alternatives.

The piece explains how brand name drug companies use a variety of anti-competitive tactics, like securing additional patents on minor product changes, to prolong monopolies, block lower-cost competition and keep prices high. As the authors note, “today’s patent system has become more of an exclusivity system for financial investment and not invention as originally intended.”

The piece highlights AbbVie’s blockbuster drug Humira, which has long drawn scrutiny as a case study of Big Pharma’s patent abuse and price-gouging behavior. AbbVie’s strategy to block competition and consistently increase the drug’s price has come at a significant cost to patients and taxpayers. During a 2019 Senate Finance Committee hearing, AbbVie CEO Richard Gonzalez acknowledged the company had accumulated 136 patents on Humira, allowing the company to stretch monopoly protection 18 years beyond Humira’s original patent expiration in 2016 and block more affordable biosimilar competition for seven additional years. As the piece notes, “AbbVie had extracted an extra seven years of market monopoly between 2016 and 2023 thanks to its thicket of patents for its so-called innovations.”

Those additional years of monopoly pricing generated massive revenues for AbbVie — while keeping prices high for American patients. The article reports that AbbVie earned $114 billion from Humira during the seven years after the drug’s original patent expired, more than the company earned in the 13 years after Humira was first approved by the U.S. Food & Drug Administration (FDA) in 2002. This strategy also allowed the company to continue hiking Humira’s price, which increased 470 percent since launch and reached roughly $77,000 for a year’s supply.

According to the authors, documents from a U.S. House Oversight Committee investigation showed a consultancy firm advised AbbVie on ways to block biosimilar competition for Humira by “finding ways to build product extensions, called ‘differentiating the product.’ This included finding different conditions the drug could be used to treat; formulation or dosage changes; new processes for making the drug; and then obtaining patents on these ‘new products,’ or innovations. Through this approach, AbbVie identified that it could block the development pathways of competitors while also allowing the patents to be used through aggressive litigation to tie up its rivals in court for at least five years.”

But Humira is not an isolated example. As the authors write, “The business model of using patents and the language of innovation to justify prolonged patent monopolies that keep knowledge privatized for longer than necessary is endemic across the pharmaceutical industry.”

That pattern is especially common among Big Pharma’s blockbuster drugs. Research cited in the piece from I-MAK found that, on average, there were 74 patents granted on each of the 10 top-selling drugs in the United States in 2021, with companies filing more than 140 patent applications on average per drug. Two-thirds of those filings came after FDA approval.

The STAT piece makes clear that many follow-on patents do not represent meaningful clinical innovation. Instead, these patent strategies allow brand name drug companies to extend exclusivity, delay competition from lower-cost generics and biosimilars and continue charging high prices for patients, taxpayers and the U.S. health care system.

Congress and the Administration must work together to lower drug prices by fostering competition, strengthening oversight of the U.S. patent system and curbing Big Pharma’s egregious anti-competitive tactics with bipartisan, market-based solutions.

Read the full STAT op-ed HERE.

Read more on Humira as a case study in Big Pharma greed HERE.

Read more on how Big Pharma games the system to block competition and keep drug prices high HERE.

Read more on bipartisan, market-based solutions to hold Big Pharma accountable HERE.