Dose of Reality: I-MAK Report Outlines How Big Pharma Extends Monopolies to Keep Drug Prices High

Analysis Demonstrates Tremendous Cost of Anti-Competitive Tactics Like Patent Thicketing and Product Hopping That Undermine More Affordable Alternatives to High-Priced Blockbusters

In case you missed it, a recent report from the Initiative for Medicines, Access & Knowledge (I-MAK) details the myriad egregious strategies brand name drug companies execute to extend monopoly pricing and delay competition from more affordable alternatives — keeping drug prices higher for longer.

The report, titled “The Monopoly Extension Menu,” outlines how Big Pharma chooses a variety of tactics – or “monopoly entrees” – to build complementary layers of patent protection on blockbuster drugs within their portfolios to keep prices high. In the study, I-MAK analyzed three high-spend Medicare drugs – Bristol Myers Squibb’s blood cancer drug Pomalyst, Janssen’s multiple myeloma treatment Darzalex Faspro and GlaxoSmithKline’s COPD drug Trelegy Ellipta – examining how each pharmaceutical company relies on a familiar playbook of legal and regulatory maneuvers to block or delay competition. According to the report, these three drugs “account for $9.9 billion in annual Medicare spending, and rank among the highest-cost drugs in the program,” with “costs that have doubled since 2021.”

“Rather than relying on new molecular breakthroughs, branded pharmaceutical companies extend their market dominance by ‘ordering’ from a curated array of schemes to extend their monopoly: filing dense thickets of follow-on patents to block or delay the entry of competitors, migrating patients to a different formulation to reset the patent monopoly clock, and combining drugs with staggered expiration dates with patented delivery systems. The result is a system-level failure where business and legal gamesmanship extracts billions of dollars in excess spending from patients, insurers, and taxpayers long after the original invention has matured,” according to the report.

Big Pharma’s anti-competitive tactics translate into billions of dollars in additional spending for patients and the U.S. health care system. For instance, Bristol Myers Squibb’s aggressive patent litigation stalled generic entry for its blood cancer drug Pomalyst by two years, keeping U.S. prices more than double those in countries with generic competition – while the brand name manufacturer generated more than $5 billion in revenue from this one drug alone.

The report highlights how these tactics are not isolated to one drug or one company. Instead, they are part of a broader pattern across some of the best-selling medicines, where the timing of patent expiration and litigation can all be used to prolong monopoly conditions. Janssen’s “product hopping” strategy for multiple myeloma treatment Darzalex Faspro involved filing formulation patents to shift from an intravenous to subcutaneous version, as well as device and method of treatment patents to extend market exclusivity more than twelve years beyond the original compound’s expiration. 

GlaxoSmithKline (GSK), the maker of its top‑selling COPD drug Trelegy Ellipta, similarly deployed a “patent evergreening” strategy by bundling the drug’s active ingredients with staggered patent expiration dates, effectively extending its monopoly period by more than seven years. These reformulations and patent strategies do not meaningfully advance clinical innovation or improve patient outcomes but instead delay competition from more affordable alternatives like generics and biosimilars to keep prices high.

As the report states: “[t]o prevent the continued extraction of billions in excess costs from the U.S. healthcare system and patients, policymakers must move beyond negotiating prices and take away the ability of pharmaceutical companies to dine out on the Monopoly Extension Menu. Only by addressing the structural failures in the patent and regulatory systems can we ensure that patients are not left footing a bill they can’t afford.”

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

Read I-MAK’s Monopoly Extension Menu Report HERE.

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

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