Congress may soon implement sweeping policy changes — with potentially dire unintended consequences for the economy and long-term public health — based on flawed information.
The Senate Judiciary Committee recently advanced a slate of bills aimed at combating drug companies’ alleged anti-competi
It’s clear that these lawmakers have been influenced by misinformation generated by an activist group, the Initiative for Medicines, Access and Knowledge. I-MAK has been on the warpath against the biotech industry generally, and its patenting practices specifically, for years. But the data it publishes — data that lawmakers are evidently relying on — isn’t just cherry-picked and distorted. In many cases, it’s outright inaccurate.
There are over 23,000 prescription drugs approved for sale in the United States. But I-MAK has historically fixated on just a handful of high-profile products — and extrapolated sweeping conclusions about the entire pharmaceutical system.
And even among the drugs they scrutinize, I-MAK’s claims don’t hold up.
Consider Eliquis, an anticoagulant I-MAK labels as “overpatented and overpriced.” I-MAK claims the drug is shielded by more than 43 patents that’d guarantee the medicine 40 years of exclusivity. But a comprehensive analysis by the United States Patent and Trademark Office and the Food and Drug Administration found that Eliquis had only three Orange Book-listed patents and less than 15 years of market exclusivity — shorter than the 20-year patent term granted by the USPTO.
The study highlighted similar discrepancies for the HIV treatment Biktarvy and cancer treatment Imbruvica, with I-MAK inflating patent counts and inaccurately claiming these patents led to significantly longer exclusivity than the data reflect. As Sen. Thom Tillis (R-N.C.) noted in a letter to the USPTO, I-MAK does not “transparently disclose or explain its underlying data,” which differs “by orders of magnitude from public sources.”
These errors aren’t insignificant. They’re fueling a myth of widespread patent gaming—and inspiring legislation that could dismantle parts of the intellectual property system that drives medical breakthroughs.
I-MAK claims that drugmakers file multiple patents on a single drug to “evergreen” their products and extend exclusivity periods.
But the reality is nuanced and far more beneficial to patients. Multiple patents don’t signal abuse; they reflect genuine, clinically valuable improvements and do not prevent competitors from inventing around.
Just as Dell or Apple would patent each improved component in a new line of computers, drugmakers patent measurable improvements over their existing medicines. These can include extended-release formulations, new uses in combination therapies, or novel delivery mechanisms. These patents do not block generic competitors of the original drug, nor do they prevent brand-name competitors from developing alternative treatments; they protect only the new, distinct contributions.
In fact, a USPTO study confirms that strong IP protections foster innovation and debunks allegations of “evergreening” and “patent thickets.” The USPTO makes it clear that the number of patents is not an accurate way to assess the length of market exclusivity, as new patents may cover different types of inventions, and the number or timing of new patents does not determine when a generic enters the market. If one were to believe I-MAK’s claims, we would never see robust brand-to-brand competition or any generic or biosimilar entry.
And new patented advances are anything but trivial. Take insulin. Before its discovery, most type 1 diabetics died within three years of a diagnosis. Today, thanks to decades of patent-backed advances — from synthetic analogs to ultra-rapid and long-acting formulas — patients manage their condition into old age.
Unfortunately, patients with deductibles and coinsurance taking brand-name diabetes medicines paid, on average, 3.5 times more out of pocket in 2021 compared to those with only fixed copays. Insurers and their pharmacy benefit managers (PBMs) continue to shift more costs onto patients through high deductibles and coinsurance — often forcing them to pay based on the full list price of brand-name diabetes drugs, rather than the lower, negotiated price. The FTC even sued the three largest PBMs “for engaging in anticompetitive and unfair rebating practices that have artificially inflated the list price of insulin drugs, impaired patients’ access to lower list price products, and shifted the cost of high insulin list prices to vulnerable patients.”
Curiously, I-MAK has turned a blind eye to how PBMs have abused their economic power and continue to force patients to pay more for life-saving medications. PBMs frequently restrict, or outright block, patients from taking certain drugs — even if they’re recommended by the patients’ doctors. In some cases, PBMs block patients’ access to cheaper alternatives in favor of costlier brand drugs that come with higher rebates for the PBMs.
If we want more lifesaving treatments, we need to protect the system that makes them possible. That means upholding strong, predictable intellectual property rights, continuing timely FDA review of generic and biosimilar applications, and focusing on actual barriers to access — like PBM behavior — not on fabricated narratives about patent abuse.