In a recent STAT article, I-MAK CEO Tahir Amin argues that abuses of the patent system are leading to higher drug costs. But this gets the logic exactly backwards — it is because of the patent system that the United States is the world leader in biopharmaceutical innovation. That leadership is the reason that Americans have the best access to the world’s new drugs, and a world-class generic drug system to make drugs affordable. The practices Amin claims are “abuses” are mischaracterizations of how the patent system works and ignores its indispensable role in the drug development process. Disrupting the patent system, as Amin proposes, would not lower patient costs. It would only ensure that fewer lifesaving drugs and therapies reach the market.
Here’s a closer look at Amin’s claims — and the realities that contradict them:
| Claim: “The real issue… [is] a rigged system that lets drug companies exploit patents, block competition, and keep prices artificially high.” |
| The truth: A strong, predictable patent system is what makes both breakthrough drugs and lower-cost alternatives possible.
Patents give innovators the confidence to invest in years of high-risk, high-cost research. That incentive has made the United States the engine of global biopharmaceutical progress — responsible for roughly half of all new treatments introduced worldwide. The result is a uniquely competitive system: about 90% of all prescriptions filled in the United States are for generic drugs, the highest rate in the world. Undermining that balance would slow innovation without meaningfully improving affordability. |
| Claim: “The pharmaceutical industry claims that the high prices in the U.S. are justified because of their investments, but most groundbreaking inventions originate in taxpayer-funded labs.” |
| The truth: Pharmaceutical companies fund and perform the vast majority of work needed to turn federally supported discoveries into real treatments.
Taxpayer-funded labs typically conduct early-stage research; this is not the same as the research that leads to specific medicines or treatments. Bringing a drug to market typically takes 10 to 15 years and more than a billion dollars. More than nine in 10 candidate medicines that enter clinical trials fail. Private firms assume that risk — funding research, trials, manufacturing, and distribution. In fact, most modern medicines are the direct result of private industry alone. One 2023 study found that 92% of medicines approved by the Food and Drug Administration between 2011 and 2020 had no government support at all. And for those medicines that do benefit from public funding, private-sector investment is still far greater than the federal contribution. |
| Claim: “If high U.S. prices actually fueled research, we’d see more lifesaving drugs. Instead, we get me-too drugs and other life cycle management strategies that evergreen existing products…” |
| The truth: The United States leads the world in developing lifesaving medicines, accounting for about 60% of new chemical entities — the novel ingredients that form the basis of new medicines. Meanwhile, the largest European countries together produce only about 30%.
And the share of new medicines that are “first-in-class” — meaning they use a novel mechanism to fight disease — remains significant as companies pursue more challenging targets. In other words, companies are increasingly concentrating their R&D efforts on truly new medicines that fill an unmet need. It’s worth noting, however, that “me-too drugs” are not meaningless duplicates. Instead, they are new products falling within the same therapeutic classes — such as new statins or antidepressants. These entrants introduce competition, expand treatment options, drive down prices, and provide alternatives for patients who don’t respond to the first available medicine. That’s distinct from innovation that improves an existing product through safer dosing, better delivery, or improved tolerability. Ultimately, both types of progress benefit patients and strengthen competition. |
| Claim: “… The U.S patent and regulatory system that allows for the never-ending ability to file and be granted patents on a drug, including for minor modifications, allowing companies to amass dozens or hundreds of patents to extend monopolies and block competition. Eliquis has more than twice as many patents on the drug in the U.S. than in Europe, while for Enbrel there are four times as many.” |
| The truth: Comparing raw patent counts between the United States and Europe tells us little about competition or patient access.
A recent U.S. Patent and Trademark Office study found no link between the number of patents on a drug and the timing of generic entry. As the USPTO explains, “simply quantifying raw numbers of patents and exclusivities is an imprecise way to measure the intellectual property landscape of a drug product because not every patent or exclusivity has the same scope.” The USPTO further notes that among the drugs it analyzed, the average period of exclusivity was just 11.4 years — far short of the 20-year patent term — and that patents filed after the initial product launch do not delay generic competition. |
| Claim: “The bottom line is that the U.S. pays more because drug companies exploit loopholes to extend monopolies. Tactics like ‘evergreening’ (slight tweaks to existing drugs to obtain new patents) and excessive incentives like statutory patent term extensions (PTE) keep generics and biosimilars off the U.S. market for longer than necessary.” |
| The truth: Evergreening is a catchy phrase but masks the reality that a new patent has no effect on the term of an earlier patent — so a new modification that is patented cannot block a generic competitor from copying an earlier patent that has expired.
Amin also mischaracterizes meaningful changes to initially approved drugs as “slight tweaks.” In reality, these changes were worthy enough to get a patent, and they offer meaningful benefits to patients. Examples are numerous: taking a medicine weekly instead of everyday, or taking a pill instead of receiving an injection. Meanwhile, the earlier version of the drug will still go off-patent on the original schedule, allowing for generic competition. Statutory patent term extensions simply restore time lost to regulatory delays. To allow otherwise would punish innovators for delays for which the government is responsible. Regardless, in practice, generics reach the market within 11 to 13 years of a drug’s launch. |
| Claim: “Other wealthy nations have done a better job at reining in some of these tricks — a key factor in why they get competition earlier and their prices are lower.” |
| The truth: The weaker patent rights and price controls in other nations delay patient access to new treatments.
Between 2012 and 2021, Americans had access to 85% of all new drugs introduced globally. In Europe, access was far lower — only 48% were available in the United Kingdom, about 60% in Germany, and just over 20% in Denmark. European patients typically wait about a year longer for new therapies, a delay the EU estimates costs hundreds of thousands of lives annually. Furthermore, the vast majority of American prescriptions are actually filled with generics. More than 90% of all U.S. prescriptions are for generic drugs, compared to about 41% in other countries. The United States also enjoys lower generic prices than other countries. |
| Claim: “Policymakers should: close the loopholes that allow the pharmaceutical industry to file exorbitant patents on their drugs … End patent term extensions … [and require companies] to disclose all of their patents to the FDA.” |
| The truth: We should strengthen the patent system, not weaken it. The current system already includes safeguards against abuse and full disclosure to regulators. Proposals to overhaul it would flood the FDA with unnecessary data and risk exposing trade secrets, while doing nothing to lower prices. Efforts to reduce costs by eroding intellectual property protections will ultimately harm innovation — and patients who depend on it. |