There's never a good time to be diagnosed with cancer. But for the millions of Americans who'll receive that diagnosis this year, their odds of beating the disease have never been better.
Consider how over 99% of prostate cancer patients diagnosed between 2005 and 2014 were still alive a decade later, largely thanks to new and improved medicines. By contrast, only 56% of men diagnosed a generation earlier, from 1975-1984, lived more than a decade. Survival rates more than doubled for leukemia and more than tripled for pancreatic cancer.
Unfortunately, future progress is now in jeopardy -- because policymakers are considering weakening the patent rights that make investment in lifesaving medical research possible.
Biotech research is staggeringly expensive and time-consuming and it is overwhelmingly financed by the private sector. Bringing a medicine to market typically takes more than a decade and over $2.5 billion. Only about one in eight experimental drugs tested in clinical trials ever proves safe and effective enough to secure FDA approval; nevertheless, biopharmaceutical innovators have to fund, develop, and test the failures, too, not just the successes.
Biotech companies would never be able to justify those risks if their rivals could immediately copy any successful drugs. That's why companies patent their discoveries. Patents give inventors a time-limited exclusive right to their innovation, after which others can copy that work without bearing the expense of research and development.
Patents don't increase the odds that an experimental drug will work. But they ensure that if a drug does work and win FDA approval, developers will have a chance to recoup their investments before generic competitors enter the market. The promise of that temporary exclusivity enables biotech companies to raise capital, pursue promising lines of research, scale up their manufacturing, and bring medicines to patients.
Crucially, patents also incentivize companies to continue improving medicines even after the initial FDA approval. Refining a complex medicine requires substantial investment and carries significant risk. Patents on these follow-on innovations enable companies to protect the improved -- but not the original -- versions of their treatments for a limited time.
But some activist groups, such as the Initiative for Medicines, Access & Knowledge (I-MAK), have convinced lawmakers that companies are gaming the patent system. They claim that companies are patenting many different aspects of their medicines to construct "patent thickets" that unfairly prevent generic competition for longer than Congress ever intended.
These groups are misrepresenting how the patent system actually works.
Medicines aren't the result of a single eureka moment. They're a combination of many different discoveries, made by different scientists over a period of years or even decades. A single therapy may involve separate discoveries in formulation, delivery mechanisms, manufacturing processes, dosing, or new therapeutic uses. So long as each discovery is truly novel, useful, and non-obvious, it can qualify for its own patent.
Medicines aren't unique in this regard, of course. Smartphones contain as many as 250,000 patented inventions -- covering everything from its display and battery chemistry to its wireless protocols, sensors, and operating-system features. Without the ability to protect each novel component, innovation in these fields would grind to a halt.
There's nothing nefarious about biotech companies obtaining multiple patents on a given drug. And contrary to what activist groups claim, more patents don't translate into longer periods of market exclusivity. A 2024 U.S. Patent and Trademark Office (USPTO) study confirmed this, finding no correlation between the number of patents on a medicine and the timing of generic competition.
Activists also claim that companies unfairly extend protection by filing additional patents on "minor" modifications -- a practice known as "evergreening." This, too, mischaracterizes how patents actually work.
Follow-on patents reflect meaningful improvements that require new research. These advances can range from an inhaler that delivers medication more precisely, to a once-daily formulation of a diabetes drug that replaces multiple doses, to a refined cancer therapy with fewer side effects that helps patients stay on treatment.
Those new follow-on patents don't extend the term of the earlier, original ones. Each patent expires 20 years from its filing date, regardless of any later patents granted. And, in practice, most medicines receive only three to 18 years of market exclusivity -- notably below the standard 20-year patent term.
After that exclusivity ends, generic versions of the original drug are free to enter the market -- and they do, promptly. The speed with which they gain share underscores that the system delivers robust competition. Generics now account for 93% of all U.S. prescriptions, the highest share in the developed world.
Simply put, activists misunderstand -- or are deliberately misrepresenting -- how the patent system works. And unfortunately, enough lawmakers have bought into these myths that they're considering several bills to weaken patent protections.
If those bills become law, and companies can't protect their medical discoveries from premature copycatting, biotech firms will be far less likely to undertake the high-risk research that produces those breakthroughs. That would mean fewer new and improved medicines for the millions of Americans battling cancer and other severe diseases.
Patrick Kilbride is a Principal at Kilbride Public Affairs and a Policy Fellow at the Center for American Principles.
