Is America’s patent system preventing millions of patients from accessing lifesaving medicines? One influential group thinks so — and is trying to persuade Congress to weaken patent protections.
The leaders of the Initiative for Medicines, Access & Knowledge (I-MAK), a group that tracks drug companies’ patent filings, recently said “our patent system incentivizes and legitimizes corporate gamesmanship at the expense of the public interest.” Drugmakers, they say, are filing duplicative patents on existing medications, ensuring that those drugs are patent-protected for far longer than they ought to be. Allegedly, these elaborate “patent thickets” keep generic manufacturers from entering the market with cheap, copycat versions of brand-name drugs.
Those are explosive claims. Fortunately, they’re not true. But there’s a real risk that I-MAK’s analyses and recommendations will sway lawmakers, causing patients to ultimately lose — not gain — access to new medicines.
I-MAK’s “statistics” differ wildly from the patent information in official databases, namely the FDA’s Orange Book, which lists approved drugs and their related patent information that pharmaceutical companies must publicize under the 1984 Hatch-Waxman Act. This Orange Book effectively lists every patent that might legitimately block a generic company from introducing a competing product.
Consider just a few examples.
In the 2019 version of its oft-published report on drug patents, I-MAK asserted that the drugs Eliquis and Xarelto — used to treat blood clots — were covered by 31 and 32 patents, respectively. The FDA’s Orange Book listed, at most, three patents for Eliquis and six patents for Xarelto.
I-MAK has claimed that certain drugs covered by patent thickets will block competition for decades — yet generic competitors to those medicines have already entered the market in some cases.
In fact, such discrepancies are so widespread in I-MAK’s “analyses” that Sen. Thom Tillis, R-N.C., scrutinized the organization’s seemingly unverifiable conclusions and asked the group for a thorough explanation of its methodology.
Not only are I-MAK’s data and conclusions questionable, to put it mildly, but its entire characterization of the U.S. patent system is misleading.
The group asserts that filing more than one patent for a single drug is a “charade” and a symptom of “waning creativity.” On the contrary, additional patent filings often represent critical follow-on innovation, which has historically been an important driver of medical progress.
Take, for instance, HIV. Treatments that previously could only be taken as daily pills are increasingly available as once-monthly injections, which have higher adherence rates and thus make it less likely that patients will skip treatment, see their viral loads increase, and put their health and the health of others at risk.
Or consider the cancer drug Keytruda, which has to be given intravenously. Keytruda’s manufacturer, Merck, is conducting trials on versions of the drug that can be injected under the skin, potentially exposing patients to less pain.
Of course, follow-on innovation isn’t unique to the biopharmaceutical industry. Inventors in a variety of sectors — from automobiles to manufacturing to technology — rely on the ability to patent incremental improvements to existing products.
Take King C. Gillette’s invention of a safety razor with replaceable blades. Gillette filed a patent for the shaving instrument in 1901. But Gillette’s innovation didn’t stop there. Over the years, he made small improvements to his invention — a redesigned handle, for instance — and patented those tweaks accordingly.
Gillette’s story illustrates a broader point. Rather than discouraging innovation, as I-MAK argues, follow-on patents encourage inventors to make incremental, yet useful, changes to existing products. Without follow-on patenting, many new inventions would remain “frozen in time.”
Just like inventors in any other sector, drug developers would have little reason to invest in the R&D and clinical trials necessary to make incremental improvements to existing medications if follow-on discoveries couldn’t be patented.
And it’s important to note that follow-on patents don’t affect a drug’s original formulation. Filing a patent on an extended-release version of an existing medication wouldn’t extend the patents behind the original formulation of the drug, as I-MAK’s leaders suggest.
The notion that America’s patent system discourages generic competition is almost laughable, considering that nine in 10 prescriptions in the United States are filled with generics — one of the highest generic use rates in the world. If pharmaceutical companies were really using “patent thickets” to block generic competition, they’re doing a terrible job at it.
I-MAK and its fellow travelers have it backward. America’s patent system isn’t preventing patients from accessing drugs. Without robust and reliable patent protections, lifesaving medications wouldn’t exist in the first place.