The Real Cost of Weakening Drug Patents

When the Food and Drug Administration (FDA) approved a new, easier-to-administer version of a popular cancer medicine called Keytruda a few months ago, patients celebrated. But critics quickly cried foul, accusing the drug’s manufacturer of gaming the patent system to preserve its monopoly and prevent cheaper competitors from coming to market.

Those critics are misinformed. Patents on the new injectable version of that drug won’t prevent rival companies from creating cheap copycats of the original IV version once the patents on that formulation expire.

And the critics aren’t just wrong about this particular incident. They keep pushing a narrative that the pharmaceutical industry, writ large, is abusing the patent system. They’ve even convinced Congress to pursue major changes to the patent system.

That would be a mistake. Patent protections are critical for incentivizing not just the expensive research that leads to new medicines, but the extensive research that leads to other versions of those therapies. Upending them would only deter companies from creating updated versions of medicines that improve patients’ lives.

Many Products Have More Than One Patent

Critics commonly repeat a claim that drug manufacturers use “patent thickets”—     many patents on the same product—     to block other companies from launching copycats.

But it’s entirely normal to file multiple patents on a single product. Apple, for instance, filed for roughly 200 patents on the first iPhone. Medicines are extraordinarily complex, often combining multiple discoveries, mechanisms, and inventions. Each of those innovations can—     and should—     be patented.

Moreover, those patents do not unfairly delay the launch of generic or biosimilar copycat products. A study from the United States Patent and Trademark Office found that the number of patents covering a drug doesn’t predict how long it will be protected from competition.

Incremental Improvements Can Be Life Changing

Critics also accuse manufacturers of “product hopping”—     patenting a modified version of a drug to extend exclusivity. But that charge ignores both the way patents work, as well as the real value of incremental innovation.

Many patients, for example, find it difficult or draining to receive treatment through lengthy IV infusions—     no matter how lifesaving that infusion might be. One patient described sitting in a room full of other sick patients, hooked up to an IV for hours, as mentally “crushing.”

But when a new version of that patient’s treatment became available as a simple shot, it transformed the experience. The patient explained that “you’re not there for hours, and you [just] get a shot and a Band-Aid. It truly gives you back a portion of yourself that you had before you were diagnosed.”

Companies frequently make these sorts of updates to existing drugs. They develop new dosing and delivery methods, time-release mechanisms, or new applications. It requires years of expensive clinical trials to prove to the FDA that these updated versions are safe and effective.

More Patents Mean More Options for Patients

Importantly, the patents on these updated versions don’t extend the patent terms on the original version. Rival companies are still free to reproduce copies of the original drug once its patents expire. And patients and their doctors can choose between a cheaper knockoff of the original version, or the updated version that’s protected by its own patents.

In other words, the current patent system incentivizes companies to offer patients and their doctors more options. It’s tough to see why that’s a bad thing.

If policymakers listen to the critics and weaken patent protections for follow-on innovations, it wi     ll erode drugmakers’ incentives to innovate. That will deprive patients of new versions of countless medicines to come.