The FDA recently approved a new version of Keytruda, a cancer immunotherapy medicine that is one of the world’s most successful drugs. Until now, all patients received Keytruda through intravenous infusions, a process that can take hours. The new formulation allows it to be delivered in just minutes as an injection under the skin.
The New York Times’ coverage of the FDA announcement characterized Keytruda’s new formulation as a “product hop” — invoking a dispelled myth that drug manufacturers make only “trivial” changes to existing products in order to extend the time they are under patent protection. But the new version of Keytruda is anything but trivial.
It is a meaningful advance on the original version of the drug that will improve patients’ quality of life and, in some cases, save lives. It’s overly simplistic and reductive of patient care to discount the benefits of a change that makes a drug so much easier to take. This improvement, moreover, demonstrates the vital importance of strong patent rights in driving medical progress.
Convenience Is a Clinical Benefit
The Times suggested that Keytruda’s new formulation is less deserving of patent protection because “[t]he changes generally do not improve the metrics patients care about most, safety and effectiveness.” But those aren’t the only things that matter to patients. Especially for medications that have already proven safe and effective, as Keytruda has, innovations that reduce the burden of treatment are immensely valuable.
Keytruda patients often spend hours traveling to specialized infusion centers, followed by hours more in infusion chairs. A switch to an injectable form not only saves patients time receiving the infusion, but also allows less specialized providers to administer the medicine, cutting down on travel burdens. For patients, it means fewer missed workdays, less childcare stress, lower travel expenses, and a simpler treatment. It can also reduce the risk of acquiring infections from IV lines.
Further, more convenient methods of administration often translate into better patient outcomes by making it easier for patients to adhere to treatment regimens. Scientific literature consistently shows that higher adherence to prescribed drug therapies is associated with better health outcomes and lower mortality.
Similar to enhancing the effectiveness of the drug’s active ingredient, Keytruda’s new formulation will almost certainly lead to better health outcomes and quality of life for patients
Expanding, Not Restricting, Patient Choice
The Times also suggested that the new shot will keep costs high by delaying competition. But this claim is founded in false narratives about “product hopping” and overlooks how patients benefit from increased choice.
Anti-patent activists often claim that drug companies patent an improved version of a medicine and then discontinue the production of older versions to maintain market share and deter competition. But this ignores the fact that patents on the initial form of a drug will still expire at the same time, regardless of whether companies obtain patents on later alterations. So regardless of whether a company may eventually stop producing a version of a drug that has become outdated, others are free to manufacture the original version.
In the case of Keytruda, this means that manufacturers of biosimilars — copycat versions of “biologic” drugs derived from living organisms — still have the same freedom to produce and market versions of the intravenous formulation. When those copies arrive on the market, the price of the original, brand-name version of Keytruda is likely to drop as well.
Many patients and their doctors will choose the new version of Keytruda over lower-cost copies of the older version due to the former’s improved method of delivery. But some will opt for the likely less expensive, infusible copycats. That’s a choice for patients and their doctors to make. The important thing is that patients will soon have a choice.
The Key Role of Intellectual Property Rights
The Times article parrots statements from prominent patent critics like Sens. Elizabeth Warren (D-MA) and Bernie Sanders (I-VT), who characterize the so-called Keytruda “product hop” as an abuse of the patent system. In reality, the new version of Keytruda illustrates how strong patent rights drive medical advancement and change lives.
Developing a new formulation of a complex biologic usually requires years of research, new clinical trials, and fresh FDA review. Even completing one Phase III clinical trial can often cost over $50 million. Without strong patent protections, companies would have far less of a chance to earn a return on such investments, making investment into life-changing “follow-on” innovations unfeasible.
It’s clear that Keytruda’s new formulation will have substantial benefits for patients — enhancing convenience, fostering adherence to treatment, and expanding choice. It makes no sense to lament the patent system that made that innovation possible.
Keytruda’s new formulation is not a case of patent abuse, but a demonstration of why patent rights matter: to fuel improvements that make life-saving medicines more humane, accessible, and sustainable for patients.