Critics of the U.S. patent system are increasingly targeting follow-on innovation in the biopharmaceutical sector. In an effort to weaken follow-on patents — or those issued after a product has already been introduced — they claim that these innovations are trivial, extend exclusivity unfairly, and drive up drug costs. But as a new report from the Information Technology and Innovation Foundation (ITIF) makes clear, these narratives severely mischaracterize the nature and purpose of follow-on patents — and could result in policy decisions that harm patients and undermine innovation.
With new legislation targeting follow-on innovation now on the congressional docket, it’s crucial to separate fact from fiction. Here’s a closer look at three of the most common arguments against follow-on innovation — and why they don’t hold up to scrutiny:
| Claim: Follow-on innovations are generally trivial. |
| In reality: Follow-on innovations require significant research and development — and they deliver meaningful, tangible improvements to patient care. As ITIF’s study notes, over 60% of R&D investments in a typical drug come after the drug’s initial FDA approval. ITIF’s report includes numerous examples of life-changing follow-on drugs, such as dissolving pills for Alzheimer’s patients, long-acting insulin for diabetes patients, and direct delivery methods for patients with Parkinson’s. The report also outlines the economic benefits of follow-on innovation: By increasing competition in the market, follow-on drugs can reduce costs for patients, while also reducing the cost burden of common chronic diseases. In total, more than 60% of drugs on the World Health Organization’s Essential Drug List are follow-on innovations. Follow-on patents are just as vital to patient outcomes as initial patents — and protecting them is crucial to promote better outcomes for patients. |
| Claim: Patents on follow-on innovations allow companies to extend their products’ market exclusivity. |
| In reality: Follow-on patents have no effect on the lifespan of other patents — meaning that generic and biosimilar competition can still enter the market when the original patent expires. A recent, congressionally directed study by the U.S. Patent and Trademark Office (USPTO) determined that the number of patents associated with a drug was not a reliable gauge of the duration of market exclusivity. None of the drugs it studied had an effective exclusivity period of more than 16 years — despite the legal length of a patent term being 20 years. Further, as ITIF’s study notes, it’s not as if drug companies can force patients to use the versions of drugs that include the latest patents. Drugmakers do not control which medicines patients take or are prescribed. If patients use the new and improved version of a drug based on follow-on innovation — rather than the older, off-patent version — it’s likely because the patient or their doctor recognizes the benefits of the improvement for that person. |
| Claim: Weakening protections for follow-on patents would benefit patients. |
| In reality: As a result of these misconceptions about follow-on innovation, many activists and even some lawmakers are working to weaken patent protections for improvements to existing products. For instance, a recent bipartisan proposal in Congress — the Affordable Prescriptions for Patients Act — aims to crack down on so-called drug “patent thickets” made up of follow-on patents. But this approach is both unnecessary and counterproductive. The United States already has an enormous number of drugs available off-patent, as nine in 10 U.S. prescriptions are filled with generics. Weakening follow-on patents would only chill the development of safer, more convenient, or more effective alternatives that help patients now and become generics down the road. Nobody benefits when innovation is suppressed — and patent policy should strengthen, not undermine, the incentives that bring better treatments to patients. |