Several academic authors recently published an article in Health Affairs Forefront advising policymakers in Congress and at the USPTO on the best way to combat “pharmaceutical patent thickets.” Their argument revived a series of longstanding myths about pharmaceutical patents, including the notion that drugmakers commonly file excessive patents to create “thickets” that block generic and biosimilar competition, as well as the idea that many drug patents are trivial or unnecessary. These claims mirror uniformed rhetoric that C4IP has repeatedly debunked — and that research from the USPTO itself contradicts.
The authors urged policymakers to pass two bills, the Affordable Prescriptions for Patients Act and the Eliminating Thickets to Increase Competition (ETHIC) Act, and implement a withdrawn USPTO proposal to limit continuation patents. However, even though the problem these proposals seek to solve is baseless, they would have real — and harmful — consequences for innovation. By weakening America’s patent system, they threaten to undermine medical innovation and jeopardize patients’ access to future cures.
To guide effective policymaking, it is essential to set the record straight on the issue of patent thickets. Below, we refute three common myths about generic and biosimilar drug development, patent “thickets,” and the various policy proposals that purport to eliminate thickets:
Below, we set the record straight:
| Claim: “Thickets” of patents are responsible for blocking generic and biosimilar competition. |
| In reality: While anti-patent activists often allege that drug companies intentionally file excessive numbers of patents in order to more effectively block competition, there is no evidence that the number of patents covering a medicine affects the timing of generic and biosimilar entry. A USPTO study responding to an inquiry from Sen. Thom Tillis (R-NC) found no correlation between the number of patents on a drug and when generic versions entered the market.
Further, the rapid growth of the biosimilar market since the passage of the Biologics Price Competition and Innovation Act in 2010 is evidence that patents are not blocking market entry. As of 2020, the FDA has approved 33 biosimilars across 13 molecules, with another 108 in development. Several high-profile, recently launched biosimilar medicines are on pace for 60% adoption within two years, which is comparable to Europe’s high uptake rates. And collectively, biosimilars generated an estimated $37 billion in savings between 2010 and 2020. In short, real-world evidence is clear that robust patent protection and vigorous market competition are not in tension, but can and do coexist. |
| Claim: Patents on medicines are often “marginal,” frivolous, or unnecessary. |
| In reality: The idea that drug companies routinely patent trivial changes is both inaccurate and dismissive of how biomedical innovation occurs. Patents that the authors characterize as “marginal” often cover meaningful improvements that significantly benefit patients — from more stable formulations that reduce side effects to safer delivery mechanisms that improve adherence. Incremental improvements to insulin medicines, for example, have transformed Type 1 diabetes — a once-fatal disease — into a manageable condition, and have transformed available treatment options from animal-derived extracts to a variety of biosynthetic, rapid-acting, and ultra-long-acting options. Patents can also incentivize and protect improvements to the manufacturing process that make drug production faster and safer. In order to protect each of these distinct improvements, inventors file patents; if individual changes were not eligible for patenting, there would be little incentive for companies to conduct costly follow-on research and development.
The authors also criticize continuation patents, which allow inventors to secure protection for aspects of their disclosed invention that were not fully captured in earlier claims. The authors portray continuation patents as contributing to “thickets,” but the law is clear that continuation patents expire at the same time as the original patent. They do not extend the original patent’s term and, as a result, do not affect the market entry of competing products. |
| Claim: Policy changes such as the Affordable Prescriptions for Patients Act and the ETHIC Act would promote innovation and competition. |
| In reality: Far from promoting innovation, the legislative and regulatory proposals that the authors support — the ETHIC Act, the Affordable Prescriptions for Patients Act, and the now-withdrawn USPTO “poison-pill” rule for terminal disclaimers — would undermine innovation by weakening IP protections.
The ETHIC Act would limit the number of related patents that can be asserted in infringement cases, even when those patents cover distinct, non-overlapping aspects of the same disclosure. That change would effectively punish innovators for disclosing improvements and could incentivize them to protect inventions as trade secrets rather than publicly disclose them as patents, which, in the long term, would weaken public knowledge. Alternatively, it could incentivize inventors to seek more patent claims upfront, in their initial patent application, to avoid these later arbitrary penalties out of an abundance of caution. This shift would increase patent fees for small companies, place a heavier burden on USPTO examiners, and exacerbate the already substantial patent application backlog. The Affordable Prescriptions for Patients Act would likewise limit the number of patents that drugmakers are able to defend in court. This change would discourage manufacturers from investing in improvements to older and existing medicines. Finally, the USPTO’s now-withdrawn rule on terminal disclaimers would have rendered entire groups of related patents unenforceable if any single claim was later found to be invalid. This rule would have increased costs for both obtaining and enforcing patents. It would also have weakened inventors’ ability to legally protect and secure investment in their innovations, discouraging follow-on R&D. Like the ETHIC Act, this could ultimately increase the use of trade secrets and encourage patent applicants to include far larger numbers of claims in their initial applications. All three of these policies would dramatically increase uncertainty, costs, and risk for innovators — and, by weakening the development of new medicines, limit the possibility of generic and biosimilar drugs being developed down the line. |