By 2025 Health Policy Lab Co-Chair, Grace Shults
Serial patent litigation refers to a branded pharmaceutical company suing a generic pharmaceutical company (i.e., a company that manufactures lower-cost versions of high-cost therapeutics) repeatedly regarding the same generic medication. This process delays the ability to bring generic medications to patients and, in some cases, may completely remove access. Serial patent litigation is, unfortunately, an increasingly abusive tactic used by branded companies to prevent competition and deter lower-cost, off-patent versions of their medicines from coming to market. Moreover, the risk of repeat litigation is a big disincentive for generic companies to continue investing in the development of small-molecule drugs and challenging vulnerable patents to bring products to market at the earliest opportunity. At bottom, serial patent litigation delays access to the specific generic medicines ensnared in this abusive tactic and chills the development of other generic medicines because generic companies will want to avoid the possibility of getting ensnared.
In 1984, Congress passed the groundbreaking Hatch-Waxman Act, which was intended to balance encouraging research into new medicines with allowing earlier market entry of more affordable generic alternatives. The Hatch-Waxman Act significantly increased the availability and affordability of generic medicines in the U.S. and helped create a competitive healthcare environment for patients, where more than 90% of prescriptions filled are now generic medicines. But the practice of serial patent litigation by branded companies is inconsistent with that aim.
To help achieve its objective of bringing lower-cost generic drugs to market quickly, the Act created a framework for resolving patent disputes promptly. One part of that patent resolution framework is a 30-month “stay” (or pause) in FDA approval of a generic medicine, which was the amount of time Congress decided would be sufficient to resolve a patent litigation between branded and generic pharmaceutical companies. This 30-month stay means that branded pharmaceutical companies automatically retain market control for 30 months longer, resulting in more monopoly profits for them and, importantly, fewer choices for patients in accessing cheaper medicines. What’s worse, through serial litigation, branded pharmaceutical companies assert patents well beyond the 30-month stay, protracting litigation exposure and costs for generic manufacturers and delaying access to lower-cost generic medicines for patients. Generic drug companies have an essential role in lowering drug prices, but they also often operate on incredibly thin profit margins. The emerging tactic of serial patent litigation threatens the sustainability of the generic industry.
One medication that has been repeatedly litigated for over 100 months is Myrbetriq (or generically known as mirabegron), which is used to treat an overactive bladder. The generic manufacturers of this drug have faced five waves of litigation that have lasted over eight years. This is well beyond the 30 months envisioned for resolving a patent dispute. This has impacted the ability of generic manufacturers to bring generic mirabegron to patients at a more affordable price for nearly a decade. But this is only one example of how manufacturers of branded medicines have sought to block patient access to the cheaper generic alternative. If left unchecked, these serial litigation behaviors could have a chilling effect on entire therapeutic areas and prevent generic companies from entering the market, which runs counter to the Congressional intent behind the Hatch-Waxman Act.
Why does this matter to the patient community? To put it simply, serial patent litigation delays the ability for a generic to come to market, which in turn creates issues for patients’ access to their vital medications. Generics being brought to market would create more opportunities for lower drug pricing, making them more accessible for patients who need them. Patent reform is gaining traction and has bipartisan support, as lawmakers recognize the potential of changing patent system incentives to ensure fair competition and patient prices.
Interested in learning more about how patent reform could help the patient community?
Join us for our Generation Patient Health Policy Updates Call on May 20th at 8pm EST. Register here: GP Policy Call Zoom Registration. This is designed for young adults with chronic and rare conditions.
Also, consider joining Generation Patient’s Patent Coalition. Fill out the interest form here: Generation Patient Patent Coalition Interest Form