Few biomedical innovations over the past three decades have been as successful and continue to offer as much promise as therapeutic antibodies.
Therapeutic antibodies—proteins that bind to specific markers on cells or tissues—can target a particular disease state.1 In 1975, researchers discovered how to produce multiple antibodies with the same structure (monoclonal antibodies). This discovery shared the Nobel Prize for Medicine and Physiology in 1984, and the first therapeutic antibody was approved in 1986. Today, dozens of drugs using this breakthrough technology have been approved in the United States and Europe.
Therapeutic antibodies effectively treat a wide range of disease states, including rheumatoid arthritis, multiple sclerosis, and several types of cancer. More than 75 antibody products are available to patients in the United States.2 Moreover, numerous therapeutic antibodies are in the pipeline. Expected growth offers exciting implications for treating complex, chronic, and sometimes life-threatening conditions. Delivering on the promise of these therapies, however, requires policies that not only encourage investment in research and development, but also ensure that, once approved, these therapies will be accessible to patients.
Delivering on the promise of these therapies, however, requires policies that not only encourage investment in research and development, but also ensure that, once approved, these therapies will be accessible to patients.
Patient-access issues often center on health plan coverage and utilization management techniques—such as prior authorizations or step-therapy protocols. But access to a therapy is first and foremost a question of development. Critical to that development are intellectual property (IP) protections that incentivize investment, spur competition, and, as the last three decades have proved, spawn innovation.
This brief examines the patent policies that govern therapeutic antibodies—how they work, how they differ from patent policies for other drugs, and how uncertainties and inconsistencies around their application may impact future innovation. It demonstrates why policies must keep pace with medical innovation and, finally, highlights how recent improvements to patent policies will help protect the promise of next-generation therapeutic antibodies for patients.
KEYWORDS: HEALTH INNOVATION