Strong patent protections are fundamental to the creation of new treatments and cures that extend and improve patients’ lives. In recent years, critics of the biopharmaceutical industry have suggested otherwise by advancing misleading and inaccurate narratives that mischaracterize the role of patents, the value of new treatment advances and the nature of competition in the biopharmaceutical industry. Robust intellectual property (IP) protections, including patents, fuel biopharmaceutical innovation and promote competition in the marketplace.
It is important to set the record straight on some common misperceptions about biopharmaceutical patents.
- Myth: Biopharmaceutical patents are impeding competition and hindering future innovation.
- Fact: The patent system is the most effective tool to reward and incentivize innovation, particularly in the biopharmaceutical industry, where it takes a tremendous amount of time and resources to bring safe and effective medicines to patients. In fact, developing a new medicine can take 10 to 15 years and costs an average of $2.6 billion. Biopharmaceutical patents let researchers around the world know what solutions work, point them to further avenues of research and development and pave the way for generic products.
- Myth: Biopharmaceutical companies utilize patents to “game” the system – prolonging monopolies and claiming newness where there is none.
- Fact: Patents and other IP protections are what allow the biopharmaceutical industry to develop life-saving medicines and cures. There is a misconception that innovation stops the minute a medicine is approved by the U.S. Food and Drug Administration (FDA). The fact is, like most other products, research continues long past a medicine’s initial approval, resulting in innovations that improve the lives of patients, including new uses, novel delivery mechanisms or new dosing schedules for previously approved medicines. Each innovation has the potential to improve the lives of patients by increasing patient adherence, improving health outcomes for patients and reducing unnecessary hospitalizations. Additional patents and exclusivities that incentivize these innovations do not extend the original patent or exclusivity and, therefore, do not prevent competing manufacturers from coming to the market with generic copies (or biosimilars) of the earlier versions whose patents and exclusivities have expired.
- Myth: Patents limit industry-wide progress and learning.
- Fact: Patents promote knowledge dissemination by requiring the description of inventions to be disclosed to the public, allowing society to understand and learn from each invention. Further, the public disclosure required to obtain a patent has allowed competition to flourish, giving innovators a roadmap of the medical progress that has already been made so that they can explore new, and inventive, ways to solve pressing challenges.
- Myth: Biopharmaceutical companies have multiple patents on their drugs in order to extend exclusivity periods.
- Fact: Medicines are much more than just their active ingredients and involve highly complex manufacturing processes and ongoing development well after an initial drug ingredient is patented and initially approved by the FDA. Thus, a medicine may be associated with multiple patents that cover various aspects of a product, including the composition of dosage forms, methods of manufacturing and use in a particular therapeutic indication. New versions of prior medicines expand treatment options and result in improved health outcomes for patients.
Strong patent protections give inventors certainty that their work won’t be stolen, give investors the confidence that they can recoup their substantial investments and improve the health of patients. As the single largest funder of business R&D in the United States and the global leader in biopharmaceutical innovation, the U.S. biopharmaceutical industry depends on strong IP protections to incentivize R&D and promote robust competition.
Follow our IP Explained series on catalyst.phrma.org to learn more about how patents enable a healthier future.