Patents key to laundry list of pharma procedures and innovation
Wilbur 19, (Tom Wilbur is Senior Director of Public Affairs at PhRMA focused on opinion research, message development and political communications. Prior to joining PhRMA in 2019, Tom worked on Capitol Hill and on political campaigns for eight years, most recently responsible for communications and strategy for U.S. Rep. “IP Explained: How patents support innovation throughout the biopharmaceutical lifecycle” August 6th 2019 (https://phrma.org/en/Blog/ip-explained-how-patents-support-innovation-throughout-the-biopharmaceutical-lifecycle) accessed on 6/19/24)--ATP
For the biopharmaceutical industry, the U.S. patent system provides for innovation and fuels the creation of new lifesaving treatments and cures for patients. In fact, patents touch nearly every facet of biopharmaceutical innovation from initial drug discovery to new uses identified after Food and Drug Administration (FDA) approval, and most medicines are associated with multiple patents.
As medical innovation transforms to target more complex diseases and as genomics and personalized medicines are pursued, manufacturing processes are also becoming more complicated. In today’s IP Explained, we are taking a closer look at four key forms of patent protections and how each plays an important and unique role in supporting innovation throughout the biopharmaceutical lifecycle.
Active ingredient or component patents protect the biologically active component of a drug.
Drug product patents refer to the particular state in which the medicine is delivered to the patient, such as the formulation or dosage form. New dosage forms for FDA-approved medicines, such as when an injectable drug can be taken as a pill instead, can improve patient adherence to treatments, ensure proper dosage, and improve quality of life for patients. As a result, these innovations may lead to improved health outcomes and a reduction in hospitalizations.
Methods of manufacturing patents cover the complex process or steps required to manufacture a medicine. Such advances can improve the safety, efficacy and quality of other types of medicines
Methods of use patents protect the use of a medicine to treat a particular disease. Innovations to medicines continue well after their active ingredients are patented and the medicines are approved by the FDA. This ongoing research can result in approvals for new uses in different patient populations, conditions or disease states. For example, medicines initially developed to treat rheumatoid arthritis have been shown to help treat other autoimmune conditions, including Crohn’s disease and ulcerative colitis. New uses give patients new, and frequently better, options to treat their illnesses.
Each of these forms of medical advancements plays a critical role in improving the lives of patients and has the potential to increase adherence, improve health outcomes and reduce unnecessary hospitalizations. By protecting all forms of biopharmaceutical innovation, we can continue to improve the lives of patients and keep the U.S. as the global leader in biopharmaceutical research and development.