Patents are unique in that they are a form of IP protection established in the U.S. Constitution that grants inventors the right to their inventions without others being able to make, use or sell them for a set period of time. Many essential industries rely on the U.S. patent system to foster innovation, and the existence of a patent doesn’t necessarily prevent others from developing and patenting different solutions to the same problem. And once the patent has expired, the invention can be freely used by anyone.
For the biopharmaceutical industry, the U.S. patent system provides critical incentives 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.
Follow our IP Explained series to learn more about how patents enable a healthier future for patients.
Tom Wilbur is Director of Public Affairs at PhRMA focusing on federal advocacy priorities including Medicare and intellectual property. Prior to joining PhRMA, Tom worked in politics and on Capitol Hill, most recently responsible for communications and strategy for U.S. Rep. Fred Upton and the House Energy and Commerce Committee. Tom is a proud Michigander and outside of the office enjoys reading, running, hiking, golfing, live music, and spending time with family and friends.