Today, we are excited to launch our new IP Explained Catalyst series, where each week we’ll break down critical components of the intellectual property (IP) system and the important role it plays in encouraging biopharmaceutical research and development (R&D). We are kicking things off today by looking at patents – the lifeblood of biopharmaceutical innovation.
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. 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.
Many essential industries rely on the U.S. patent system to foster innovation. Research has identified that an IP system that provides robust patent rights and regulatory protection is key to driving biopharmaceutical growth in the United States and sustaining continued investment in the lengthy and costly R&D process needed to develop new medicines.
Biopharmaceutical companies differ from other industries in terms of the level of scientific and regulatory uncertainty, long time horizons and high costs of R&D. In addition, while the law has established a patent term of 20 years from the patent application filing date, given the nature of the R&D process, up to half of the patent term may be lost before a medicine is ultimately reviewed and approved by the U.S. Food and Drug Administration (FDA). The facts are that, for the biopharmaceutical industry, the availability of patents enables companies to invest an average of $2.6 billion over a 10 to 15-year period to bring a medicine to patients and enables them to accept the risk that only 12% of investigational medicines will ultimately be approved by the FDA.
Patents incentivize different forms of biopharmaceutical innovation, and a medicine may be associated with multiple types of patents that may cover such aspects as the biologically active component of a drug, as well as the composition of dosage forms, methods of manufacturing and use in a particular therapeutic indication. While a single medicine, like any other product, may be covered by a range of patents, individual patents may also be part of a larger technology solution or platform applicable to different products. Innovation doesn’t stop when a new medicine is brought to market. In fact, biopharmaceutical companies are constantly innovating toward better medicines for better health.
Because of a strong U.S. patent system, the U.S. biopharmaceutical industry is willing to invest more than any other industry in R&D and bring forward medical advances critical to addressing some of our most challenging diseases. Robust IP protections including patents are necessary to foster the investments that allow researchers to harness scientific and technological breakthroughs as they develop new medicines that improve and save lives.
Without strong patent protections, researchers may not have the ability to invest in new areas of medical innovation that could lead to tomorrow’s treatments and cures.
Learn more about intellectual property on the IP page and check back for next week’s IP Explained blog.
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.