The historic signing of the America Invents Act on September 16, 2011, represented a huge win for innovators and took needed steps to improve U.S. competiveness globally by aligning new patent laws more closely with those of other countries. This new law is the most significant overhaul of the U.S. patent system in 175 years. Lilly has championed efforts to modernize the patent system for many years, and we’re extremely pleased that the America Invents Act is now a reality.
The America Invents Act will provide a simpler path forward for innovators by reducing red tape and enhancing the quality of patents that are granted, and it will provide resources needed to help eliminate the backlog of 700,000 applications awaiting action in the U.S. Patent and Trademark Office. Additionally, transitioning the U.S. from a “first-to-invent” to a “first-inventor-to-file” system, the new law creates a set of transparent, objective, predictable and simple standards for gaining a patent – securing the U.S. as a leader in international efforts aimed at achieving greater consistency in global patent laws.
A strong patent system is crucial to driving America’s economic competitiveness and global leadership in fields like biopharmaceutical research, which employs more than 650,000 people and supports more than three million U.S. jobs. Intellectual property protections – such as patents – help drive the economy in three key ways: they promote incentives for innovation; they provide holders with certainty regarding their rights; and they provide enforcement tools to defend one’s property.
Biopharmaceutical innovation is costly and risky. However, maintaining a predictable and reliable patent system helps to encourage the innovation that supports jobs and leads to real and significant health benefits for America’s patients. Biopharmaceutical research companies generally file relevant patent applications early in the R&D process, years before a new medicine actually reaches patients. This means a significant part of the medicine’s patent life is spent prior to reaching the market; in fact, the average time on the market for the vast majority of innovative medicines is only 11.5 years before generic versions can enter the market, dramatically – and rapidly – reducing brand share by up to 90% in the first month alone. What’s more, generics can apply for approval as early as four years after the innovator medicine is approved.
Innovation is cyclical, and the ability to protect and defend their current patents provides an incentive for biopharmaceutical research companies to continue innovating, perhaps leading to the groundbreaking new technologies – and life-saving new medicines – of the future.