Intellectual Property

Intellectual property is at the center of U.S. biotech leadership. It plays an essential role in the development of lifesaving scientific advances - and the safeguarding of America's national security. Strong patents, and an efficient, predictable, and objective patent system, are critical to ensuring that America continues to leads the world in innovation, providing the United States with a global competitive advantage and spurring economic growth and the creation of high-paying jobs here at home.

Powering Biotech's Golden Age
Strong, reliable IP protections allow startups to turn breakthrough science into lifesaving treatments — which is no easy feat. Roughly nine in 10 medicines ultimately fail in clinical trials. Without IP, the financial risks of drug development would be insurmountable.

Putting U.S. Patients First
A strong patent system ensures that U.S. patients continue to have priority access to first-in-class treatments — as well as the best and newest formulations of existing medicines. On average, new drugs are launched in the U.S. a full year before they hit other major markets like Germany and Canada.

IP and the "Virtuous Circle" of Innovation
 

Advancing newer and better medicines, therapeutics, and vaccines is a collective effort that involves an entire ecosystem, not just one person or company. This virtuous circle of innovation often begins with a patient or family expressing a need, and is followed by researchers responding with innovative ideas. BIO's role is to protect, advance, and enlarge this innovation ecosystem.

"The role of BIO is going to be to make sure that that entire innovation ecosystem, that virtuous circle, is protected and advanced.”
- BIO President & CEO John F. Crowley

Each Step Depends on Strong IP Protections

Every new medicine starts with an idea - sometimes in a lab, sometimes far outside it. From that first spark, innovators take on the high-risk, multi-step journey that turns discoveries into treatments and cures. 

Step 1 - Spark an Idea
Biotech innovation often begins by exploring ways to connect scientific insights to unmet medical needs. U.S. firms originate 61% of FDA-approved medicines.

Step 2 - Secure IP
Even in early stages, innovators file for patents to protect their novel inventions. These patents provide a foundation for everything that follows.

Step 3 - Identify a Potential Medicine
Through testing and refinement, researchers narrow in on a promising candidate with the potential to become a medicine. While scientists screen 5,000 to 10,000 chemical compounds, only one receives approval for human use.

Step 4 - Enter the Shark Tank
Armed with a patent and a smile, biotech startups seek venture capital to fund development.

Step 5 - Partner Up
At this stage, small firms — who are responsible for over 50% of all new medicines — often collaborate with other companies to run clinical trials and navigate regulatory approval.

Step 6 - Bring It to Market
After FDA approval, companies must manufacture, educate, and distribute. On average, new drugs are launched in the U.S. a full year before they hit other major markets like Germany and Canada.

Step 7 - Reinvest in the Next Breakthrough
Revenue from product sales helps fund future research. U.S. biopharma firms reinvest about 34% of their revenue into R&D, more than almost every other industry. This is how IP completes — and powers — the circle of biotech innovation.