|
|
|
We’re heading to Southern California to cover the BIO IP Conference—and why biotech needs strong patents. Here’s what we’re watching, plus a recap of BIO on the American Road in Indiana. (853 words, 4 minutes, 15 seconds) |
|
|
|
BIO IP Conference will highlight biotech’s need for strong patents |
|
|
The annual BIO IP Conference, the only industry-sponsored conference focused specifically on intellectual property in biotechnology, brings together IP experts to share insights and network in Southern California, today through Wednesday.
Why IP matters: In a research-heavy industry like biotech, the most valuable properties companies own are their ideas. Investors need strong patent protection for those ideas to ensure their investments into innovative treatments retain value.
“Ultimately, IP is what gets new medicines to patients,” explains Dr. Hans Sauer, BIO’s Deputy General Counsel and VP for Intellectual Property.
Research confirms the connection: A series of court decisions and legislation weakening patent protections reduced America’s share of VC investment in patent-intensive industries—from over 50% in 2004 to 28% in 2017. “The share of VC for pharmaceutical startups collapsed from 7% to under 1%,” the research shows.
What we’re watching at BIO IP 2025. Sessions BIO will be covering include: - “Navigating the Road of Joint Inventorship.”
- “Fireside Chat: How to Work with Academics in IP Policy Research.”
- “BPCIA Litigation Update: Key Cases, Trends, and Takeaways from 2024–2025.”
- “Using AI In Patent Practice: Practical and Ethical Issues.”
And there’s more: There will also be panels on evolving patentability standards, U.S. vs EU rules on disclosure, and the scope of genus claims and other means of patenting antibody inventions. Watch for additional coverage: We’ll publish stories on the Bio.News website and send another newsletter about the conference on Wednesday. Read more on Bio.News. |
|
|
|
BIO on the American Road: Indiana, a production powerhouse, is still expanding |
|
|
At a time when the biopharma industry is seeking to increase U.S. manufacturing, Indiana is in the vanguard—and still expanding, as BIO experienced firsthand on Nov. 11.
What happened: BIO President & CEO John F. Crowley led the latest stop in the BIO on the American Road tour—a series of visits around the U.S. to learn more about the needs and unique features of the country’s biotech ecosystems.
Indiana’s exporting: Employing more than 70,000 in the bioscience industry, Indiana overtook California in 2024 to become the nation’s top life sciences exporting state, with $27 billion in exports and over $99 billion in total economic activity.
Hoosier history: The first stop on the tour was Eli Lilly’s global HQ, which has been in Indianapolis since 1876. Lilly has announced plans for $50 billion in investment to expand its U.S. manufacturing, including at sites in Indiana.
Next stop was Novartis’s facility to produce radioligands, a potentially transformative new therapy combining a compound that binds to a cancer cell marker with a radioisotope, to allow for more precise cancer treatment. The 70,000-square-meter facility will be expanded under Novartis’s plans for $23 billion in U.S.-based infrastructure development.
The Radiopharmaceutical Capital of the World: Novartis’s site, Purdue University’s unique Master of Science in Radiopharmaceutical Manufacturing, and 15 local firms involved in radiopharmaceuticals have helped earn Indiana the official title “Radiopharmaceutical Capital of the World.”
BIO’s view: “Thriving ecosystems like Indiana’s don’t just happen. It takes great universities, a positive policy environment, an entrepreneurial mindset, capital, a trained workforce, and PURPOSE,” said Crowley, a graduate of nearby Notre Dame Law School. Read more on Bio.News. |
|
|
|
|
Richard Pazdur, M.D., to head CDER. The FDA announced that 26-year FDA veteran Richard Pazdur, M.D., would be the new director of the agency’s Center for Drug Evaluation and Research (CDER). The founding director of the FDA’s Oncology Center of Excellence, Pazdur is described by FDA as a “renowned regulatory innovator.” The New York Times noted he “presided over an era that has brought a flurry of approvals of new cancer drugs that have helped patients.”
FDA outlines new pathway for approval of rare disease treatments. The FDA outlined a “Plausible Mechanism Pathway,” an alternative means of approval for treatments targeting rare genetic disorders that have a small number of patients, making randomized clinical trials difficult. The new pathway was described in an article in the New England Journal of Medicine by FDA Commissioner Martin Makary, M.D., and Vinay Prasad, M.D., director of FDA’s Center for Biologics Evaluation and Research (CBER). The pathway is especially designed for bespoke gene therapies, like the one used recently to save an infant with a liver condition, but could theoretically be used for other treatments, they write.
World AMR Awareness Week (WAAW) urges action now to protect the future. Running Nov. 18-24, WAAW calls attention to the dangers of antimicrobial resistance (AMR) as the World Health Organization (WHO) urges global action. Given the challenges of bringing new antimicrobials to market, Emily Wheeler, BIO’s VP of Infectious Disease Policy, calls for legislation to support their development. “Simply put, this broken market is hindering the development of new, lifesaving antimicrobials. Without reform, clinicians will not have the treatments that they need to fight infections." she wrote in Medical Economics. Watch this space for coverage of BIO’s work during WAAW. |
|
|
|
|
|
|
|
|
