Doubling down on IP rights

BIO expands its work to defend IP

BIO is building on decades of work to strengthen IP, using a public-facing task force and a Board committee to drive a coordinated IP strategy.

Why it matters: “IP impacts so many areas that are really important to BIO, like national security, trade, and regulatory modernization,” says Joe Franklin, BIO’s Chief Legal and Policy Officer. International IP Day yesterday raised awareness of IP’s importance for research-heavy industries like biotech.

BIO has enabled IP knowledge sharing since 2004, convening a group of lawyers with patent and IP specialties in the BIO IP Counsel’s Committee.

BIO’s new IP initiatives: The BIO Board’s Economic Growth, Innovation, and Intellectual Property Committee sets BIO’s overall IP strategy. The BIO IP Task Force drives that strategy by bringing together experts from member companies with BIO staff.

What they’ll do: Reach a wider network impacted by IP using advocacy and promotion in Congress, international fora, the courts, and the media.

A national security priority: As BIO explains in comments to the U.S. Trade Representative, China uses unfair IP practices in seeking to dominate global biotech—an effort with strategic and economic implications. “A robust biotech ecosystem in the U.S. is a national security priority,” Franklin says. “IP is obviously central to that.”

Read more on Bio.News.

HHS budget hearings: Clinical trial competition, vaccines, 340B, and more

Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. addressed vaccines, China, price controls, and more in four congressional hearings held during his second week of testifying on the 2027 HHS budget.

China competition: Kennedy told the April 22 Senate Health, Education, Labor & Pensions (HELP) Committee hearing China attracts more clinical trials because going from concept to commercialization takes too long in the U.S.

Kennedy was questioned on vaccines, including declining vaccination rates and the administration’s response to measles outbreaks. Kennedy told HELP, “I’ve authorized $500 million now for cancer vaccines, and I think mRNA is a promising technology for cancer vaccines.” In several hearings, Kennedy said he promotes measles vaccines. He blamed a global measles outbreak for rising case numbers.

340B: In a House Energy & Commerce Health Subcommittee hearing, Kennedy agreed with Rep. Earl “Buddy” Carter (D-GA) that hospitals abuse 340B programs designed to help underserved neighborhoods.

NIH funding: Senators raising concerns about National Institutes of Health (NIH) funding cuts included Sen. Susan Collins (R-ME) in the April 21 Senate Appropriations Subcommittee hearing, Sen. Patty Murray (D-WI) in the HELP hearing, and Sen. Thom Tillis (R-NC) in the April 22 Senate Finance Committee hearing.

Price controls stop innovation, said Sen. Tillis, noting most favored nation (MFN) price controls “slash private R&D by 30-50%” and price controls in the previous administration spawned a 40-60% drop in small molecule research. “MFN tells the world that America will no longer invent in the future,” he said.

Speaking of prices: An April 22 House Education & Workforce subcommittee hearing criticized drug price increases caused by pharmacy benefit managers (PBMs). Chair Rick Allen (R-GA), Rep. Virginia Foxx (R-NC), and others urged reform of PBM market concentration. Read more: Simplify the System.

What Else to Read

Regeneron gets FDA OK for gene therapy to treat hearing loss and makes a deal to lower prices. Regeneron on April 23 announced it had entered into an agreement with the White House to lower Medicaid prices for some medicines based on prices in other developed countries. Simultaneously, Regeneron announced Food and Drug Administration (FDA) accelerated approval for the gene therapy Otarmeni™ to treat hearing loss due to otoferlin deafness, a rare genetic condition. Otarmeni™, which was granted an FDA Commissioner's National Priority Review Voucher, will be offered for free in the U.S.

FDA approves Merck’s HIV treatment. “The U.S. Food and Drug Administration (FDA) approved IDVYNSO™, a new, two-drug single-tablet regimen of 100 mg doravirine and 0.25 mg islatravir, for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine,” Merck announced. Read more here.

BIO goes to Ohio. The next stop for BIO on the American Road will be tomorrow when BIO President & CEO John F. Crowley leads a visit to Columbus Ohio, where innovative work at Nationwide Children’s Hospital, Sarepta Therapeutics, and Ohio State University help to drive a biotech ecosystem with expertise in gene therapy. Watch for more next week.

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