Yesterday was a big day for BIO on Capitol Hill as three bills we helped develop were introduced in Congress.
Bill #1: The Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act better balances interests of patent owners and patent challengers by reforming the Patent Trial and Appeals Board (PTAB) at the U.S. Patent and Trademark Office (USPTO). The bill was introduced by Sens. Chris Coons (D-DE) and Thom Tillis (R-NC), and Reps. Ken Buck (R-CO) and Deborah Ross (D-NC).
Why it matters: USPTO is proposing reforms to PTAB patent invalidation proceedings. BIO VP for IP Hans Sauer, who submitted recommendations on those proposals Tuesday, said PREVAIL would codify important reforms.
BIO’s take: “Strong intellectual property protections sustain America’s global leadership in biotechnology innovation and the creation of hundreds of thousands of high-wage, high-value jobs,” Sauer explained.
Bill #2: The Patent Eligibility Restoration Act of 2023, also from Sens. Tillis and Coons, would clarify patent eligibility for complex new technologies—such as gene therapy.
BIO’s take: “Courts and stakeholders have long called for clarification in the law on what is eligible for patent protection. Providing clearer guidance will help early-stage innovators,” said a BIO statement.
Bill #3: The Medical Supply Chain Resiliency Act, from Sens. Tom Carper (D-DE) and Tillis, aims to ensure critical medical supplies are delivered safely, swiftly, and efficiently by authorizing POTUS to negotiate with “trusted trading partners” committed to global health security, rule of law, and transparency.
BIO’s take: “The COVID-19 pandemic highlighted the need to create robust supply chains to meet global medical needs. Senator Carper’s legislation is an important step in that direction.”
More Health News:
U.S. Food and Drug Administration (FDA): FDA approves first gene therapy for treatment of certain patients with Duchenne muscular dystrophy
“Today’s approval addresses an urgent unmet medical need and is an important advancement in the treatment of Duchenne muscular dystrophy, a devastating condition with limited treatment options, that leads to a progressive deterioration of an individual’s health over time,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. The drug is developed by BIO member Sarepta Therapeutics, Inc.