|
|
|
We recap what BIO Board member company Ginkgo Bioworks said about AI and IP on Capitol Hill yesterday—plus, BIO comments on a proposed update to the Medicaid Drug Rebate Program (MDRP) and BIO CEO John F. Crowley wins a leadership award from Life Sciences PA. (881 words, 4 minutes, 24 seconds) |
|
|
|
|
|
|
People invent – AI just helps, BIO member tells Congress |
|
|
Patent laws must protect innovators use of artificial intelligence tools to create cutting-edge technologies to ensure continued U.S. leadership in biotech, an IP expert at BIO Board member Ginkgo Bioworks testified in Congress yesterday.
The hearing:IP Protection for AI-Assisted Inventions and Creative Works, hosted by the House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet, featured Claire Laporte, Intellectual Property Fellow and former Head of Intellectual Property at Ginkgo Bioworks, which programs cells for a variety of applications.
The concern: While current U.S. patent law ensures humans own patents, U.S. Patent & Trademark Office (USPTO) guidance issued in February could allow different treatment of inventions made with AI—clouding questions about IP and discouraging use of AI for innovation, Laporte testified.
Why it matters: Our competitors are using AI to advance biotechnology, and if the United States can’t do that, we’ll fall behind, said Laporte.
AI does not create—AI is a tool, which “must be guided and prompted by humans to create useful results,” said Laporte.
Current law is clear: Regardless of the tools used in R&D, the invention must be conceived by a human mind, and the human who conceived the idea legally owns the invention, she explained.
Members of Congress agreed: Subcommittee Chair Darrell Issa (R-CA) warned against “dismantling a system that has made the United States the most innovative successful country in the history of mankind.” Rep. Deborah Ross (D-NC) said, “IP protections should be extensive enough to incentivize investors to utilize new technologies like AI.” The bottom line: “Our patent law should support, not hinder, the responsible use of AI to achieve transformative results for the economy and human health,” Laporte testified. “The last thing we should do is discourage scientists from using the best tools available to them.” Read more at Bio.News. Watch highlights: |
|
|
|
|
|
Proposed MDRP update would upend patient access, says BIO |
|
|
A proposed update to the Medicaid Drug Rebate Program (MDRP) would “deny some of the nation's most vulnerable patients access to the state-of-the-art medical care they deserve,” says a letter from BIO leadership and dozens of small- and mid-sized companies to the Centers for Medicare and Medicaid Services (CMS) and the Office of Management and Budget (OMB).
The proposed rule (CMS-2434-P) would require manufacturers to aggregate, or “stack,” price concessions provided to separate entities across the supply chain when determining the Best Price through the Medicaid Drug Rebate Program. The rule would also expand the definition of “covered outpatient drug (COD),” with a particular impact on reimbursement and potential coverage for drugs administered in inpatient settings.
Why it matters: “If finalized in its current form, the proposed rule would impose significant costs to the government and industry and create extensive barriers to patient access to existing innovative therapies and to developing new cures for Medicaid enrollees,” says the letter. “As a result, it will deny some of the nation's most vulnerable patients access to the state-of-the-art medical care they deserve, both now and in the future.”
The “best price” change is “at present, impossible to implement,” they explain. “No system exists today that is capable of tracking price concessions given to all entities that purchase or cover a given drug across the supply chain.”
It’s especially cumbersome for small and medium-sized biotechs—and the overall cost “would be very significant and could make ongoing participation untenable,” thus discouraging investment in R&D.
The proposed COD change could impact cell and gene therapy: Removing “the requirement that inpatient-administered therapies be paid for separately from the reimbursement for the underlying hospital stay in order to qualify for the Medicaid Drug Rebate” could lead to financial losses for low-income hospitals and threaten innovation and patient access, too.
The bottom line: “The Medicaid Drug Rebate Program has helped bring hundreds of revolutionary therapies to underserved and marginalized patients while maintaining incentives for continued research into new treatments and cures. Unfortunately, the proposed rule would put this carefully struck balance in jeopardy,” says the letter.
What’s next?: The proposed rule is currently at OMB for final review. |
|
|
BIO CEO receives leadership award from Life Sciences PA |
|
|
|
"Biotech involves an incredibly challenging but ultimately rewarding pursuit of the mission to “enhance and extend human life,” said BIO CEO John Crowley, acknowledging an award yesterday from Life Sciences PA.
The Hubert J.P. Schumacher Leadership Award recognizes a Pennsylvania “leader in the life sciences community who best exemplifies the spirit of innovation,” said Christopher Molineaux, President & CEO at Life Sciences PA, in a podcast conversation with Crowley.
Why it matters: “Everything we do at BIO, and everything we do throughout the industry, is done with an extraordinary focus on patients, families, and caregivers,” said Crowley, noting access is as important as innovation. Listen to the podcast here. |
|
|
|
|
|
|
|
|
|
