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Today, the House Committee on Oversight and Accountability will mark up the amended BIOSECURE Act—we’ll be watching. Meanwhile, BIO explains why new AI patent guidance creates uncertainty and a North Carolina treasurer’s report calls out 340B abuses in the state. (592 words, 2 minutes, 57 seconds) |
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AI patent guidance creates unneeded uncertainty, BIO says |
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New U.S. Patent and Trademark Office (USPTO) guidance is concerning because it can raise questions about whether inventions made with the help of AI can be patented, BIO says in comments this week.
They key point: “The USPTO Guidance implicitly but clearly casts doubt upon the substantive patentability of inventions that result from the use of AI. It suggests that even where there has been some human involvement, there may be no patentable invention because no natural person contributed ‘enough,’” explains Hans Sauer, BIO’s VP for Intellectual Property.
Why it matters: More biotech companies are utilizing AI. Guidance casting doubt on whether resulting inventions are patentable will inhibit the use of AI in inventions, limit innovation, and put the U.S. at a competitive disadvantage.
In other countries, patent laws treat inventions the same whether they were made with AI support or conceived in the inventor’s mind, Sauer notes.
Not future-proofed: “The extent of human involvement, at least in the biotech space, is such that the Guidance’s standard of ‘significant human contribution’ will likely usually be met at the current stage of technology implementation,” Sauer writes. But AI advances will soon “present additional, thorny questions that the current Guidance conservatively avoids.”
The bottom line: Inventions made with the help of AI belong to human inventors and should be patentable, BIO has consistently argued. “AI must be guided and prompted by humans to create useful results. Humans are the sole inventors of AI-assisted biological inventions,” Claire Laporte, a patent expert at BIO member Ginkgo Bioworks, has told Congress. |
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North Carolina treasurer’s report calls out 340B abuses |
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North Carolina 340B hospitals profit from huge markups on oncology drugs while neglecting vulnerable populations they are supposed to serve, finds an investigation released last week by the state treasurer.
Under the 340B program, hospitals and certain entities that treat large numbers of low-income or uninsured patients can purchase medications at steep discounts.
The problem now: Statutory and regulatory changes in 2010 expanded the program and resulted in hospitals in wealthy areas taking advantage of the program and profiting through use of unlimited contract pharmacy arrangements, which grew 4,228% from 2010-2020.
How much do they profit? The North Carolina State Health Plan investigation shows: - 340B hospitals billed the State Health Plan 5.4 times their discounted acquisition costs for oncology drugs, collecting an 84.8% higher markup than non-340B hospitals, earning as much as $13,617 per claim.
- 340B hospitals recorded higher net profit margins than non-340B hospitals.
- North Carolina 340B contract pharmacy arrangements leapt from six in 2010 to 1,059 in 2022.
340B reform is needed, says North Carolina Treasurer Dale R. Folwell, CPA. According to the report, “Policymakers should consider strengthening public oversight of the 340B program by introducing transparency requirements and bolstering accountability for hospitals’ charitable mission.” More Health News: Inside Health Policy: Group argues Sanders’ GLP-1 price estimate omits costs of innovation
“As Senate health committee Chair Bernie Sanders (I-VT) demands Novo Nordisk share pricing and sales data for its lucrative type-2 diabetes drugs, Wegovy and Ozempic, a think tank has released a report countering the Yale University report Sanders relied on in calculating the drugs cost less than $5 to produce, saying it doesn’t factor in the costs of creating an innovative medication.” |
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