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1.
J Health Polit Policy Law ; 2022 Jul 14.
Article in English | MEDLINE | ID: covidwho-2310816

ABSTRACT

Over forty years have passed since the enactment of the Patent and Trademark Amendment (Bayh-Dole) Act, which authorized institutions to patent inventions arising from federally-funded research. Although some experts have heralded the Bayh-Dole Act as ushering in a new era of technological advances, others have been less sanguine about its impact. In recent years, the rising price of prescription drugs and the patenting of COVID-19 therapeutics and vaccines developed with substantial federal government support have rekindled the debate whether companies should receive more restricted rights to such products. In this article, we trace the history leading to the enactment of the Bayh-Dole Act and critically assess its strength and weaknesses as well as unresolved questions concerning its scope. Based on this analysis, we propose reforms to better align the Bayh-Dole Act with public values and health outcomes, including clarifying the scope of government use rights, making it easier to invoke march-in rights for failure to meet health and safety needs, increasing transparency in how patents are licensed, and testing different approaches to foster the development and application of inventions.

2.
Health Policy Open ; 3: 100069, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-1778164

ABSTRACT

In 2006, the U.S. federal government launched a project to create a cheap, easily produced, and easy to use ventilator that could be stored for long periods of time for pandemic response. Despite successful funding and contracts with two separate medical device companies, not a single ventilator had been added to the stockpile by 2020. The company currently under federal contract for these ventilators is selling its product to private parties, rather than supplying it to the federal government. In the current crisis, government has instead turned to the Defense Production Act to supply ventilators. Inaccessibility of medical equipment is a detriment to Americans' health, particularly during a public health emergency like COVID-19. This persists despite the central role of the federal government in the funding of healthcare innovation. We place the shortage of ventilators in context of the ongoing debate about the federal government's intellectual property powers, as well as the legal recourses available, then discuss why this situation is a strong argument for expanding compulsory licensing powers as a component of federal policy.

3.
Hastings Cent Rep ; 51(5): 3, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1413544

ABSTRACT

The United States developed penicillin and vaccines during World War II. The partnership of government, industry, and academe was crucial. In an essay, Vannevar Bush credited that partnership with the technological achievements that led to winning the war. The policies used to address the Covid-19 pandemic closely resemble how penicillin was developed, and similarly produced spectacular success in the form of RNA-based vaccines. But will today's politics of hyperpartisan vitriol and credit-mongering that pit industry against government and academe prevent carrying that success into the postpandemic era?


Subject(s)
COVID-19 , World War II , Humans , Pandemics , Politics , SARS-CoV-2 , United States
4.
Issues in Science and Technology ; 37(1):89-92, 2020.
Article in English | ProQuest Central | ID: covidwho-884299

ABSTRACT

A few months into my medical training, I heard Fred Sanger, the Nobel prize-winning biochemist, describe a miracle-DNA sequencing in his lab-and Ray White, a pioneer in human genetics, excitedly reveal the first genetic markers that would grow into a human genetic linkage map. [...]the US Patent and Trademark Office has granted patents on gene editing technologies, but is now-eight years after the critical science was conducted- reviewing a possible "interference," an administrative procedure to sort out competing patent claims on related inventions. While the US Congress passes secretive, sloppy funding legislation and patent offices in different jurisdictions craft incoherent policies, a hot debate plays out about whether, when, and under what conditions it might make sense to introduce heritable forms of genome editing into human beings. Baylis's book, Altered Inheritance, is a plea for broadening the debate beyond a case-by-case technical assessment of risk and potential benefit.

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