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President Biden: Don’t misuse Bayh-Dole march-in rights – Boston, Massachusetts

Boston, Massachusetts 2021-09-17 04:45:45 –

MeFalse attempts to control drug costs, some parliamentary leaders prompt Biden administration misuses 40-year-old law support With 6 million jobs, it helped launch 15,000 start-ups and contributed $ 1.7 trillion to US economic production.Senators Elizabeth Warren (Democratic Party), Amy Klobuchar (Democratic Party), and Lloyd Doggett (Democratic Party) — with the Department of Health and Human Services. Pentagon, Exploiting the Bayh-Dole Act’s March-in Clause to price federally funded medicines. This clause does not allow it. Such actions would do catastrophic damage to the United States, but at the same time undermine Baydor’s intentions.

This is the reason.

Congress passed Baydor method This allows academic institutions and SMEs to patent and license inventions that are, at least in part, federally funded. Prior to its bipartisan reforms, which helped draft Senator Birchbay (D-Ind.), The government took ownership of such discoveries and destroyed their incentives for commercialization. as a result, Almost 28,000 Government-funded inventions have collected dust.Not single New drug What was discovered with the support of the federal government was developed. The multi-billion dollar R & D results backed by taxpayers were simply wasted.

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NS The Beidor Act ended that waste You can let academic institutions and small businesses license your discoveries to turn them into useful products. Since its inception, the United States has, on average, become a world leader in innovation. 3 new start-ups and 2 new products Every day of the year under Bayh-Dole.The law also supports most discoveries 300 new treatments..

Under Bayh-Dole, the federal government “march” It forces universities and SMEs to license inventions to additional companies, primarily if the original licensee has not made a sincere effort to develop the technology into a real product that can be used. The patentee actively monitors the licensee to ensure that he is working hard to turn the invention into a useful product. If not, the technology transfer office will terminate the license and find a better partner. For 40 years, the government never marched because federal-funded inventions were effectively managed and developed.

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Warren, Klobuchar, and Doggett’s request for the Biden administration to exercise its march to control drug prices confuses this delicate balance. Making health care more affordable is a commendable goal, but you can’t do it behind the scenes of Bayh-Dole. It’s not how the law works — and pretending to work will have dire consequences.

Commercializing federally funded inventions in the private sector is a risky endeavor, especially when it comes to developing new drugs, which are far more likely to fail than to succeed. It can take more than a decade, hundreds of millions of dollars, or even billions of dollars for a company to turn an invention into a new treatment. The system of public-private cooperation established by the Beidor Act is the most successful in the world. By making the commercialization process even more risky, you can reduce the number of drugs that are highly needed without doing anything to control costs.

The commercialization system supported by Bayh-Dole is being driven by SMEs.They receive about 70% of university patent licenses Create More than half These companies “bet on farms” when trying to commercialize federally funded research. Allowing the government to advance because someone believes that the price the company charges for its treatment is not “reasonable” is a fully undefined term for the U.S. economy and the United States. It will have a devastating impact on human health.

The federal government has previously tried the theory of Marchin supporters, but it was a disaster.In 1989, nine years after the passage of Beidor, the National Institutes of Health Reasonable price clause For patent licenses and cooperative research and development agreements (CRADAs) (research and development agreements between the public sector and private companies) based on the theory of progressive march-in rights abuse.

But instead of lowering drug prices, the CRADA between NIH and the private sector has collapsed. Harold E. Varmus, who directed NIH at the time, Abolished policy in 1995, “Pricing clauses keep the industry away from potentially beneficial scientific collaboration. [government] Scientists without offering the benefit of offsetting to the public. Number of Cooperative Research and Development Agreements I shot immediately..

As a senator, Joe Biden had a commendable record of upholding the Baydor Act. He voted in favor in 1980. At that time-Representative Bernie Sanders (I-Vt.) Introducing the bill In 2000, in order to revive the reasonable pricing clause that NIH had previously revoked. Biden voted to submit a motion, And the bill did not pass. The Obama Biden administration has rejected any attempt to abuse the march to control drug prices, saying it is not permitted under the law.

As President, Biden needs to continue to protect the Baydor Act. This is the cornerstone of the historic development of the Covid-19 vaccine, ahead of the United States with economic competitors like China. Failure to support Bayh-Dole undermines important alliances between academic research institutes, federal laboratories, and private entrepreneurs that help maintain the country’s prosperity and security. It’s a failure we can’t afford to buy.

Joseph P. Allen is Executive Secretary of the Beidor Union and previously a member of the US Senate Judiciary Committee.



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