Posts Tagged: "NIH"

On its way out the door, the Biden administration took a parting shot at America’s most innovative companies in a self-described bid to “expand equitable patient access to products that emerge from NIH-owned patents.”

The Bayh-Dole Coalition yesterday released an issue brief warning that there will be dire consequences if the Trump Administration doesn’t “immediately” roll back a Biden-imposed National Institutes of Health (NIH) policy published on January 10, titled “NIH Intramural Research Program Access Planning Policy.”

On its way out the door, the Biden Administration just released new guidelines  for those seeking to license inventions made at the National Institutes of Health (NIH) that could lead to new “drugs, biologics (including vaccines) or devices for the prevention, diagnosis or treatment of human disease.” The administration has claimed this is being done “to expand patient access to products that emerge from NIH-owned inventions.” The guidelines apply to all licenses, exclusive and non-exclusive.

With exquisitely bad timing, the National Institutes of Heath (NIH) floated a new policy governing licensing inventions made by its scientists subtitled “Promoting Equity in Access Planning.”. With stakeholders still stunned by the Administration’s attempt to misuse the Bayh-Dole Act to impose Washington price controls on products based on federally funded inventions, the new plan could hardly have been floated at a worse time. The document asks for public comments by July 22, 2024.

On May 22, 2024, the National Institutes of Health Office of Science Policy issued a Request for Information on its Draft NIH Intramural Research Program Policy: Promoting Equity Through Access Planning (“NIH RFI”). . This RFI describes an NIH proposal to develop and implement a policy to promote access to products stemming from taxpayer-funded inventions under the Bayh Dole Act 35 USC 200: Policy and objective (house.gov). The comment period for this RFI closes July 22.

One day before comments closed on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, published by the National Institute of Standards & Technology (NIST) and the Department of Commerce last month, the Department of Health and Human Services (HHS) denied an appeal of a decision not to march in on the blockbuster prostate cancer drug, Xtandi®.

On July 31, the National Institutes of Health (NIH) hosted a virtual workshop titled Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer. Public comments submitted to the NIH ahead of the event reflect current tensions between advocates supporting either private commercialization or government pricing control of federally-funded medical breakthroughs commercialized by private companies.

Rattled by the failure of the Biden Administration to bow to pressure to misuse the march-in rights provision of the Bayh-Dole Act so the government can regulate prices on products based on federally funded inventions, Senator Bernie Sanders (I-VT) and his allies are doubling down. And the impact of National Institutes of Health (NIH)-supported research is now in jeopardy. Sanders taunted the Administration, pledging to hold up the nomination of Dr. Monica Bertagnolli to head the NIH until President Biden submits to his demands to do more to control drug prices, including requiring that any therapy-based on an invention arising from NIH funding must be sold at a “reasonable price.”

Just when you think you have enough things to worry about, you stumble  upon  one more. In its wisdom, Congress enacted a “Medicare Drug Price Negotiation Plan” as part of the Inflation Reduction Act. The program kicks in by imposing “maximum fair prices” for drugs as determined by the Centers for Medicare & Medicaid Services (CMS). In setting these prices, Congress included such factors as the R&D costs for each drug and whether they have been recovered and the current cost of producing and distributing the drug in question. But it was the third criteria which caught my eye—“Prior Federal financial support for novel therapeutic discovery and development with respect to the drug.”

On March 22, the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) sent a letter addressed to Senators Bernie Sanders (I-VT) and Bill Cassidy (R-LA), respectively the Chair and Ranking Member of the U.S. Senate Committee on Health, Education, Labor, and Pensions, regarding a Health Committee hearing held that same day on the pricing of Moderna’s COVID-19 vaccine. The GIPC’s letter sought to push back on false narratives regarding the role of public funding in private pharmaceutical research & development (R&D,) and also doubled down on the Center’s criticisms of drug pricing controls in the recently enacted Inflation Reduction Act.

Perhaps after their favorite theory was blown apart again, as it has been every time it’s been trotted out over the past 20 years, the critics of the Bayh-Dole Act learned a painful lesson. Their carefully constructed thesis that the law contains a hidden provision allowing the government to set prices on successfully commercialized products has been summarily rejected by every Democratic or Republican Administration which has considered it. They say the definition of insanity is doing the same thing repeatedly while expecting a different result. But that didn’t keep the proponents from refiling the same petition which was rejected three times in the Obama-Biden Administration. So once again, the National Institutes of Health (NIH) denied the request that it should “march-in” under the law against the prostate cancer drug, Xtandi, because critics felt it is not “reasonably priced.” Apparently, the petitioners thought that the fourth time would be the charm. Now they know better. And this time, NIH included a subtle, but fatal blow to attempts to go down this path again.

AUTM, which represents the academic technology management profession, just released the results of the survey of its members for 2021. Once again, the results are impressive, particularly considering that the U.S. economy was just beginning to emerge from the devastating effects of the COVID-19 pandemic…. It’s clear that despite continual attacks on the Bayh-Dole system, which allows academic institutions to own and manage federally funded inventions without Washington micro-management, our system keeps truckin’ right along, year after year, leading the world.

The United States National Institutes of Health (NIH) signed a deal today with the World Health Organization’s COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP) that allows manufacturers greater access to key COVID-19 technologies owned by NIH. The licensing agreement offers 11 technologies under transparent, global and non-exclusive licenses. They include “the stabilized spike protein used in currently available COVID-19 vaccines, research tools for vaccine, therapeutic and diagnostic development as well as early-stage vaccine candidates and diagnostics.”

The National Institutes of Health (NIH) is at legal odds with Moderna, claiming that Moderna neglected to add three NIH scientists to Moderna’s patent application on a principal COVID-19 vaccine. If a court ends up siding with NIH, it would co-own any issued patents on the technology, which could prove to be quite valuable; in 2021, Moderna’s vaccine sales were forecasted to be in the range of $15 billion and $18 billion. With an equal undivided interest in the patent, NIH could do whatever it wishes with it, such as licensing it to others and collecting royalties.