Posts Tagged: "National Institutes of Health"

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.”

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.

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.”

As Knowledge Ecology International and its allies await the decision of the National Institutes of Health (NIH) on their latest attempt to misuse the Bayh-Dole Act for the government to set prices on any product based on a federally funded invention, they’re growing more uneasy. And that’s understandable. If you’d bet the house on an ivory tower theory that’s been summarily rejected for the past 18 years every time it’s been trotted out, you’d be uneasy too. They know that if the Biden Administration rejects the pending petition to march in on the prostate cancer drug Xtandi because of its cost, this leaky vessel can’t be credibly refloated again.

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.

As discussed previously, the critics are in full howl now that their attempts to enact legislation controlling drug prices has failed once again. They are applying unprecedented political pressure on Secretary Xavier Becerra at the Department of Health and Human Services (HHS) to misuse the march in provisions of the Bayh-Dole Act to accomplish their goal. Nearly 100 distinguished organizations and individuals endorsed the following letter from the Bayh-Dole Coalition, which I lead, warning HHS not to take this disastrous misstep. Here’s what we said.

Some say the definition of insanity is doing the same thing over and over while expecting a different outcome. That would appear to be the case with the recent refiling of a petition by Knowledge Ecology International (KEI) to the National Institutes of Health (NIH) asking it to march in under the Bayh-Dole Act to force licensing to additional parties of the prostate cancer drug Xtandi, because of its cost. The law allows academic institutions, companies and federal laboratories to own and license inventions made with government support. Similar petitions were rejected by NIH and the Department of Defense (which funded the research on the underlying invention) in the Obama/Biden Administration for a simple reason: the law is for the commercialization of federally funded inventions; it does not allow the government to set prices for successful products.

In the wake of the development of COVID-19 vaccines, the Biden-Harris Administration has suggested major shifts in U.S. policy concerning patent protection. In May of this year, Ambassador Katherine Tai, the U.S. Trade Representative (USTR) announced the Administration’s support for waiving intellectual property protections for COVID-19 vaccines. Most recently, the National Institutes of Health (NIH) Director Dr. Francis Collins accused Moderna of excluding three NIH scientists as co-inventors of a key patent for the COVID-19 vaccine. This article explores an alternative possibility of the Administration exercising certain rights in the COVID-19 vaccine invention under the 1980 Bayh-Dole Act—one day after the bill’s co-sponsor, Senator Bob Dole, passed away—and whether such an exercise of rights is in line with past precedent or would be a violent disruption to the status quo.  

Moderna and the National Institutes of Health (NIH) are poised for a legal battle over inventorship of a vaccine for COVID-19. While a court may resolve the dispute over inventorship for the patent application, court review of current inventorship rules could be a slippery slope to chaos. Moderna and NIH collaborated on developing a functional vaccine for COVID-19, which is not in dispute. As a result of the collaboration, a vaccine labeled “mRNA-1273” was created and a U.S. patent application was filed by Moderna, with no NIH scientists listed as inventors. Moderna has commented that, after an internal review, no NIH scientists designed the actual vaccine claimed in the U.S. patent application. NIH has commented that it believes three scientists should be included in the U.S. patent application as co-inventors with the Moderna scientists.

Two organizations with which I work have filed comments with NIST on its Bayh-Dole regulatory proposals. The National Institute of Standards and Technology, or NIST, approaches completion of its two-and-a-half-year effort known as the Return on Investment Initiative, as the regulatory revision stage nears its close. NIST has conducted a commendable process and proposed mostly constructive or reasonable updating to rules associated with the Bayh-Dole Act. But one proposal puts at risk the continued success of the storied law for democratizing technology transfer and commercializing inventions coming from federally sponsored research. That is, this law facilitates bringing to practical use inventions that otherwise would sit on shelves.

How many people or organizations could undergo an exhaustive investigation into everything they’ve done over the past 30 years and emerge unscathed? That’s what just happened to the technology transfer operations at the Department of Health and Human Services (HHS), with the spotlight primarily focused on the National Institutes of Health (NIH). Of course, an exercise like this has to find something, so the report that resulted from this exercise is titled “NIH Should Publicly Report More Information about the Licensing of Its Intellectual Property”. After extensive digging, all it uncovered are some pretty small potatoes.

Our current experiences with COVID-19 in the United States, together with headlines warning of major efforts by the Chinese and Russian governments to hack corporate, academic and federal laboratories to steal information on pending therapies, underline the importance of maintaining the U.S. lead in the life sciences. It’s not just our health at risk—it’s also our security. We’ve just had a taste of what it’s like depending on China for medicines and protective gear. We also face an internal threat posed by “drug populists” calling for arbitrary government price controls while blaming patents for costs and blocking innovation. Ironically, a perfect example of this school of thought appeared in the  New York Daily News the same day as an important new report issued from the Information Technology & Innovation Foundation (ITIF). Titled “Ensuring U.S. Biomedical Competitiveness”,  the report is a treasure trove of critically needed information.

It may seem odd, as unprecedented public/private sector R&D alliances work to discover and develop therapies to counter COVID-19, that some are trying to punish the companies trying to get us out of this mess. For example, House “Progressive” leaders unveiled the  “three protections”  they will try to insert in the next Congressional aid package, beginning with this: “NO EXCLUSIVITY: Pharmaceutical manufacturers should not be granted exclusivity for any COVID-19 vaccine, drug, or other therapeutic-whether it has been developed with U.S. taxpayer dollars and publicly funded, or not.” Consider the last phrase. They would take away rights to technologies developed entirely with private funding without evidence of any public need for doing so.

The world is teetering on the brink of a public health and economic catastrophe, depending on emergency partnerships between our public and private sectors to develop a successful treatment for the coronavirus. If there was ever a time to be thankful that we have policies in place making that possible, it’s now. But there are those who want to use this crisis to return to the failed policies of the past. Here’s the bottom line: the Bayh-Dole Act works. It allows the private sector to collaborate with universities and federal laboratories, like the National Institutes of Health, knowing that intellectual property they bring into such partnerships will be protected. It also allows academic institutions and federal labs to determine what type of license is best suited to promptly commercialize their inventions.