Posts Tagged: "Bayh-Dole"

In recent months, two U.S. government executive initiatives have reshaped the landscape concerning intellectual property and the domestic production of products resulting from federally funded research. These initiatives are poised to bring substantial changes to the dynamics of academic-industry collaborations as inventions are brought to market.

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.

On Friday, July 28, President Biden announced a new Executive Order titled “Federal Research and Development in Support of Domestic Manufacturing and United States Jobs.” Rumors that the Administration was considering extending the deeply flawed Department of Energy (DOE) policy (see “More DOE Bureaucracy Equals Less Innovation” to all agencies had been swirling for months. Luckily, the new Executive Order doesn’t do that, but how it will be applied is subject to a convoluted interagency process, so it will be months before we see if it’s meeting its intended goal or not.

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.

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.

Last week, the Bayh-Dole Coalition held a webinar titled “The Three-Pronged Attack on U.S. Innovation and Intellectual Property.” Before we consider each prong, it’s worthwhile reflecting on a larger point. Each would deal a body blow to American innovation just as we struggle to keep the economy on track. And each would be a self-inflicted wound that must have our foreign rivals shaking their heads at our folly.

How about some good economic news? That’s in short supply these days as the nation teeters on the brink of recession, driven by raging inflation and skyrocketing gas prices. But in good times and bad, our technology transfer system created by the Bayh-Dole Act just keeps chugging along. A just released study by the Biotechnology Innovation Organization (BIO) and AUTM, which represents the academic technology management profession, shows that academic patent licensing contributed up to $1.9 trillion to the U.S. economy while supporting 6.5 million jobs between 1996 – 2020. Even more impressively, this impact increased substantially since the last survey was released three years ago. That showed an economic impact of $1.7 trillion with 5.9 million jobs supported.

A principal purpose of the Bayh-Dole Act of 1980 was imposing a uniform patent ownership policy on all federal agencies. Previously, agencies took rights to inventions made with their funding, but over the years they had developed a multiplicity of often conflicting procedures for filing appeals, with some agencies having different policies for different programs. The resulting confusion made companies crazy trying to navigate through them. The burden was particularly heavy on small businesses. The Bayh-Dole Act established a uniform policy requiring all agencies to waive invention ownership to those making patentable discoveries with their support. It also allows agencies to deviate from automatic contractor ownership of  inventions in exceptional circumstances: “when it is determined by the agency that restriction or elimination of the right to retain title to any subject invention will better promote the policies and objectives of this chapter.” 

Thirty-one signatories from 29 center-right public policy organizations have written U.S. Health and Human Services Secretary Xavier Becerra, urging him to deny a petition from Knowledge Ecology International that requests use of march-in rights under the Bayh-Dole Act against the prostate cancer medicine, Xtandi. The conservative organizations represented on the letter include some of the most prominent center-right groups, such as the American Conservative Union, Americans for Prosperity, Americans for Tax Reform, the Competitive Enterprise Institute, Eagle Forum Education & Legal Defense Fund, FreedomWorks Foundation and Heritage Action for America. Conservatives for Property Rights led the letter initiative.

The lead story in last weekend’s Wall Street Journal made an exciting announcement: “Merck Covid-19 Pill Cuts Risks of Hospitalizations and Death”: “Merck & Co. and its partner Ridgeback Biotherapeutics LP said their experimental Covid-19 pill helped prevent high-risk people early in the course of the disease in a pivotal study from becoming seriously ill and dying, a big step toward providing the pandemic’s first easy-to-use, at home treatment.” In case its readers missed the significance, the same issue included an editorial, “There May Soon Be a Covid Pill”, stating: “In what is rare good news these days, Merck and Ridgeback Biotherapeutics said Friday that their Covid pill molnupiravir reduced hospitalizations by about half… Since the beginning of the pandemic, doctors have been hoping for an oral antiviral that could prevent recently infected patients from getting sicker… Merck has also signed licensing agreements with generic manufacturers to accelerate the pills availability world-wide. Manufacturers in low-income countries don’t need special expertise and supervision to produce the pills, unlike with Covid vaccines. Molnupirvir can be easily distributed in poorer countries… Evidence also indicates that the drug is effective against different variants and is unlikely to produce viral resistance.” The partnership between Emory University, Ridgeback Biotherapeutics and Merck could turn out to be one of the most significant Bayh-Dole alliances ever, yet just a few months ago all three were under fire. And the critics are renewing their attacks.

Sensing an opening after the Biden Administration’s recent Executive Order put a hold on a pending regulation prohibiting the misuse of the march-in rights provision of the Bayh-Dole Act for price control, Congressional opponents of the law dusted off a ploy that failed in the Obama Administration to try their luck again. They’ve written to Secretary of Defense Lloyd Austin and Health and Human Services Secretary Xavier Becerra urging them to march in to control prices of drugs created from inventions arising from R&D their agencies supported. We likened that aspect of the Executive Order to shooting ourselves in the foot, and it seemed as though it would be a while before we would know if the Administration would pull the trigger or not. With the recent Congressional actions, the day of reckoning may not be far off.

Late Friday, the Biden Administration unveiled what must be one of the longest Executive Orders in history, titled “Promoting Competition in the American Economy.” In 31 pages, it covers everything from agriculture, shipping and railroads to the internet. The aim is to promote a “fair, open and competitive marketplace” against the threats of “excessive market concentration.” Among the intended beneficiaries are entrepreneurs, who will receive “space to experiment, innovate, and pursue the new ideas that have for centuries powered the American economy and improved the quality of life.” Unfortunately, tucked away on page 28 is a directive to the Secretary of Commerce that could threaten to undermine the Bayh-Dole Act, which allows entrepreneurs to commercialize federally-funded inventions. The law has spurred the impressive formation of academic spin-out companies and resulted in approximately 70% of these discoveries being licensed to small companies. It’s also critically important to our economic growth and continued well-being.