Posts Tagged: "Bayh-Dole"

DOE’s Misuse of Bayh-Dole’s ‘Exceptional Circumstances’ Provision: How Uniform Patent Policies Slip Away

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.” 

Conservatives Urge HHS to Deny Turning Bayh-Dole March-In Provision into Price Controls

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.

Let No Good Deed Go Unpunished—The Tale of a COVID-19 Breakthrough

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.

Don’t Go Down the Rabbit Hole with the Foes of Bayh-Dole

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.

The New Biden Executive Order: Undermining Bayh-Dole is Like Shooting Ourselves in the Foot—Let’s Not Go There

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.