What’s Kamala Harris’s Position on Patents?

Recently, a short video clip of Vice President (and Democratic presidential nominee) Kamala Harris began circulating and (as of this writing) has reached 2.8 million views on X (formerly known as Twitter).

In the 19-second clip from 2019, she says “I will snatch their patent.”

However, the clip is missing context, as can be seen in the longer C-SPAN video.

As The Dispatch explains,

Then Sen. Harris was referring specifically to the potential for seizing some pharmaceutical patents in limited circumstances in an effort to implement price controls for specific drugs.

Harris was responding to a question from a voter about her plan to lower the cost of insulin prescriptions for diabetics.

(As CNN reported, President Biden, before he dropped out of the race for the Presidency, campaigned on his administration’s success in getting seniors with diabetes a $35-per-month cap on their insulin costs.)

Harris responded to the question as follows:

Essentially what we’re going to do is set drug prices so that American consumers are charged a price for drugs that is the average price that is being charged around the globe. For any drug where they fail to play by our rules—and if that drug came about because of federal funding for what is called R&D, research and development—I will snatch their patent so that we will take over.

As The Dispatch noted,

While the government does not have the ability to seize privately owned patents for itself per se, certain conditions—including projects developed with the help of federal funds—permit the government to license the patent to a different entity.

In December, 2023, the White House issued a statement that

The Biden-Harris Administration believes taxpayer-funded drugs and other taxpayer-funded inventions should be available and affordable to the public. When an invention is made using taxpayer funds, under certain circumstances march-in authority under the Bayh-Dole Act enables the federal government to license the invention to another party.

As the Center for Strategic & International Studies explains,

The Bayh-Dole Act deals with intellectual property arising from federal government-funded research. The Act permits universities, businesses, and non-profit organizations that receive federal funding to pursue ownership of an idea or product they created, rather than forfeiting the rights to that technology or invention to the federal government. In essence, it allows institutions and other grant recipients to hold patents on inventions that stem from government-funded research, enabling them to license the rights to those inventions to private sector partners who can then commercialize them. In this way, Bayh-Dole created an incentive for private sector development and commercialization of federally funded research and development (R&D). It decentralized technology management to universities and businesses that invented the product with government support.

Before the Act (title 35 of the United States Code (U.S.C.) 200 et seq.), the US government took the position that any inventions created from federally funded research would belong only to the government and would be solely non-exclusively licensed. This decreased commercial development and discouraged potential inventors because the government would own whatever they created.

But under the Act, the government retained the right to “march-in” if a patented product created with government funds wasn’t offered to the public on “reasonable” terms.

These “march-in” rights are controversial in the patent world. In practice, the rights have never actually been exercised.

In December, 2023, the National Institute of Standards & Technology (NIST) and the Department of Commerce published a draft version of a Federal Register Notice seeking comments on when and whether the government should exercise such rights.

As the Notice explained,

The Federal Government invests approximately $115B each year in extramural research and development at universities, non-profits, and small and large businesses. This results in the creation of thousands of inventions annually.

Although the Act mentions such march-in rights, it limits the situations in which they can be used and doesn’t mention high prices as a reason to march in.

Under the proposed new framework, a federal agency may take into account

“[a]t what price and on what terms has the product utilizing the subject invention been sold or offered for sale in the U.S.” and whether “the contractor or licensee [has] made the product available only to a narrow set of consumers or customers because of high pricing or other extenuating factors.”

Under the proposal,

The agency may also consider whether “the contractor or licensee has provided any justification for the product’s price or background on any extenuating factors which might be unreasonably limiting availability of the subject invention to consumers or customers.”

The proposal was criticized by some. For example, the US Chamber of Commerce called it “government confiscation.”

A Final Rule, published in March of 2023, included seven hypothetical situations in which federal agencies might consider march-in rights, including when prices have jumped considerably.

US Secretary of Health and Human Services Xavier Becerra said that

March-in authority is one powerful tool to ensure that the American taxpayer is getting a fair return on their investment in research and development.

In 2019, during the Trump administration, an editorial in the New York Times stated that

a growing number of policy experts and consumer advocates are pressing the federal government to use [march-in rights] now, for drugs like Truvada (the only drug approved to prevent infection with H.I.V.), which the government funded and holds some patents on. Patent overrides certainly won’t work for every medication, but they have been used successfully in the past to force the drug industry to the negotiating table. Mr. Trump could send a powerful signal to drug makers if he utilized them now.

According to Inside Health Policy,

A final version of the Democratic party platform hints that Vice President Kamala Harris, should she win the 2024 presidential election, will press forward with the Biden’s administration's controversial consideration of the use of march-in rights under the Bayh-Dole Act to ensure prescription drugs made with taxpayer dollars are made available to the American public at reasonable prices, or other efforts to ensure such drugs are affordable to patients.

However, the site referred to this as a “vague implication.”