AI and inventorship guidance: Incentivizing human ingenuity and investment in AI-assisted inventions; United States Patent and Trademark Office (USPTO), February 12, 2024

 Kathi Vidal, Under Secretary of Commerce for Intellectual Property and Director of the USPTO, United States Patent and Trademark Office (USPTO) ; Director's Blog: the latest from USPTO leadership

AI and inventorship guidance: Incentivizing human ingenuity and investment in AI-assisted inventions

"Today, based on the exceptional public feedback we’ve received, we announced our Inventorship Guidance for AI-Assisted Inventions in the Federal Register – the first of these directives. The guidance, which is effective on February 13, 2024, provides instructions to examiners and stakeholders on how to determine whether the human contribution to an innovation is significant enough to qualify for a patent when AI also contributed. The guidance embraces the use of AI in innovation and provides that AI-assisted inventions are not categorically unpatentable. The guidance instructs examiners on how to determine the correct inventor(s) to be named in a patent or patent application for inventions created by humans with the assistance of one or more AI systems. Additionally, we’ve posted specific examples of hypothetical situations and how the guidance would apply to those situations to further assist our examiners and applicants in their understanding."

Addressing the epidemic of high drug prices; Harvard Law Today, January 5, 2024

Jeff Neal, Harvard Law Today; Addressing the epidemic of high drug prices

"The Biden administration is once again targeting high drug prices paid by Americans. This time, officials are focused on prescription medications developed with federal tax dollars. The United States government, through the National Institutes of Health (NIH), awards billions of dollars of research grants to university scientists each year to fund biomedical research, which is often patented. The universities in turn grant exclusive licenses to companies to produce and sell the resulting drugs to patients in need. But what happens if a drug company fails to make a medication available, or sets its price so high that it is out of reach for a significant percentage of patients?

To tackle this problem, the Biden administration recently released a “proposed framework” that specifies when and how the NIH can “march in” and award the rights to produce a patented drug to a third party if the patent licensee does not make it available to the public on “reasonable terms.” The plan is based on a provision included in the Bayh-Dole Act, a 1980 federal law which was designed to stimulate innovation by encouraging universities to obtain and license patents for inventions resulting from federally funded research.

According to Harvard Law School intellectual property expert Ruth Okediji LL.M. ’91, S.J.D. ’96, although the Biden administration’s proposed framework for using government march-in rights to lower drug costs is an important development, whether it will be successfully implemented and result in meaningful drug price reductions remains to be seen. Harvard Law Today recently spoke to Okediji, the Jeremiah Smith, Jr. Professor of Law and faculty director of Global Access in Action(GAiA) at the Berkman Klein Center, about the new proposal and the legal challenges it might face."

What 70% of Americans Don’t Understand About Intellectual Property; Stites & Harbison, October 26, 2023

Mandy Wilson Decker, Stites & Harbison; What 70% of Americans Don’t Understand About Intellectual Property

"The United States Intellectual Property Alliance (USIPA) recently published the results of its US Intellectual Property Awareness & Attitudes Survey. Among its findings, the survey results revealed that 70% of Americans are unable to distinguish between mechanisms – patents, trademarks, copyrights, and trade secrets – for protecting Intellectual Property (IP).

Given these results, it's worth exploring the principal mechanisms for protecting IP, which each possess some distinctive features."

How a Drug Maker Profited by Slow-Walking a Promising H.I.V. Therapy; The New York Times, July 22, 2023

 Rebecca Robbins and Sheryl Gay Stolberg, The New York Times; How a Drug Maker Profited by Slow-Walking a Promising H.I.V. Therapy

"Gilead, one of the world’s largest drugmakers, appeared to be embracing a well-worn industry tactic: gaming the U.S. patent system to protect lucrative monopolies on best-selling drugs...

Gilead ended up introducing a version of the new treatment in 2015, nearly a decade after it might have become available if the company had not paused development in 2004. Its patents now extend until at least 2031.

The delayed release of the new treatment is now the subject of state and federal lawsuits in which some 26,000 patients who took Gilead’s older H.I.V. drugs claim that the company unnecessarily exposed them to kidney and bone problems."

Something is afoot with copyright this Public Domain Day; The Guardian, January 1, 2023

John Naughton, The Guardian; Something is afoot with copyright this Public Domain Day

"The issue highlighted by Public Domain Day is not that intellectual property is evil but that aspects of it – especially copyright – have been monopolised and weaponised by corporate interests and that legislators have been supine in the face of their lobbying. Authors and inventors need protection against being ripped off. It’s obviously important that clever people are rewarded for their creativity and the patent system does that quite well. But if a patent only lasts for 20 years, why on earth should copyright last for life plus 70 years for a novel? You only have to ask the question to realise that the founders of the American republic at least got that one right. Happy new year."

How the intellectual property monopoly has impeded an effective response to Covid-19; The Conversation, February 14, 2022

 Salam Alshareef; The Conversation ; How the intellectual property monopoly has impeded an effective response toCovid-19

"As of October 2021, only 0.7% of all manufactured vaccine doses had gone to low-income countries. Manufacturers had delivered 47 times as many doses to high-income countries as they had to low-income countries.

Since its inception, COVAX, the UN-backed initiative dedicated to promoting access to Covid vaccines, has struggled to obtain doses. It recently passed the 1 billion doses delivered – half way to its goal of delivering 2 billion doses by the end of 2021. Indeed, AstraZeneca, Pfizer/BioNTech, Moderna, and Johnson & Johnson have delivered between 0% and 39% of their already inadequate commitments to COVAX in 2021.

The Global Commission for Post-Pandemic Policy, meanwhile, estimates that while Asia and Europe will be able to fully vaccinate 80% of their populations by March 2022 and North America by May 2022, Africa will not reach 80% at current rates until April 2025."

Want to Reverse Inequality? Change Intellectual Property Rules.; The Nation, February 8, 2021

Dean Baker, February 8, 2021; Want to Reverse Inequality? Change Intellectual Property Rules.

Changes in IP have done far more than tax cuts to increase inequality—and US protection of IP could lead to a cold war with China.

"While the Reagan, George W. Bush, and Trump tax cuts all gave more money to the rich, policy changes in other areas, especially intellectual property have done far more to redistribute income upward. In the past four decades, a wide array of changes—under both Democratic and Republican presidents—made patent and copyright protection both longer and stronger."

Sold: An 1891 Patent by Granville T. Woods, Innovative Black Engineer; Atlas Obscura, July 22, 2020

Matthew Taub, Atlas Obscura; Sold: An 1891 Patent by Granville T. Woods, Innovative Black Engineer

Woods was prolific, but was largely forgotten for many years after his death.

"Beginning during Woods’s lifetime, trade publications and other newspapers took to calling Woods the “Black Edison,” a nickname that reflected the virtual absence of Black Americans in engineering during Reconstruction and the late 19th century. That reality haunted Woods, who, according to a recent belated obituary in The New York Times, often said that he was born in Australia in order to distance himself from the strictures of America’s racial hierarchy. Though Woods found (relatively) more financial success later in life, after selling a series of inventions to the likes of General Electric and George Westinghouse—including an early version of the “dead man’s brake,” which can stop a train with an incapacitated conductor—he was still deprived of the recognition that others in his field enjoyed. In fact, despite working at the top of his field, alongside figures such as Westinghouse, Woods was buried in an unmarked grave in Queens, which only received a stone in 1975.

His life is a lesson not only in science and innovation, but also in the precariousness of legacy. Inventors, says Fouché—both those who enjoy credit and those who are denied it—rarely innovate in isolation. Many brilliant minds work simultaneously on the same problem, and for reasons of prejudice, luck, or law, just a few of them enter the historical record."

Study of Underrepresented Classes Chasing Engineering and Science Success (SUCCESS) Act of 2018; U.S. Patent and Trademark Office, October 2019

U.S. Patent and Trademark Office, October 2019; Study of Underrepresented Classes Chasing Engineering and Science Success (SUCCESS) Act of 2018.

"America’s long-standing economic prosperity and global technological leadership depend on a strong and vibrant innovation ecosystem. To maximize the nation’s potential, it is critically important that all Americans have the opportunity to innovate, seek patent protection for their inventions, start new companies, succeed in established companies, and achieve the American dream. 

The Study of Underrepresented Classes Chasing Engineering and Science Success (SUCCESS) Act of 2018 directed the Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office (USPTO), in consultation with the administrator of the Small Business Administration, to prepare a report that: 

• Identifies publicly available data on the number of patents annually applied for and obtained by women, minorities, and veterans 
• Identifies publicly available data on the benefits of increasing the number of patents applied for and obtained by women, minorities, and veterans and the small businesses owned by them
• Provides legislative recommendations for how to promote the participation of women, minorities, and veterans in entrepreneurship activities and increase the number of women, minorities, and veterans who apply for and obtain patents. 

Final report to Congress

The USPTO's SUCCESS Act report was transmitted to Congress on October 31, 2019. Among its major findings:

• A review of literature and data sources found that there is a limited amount of publicly available information regarding the participation rates of women, minorities, and veterans in the patent system.
• The bulk of the existing literature focuses on women, with a very small number of studies focused on minorities, and only some qualitative historical information on U.S. veteran inventor-patentees.
• One of the most comprehensive studies focused on women inventor-patentees is "Progress and Potential: a profile of women inventors on U.S. patents," a report published by the USPTO in February 2019. It found that women comprised 12% of all inventors named on U.S. patents granted in 2016, up from 5% in the mid-1980s.
• Overall, there is a need for additional information to determine the participation rates of women, minorities, and veterans in the patent system.
• The report concludes with a list of six new USPTO initiatives and five legislative recommendations for increasing the participation of women, minorities, and veterans as inventor-patentees and entrepreneurs."

U.S. Accuses Harvard Scientist of Concealing Chinese Funding; The New York Times, January 28, 2020

Ellen Barry, The New York Times; U.S. Accuses Harvard Scientist of Concealing Chinese Funding


“Charles M. Lieber, the chair of Harvard’s department of chemistry and chemical biology, was charged on Tuesday with making false statements about money he had received from a Chinese government-run program, part of a broad-ranging F.B.I. effort to root out theft of biomedical research from American laboratories.
 
Dr. Lieber, a leader in the field of nanoscale electronics, was one of three Boston-area scientists accused on Tuesday of working on behalf of China. His case involves work with the Thousand Talents Program, a state-run program that seeks to draw talent educated in other countries.

American officials are investigating hundreds of cases of suspected theft of intellectual property by visiting scientists, nearly all of them Chinese nationals or of Chinese descent. Some are accused of obtaining patents in China based on work that is funded by the United States government, and others of setting up laboratories in China that secretly duplicated American research.”

Why Patents and Copyrights Matter; Ayn Rand Institute, Janaury 15, 2020

[47 min. Video] Elan Journo, Ayn Rand Institute; Why Patents and Copyrights Matter

"Why do patents and copyrights matter? What do they protect? What to make of the objections against them? For instance: that no one is really hurt by violations of copyrights or patents; or that these rights are obstacles to progress and innovation; or that they’re an unfair, government-granted privilege or favor?   

To explore these issues, I talked to Professor Adam Mossoff, who teaches law at George Mason University. Mossoff is an expert on intellectual property law and policy, who has published extensively in academic journals and popular outlets, including the Wall Street Journal, New York Times, and Politico, among many others. He has testified several times before the Senate and the House of Representatives."

Scientists With Links to China May Be Stealing Biomedical Research, U.S. Says; The New York Times, November 4, 2019

Gina Kolata, The New York Times; Scientists With Links to China May Be Stealing Biomedical Research, U.S. Says
 
"The investigations have fanned fears that China is exploiting the relative openness of the American scientific system to engage in wholesale economic espionage. At the same time, the scale of the dragnet has sent a tremor through the ranks of biomedical researchers, some of whom say ethnic Chinese scientists are being unfairly targeted for scrutiny as Washington’s geopolitical competition with Beijing intensifies...

The alleged theft involves not military secrets, but scientific ideas, designs, devices, data and methods that may lead to profitable new treatments or diagnostic tools.

Some researchers under investigation have obtained patents in China on work funded by the United States government and owned by American institutions, the N.I.H. said. Others are suspected of setting up labs in China that secretly duplicated American research, according to government officials and university administrators...

The real question, [Dr. Michael Lauer, deputy director for extramural research at the National Institutes of Health in Bethesda, Md] added, is how to preserve the open exchange of scientific ideas in the face of growing security concerns. At M.D. Anderson, administrators are tightening controls to make data less freely available."

Equity pending: Why so few women receive patents; The Christian Science Monitor, July 2, 2018

E'oin O'Carroll, The Christian Science Monitor; Equity pending: Why so few women receive patents

"The causes for the gender gap are varied and complex, but much of it can be explained by women’s underrepresentation in patent-intensive jobs, particularly engineering. Research shows women make up roughly 20 percent of graduates from engineering schools, but hold less than 15 percent of engineering jobs. Female engineering grads are not entering the field at the same rate as their male counterparts, and they are leaving in far greater numbers.

“It’s the climate,” says Nadya Fouad, a professor of educational psychology at the University of Wisconsin-Milwaukee. “The organizational environment is very unforgiving.”

Professor Fouad, who spent three years surveying women with engineering degrees about their career choices, cites inflexible schedules, a lack of opportunities for advancement, and incivility toward women. “It’s not the women’s fault,” she says, noting that she found no difference in levels of confidence in those who stayed and those who left.

Other barriers women face are an absence of supportive social networks and implicit bias on the part of venture capitalists."

Behind the EpiPen controversy are questions about patents granted to drugmaker; St. Louis Post-Dispatch, 9/4/16

Samantha Liss, St. Louis Post-Dispatch; Behind the EpiPen controversy are questions about patents granted to drugmaker:

"Drugmaker Mylan NV has received the brunt of criticism for alleged price-gouging on the lifesaving EpiPen, but other factors — and players — contributed to the monopoly it enjoys today, say experts familiar with the drug industry.

First approved in 1987, the EpiPen is protected from competition until 2025 by four patents. Three of those patents were awarded within the last six years."

31st Annual Intellectual Property Law Conference; American Bar Association (ABA), Bethesda, Maryland, April 6-8, 2016

American Bar Association (ABA); 31st Annual Intellectual Property Law Conference:

"The 31st Annual Intellectual Property Law Conference from the American Bar Association Section of Intellectual Property Law is recognized as the world's premier IP conference.

These three packed days of learning enable you to earn a year's worth of CLE credit from expert sessions presented by the leaders in every area of the profession. We offer what you need to know along with multiple opportunities to mingle with those who should be part of your network."