U.S. Patent and Trademark Office building

Visualizing the Growing Intersection of Life Sciences and Computing Patents in the US from 1976-2021

By Matthew Chun

With its leadership in drug development, biotechnology, and computing technologies, the United States touts itself as being “the most innovative economy in the world.”

But when did the U.S. rise to its position as a global leader in these areas? Which regions of the country have led the charge? And what is the next frontier of American innovation?

To begin exploring these questions, I analyzed 45 years of publicly available patent data to map the growth of U.S. innovation in the life sciences and computing fields from 1976-2021. I also mapped the recent growth of patented “hybrid” inventions, which are closing the gap between these historically disparate fields. In particular, the hybrid inventions explored in this project represent interdisciplinary advances in areas including bioinformatics, cheminformatics, artificial intelligence, and quantum computing.

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Grayslake, IL - January 30, 2021: Drive-through indoor COVID-19 vaccination facility at the Lake County Fairgrounds in Grayslake. The facility is dispensing both the Moderna and Pfizer vaccine.

COVID-19 Vaccine Patent Infringement? The Battle Between Moderna and Pfizer/BioNTech Continues

By Aparajita Lath

Last month, the patent battle between COVID-19 mRNA vaccine manufacturers continued with BioNTech/Pfizer filing a strong defense and counter-claim to Moderna’s allegations of patent infringement.

In their initial August 2022 complaint, Moderna alleged that three of its mRNA patents were infringed by Pfizer/BioNTech. Interestingly, as of January 12, 2023, Moderna has listed 10 patents covering Spikevax (its mRNA vaccine) on its website. Since biotechnology inventions can be covered by several patents, each of which may not be easy to identify through public searches, the decision to publish a consolidated list of patents is a move in the right direction. However, the list is an evolving one, and, as it happens, one of three patents at issue, i.e., patent no. 10,933,127 (‘127) has not been listed.

The following article explains the key patents at stake in the intellectual property dispute.

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Single strand ribonucleic acid.

The Secret World of mRNA: HDT Bio Corp v. Emcure and Access to Next-Gen mRNA

By Aparajita Lath

The future of public health in an “RNA world” is on trial in a trade secrecy dispute worth $950 million currently being fought before the District Court of the Western District of Washington, Seattle between HDT Bio Corp. and Emcure Pharmaceuticals.

The trade secrets at issue concern an improvement over existing mRNA technology called “self-amplifying RNA” or “saRNA.” saRNA are effective at much smaller doses and lower costs. The saRNA technology is being used to develop vaccines for COVID, Zoster, Zika and Rabies.

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Augsburg, Bavaria, Germany - March 23, 2021: Vials with the Moderna Covid-19 vaccine are used at the corona vaccination centers worldwide.

No Take-Backs: Moderna’s Attempt to Renege on its Vaccine Patent Pledge

By Jorge L. Contreras

On October 8, 2020, Moderna, the maker of one of the first mRNA-based vaccines for COVID-19 and the recipient of billions of dollars of U.S. government funding, announced that it felt “a special obligation … to use our resources to bring this pandemic to an end as quickly as possible.” As a result, it publicly promised that “while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic.” Moderna broke that promise on August 26, 2022, when it sued Pfizer and BioNTech, the producers of a competing mRNA vaccine, for patent infringement in the U.S. and Germany. This post explains why Moderna’s lawsuits should fail given its irrevocable and continuing nonenforcement pledge.

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A male pharmacist is examining a drug from a pharmacy inventory.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, andAaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of April. The selections feature topics ranging from a discussion of manufacturer’s restricted delivery of 340B drugs to contract pharmacies and ensuing litigation, to an analysis mapping the European patent landscape for medical uses of known products, to an evaluation of the clinical benefit of novel drugs approved in the U.S. from 2018-2019. A full posting of abstracts/summaries of these articles may be found on our website.

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Two hands holding the light bulb that is illuminating. Creative protecting patents and ideas concept.

Graduate Students’ Curricula Should Include Intellectual Property

By Matt Bauer

Science and engineering graduate students’ curricula should include cross-disciplinary studies in intellectual property (IP).

These students research, discover, and invent new technology and methodologies for their thesis work. Accordingly, they should be better equipped to understand and navigate the fundamentals of intellectual property to protect those innovations.

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Front view of light silver bank vault door, closed. 3D Render.

The Risk of Pervasive Trade Secret Practices Within the Life Sciences

By Matt Bauer

The changing landscape of the life sciences industry relies more and more on a form of intellectual property protection called trade secrets to safeguard mechanisms of manufacturing and process knowledge not always included within life science patents.

To the public, this means the methods of production for life saving therapeutics may be kept indefinitely in the hands a single company, never to enter the public domain.

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BETHESDA, MD - JUNE 29, 2019: NIH NATIONAL INSTITUTES OF HEALTH sign emblem seal on gateway center entrance building at NIH campus. The NIH is the US's medical research agency.

Will NIH Learn from Myriad when Settling Its mRNA Inventorship Dispute with Moderna?

By Jorge L. Contreras

The National Institutes of Health (NIH) is currently embroiled in a dispute over the ownership of patent rights to Moderna’s flagship mRNA COVID-19 vaccine (mRNA-1273).

The NIH, which funded much of Moderna’s research on the COVID-19 vaccine, should be assertive in exerting control over the results of this taxpayer-funded research. Failing to do so would be a missed opportunity for the public sector to have a say in the distribution and pricing of this critical medical technology.

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Photo of person with gloved hand holding flask at lab bench.

In Academia, Innovators Receive Unfair Compensation for Their Discoveries

By Matt Bauer

In academia, many of the scientists who are recognized as inventors on patents see little economic gain from these agreements.

Instead, royalties are primarily assigned toward their home institutions.

The scientists who drive discoveries within the walls of academia are not receiving an equitable share of the benefits of their innovations. Despite being the source of these discoveries, students and postdoctoral researchers don’t see the financial upside of the commercialization of their inventions.

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Concept illustration of DNA and genes.

The Civil Rights Challenge to Gene Patenting

By Jorge L. Contreras

In 2009, the American Civil Liberties Union (ACLU) launched a unique lawsuit against Myriad Genetics, challenging fifteen claims of seven patents covering various aspects of the BRCA1/2 genes and their use in diagnosing risk for breast and ovarian cancer. In mounting this case, the ACLU assembled a coalition of lawyers, scientists, counselors, patients and advocates in an unprecedented challenge not only to one company’s patents, but the entire practice of gene patenting in America. And, against the odds, they won. In 2013, the U.S. Supreme Court ruled in Association for Molecular Pathology v. Myriad Genetics that naturally occurring DNA sequences are not patentable, a ruling that has had repercussions throughout the scientific community and the biotechnology industry.

In The Genome Defense: Inside the Epic Legal Battle to Determine Who Owns Your DNA (New York: Hachette/Algonquin, 2021), I describe the long road that led to this unlikely Supreme Court victory. It began in 2003 when the ACLU hired its first science advisor, a Berkeley-based cellist and non-profit organizer named Tania Simoncelli. At the ACLU, Simoncelli’s job was to identify science-related issues that the ACLU could do something about, from DNA fingerprinting to functional MRI brain imaging. A couple of years into the role, Simoncelli mentioned gene patenting to Chris Hansen, a veteran ACLU litigator who had been involved in cases covering mental health to school desegregation to online porn. At first, Hansen didn’t believe her. How could a company patent something inside the human body? But Simoncelli persisted, showing him articles and statistics demonstrating that, by 2005, more than 20% of the human genome was covered by patents. The realization led to Hansen’s oft-quoted exclamation, “Who can we sue?”

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