By Aparajita Lath
Amid ongoing patent disputes over the mRNA platform, a significant scientific question remains unanswered: whether mRNA itself even is patent-eligible.
Tag: patents
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.
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.
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.
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.
Monthly Round-Up of What to Read on Pharma Law and Policy
By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, and Aaron 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.
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.
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.
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.
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.