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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Bill of Health - Globe and vaccine, covid vaccine

Biotech Companies Are Opening Manufacturing Sites in Africa: Will This Help Vaccine Equity?

By Sarah Gabriele

Two pharmaceutical giants of the pandemic, Moderna and BioNTech, are taking steps for increasing the manufacturing capacity for the COVID-19 vaccine in Africa. Last March, Moderna announced its plan to set up a manufacturing facility in Kenya to produce messenger RNA (mRNA) vaccines, including COVID-19 shots. Similarly, in 2021, BioNTech started planning its own manufacturing plant in Africa, which will be composed of modular shipping containers.

Measures to address global vaccine inequity could not come sooner. As of December 15, 2022, only 34% of the population in Africa has received at least one dose of the COVID-19 vaccine, with Moderna and BioNTech having provided fewer doses compared to Oxford-AstraZeneca and Johnson & Johnson. After failing to successfully deliver vaccines equitably during the first two years of the pandemic, Moderna and BioNTech appear now to be taking steps to shoulder greater responsibility for vaccine equity.

However, if companies are ethically required to address the availability of vaccines, these well-intended efforts might still fail to fulfill their moral obligations. Indeed, while the construction of these new sites might sound like great news for fostering the delivery of vaccines in low- and middle-income countries, we should be aware that these manufacturing sites, as well as the existence of manufacturing capacity, might not be enough to achieve desired outcomes.

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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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Tilpath Valley Biodiversity Park spreads over an area of 69.56 ha on the Southern Ridge that is contiguous with Aravalli ranges of Haryana, in south Delhi, New Delhi India.

Proposed Amendments Would Make Foreign Investment in India’s Biological Resources Easier

By Aparajita Lath

Indian lawmakers are currently debating proposed amendments that would make it easier for foreign investors to research and develop products from native biological resources, such as plants.

India is one of the 17 internationally recognized mega biodiversity countries, and hosts four of the 35 globally recognized biodiversity hotspots.

Since countries have sovereign rights over their biological resources, Indian companies enjoy easier access to and use of these biological resources for various commercial applications, including pharmaceuticals, cosmetics, and biotechnology. Foreign companies and Indian companies with any foreign participation in share capital or management are strictly regulated.

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Bill of Health - Globe and vaccine, covid vaccine

Reclaiming Global Public Health

By Zain Rizvi

By December 2020, the world had astonishingly powerful tools against COVID-19. New mRNA vaccines, underpinned by decades of public investment, had been authorized by global regulators. Yet the promise of the vaccines was unevenly realized: deep fault lines emerged between those who were able to secure vaccines and those left behind, or what South Africa’s president Cyril Ramaphosa called “vaccine apartheid.”

Dose shortages elevated the role of pharmaceutical executives. Fielding calls from heads of state, they decided what vaccine deliveries to prioritize, shaping which countries could protect lives and livelihoods. The answer to one of the most important public health questions of our time — who gets access to vaccines? — was mostly determined neither by political representatives nor scientists, but by corporate executives.

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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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Vaccines.

COVID-19, Patents, and Trade Secrets

By David Gindler & Jasper L. Tran

Has the worldwide distribution of COVID-19 vaccines been impacted by patent rights? David Gindler, head of IP at Milbank LA, and Jasper L. Tran, senior associate at Milbank LA, argue that the story is much more complicated — making vaccines involves much more than waiving patents, they explain.

The following article, which is adapted from the authors’ conversation with Vanderbilt Law Review podcast editor Jacob Goodman on Hot Topics in Intellectual Property Law, provides an overview of the complicated intellectual property landscape associated with COVID-19 vaccines and therapeutics.

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POPLAR affiliated reseachers

Introducing Affiliated Researchers for the Project on Psychedelics Law and Regulation

(Clockwise from top left: Kwasi Adusei, Ismail Lourido Ali, Jonathan Perez-Reyzin, Dustin Marlan.)

We are excited to welcome our inaugural group of affiliated researchers for the Project on Psychedelics Law and Regulation (POPLAR). Through regular contributions to Bill of Health, as well as workshops and other projects, POPLAR affiliated researchers will share their expertise and perspectives on developments in psychedelics law and policy. We look forward to learning from and sharing their insights with our audiences. Keep an eye out for their bylines!

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Bill of Health - Globe and vaccine, covid vaccine

COVID ‘Compromise’ on International IP Underscores Need for New Approach

By Cynthia M. Ho

The leaked compromise regarding a “waiver” of international intellectual property (IP) obligations under the TRIPS Agreement for World Trade Organization (WTO) members has met harsh criticism as a shadow of the original proposal to waive international obligations regarding patent, trade secret, and copyright obligations relating to any COVID vaccine, treatment, diagnostic, or personal protective equipment (PPE).

The compromise excludes diagnostics, treatments, and PPE. It only narrowly modifies compulsory licenses of patents covering COVID vaccines. Moreover, it imposes additional restrictions on use of compulsory licenses. But still, multinational pharmaceutical manufacturers have protested even these modest changes from the status quo, arguing that there is no IP problem that needs to be fixed.

Clearly there is a problem. It has taken 18 months since the original Indian and South African proposal to get to this limited compromise, while gross vaccine inequity between wealthy and poor countries continues. In addition, the leaked compromise between four WTO members is still being debated — and even if agreement can be reached, it needs agreement of over 100 other WTO members. We need a new approach.

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