Genetic engineering and digital technology concept.

The ‘Res Nullius’ Construction of Human Genomic Data

By Donrich Thaldar

No one domain of the law holds exclusive sway over human genomic data. Instead, genomic data have a multidimensional legal nature, meaning that multiple legal domains — including property law, privacy law, contract law, and intellectual property law — are all applicable. This opens the door for different persons to have rights originating in different legal domains with respect to the same genomic data.

To determine who has rights with respect to a particular person’s genomic data, the rules of each relevant legal domain must be applied. The application of these rules to genomic data may be relatively straightforward in some domains, but in property law — which is relevant in determining ownership of genomic data — it is often more complicated. Only a handful of jurisdictions have specifically legislated on the ownership of genomic data. In the absence of such specific legislation that provides who owns genomic data, general property law rules must be applied. (In common law legal systems, and some mixed legal systems where legislation is absent, this would entail resorting to the jurisdiction’s common law.) However, given the novelty of applying property law rules to genomic data, it is not always obvious which of the general rules would apply. In this post, I will share some of my research group’s thinking in this regard. Although our thinking is based in South African law, many of the principles are shared with other legal systems.

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see saw with earth as fulcrum and a pile of vaccines weighing down one side with nothing on the other side.

What Happened to the COVID-19 Vaccine Patent Waiver?

By Sarah Gabriele

In June 2022, after almost two years of debate over a potential COVID-19 vaccine patent waiver, the World Trade Organization adopted the Ministerial Decision on the TRIPS Agreement (“WTO Decision”), which provided for a partial waiver of intellectual property rights.

More specifically, the WTO Decision waived patent rights on vaccines and allowed for the use of protected clinical trial data for regulatory approval of vaccines. However, after almost four months since the adoption of the WTO Decision, there is still a large gap in vaccination rates worldwide.

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Grassy field with white picket fence encircling it.

Accessing COVID-19 mRNA Vaccines for Research: The Re-emergence of the Tragedy of the ‘Anticommons’

By Aparajita Lath

Some COVID-19 vaccine manufacturers in the US have refused to share vaccine samples for research purposes, creating an access issue with the potential to delay comparator studies, follow-on research, and new vaccine / drug development.

This issue may be the latest example of the tragedy of the “anticommons” in biomedical research.

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Gamblers make bets at the roulette table in a casino.

We All Stand to Benefit from Biden’s $2 Billion Bet on the Bioeconomy

By Matthew Chun

Business is bustling for biotechnology and biomanufacturing. On September 12, 2022, President Biden signed an executive order, launching a “whole-of-government approach to advance biotechnology and biomanufacturing.” And two days later, he backed it up with a national summit and a $2 billion spending plan.

But who stands to benefit from this large commitment of federal money? We all do.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

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

By Ameet Sarpatwari, Liam Bendicksen, Alexander Egilman, 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 August. The selections feature topics ranging from a discussion of opportunities for improving the use of U.S. Food and Drug Administration (FDA) advisory committees, an analysis of the key patents covering drugs recently approved by the FDA, and an examination of high-risk cardiovascular devices approved by the FDA for use in children and adolescents. A full posting of abstracts/summaries of these articles may be found on our website.

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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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Businessman crossing fingers behind his back.

Get Your Story Straight: Patent Office Cracks Down on Inconsistent Statements Made Before the FDA

By Matthew Chun

In an effort to “promote robust and reliable patents” and increase access to life-saving drugs, the United States Patent and Trademark Office (USPTO) recently issued a Federal Register Notice clarifying the responsibilities of individuals involved in the patent application process.

In the July 29, 2022 notice, the USPTO set forth its views on the “duty of disclosure” and “duty of reasonable inquiry,” emphasizing the importance of consistency between statements made to the USPTO, the FDA, and other governmental agencies. While the goals of the Federal Register Notice are certainly noble, its disruptive practical effects leave much to be desired.

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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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