Intellectual property rights in outer space: How can pharmaceutical companies protect COVID‐19 vaccine and immunotherapy developments aboard the ISS US national laboratory?

• Published date: 01 July 2023
• Author: Adnan Jashari,Stefani Stojchevska
• Date: 01 July 2023
• DOI: http://doi.org/10.1111/jwip.12270

Received: 8 July 2022

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Accepted: 11 March 2023

DOI: 10.1111/jwip.12270

ORIGINAL ARTICLE

Intellectual property rights in outer space:

How can pharmaceutical companies protect

COVID‐19 vaccine and immunotherapy

developments aboard the ISS US national

laboratory?

Adnan Jashari |Stefani Stojchevska

Faculty of Law, South East European

University, Tetovo, North Macedonia

Correspondence

Adnan Jashari, Faculty of Law, South East

European University, Ilindenska n.335,

1200 Tetovo, North Macedonia.

Email: a.jashari@seeu.edu.mk

Abstract

Believing that space pharmaceuticals might be the key to

winning the battle against COVID‐19, global pharmaceutical

companies such as AstraZeneca and Sanofi Pasteur are

currently collaborating with the International Space Station

National Laboratory (ISS‐NL) on research projects aiming to

develop vaccine‐and‐immunotherapy products. The present

legal regime for outer space, however, does not provide

clear guidelines on safeguarding intellectual property rights

(IPRs), due to the difficulties of reconciling the territorial

nature of patent law and the nonterritorial nature of space

law. Responding to such a legal gap, this research paper

argues how pharmaceutical companies can protect such

medical innovations by taking into consideration the

international princip les of space law addre ssing IPRs and

extraterrestrialjurisdiction, as well as the legal regime of the

ISS‐NL. With the exception of the possibility of the barriers

between the two areas of lawnot being insurmountable, the

proposed COVID‐19 TRIPS Waiver furthermore impacts

space pharmaceuticals' IPRs and commercialization, which

leads to the identification of some advantageous forms of

agreements, including the Joint Endeavor Agreement, the

Space Act Agreement, as well as the Cooperative Research

and DevelopmentAgreement, for pharmaceuticalcompanies

J World Intellect Prop. 2023;26:227–258. wileyonlinelibrary.com/journal/jwip © 2023 John Wiley & Sons Ltd.

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defined as agreement partners with the National Aeronau-

tics and Space Administration.

KEYWORDS

COVID‐19 medical innovations, intellectual property rights, ISS

National Lab, pharmaceutical companies, space law, space

pharmaceuticals

1|INTRODUCTION

In less than 3 months since the first case of COVID‐19 was identified in Wuhan in December 2019, the pandemic

has brought the entire world to its knees. As humanity collectively braces up for the most trying times since World

War II, there is suddenly a realization that despite tremendous advancements in science and technology, our

healthcare facilities are inadequate, especially in the face of an unknown enemy.

1

Moreover, the threat of new

emerging viruses demonstrates that there is clearly a need to innovate new approaches to vaccine discovery and

delivery as well as opportunities to use vaccines for the treatment of some diseases.

2

Such advancements indicate

that outer space would undoubtedly serve as a necessary advantage toward highly progressive benefits in battling

deadly pandemic outbreaks in the future. It has been discovered that cells in culture change their physiology in

interesting ways in microgravity. For example, rates of proliferation may increase. There have also been reports of

the reactivation of latent viruses in astronauts during their time in microgravity. These observations have led

researchers at Sanofi Pasteur to investigate a mechanism that would contribute to greater rates of proliferation of

the influenza virus in a cell culture model. A second project from Sanofi Pasteur seeks to understand how human

immune cells change in microgravity. Results from this work could lead to better methods of vaccine production and

improved vaccine efficacy.

3

Hence, the ISS US National Laboratory (ISS‐NL) is currently collaborating with global

pharmaceutical companies AstraZeneca and Sanofi Pasteur on projects that push the boundaries of discovery in

immunotherapy and vaccine development, respectively, where AstraZeneca in particular, seeks to learn how

microgravity might impact the production and secretion of monoclonal antibodies from a cell line, ultimately aiming

to improve the rate at which quality immunotherapies can be manufactured here on Earth.

4

And with the previous

worldwide demand for doses of a vaccine to protect against COVID‐19, insights from outer space had been

regarded as the key to making the process cost‐effective and delivering the vaccine to the masses sooner.

5

Be that

as it may, the concept of “space pharmaceuticals”is not new, considering that US companies have already been

conducting pharmaceutical productions experiments in outer space before. In one such experiment, McDonnell

Douglas produced a drug 716 times more separated than could be produced on Earth, while obtaining five times

greater purity. These positive results have led to predictions that space production will revolutionize pharmaceutical

development by enhancing our ability to produce drugs of sufficient purity to help fight many heretofore incurable

diseases. As a result, using space as a laboratory for producing pharmaceuticals is a major goal of US pharmaceutical

companies.

6

With the currently ongoing global pandemic, the extraterrestrial environment had become a major goal

for many foreign and multinational pharmaceutical companies which initially prioritized COVID‐19 vaccine and

immunotherapy developments. Today, people are aware of the importance of effective patent production for the

industry most directly involved in discovering new pharmaceuticals. Indeed, without the incentive of patents it is

doubtful the pharmaceutical sector would have invested so much in the discovery or development of medicines,

many of which are currently in use both in developed and developing countries.

7

Intellectual property rights (IPRs)

traditionally have been matters of national concern. Individual nation‐states have developed IPR regimes reflecting

their national needs and priorities. Over time, intellectual property (IP) protection and enforcement have come to

the forefront as key international issue.

8

When conducting research aboard the ISS‐NL concerning the

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development of space pharmaceuticals under the threat of new emerging viruses, however, IP laws are giving

companies the reason to pause and consider the ramifications of such a decision. That is the case with Zero Gravity

Solutions which planned to conduct research on the ISS‐NL aimed at producing plants that thrive in new

environments: rice that grows in brackish water, drought‐resistant corn, and citrus trees immune to cold snaps. If

the company succeeded in developing those new crops on Earth, the US Plant Varieties Protection Act would

provide it with exclusive control over discoveries for at least 20 years. If the discoveries occur on the space station,

however, Zero Gravity Solutions would have exclusive rights to its inventions for only 5 years. Richard Godwin,

director for Boca Raton, FL—based Zero Gravity, had stated that “it could take five years of research to get to the

point where you have something that you can patent.”

9

Under the usual terms of an agreement with the National

Aeronautics and Space Administration (NASA) to use the ISS‐NL, researchers give the US government the right to

use their results and inventions after those first 5 years. While this provision of the agreement can be reviewed and

changed on a case‐by‐case basis, many fear the corporate research world will find this too much of a roadblock to

surmount.

10

Namely, other commercial researchers eager to explore the potential benefits of microgravity on

plants, pharmaceuticals, and materials express similar concerns that government rules limiting their IPRs could

prevent them from profiting from new discoveries. People working for the Center for the Advancement of Science

in Space (CASIS), the organization selected by NASA to promote and manage commercial research aboard the

orbiting outpost, “have come into contact with people, particularly from the pharmaceutical companies, who have a

lot of anxieties about their potential loss of rights as a result of involving international space station research in their

projects,”said Brad Carpenter, acting director of NASA's Space Life and Physical Sciences Research and

Applications Division.

11

These factors raise the legal question of how pharmaceutical companies can protect their

developments resulting from international cooperation aboard the ISS‐NL in regard to IPRs. Given that IPRs are

legal rights granted by governments to encourage innovation and creative output, they ensure that creators reap

the benefits of their inventions. Through IPR, governments grant a temporary legal monopoly to innovators by

giving them the right to limit or control the use of their creations by others.

12

One of the main reasons why IPRs are

so important in the presented issue is due to their object of protection—developed space pharmaceuticals

commercially used by exclusive rights given to pharmaceutical companies. Despite their commercial values, space

pharmaceuticals often find themselves in the middle of the theoretical clash of values between the space law

principles of nonappropriation with the territorial application of national IP laws, where such contrast leads to

significant legal concerns among pharmaceutical companies. Moreover, it is theoretically questioned whether the

outer space legal regime theoretically precludes the IP legal regime and result in existing legal status that neither the

international treaties of IP nor the issue of IP protection in outer space explicitly state in their provisions. This paper,

responding to such a legal gap, presents a pragmatic review which concerns the integration of international space

law and IP law in the particular cases of global pharmaceutical companies such as Sanofi Pasteur and AstraZeneca

currently conducting COVID‐19 vaccine and immunotherapy‐related projects, as well as other space

pharmaceuticals. Presuming that months or even years of research could lead to such developments being

patented, establishing a legal system that would solve the disputes between IP Laws and Space Law regimes is

necessary for safeguarding IPRs in such space operations.

2|INTERNATIONAL PRINCIPLES OF SPACE LAW CONCERNING IPRS

AND EXTRATERRESTRIAL JURISDICTION

The foundation of international space law lies in space exploration and operation principles characterized by

nonappropriation, as opposed to the territorial application of national IP laws, where academics often debate about

the connection between space law and IP law in the sense of whether they could be applied in parallel or does one

legal regime supersede the other. It would be expected for the practice of extraterrestrial jurisdiction—where

space‐faring nations may extend their legal power beyond planet Earth to certain instances—to allow such

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