Quantum Computing and Intellectual Property Law →

Berkeley Technology Law Journal, Vol. 35, No. 3, 2021, Forthcoming

New Stanford University Beyond IP Innovation Law research article: “Quantum Computing and Intellectual Property Law”.

By Mauritz Kop

Citation: Kop, Mauritz, Quantum Computing and Intellectual Property Law (April 8, 2021). Berkeley Technology Law Journal 2021, Vol. 35, No. 3, pp 101-115, February 8, 2022, https://btlj.org/2022/02/quantum-computing-and-intellectual-property-law/

Please find a short abstract below:

Intellectual property (IP) rights & the Quantum Computer

What types of intellectual property (IP) rights can be vested in the components of a scalable quantum computer? Are there sufficient market-set innovation incentives for the development and dissemination of quantum software and hardware structures? Or is there a need for open source ecosystems, enrichment of the public domain and even democratization of quantum technology? The article explores possible answers to these tantalizing questions.

IP overprotection leads to exclusive exploitation rights for first movers

The article demonstrates that strategically using a mixture of IP rights to maximize the value of the IP portfolio of the quantum computer’s owner, potentially leads to IP protection in perpetuity. Overlapping IP protection regimes can result in unlimited duration of global exclusive exploitation rights for first movers, being a handful of universities and large corporations. The ensuing IP overprotection in the field of quantum computing leads to an unwanted concentration of market power. Overprotection of information causes market barriers and hinders both healthy competition and industry-specific innovation. In this particular case it slows down progress in an important application area of quantum technology, namely quantum computing.

Fair competition and antitrust laws for quantum technology

In general, our current IP framework is not written with quantum technology in mind. IP should be an exception -limited in time and scope- to the rule that information goods can be used for the common good without restraint. IP law cannot incentivize creation, prevent market failure, fix winner-takes-all effects, eliminate free riding and prohibit predatory market behavior at the same time. To encourage fair competition and correct market skewness, antitrust law is the instrument of choice.

Towards an innovation architecture that mixes freedom and control

The article proposes a solution tailored to the exponential pace of innovation in The Quantum Age, by introducing shorter IP protection durations of 3 to 10 years for Quantum and AI infused creations and inventions. These shorter terms could be made applicable to both the software and the hardware side of things. Clarity about the recommended limited durations of exclusive rights -in combination with compulsory licenses or fixed prized statutory licenses- encourages legal certainty, knowledge dissemination and follow on innovation within the quantum domain. In this light, policy makers should build an innovation architecture that mixes freedom (e.g. access, public domain) and control (e.g. incentive & reward mechanisms).

Creating a thriving global quantum ecosystem

The article concludes that anticipating spectacular advancements in quantum technology, the time is now ripe for governments, research institutions and the markets to prepare regulatory and IP strategies that strike the right balance between safeguarding our fundamental rights & freedoms, our democratic norms & standards, and pursued policy goals that include rapid technology transfer, the free flow of information and the creation of a thriving global quantum ecosystem, whilst encouraging healthy competition and incentivizing sustainable innovation.

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Safeguards for accelerated market authorization of vaccines in Europe

by Suzan Slijpen & Mauritz Kop

This article has been published by the Stanford Law School ‘Center for Law and the Biosciences’, Stanford University, 15 March 2021. link to the full text: https://law.stanford.edu/2021/03/15/safeguards-for-accelerated-market-authorization-of-vaccines-in-europe/

The first COVID-19 vaccines have been approved

People around the globe are concerned about safety issues encircling the accelerated introduction of corona vaccines. In this article, we discuss the regulatory safeguards for fast-track market authorization of vaccines in Europe. In addition, we explain how the transmission of European Union law into national Member State legislation works. We then clarify what happens before a drug can be introduced into the European market. We conclude that governments should build bridges of mutual understanding between communities and increase trust in the safety of authorized vaccines across all population groups, using the right messengers.

Drug development normally takes several years

Drug development normally takes several years. The fact that it has been a few months now seems ridiculously short. How is the quality and integrity of the vaccine ensured? That people - on both sides of the Atlantic - are concerned about this is entirely understandable. How does one prevent citizens from being harmed by vaccines and medicines that do not work for everyone, because the admission procedures have been simplified too much?

The purpose of this article is to shed a little light upon the accelerated market authorization procedures on the European continent, with a focus on the situation in the Netherlands.

How a vaccine is introduced into the market

In June 2020, the Dutch government, in close cooperation with Germany, France and Italy, formed a Joint Negotiation Team which, under the watchful eye of the European Commission, has been negotiating with vaccine developers. Its objective: to conclude agreements with drug manufacturers at an early stage about the availability of vaccines for European countries. In case these manufacturers are to succeed in developing a successful vaccine for which the so-called Market Authorization (MA) is granted by EMA or CBG, this could lead to the availability of about 50 million vaccines (for the Netherlands alone).

Who is allowed to produce these vaccines?

Who is allowed to produce these vaccines? The Dutch Medicines Act is very clear about this. Only "market authorization holders" are allowed to manufacture medicines, including vaccines. These are parties that have gone through an extensive application procedure, who demonstrably have a solid pharmaceutical quality management system in place and have obtained a pharmaceutical manufacturing license (the MIA, short for Manufacturing and Importation Authorisation). This license is granted after assessment by the Health and Youth Care Inspectorate of the Ministry of Health, Welfare & Sport (IGJ) – by Farmatec. Farmatec is part of the CIBG, an implementing body of the Ministry of Health, Welfare and Sport (VWS). The M-license is mandatory for parties who prepare, or import medicines.

Read more at the Stanford Center for Law and the Biosciences!

Read more on manufacturing licenses, fast track procedures and market authorization by the European Medicines Agency (EMA) and the EC, harmonisation and unification of EU law, CE-markings, antigenic testing kits, mutations, reinfection, multivalent vaccines, mucosal immunity, Good Manufacturing Practices (GMP), pharmacovigilance, the HERA Incubator, clinical trials, compulsory vaccination regimes and continuous quality control at Stanford!

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Machine Learning & EU Data Sharing Practices →

Stanford - Vienna Transatlantic Technology Law Forum, Transatlantic Antitrust and IPR Developments, Stanford University, Issue No. 1/2020

New multidisciplinary research article: ‘Machine Learning & EU Data Sharing Practices’.

In short, the article connects the dots between intellectual property (IP) on data, data ownership and data protection (GDPR and FFD), in an easy to understand manner. It also provides AI and Data policy and regulatory recommendations to the EU legislature.

As we all know, machine learning & data science can help accelerate many aspects of the development of drugs, antibody prophylaxis, serology tests and vaccines.

Supervised machine learning needs annotated training datasets

Data sharing is a prerequisite for a successful Transatlantic AI ecosystem. Hand-labelled, annotated training datasets (corpora) are a sine qua non for supervised machine learning. But what about intellectual property (IP) and data protection?

Data that represent IP subject matter are protected by IP rights. Unlicensed (or uncleared) use of machine learning input data potentially results in an avalanche of copyright (reproduction right) and database right (extraction right) infringements. The article offers three solutions that address the input (training) data copyright clearance problem and create breathing room for AI developers.

The article contends that introducing an absolute data property right or a (neighbouring) data producer right for augmented machine learning training corpora or other classes of data is not opportune.

Legal reform and data-driven economy

In an era of exponential innovation, it is urgent and opportune that both the TSD, the CDSM and the DD shall be reformed by the EU Commission with the data-driven economy in mind.

Freedom of expression and information, public domain, competition law

Implementing a sui generis system of protection for AI-generated Creations & Inventions is -in most industrial sectors- not necessary since machines do not need incentives to create or invent. Where incentives are needed, IP alternatives exist. Autonomously generated non-personal data should fall into the public domain. The article argues that strengthening and articulation of competition law is more opportune than extending IP rights.

Data protection and privacy

More and more datasets consist of both personal and non-personal machine generated data. Both the General Data Protection Regulation (GDPR) and the Regulation on the free flow of non-personal data (FFD) apply to these ‘mixed datasets’.

Besides the legal dimensions, the article describes the technical dimensions of data in machine learning and federated learning.

Modalities of future AI-regulation

Society should actively shape technology for good. The alternative is that other societies, with different social norms and democratic standards, impose their values on us through the design of their technology. With built-in public values, including Privacy by Design that safeguards data protection, data security and data access rights, the federated learning model is consistent with Human-Centered AI and the European Trustworthy AI paradigm.

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