---
title: "Biological patent"
chunk: 3/3
source: "https://en.wikipedia.org/wiki/Biological_patent"
category: "reference"
tags: "science, encyclopedia"
date_saved: "2026-05-05T04:27:06.993445+00:00"
instance: "kb-cron"
---

=== Patents relating to the diagnosis, treatment and prevention of COVID-19 ===
In light of the COVID-19 pandemic, several companies around the world raced to develop testing, vaccines, and cures for COVID-19. This required a substantial investment of time and money, and patents were used to protect this innovation. Patent holders are able to refuse licensing for third-parties to manufacture the patented medicine, creating a monopoly for the patent holder and lower supply levels. Furthermore, patent-holders control pricing for licensing and access. This patent-regime has the potential to limit access to life-saving vaccines and cures, especially for those in poor countries. Pharmaceutical industry executives diminished the idea of sharing intellectual property, arguing that companies would have no incentive to innovate if their patents were considered worthless during a pandemic. However, health advocates argue that taxpayers substantially contributed to the development of the vaccines and they should thus be regarded as global public goods.
A lack of access to medication and vaccines is especially problematic during a global pandemic. In April 2020, the Director General of the World Health Organization supported a proposal by Carlos Alvarado, to create a pool of rights for testing medicine and vaccine with free access or affordable licensing terms for all countries. He asked all companies, countries, and research institutions to support “open data, open science, and open collaboration.” He warned that poorer countries would be the hardest hit by the pandemic and failure to assist could prolong the pandemic.
Instead, patent-holders have undertaken case-by-case negotiations to form exclusive licensing contracts. This approach is criticized by the global health community as being too slow, especially where variants are concerned. Further, some poor countries such as South Africa paid more per dose for vaccines than rich countries and the European Union.
One potential remedy is for States to implement compulsory patent licenses. These licenses give the State power to grant permission to third parties to formulate generic versions of the medicine for use in that state. This is beneficial to states with lesser buying power. However, such initiatives are not popular with industry. In March 2020, Israel became the first country to issue a COVID-19 related compulsory license under Section 104 of the Patent Statute. This provision allowed Israel to undermine the patent regime for national defence purposes. No consultation with the patent-holder is required and there is no right for judicial review. The permit allowed Israel to import a generic version of Kaletra from India to treat COVID patients.  Canada's Bill C-13, which came into force in March 2020, allows the Commissioner of Patents to allow the country to produce, sell, and use a patented invention if the Federal Minister of Health deems there to be a public health emergency. Although no consultation with patent-holders is required, the country will compensate them with an amount “the Commissioner considers to be adequate remuneration in the circumstances.”  Germany also has allowed its Federal Health Minister to take executive action to make medicines available in return for adequate compensation. France amended their patent law to preclude the need for amicable negotiations with patent-holders where urgency exists.
These issues may also be addressed through  use of voluntary licensing proposals. Alternatively, public pressure on patent holders may play a significant role. For example, Labrador Diagnostics LLC, which purchased patents from the defunct Theranos, brought an action, and sought an injunction against BioFire Diagnostics for making COVID-19 diagnostic tests. The action was abandoned after public backlash.

== See also ==
Bioprospecting and biopiracy
Budapest Treaty
Copyright status of genetic sequences
Human Genome Project
The Lens

== References ==

== External links ==
Relevant legal provisions of the European Patent Convention:
Article 53(a) EPC: "Exceptions to patentability" (formerly Article 53a EPC 1973)
Rule 28 EPC: "Exceptions to patentability" (formerly Rule 23c EPC 1973), barring the patentability of, notably, "processes for cloning human beings" (Rule 28(a) EPC); "processes for modifying the germ line genetic identity of human beings" (Rule 28(b) EPC); and "uses of human embryos for industrial or commercial purposes" (Rule 28(c) EPC)