Can open source IP bring the vaccine to the world?

19 October 2020

Can open source IP bring the vaccine to the world?

As scientists around the world work feverishly on a vaccine for Covid-19, lawyers are exploring ways to share the intellectual property involved in the research. Excel V. Dyquiangco explains why open source licensing might be the solution.

While most creators want to protect their inventions and creations, some IP owners may desire to make their original items available for others to use and develop. The collaboration around the Covid-19 coronavirus is one example, with a number of researchers granting licences to use their IP for certain purposes, without payment, until the pandemic is under control. Separately and prior to Covid-19, there have also been projects focused on encouraging environmentally sustainable technologies.

But the benefits of open source science have come to the forefront during the Covid‑19 pandemic. The United Nations Educational, Scientific and Cultural Organization (UNESCO) has highlighted the value and necessity of open source science in facilitating faster and higher quality research towards a vaccine, and informing public health measures to contain the spread of the virus. In March 2020, UNESCO director‑general Audrey Azoulay called on governments to reinforce scientific cooperation and to integrate open science within their research programs.

According to Frances Wheelahan, a partner at Corrs Chambers Westgarth in Melbourne, researchers at Australia’s Peter Doherty Institute for Infection and Immunity have also supported the use of open source science as “an important step in collaborative scientific efforts to diagnose, prevent and treat this public health emergency.”.

“In January 2020, a team of researchers at the Institute shared the first Australian viral isolate of SARS‑CoV‑2 with the World Health Organization (WHO), which distributed the samples to research labs around the globe and published the genome,” she says. “The genetic map was made freely available for access to all. This allowed the virus and its mutations to be sequenced over 3,000 times, contributing significantly to vaccine research. Following the success of this initial use of open source science, an international coalition of scientists and lawyers called on organizations to sign up to the Open Covid Pledge, a public pledge to make available patents on an open basis for the purpose of ending the Covid‑19 pandemic. Organizations may implement the pledge through one of three standard Open Covid Licenses, which detail the terms and conditions under which intellectual property is made available.”

She adds that as an example, the initial Open Covid License (version 1.0), which was published on March 31, 2020, provides that users may make, use, sell or otherwise exploit the IP licensed under the terms for the sole purpose of minimizing the impact of, and ending the Covid‑19 pandemic, including “the diagnosis, prevention, containment, and treatment of the Covid‑19 Pandemic” up until a year after the WHO declares Covid‑19 is no longer a pandemic.

“The key difference between versions 1.0 and 1.1 of the Open Covid License is the introduction of an end date of January 1, 2023, if the WHO hasn’t declared an end to the pandemic by that time – this is to provide more certainty to organizations about when the license would end. However, organizations may modify or use the licence as-is, and extend the licence voluntarily,” she says.

More generally, many governments now adopt an open source approach to IP in reports and certain de-identified data sets which may be usefully utilized by others for a range of purposes.

 

“Open source IP will play an increasingly important role in the development of diagnostics, treatments and vaccines for this and subsequent crises,” Wheelahan says. “Particularly as the capacity to easily share and analyze very large data sets increases. Ultimately, however, I suspect the proprietary IP model will continue to play a crucial role in the development of new technologies as it effectively rewards and incentivizes investment in the costly development of new technologies.” 

 

The need for open source

As with any licence terms, whether to share IP on open source terms depends on the IP owner’s aims and circumstances and should be carefully thought through.

Wheelahan says: “There are no hard and fast rules about when IP should be open source – this is at the discretion of the IP owner and will depend on the owner’s objectives for the exploitation of their IP. Sometimes there may be a degree of public pressure to make IP open source where there is a significant public benefit in doing so (for example, as we have seen with the Open Covid Pledge).”

“Fast-paced, highly innovative industries and those reliant on some level of standardization may be more obvious candidates for some open source licensing in the sense of pooling of certain IP rights,” says Sue Gilchrist, a senior partner and head of intellectual property at Herbert Smith Freehills in Sydney. “Similarly, where an IP owner is seeking to create a market for a new product, sharing IP can help the industry to develop more quickly and efficiently, and can also share the investment burden – think electric vehicles. In some cases, IP owners also choose to make their IP available on open source terms to encourage collaboration or development in a particular field.”

Open source access can allow owners to retain their IP rights, while still facilitating collaboration without the usual financial arrangements (again, as long as users comply with the owner’s terms). This can be particularly attractive where an IP owner wishes to foster development in a particular area, or where standardization is useful or necessary, but it is always important to bear in mind the restrictions on any future use that may flow from relying on such open source IP.

“Open source IP has the potential to be a great equalizer because it facilitates access to IP, data and other information without the financial barriers,” says Wheelahan. “It can assist to distribute financial risks in the development of new IP across the open source community, particularly where there might be an ongoing obligation on users to disclose their improvements to the original IP. It can be particularly beneficial for developing countries where there may be gaps in research capabilities and the funds to pay for access. The open source IP model may also enhance an IP owner’s market position. If an IP owner makes its platform technology available on an open basis, this platform can become the de facto standard in that field. Other bolt-on technologies might be developed by users of the open sourced IP and this may further embed the original open source IP as the leading technology in the market.”

But can you still profit from this?

“You really only need to look at the tech sector to know that the answer to this question is yes,” says Gilchrist. “The tech sector are the pioneers in open source, having developed the model of open source licensing many years ago. And the tech sector shows us that there is no one-size-fits-all approach to open source – there are multiple different open source software licenses, each with its own features. What is clear, however, is that IP can be used in multiple different ways to drive innovation and create profit. In some cases that will still be based on the traditional exclusive IP rights approach. Increasingly, IP is a key a tool that gives IP owners the ability to collaborate with a range of partners, drive step changes in technology development, and harness the value of their IP in many different ways, all of which will ultimately produce a profit.”

 

She adds that being open about your IP can actually make you more money in the long run. “In some circumstances, absolutely. We all recognize that collaboration and a diversity of contributions to any research project, for the right project, can make the research outcomes more robust, and being more open with IP is one way of facilitating collaboration. But perhaps a different way of thinking about this is to recognize that IP is the key to an open source environment. It is the important asset which has value, and that allows businesses to enter into a range of different collaborations and arrangements, and have control over the decisions they make about how they will engage, how they will share, and how they ultimately make a profit from that engagement.”

Wheelahan agrees. She states that IP owners who make their IP available on an open source basis could still obtain financial or other benefits from doing so.

“Open source IP may result in the widespread adoption of the IP owner’s platform as the default standard,” she says. “This could have a significant knock-on economic benefit to the IP owner. An open source IP model may also increase the market for complementary goods and services supplied by the IP owner. In addition, IP owners commonly make a public announcement of the open sourcing of their IP. This can assist to enhance an organization’s reputation for commitment to innovation and expertise in the relevant field. Where the open sourcing is done for a benevolent objective, this can also be recognized as an important and ethical contribution to societal goals by the IP owner.”

 

Risks and challenges

According to Wheelahan, organizations proposing to make IP available on an open source basis should ensure their objectives are balanced with a sensible approach to managing legal risk. This requires organizations to:

  • Consider whether the IP owner has the right and authority to license the particular IP;
  • Clearly define the licence terms, including:
    • the particular IP being licensed,
    • the licence period,
    • the territory of the licence,
    • the permitted purpose for which the IP may be used (e.g., can the user further develop and modify the technology or just use it as-is?),
    • whether the license includes sublicensed rights,
    • ownership of improvements to the licensed IP,
    • whether there is an obligation on the licensee to make improvements and other results available to the IP owner (and perhaps other licensees of the IP), and
    • termination rights and the licensee’s obligations on termination;
  • Carefully consider and include appropriate provisions in the licence in relation to liability, indemnity and insurance issues (including the provision or exclusion of any warranties);
  • Consider any statutory obligations that may apply and how these obligations may impact on the licence term; and
  • Ensure the licence permits the organization to monitor and audit the use of the IP to ensure it is being used within the terms of the licence.

“IP owners can make their IP available on an open source basis by making a public statement, sometimes called a pledge,” says Wheelahan. “A recent example is the Open Covid Pledge I mentioned earlier. The Open Covid Pledge seeks to accelerate the rapid development and deployment of diagnostics, vaccines, therapeutics, medical equipment and software solutions in this urgent public health crisis. When an IP owner makes a pledge like the Open Covid Pledge, they agree to make their specified IP freely available to the public, either on the licence terms specified by the group or their own licence terms which reflect the intent of the pledge.”


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