BiOS Agreements FAQs
How do BiOS-compliant agreements work?
Under BiOS-compliant agreements, technology is available royalty-free for use in research or in creating products, by anyone in any country, based on a legally binding agreement to the following elements:
- All the agreements are non-exclusive;
- An owner of technology made available for use under a BiOS-compliant agreement, or an improvement to such technology, may not assert IP rights over that technology or improvement against any other entity that abides by the terms of a BiOS-compliant agreement;
- All licensees covenant to share improvements, making them available for use, even though they may be patented, to all other licensees;
- Participants share biosafety data and any other information needed to meet regulatory requirements for use in commercial products
What is a ‘protected commons’?
A protected commons provides a secure platform where discussion concerning an invention or improvement can take place without the invalidation of future patent applications, or the misappropriation of information by third parties.
How does a ‘protected commons’ differ from the public domain?
Information that is publicly disclosed outside the context of a patent application has entered the public domain. Information that has been deposited in the public domain may be readily misappropriated, because those with resources can most rapidly analyse and define utilities for it, and then cover these utilities and any improvements on them with patent applications to prevent others from using them. Thus, open access to information “in the public domain” does not guarantee open capability to use it.
How does a ‘protected commons’ differ from patenting?
By placing patented and patentable technology in a protected commons, patents can be exploited for enabling use of technology by others instead of preventing it. The protected commons includes both patent owners and licensee users of the technology in the rights to share improvements and the capability to use them, whether these improvements are patented or not.
Allowing licensees the option to do this sharing in a “protected” (confidential) commons is deferring to the legal framework of patenting, which mandates that public disclosure of an invention should occur via the patent application. Owners of improvements may wish to patent them, so we provide a space for confidential, non-public disclosure of improvements to all licensees. All licensees have made binding agreements to the legal conditions of maintaining the improvements accessible to all other licensees, so there is an incentive to protect the technology for open use.
Is using open source technology any different from putting the technology into the public domain?
Open access to information “in the public domain” does not guarantee open capability to use it, for several reasons.
The fact that information is published or “open access” does not mean that it is in the public domain. Often, technology is published only after patent applications are filed. We’d like publishers of technology to be transparent about the conditions under which the technology is available, but most often they are not.
Even if information is truly placed in the public domain, it may not remain available for all public uses. For example, significant portions of the human genome, though published, have become covered by patents for diagnostic tools. Because patent monopolies can support high prices and effectively reserve these tools for rich markets, many diagnostic tools are effectively unavailable to the world’s uninsured.
Any useful information placed into the public domain can be quickly seized upon and developed into patentable products by the large companies who can afford to do so. For example, the rice genome project placed masses of information into the public domain. Private companies in the developed world with modern labs and computer equipment were able to take this information and quickly move it into patent applications over genetic markers, targets for herbicides, specific genotypes related to nutrition, fiber quality, and so on. The rights to much of the technology have now largely been acquired by a few multinational corporations. Meanwhile, small and medium-sized enterprises that lacked immediate capacity to make use of such information, particularly enterprises based in developing countries, were effectively locked out. Individuals are usually not able to make use of the information either.
The fact that public funding was used for the technology does not guarantee a public right to use it, either. There are many examples of technology now essentially unavailable to all but the wealthiest, even though developed primarily with public funding! Much of biotechnology, including the fundamental enabling tools of agricultural biotechnology, much genomic information, and much of the chemistry underlying pharmaceuticals falls into the category of having been developed largely with public funds, but unavailable for use in products except by certain multinationals.
In contrast, placing technology under the equity-based provisions of BiOS Licenses enables individuals and enterprises of all sizes and in any location to benefit from use and improvement of technologies by agreeing to the license terms.
Why bother to obtain a BiOS license?
Without a license you may be infringing valid patent rights. Licenses to many patents are difficult to obtain, but the BiOS license is available to any entity that agrees to its conditions.
The benefits to BiOS licensees are both economic and non-economic:
- ability to access the intelligence, creativity, goodwill, and testing facilities of a larger and wider community of researchers and innovators;
- decreased transactions costs relative to out-licensing or obtaining technology via bilateral license agreements;
- portfolio growth through synergies obtained by combining pieces of technology that may, by themselves, be too small to make a profit, or lack sufficient freedom to operate or enablement;
- high leverage of costly investments in obtaining proofs of concept, developing improvements, and obtaining regulatory and utility data
- ability to commercialise products without an additional royalty burden
What happens when researchers use patented technology without licenses?
Many universities, and many research organisations, use patented technologies in the hope that multi-national patent holders will not prosecute them or their organisations. Also, many scientists or companies are not currently aware of the implications of patents and IP restrictions on their work. They may find out after spending years, and large amounts of money, often public funding, on their projects, that because they used technology that they do not have the legal right to use, they cannot supply any deliverables that can be incorporated in a product.
Many researchers believe that no license is required to practice patented methods in research. This may or may not be true in your jurisdiction. For example, it is not true for most research in the US. It may appear to be true in that patent holders often choose not to prevent universities and research organisations from using patented technologies without licenses. In some countries such use is under a research exemption. Either way, however, there are still long-term implications of patents and IP restrictions on research work.
Scientists may find out after spending years, and large amounts of money (often public funding), on their projects, that because they used technology that they do not have the legal right to use commercially, they cannot supply any deliverables that can be incorporated in a product. An example of this was ten years of development by Australian researchers of a pea crop resistent to a multimillion dollar weevil pest. It still wasn’t possible to commercialise a product because a single company that held a blocking patent would not allow it. Companies that could bring to market any products and services based on university and institutional research are concerned about infringement liability risks.
For BiOS-licensed technologies, researchers do not need to risk operating outside of license regulations, because agreeing to the terms of the BiOS license gives them access to the tools they need. We want to allow a re-creation of the connection that should exist between publicly funded research and applied implementation of that research for the fostering of small and medium enterprises and public good.
How can a business make a profit using technology obtained under a BiOS agreement?
No BiOS-compatible agreement constrains the parties from using information that is learned or developed under the agreement to patent improvements or products. However, they must agree not to prevent anyone else who’s agreed to the same terms from using the same information.
Therefore, an important distinction of BiOS-compatible licenses is that licensees cannot constrain other licensees from using the same information, which they may be able to use to do something potentially quite different. Some of the world’s most profitable companies have learned that they can make profits not by squeezing out the competition by taking out contracts of exclusivity (patents and licenses), but by developing products and services that are the best in their field.
As companies such as IBM, Google and Apache have shown with products and services derived from the open source movement in software, making money is definitely possible using the business models that can evolve from this initiative. Hopefully many small-to-medium enterprises can spring up and start creating value and sharing that value. Many of these can, and we hope, will, be in countries and regions that are economically disadvantaged. Even large companies, if they embrace a very different business model, can make serious money – probably more than current earnings – by decreasing costs of accessing technology, litigation and developing early-stage innovation. Mostly, we hope the ultimate ‘beneficiaries’ of these models will allow farmers to make better money than current models. When farmers (non-subsidized in the real world) make money, they almost always re-invest it in their land and communities. This is good policy and good business. This is what we want to see; productive, sustainably prosperous agriculture and industries.
Do BiOS agreements allow patenting of improvements?
There is no provision in any BiOS-compatible agreement preventing any party from patenting anything, including improvements to BiOS-licensed technology.
However, those who benefit by non-assertion over BiOS-licensed intellectual property agree to the same obligation of non-assertion against all others who’ve agreed to the same terms.
The “grantback” is a concept found in many traditional licenses. The Improvements remain the intellectual property of the improver, but the owner of the improvements agrees to allow the licensor to use the improvements without infringing those rights. In the BiOS license, the owners of improvements agree to allow others, who’ve agreed to the same terms, to use the improvements, but exclusionary rights may still be enforced legally against any entity that does not agree to those terms.
No licensor or licensee under a BiOS license is under any obligation to patent Improvements or maintain patents, but patenting can be requested and supported by the community of contributors. Indeed, strategic patent applications and patents are part of the foundation of the license’s enforceability, just as legally enforceable copyright is at the foundation of the UC Berkeley-based open source BSD license (http://www.opensource.org/licenses/bsd-license.php) that’s fostered much university research and private sector product development.
Who would want a BiOS license?
- Anyone interested in materials and technology from CAMBIA, such as GUSPlus or TransBacter (these are available only under BiOS-compatible agreements)
- Research organisations that want access to information that might help complete a project they are working on, and bring it to successful real-world implementation
- Small and medium enterprises with creative staff that want some protection from patent thickets that impede their progress
- Large multi-national companies that can see how sharing information would not be detrimental to their profit margins, but may actually help them leverage investment by obtaining the improvements of others
To what entities is a BiOS license available?
The BiOS license is available to for-profits and non-profits. For-profits are being asked to provide partial support of the costs of providing services such as the BioForge, in which improved protocols, descriptions of improved materials, implementation and regulatory data are being supplied and documented, and costs of providing materials and knowhow to truly enable use.
Support requested from for-profits based in non-OECD countries is oriented more to in-kind provision than financial support.
The BiOS license is available to entities along any portion of the value creation chain, including research institutions, commercializers, entities such as hospitals or landowners providing clinical or field test data, end users.
What types of technology are available under BiOS licenses now?
All of CAMBIA’s technologies for crop genetics have been used to seed BiOS licensed technology portfolios. Two initial technology portfolios have been established, consisting of Genetic Resource Indexing Technologies and Plant Enabling Technologies currently under CAMBIA’s control. Each has a separate BiOS License.
The first BiOS license covers plant molecular enabling technologies including Transbacter, GUSPlus, and knowhow related to these and other plant molecular enabling technologies. There are already multiple licensees, members of the community improving the technologies.
A second BiOS license is already on offer, covering Genetic Resources technologies not limited to plants, not strictly an enabling technology (e.g. it is being used for value-added licensed services).
BiOS licenses are being developed to cover certain health technologies including a technology that can be used for cancer diagnostics and stem cell research, and technology based on glucuronidase-related enzymes that can be used for various types of diagnostics and medical devices.
Other technology owners may make other types of technology available.
Can other types of technology be licensed?
Any technology owner can make the technology available for use under a BiOS license. This may be done to foster development and improvement of the technology as projects within the BioForge to leverage the intellectual contributions of employees and others.
BiOS licensing does not involve donating the technology to the BiOS Initiative, to CAMBIA or any other entity (although such donation is possible and may be tax-deductible). Under a license, ownership of the technology remains with the owner. What is made available under a BiOS license is the right of others to use and improve the technology. Unlike a traditional license, the BiOS license contains provisions for a growing pool of licensees to contribute improvements to each other, so that not only the right but also the capability to use the technology is truly enhanced.
Does the license cover only patented technologies?
The BiOS license was designed to extend “open source” provisions designed for copyright, a very different type of intellectual property, so that it could cover technology subject to patent claims.
However, the BiOS license includes unpatented knowhow now, and will soon include some significant technology developed by CAMBIA related to promoters, which CAMBIA made the decision not to patent. The grant of allowance to use patented technology in the license is what allows the enforcement of license provisions, but much of the license is about norms of sharing that are to be encouraged.
The associated support agreement covers not only knowhow and materials not necessarily covered by the patent claims, but also technology data, for example data related to biosafety and data needed for regulatory approvals.
CAMBIA and Licensees have the option at any time of designating further unpatented and non-patentable technology and information as being additional improvements and technology data available to all licensees to be shared under the license.
Is there a research exemption?
What a “research exemption” or “research license” means is that “monopoly rights are retained over delivery-related downstream development”.
The BiOS license is not being segmented such that a research license is granted and then licensees have to come back for a commercial license under different terms. We feel that good research should be able to lead to products and public goods. Therefore, the BiOS license grant allows the worldwide royalty-free making and dissemination of products embodying the technology or using the methods, whether for commercial purposes or public good uses.
Many good scientists probably don’t realise that by using patented technology under a perceived or real “research exemption” they are making the decision that anyone who wants to use the technology anywhere in a deliverable will have to “partner” with the patent rights-holder(s).
This is a decision of such magnitude that it shouldn’t be made unaware or lightly. Such decisions early in the research can completely block the path to delivery by all but a few major multinationals. Any other entity wanting to go past “research” would need such a net of permissions that the painstaking downstream work to transfer the research from models into useful germplasm, test and scale-up is rendered uneconomic.
Scientists who have realised that early decisions to use whatever technology is easiest to hand “contaminate” the entire results consider that the “best” technology to use to do “good science” isn’t necessarily the technology available under a “research exemption”. Quite the opposite–if there’s a “research exemption” associated with it, anyone wanting to see the science go anywhere should avoid it!
How do I obtain a BiOS license?
Your institution must execute the license by agreeing in writing to the terms, which include no royalties but require covenants not to prevent other licensees from using improvements (non-assertion of intellectual property rights against other licensees).
These licenses allow development of products and there is no distinction between research and commercial licenses.
For-profit companies that wish to license the technology will be requested to take up a subscription to cover the costs of support services such as maintenance of the database and access structures, and patent prosecution and maintenance. Cost recovery for non-profit institutions, small and medium enterprises, and institutions in disadvantaged locations may be partially or completely covered by in-kind support of various sorts such as making infrastructure available for cooperative research, exchanges of staff, helping a student etc.
How do BiOS-compatible agreements encourage investment?
Any advantage that a business has can be used to encourage investment, including rights to use intellectual property in whatever form, specialised knowledge, etc.
Similarly, any risk that a business poses can discourage investment, including uncertainty about future royalties due or improvements that will be blocked from use, uncertainty about the availability of commercial licenses for technology in an R&D phase, regulatory uncertainties, uncertainty as to whether the resources internal to the business will be adequate to develop the technology further…
The BiOS Initiative aims to address some of the major uncertainties that can discourage investment, by providing not only license provisions supporting the growth of the technology, biosafety data etc. and no royalties, but also by providing support for the growth of a community, via the protected commons, that can capture improvements made by others, combine efforts for targeted improvements, overcome third party patent challenges etc.
Is there a humanitarian use exemption?
Our goal is that disadvantaged communities become enabled to overcome obstacles such as lack of access to intellectual property, lack of access to unpatented knowhow, and lack of access to investment. “Humanitarian” licenses become unavailable as soon as a disadvantaged community begins to climb out of poverty! While licensees may be encouraged to provide products in tiered pricing schemes to overcome financial barriers faced by certain communities, the BiOS license itself is not segmented. This means that the technology is subject to the same license grant provisions for all users, whether or not they choose to use the technology to overcome their disadvantages.
Isn’t open source anti-business and anti-patent?
“Being Pro-Business today may mean being Anti-Patent: Business interests in the majority of fields do not enforce their patents to obtain or maintain an exclusive patent right; many have a generally negative view of the patent system. (The minority view is found in the pharmaceutical, chemical, biotech and other emerging technologies and amongst small businesses and universities where a patent-based exclusive position is essential to development and exploitation of new technology.)
Many businesses that do not seek an exclusive patent-based position pay a lot of money to create a patent thicket principally for cross-licensing settlements with other manufacturers who would otherwise sue them for infringement. Yet, these patent thickets provide no protection against non-manufacturing patentees who have everything to gain from an infringement litigation and nothing to lose. ”
Source: Hal Wegner, Partner, Foley and Lardner, a prominent patent attorney, as a guest opinion in the blog of Dennis Crouch, another prominent patent attorney, 28 January 2007.