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dissemination of the information and research results it generates.

4. Permit members of the scientific commu-nity to use its results without having to con-clude restrictive agreements that would limit research freedom and integrity.

5. Not use intellectual property (IP) to limit access to the project, its results or to dis-criminate between different uses or differ-ent users.

Possibly, such a project could also include a mechanism to allow the initial researchers to recuperate reasonable production costs invested in its realization. However, this mech-anism should not impede the open nature of the project.

It can be seen from these broad criteria that open biotechnology is not necessarily antagonistic to IP and that it is possible to develop an open source project that would make use of the patent system. A variety of licensing schemes with or without IP (e.g., patent pool, non-assertion covenants, public domain, protected commons agree-ment, contractual licenses) can theoretically be used as the engine to support the open nature of the project (Table 1).

ferent projects as an open journal (e.g., Public Library of Science), a new bioinformatic tool (e.g., the BioMoby messaging standard), a data-base (e.g., NIH db GaP), a big science project (e.g., HapMap or the Human Genome Project), a project to facilitate access to biotech research tools (Cambia BiOS) or a combination of these. In this confusing environment, projects having little to do with open biotechnology have even been presented as such by dishonest entrepre-neurs hoping to piggyback on the movement’s popularity. It is thus becoming increasingly important to agree on some broad criteria that would allow us to separate genuine open projects from imitations. Based on an in-depth analysis of the literature, we propose that, at a minimum, an open biotechnology project should meet the following criteria:

1. Make use at one stage or another of the internet and other information technologies (e.g., to promote quicker dissemination of results, promote collaboration and/or to improve project coordination).

2. Be designed in a way that will permit other members of the scientific community to col-laborate on the project.

3. Include a strategy to ensure rapid public

In the last few decades, the application of the patent system to the field of biotech has faced

an increasing amount of criticism from scien-tific researchers, ethicists and lawyers alike1. According to these critiques, the broad utiliza-tion of the patent system in this scientific field leads to counterproductive results2,3, is unethi-cal4,5 and of dubious legal validity6. Evidence has yet to be found that patents have a wide-spread negative impact on research7. However, most researchers agree that patents, the threat of patents or restrictive patent licenses have at times generated specific problems in the field of biotech—for example, problems of access to new genetic tests by clinicians in the case of Myriad Genetics’ breast cancer gene patents or problems linked to broad patents such as those for embryonic stem cells8–10. The growing unpopularity of biotech patents has motivated researchers to find alternative or complemen-tary solutions that would foster the develop-ment of, and facilitate access to new biotech goods. One of the most promising solutions, inspired by the open source movement in the field of information technology (IT) (Box 1), as well as by the already existing open science ideal within the academic community, is open biotechnology.

In recent years, an impressive number of open projects have been developed in several spheres of activity associated with biotech research. It would be difficult, if not impos-sible, to find a definition that would encom-pass the many radically different open projects currently existing in the field. Because there is no source code involved in open biotechnol-ogy projects, they will likely be quite different from those observed in IT. The term ‘open bio-technology’ has been used to refer to such dif-

Open biotechnology: licenses neededYann Joly

Open biotechnology may be the ideal solution to ensure scientific progress and the realization of the common good, but it has yet to deliver on its promises.

Yann Joly is at the Centre of Genomics and Policy, McGill University and Genome Quebec Innovation Centre, Montreal, Quebec, Canada. e-mail: yann.joly@mail.mcgill.ca

Box 1 The success of open source informatics

The open source project in the field of IT was developed by idealist programmer/hacker Richard Stallman in the early 1980s in resistance to the increasing commercialization of computer software. Stallman created the Free Software Movement (FSM) and helped develop the copyleft license to protect the open nature of the various informatics tools developed by the FSM. Since Stallman’s early successes, the popularity of open source has been growing continuously and has led to the creation of the Open Source Initiative. The greatest success of the open source movement remains the development of the GNU/Linux kernel in the early 1990s. The Linux operating system now has >30 million users worldwide, whereas collaborators to the Open Source Initiative were estimated to be >1.5 million in 2008.

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growing tendency to use these licenses to pro-tect goods that are not protectable through IP (e.g., natural phenomena or raw data) has also been recently observed in biotech21. Although sometimes warranted by the need to better protect the identity of research par-ticipants22, such use of contractual licenses could have the counterproductive and para-doxical effect of limiting access to an already public good to protect open access. Finally, a third strategy, leaving the good in the pub-lic domain unprotected, although appeal-ing, remains vulnerable to abuse from more commercially minded parties. Large biophar-maceutical companies could access the good, modify it in small ways and use IP to control and market it, restricting its future use by members of the scientific community23.

An additional problem common to most open biotechnology projects has to do with the sheer complexity of existing licenses and access agreements18. Because most scientists are not legal experts, it makes sense that access licenses should be short and simply written so as to encourage wide use of a good. Sadly, this is generally not the case and many access agreements and licenses developed with the best intentions have ended up much more complicated than the traditional IP licenses they were seeking to replace.

DiscussionEarly setbacks designing satisfactory licenses should not be seen as a sign of failure for the open biotechnology movement. The free software movement in the field of informat-ics took 20 years to blossom into a strong, competitive force. Open biotechnology is still in its infancy. However, the dynamism of the open biotechnology movement can be seen not only in the increasing number of open projects but also in the growing support and interest of policy makers, nongovernmental organizations and research funders, which bodes very well for the future of open bio-technology22.

One of the main obstacles on the road to success for biotech proponents will be the need to develop simple, efficient and legally valid open licenses to support their projects. Such licenses will give the open biotechnol-ogy movement the credibility and strength it needs to foster collaboration, transparency and access on a large-scale basis. Work has already begun on this challenging task, albeit in a rather uncoordinated manner. To stream-line and standardize current efforts, the cre-ation of an international association where researchers interested in open biotechnology licensing could discuss common problems and harmonize their efforts would be very

tainty associated with genetic patents would seriously jeopardize the viability of such an approach. Indeed, patents are very expen-sive to obtain, maintain and defend16,17. This means that any inventor relying on an open patent license would need to charge a sufficient cost to its licensees to recuper-ate its investment in the patent (including, prospectively, a part of the cost of defending its patent in court against potential infring-ers). This amount alone could be sufficient to deter potential users from obtaining a license. Moreover, many small projects (private or public) simply cannot afford the cost of pat-ents and prefer to rely on commercial secrecy to protect their inventions.

One suggested solution to the cost issue is an umbrella organization that could assume the responsibility for maintaining and pro-tecting donated patents for researchers18. This organization could be financed through voluntary donations, membership fees and licensing revenues obtained from users. However, getting sufficient numbers of inter-ested parties to contribute to the development of such an organization has proven an insur-mountable obstacle so far. Another potential strategy involves using the international pat-ent filing system to postpone both national patent applications and part of the financial burden of patenting in most countries by 30 months after the priority date. Following that delay, because of the fast-paced rate of bio-tech innovation, patent protection will often no longer be necessary.

Because of the high cost of patents and of the uncertainty concerning the patentability of a growing number of basic research find-ings, an increasing number of scientists have turned to contractual licenses (often referred to as access agreements) to ensure open or controlled access to the fruits of their research to members of the scientific community19,20. Purely contractual licenses, although less expensive and easier to design than patent licenses, are not particularly efficient against use by third parties to the original contract. A

Open licenses: new models neededThe central element that will determine the success or failure of any open biotechnology model is its license. A license is a contract with a series of conditions, financial or oth-erwise, that will allow the licensee the use of a licensed good. Open licenses are at the heart of any open project. They are the legal tools used to guarantee that the project remains acces-sible for all users and customers. Additional clauses can also permit researchers to ensure that their goods are used efficiently and ethi-cally by members of the scientific community. In the field of IT, the open source movement has relied on a series of copyright licenses based on Richard Stallman’s ‘copyleft’ model to ensure open access to the software codes by the broad computing community11. The legal validity of some open source copyright licenses as well as that of similar Creative Commons copyright licenses has recently been confirmed by courts of law in a variety of countries12,13. This legal recognition has given legitimacy to the open source project and that of Creative Commons.

In the field of biotech, things are very dif-ferent. Unlike in IT, where most software is protectable through copyright, products of biotech are usually protected through the pat-ent system. Moreover, several biotech devel-opments initially thought to be protectable through the patent system have been found not deserving of such reward in recent legal decisions, forcing developers to rely on other weaker IP rights (e.g., copyrights, sui generis database rights), contractual law or commer-cial secrecy for protection14,15. Accordingly, it is extremely difficult to develop simple license models to ensure the openness of a given project and even more challenging to develop model licenses that could be used for a variety of projects.

In the case of potentially patentable goods, the central question is, can the patent sys-tem be used, as copyright is, to ensure open development and access? Although theoreti-cally feasible, the high cost and legal uncer-

Table 1 Possible open biotechnology licensing strategiesPatent pools IP An arrangement between at least two patent owners to license their

patents to one another or to third parties. A governance structure can be set up to administer the pool for the patent owners.

Open IP licenses IP Inventions or creations protected by IP rights and made accessible through open licenses often based on the original open source copyleft model.

Contract (access agreement) Non-IP A legal agreement whereby two or more parties bind themselves.

Public domain (including defensive publishing)

Non-IP Inventions or creations not protected by IP rights and disclosed to the public generally through the internet or scientific publications.

Non-assertion covenants IP Agreement or unilateral promise by an IP owner not to enforce its IP against third parties in certain predetermined circumstances.

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10. Murray, F. N. Engl. J. Med. 356, 2341–2343 (2007).11. St.-Laurent, A.M. Understanding Open Source and Free

Software Licensing, (O’Reilly Publishing, Sebastopol, California, 2004).

12. Curry v. Audax, District Court of Amsterdam Case no. 334492/KG 06–176 SR (2006).

13. Jacobsen v. Katzer, 535 F.3d 1373 (Fed. Cir. 2008).14. In re: Dane K. Fisher and Rughunath v. Lalgudi 421 F.3d

1365 (Fed Cir. 2005).15. In re: Marek Z. Kubin and Raymond G. Goodwin No.

09–667,859 (Fed. Cir. April 3, 2009).16. US General Accounting Offices. Report to Congressional

Requesters (GAO-02–789) (US General Accounting Offices, Washington, DC, 2002).

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(2006).19. Data Access Policy for the International HapMap Project

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20. Wellcome Trust Case Control Consortium. <https://www.wtccc.org.uk/info/access_to_data_samples.shtml>

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financial support of the PRIVAC project Genomics Applied to the Discovery and Development of Vaccines and Immunotherapies.

COMPETING FINANCIAL INTERESTSThe author declares no competing financial interests.

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3. Merges, R.P. & Nelson, R. Columbia Law Rev. 90, 839–916 (1990).

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5. Kass, L. Public Interest 107, 65–86 (1992).6. Greenfield, D. Santa Clara Comput. High Technol. Law

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J.P. Nat. Biotechnol. 24, 1091–1094 (2006).8. Cho, M.K., Illangasekare, S., Weaver, M.A., Leonard,

D.G.B. & Merz, J.F. J. Mol. Diagn. 5, 3–8 (2003).9. Matthijs, G. & Halley, D. Eur. J. Hum. Genet. 10, 783–

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beneficial. The creation of similar informal groups has been a key to the success of the open source movement in informatics.

Open biotechnology is desirable to ensure the quick and efficient development and integration of genomic research, but also as a much needed reward to thank the impres-sive number of volunteers who have con-tributed altruistically to the progress of this highly prospective scientific field. Hopefully, the current problems designing suitable open licenses will only prove a minor impediment on the way to democratizing biotechnologi-cal research.

ACKNOWLEDGMENTSThe author would like to thank F. Hemmings and B.M. Knoppers for reviewing the manuscript, E.R. Gold for comments on an earlier version of the draft and Genome Canada/Genome Quebec for their

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