Open Source Biotechnology Project

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* Open Source as a Business Approach
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Copyright (c) 2003 Janet Hope, Research School of Social Sciences, Australian National University, Canberra, ACT 0200. Verbatim copying and distribution of this site is permitted in any medium, provided this notice is preserved.

Research Plan

Study aim

To determine whether biotechnology research tools can be commercially exploited according to "open source" licensing and business strategies.

(For explanations/definitions of key terms in this statement, click here)

Approach

Part 1: Develop a suite of "open source" licence templates for biotechnology research tools

First step

Determine whether there is any generic reason why biotech research tool licences couldn't comply with the Open Source Definition [http://opensource.org/docs/definition.php] (OSD) (eg references to code, software etc). Modify the OSD as necessary to accommodate generic issues while remaining as close as possible to the original document.
Specific issues
The OSD was drafted specifically to apply to software. It therefore incorporates terms and concepts that have no one-to-one correspondence with terms and context in the biotechnology sphere. These include "software", "aggregate software distribution" and "software distribution", "source code", "compiled form", "reasonable reproduction cost", "patch files" and "program". It seems unlikely that replacing these terms with biotechnology-specific terms will be enough on its own to create an open source biotechnology definition (OSBD) that has the same ultimate effects as the OSD, and in fact there may be many different possible versions of an OSBD that would all come equally close to the spirit and effect of the OSD. The aim of this part of the project is to develop a working OSBD that is recognisable as being derived from and closely related to the OSD and can serve as a platform for later stages of the study.

Second step

Draft licences that comply with the OSBD that correspond as closely as possible to each of the
GPL[http://www.opensource.org/licenses/gpl-license.php]
MPL[http://www.opensource.org/licenses/mozilla1.1.php]
BSD [http://www.opensource.org/licenses/bsd-license.php]
licences for each of several research tools (to be identified as the first action in this part of the study) that are selected to represent
(1) different categories of intellectual property protection, eg
patent
PVP
trademark
design
database
copyright
MTAs etc
(2) different classes of biotechnologies used in research, eg
molecular cloning
genomics (structural and functional)
proteomics
gene knockouts and antisense technologies
cell culture technologies
stem cell technology
animal cloning
bioinformatics
Specific issues
a) Open source software licences may be open to challenge on a number of grounds. The aim here is not to draft licences that cannot be challenged on those same grounds, but to overcome any drafting issues that arise out of technical differences between biotechnology and software tools or out of differences between IP regimes. If it is possible to overcome or sidestep existing enforceability issues relating to open source software licences when drafting open source biotechnology licences, that is a bonus.

b) One difference between biotechnology and software tools is that biotechnology research tools are often (though not always) protected by patents, whereas software tools are usually (though again, not always) protected by copyright. Therefore a key issue to be addressed in this part of the study is the feasibility of drafting an "open source" patent licence.

c) Each biotechnology listed above, taken from the BIO 2002-3 Report, is made up of a large number of individual tools. The idea behind choosing a number of different individual tools that together represent a range of biotechnologies is that if it is possible to successfully draft licences for all these tools, it will be reasonable to argue that the potential applications of open source licensing to biotechnology research tools may be found in any sector of the industry.

d) The choice of GPL, MPL and BSD licences is intended to give a range of options that strike different balances between user and owner freedoms.

e) Typical clauses in a biotechnology research tool licence include terms relating to:

extent of the grant
permitted field of use
improvements
confidentiality
technical assistance
indemnity
due diligence
remuneration
For each drafting exercise, each of these typical clauses must be individually considered in the light of the OSBD.
Sources of information (not an exhaustive list)
  • OSD (annotated)
  • GPL, MPL, BSD
  • Commentary on the evolution of the OSD, GPL, MPL, BSD
  • Interviews with people who have drafted the OSD or free or open source licences (FSF and OSI members and attorneys/counsel to OS businesses)
  • Texts on drafting technology licences generally
  • Interviews with people experienced in drafting biotechnology licences (e.g. technology transfer officers, licensing executives)
  • Sample online biotechnology licences and material transfer agreements and examples sighted in interviews
  • Molecular biotechnology texts, BIO report, patents, company websites and Internet and academic literature sources for information on specific biotechnology research tools
  • Interviews with owners of specific research tools
  • Patent attorney or other IP specialist for information on how specific research tools are legally protected

Part 2: Assess the viability of "open source" business models in the biotechnology context

First step

Develop a checklist of questions that owners of early-stage research tools can ask themselves in order to determine whether an "open source" approach to further development and commercialisation would be viable.

[Note to myself: an unsorted, preliminary list of questions to be included in this checklist is at Desktop/Janet/Notes for Research Questions Page]

Preliminary questions
a) Is the cost of obtaining patent protection so high that it will always or generally outweigh the economic advantages of an open source approach?

b) Can biotechnology research tool development be made sufficiently modular and granular for commons-based peer production? (Do changes to one part of the tool impact the rest of the tool in unforeseen ways so as to preclude distributed development? -- Bear in mind that many existing biotech research tools were prodcued in an academic context.)

c) Are human creativity costs too small a proportion of the total cost of production of biotechnology research tools? (Is biotechnology research and development always too capital intensive to be amenable to open source methods? Is the level of capital-intensiveness crucial anyway?)

d) Is there cultural resistance to open source licensing and business strategies in the biotechnology community that does not exist in the software community and that may defeat the implementation of open source biotechnology?

e) Are the costs of effective communication and coordination among contributors to an open source biotechnology project too high for such a project to get off the ground, due to the need to exchange uncodified information and materials? On the other hand, do high information transaction costs suggest that market mechanisms are also unlikely to be well-suited to biotechnology research tool development (see Mandeville)?

f) What issues are raised by biosafety and biosecurity considerations?

g) Is there sufficient demand for open source products in the biotechnology context to drive contributions to an open source project? (Another way to put this is to ask whether choice and control with respect to research tools are important to biotechnology researchers.)

h) Do there exist viable equivalents in the biotechnology sphere to the secondary product and service markets exploited by open source software businesses?

Sources of information (not an exhaustive list)
  • Internet guides to commercialising biotechnology research and other information sources referred to therein
  • Interviews with open source software businesses and venture capitalists that have provided funding to those businesses
  • Interviews with biotechnology businesses and research institutions identified through industry associations, funding agencies and personal networks
  • Interviews with technology transfer officers and licensing experts
  • Interviews with biotechnology industry venture capitalists and grants bodies
  • Software community commentary (summarised in this website) on essential elements of the open source business model
  • Academic commentary on conditions for successful commons-based peer production

Second step

Administer checklist as a questionnaire to a range of organisations in (a) agricultural biotechnology and (b) biomedical biotechnology sectors to identify any willing to consider adopting an open source approach.

(a) agricultural biotechnology organisation types:

large multinationals
smaller biotechnology firms
farmers, agricultural cooperatives and growers' associations
medium and small-scale seed enterprises
nurseries in developed countries
national seed companies of developing countries
land grant and public universities
private universities
CGIAR's International Agricultural Research Centres
National Agricultural Research Services of developing countries
non-government agricultural development organisations
non-profit funding agencies, e.g. Rockefeller Institute
(b) biomedical biotechnology organisation types:
universities
hospitals
private non-profit research institutions
government agencies
small biotechnology firms
major pharmaceutical firms

Part 3: Draft "open source" licences for real-world commercialisation efforts.

Ideally, results from the first two parts of the study will eventually be brought together and given practical application in the drafting of specific open source licences for research tools that are being actively commercialised. Whether the study ever reaches Part 3 will depend upon the outcome of the previous two parts. It may be that open source licensing and commercialisation strategies are not feasible or appropriate in the biotechnology context. If so, the first two parts of the study should reveal the reasons. If open source is or can be made into a genuine option, however, the first two parts of this study will constitute only a preliminary exploration, and more detailed practical issues will remain to be worked out in the course of attempts to implement an open source approach in the real world.

If this study does reach Part 3, potential case study participants will be identified from among participants in the earlier parts of the study.

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