Home > Topics > Specific Strategies and Mechanisms for Facilitating Access to Innovation > Patenting and Licensing Research Tools > Editor's Summary, Implications and Best Practices

It is widely acknowledged that IP rights are big drivers of innovation. But if IP rights owners of key technologies seek to block rather than facilitate access, then progress will be stymied—even truncated. Instead of marking a path to innovation, patents become a thicket, an impenetrable tangled mass of barbed wire.

Research tools are good examples of this difficulty. They encompass a wide range of resources, including genes/gene fragments, cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools (such as the polymerase chain reaction or PCR), methods, laboratory equipment and machines, databases, and computer software. Without these tools, R&D advances in both medical and agricultural biotechnology are impossible. Unfortunately, a complex, interconnected web of research tool patents has arisen, largely due to changes in public policy and patent law. These patents have the potential to block access to research tools, a situation often referred to as the anticommons.

The IP rights attached to research tools have global implications, and so they should be managed carefully. A balance needs to be worked out. IP rights should be adequately protected and properly managed but they should not block widespread access to research tools. This chapter addresses these complex and timely issues in a sensible, nuanced, and even-handed way, offering a suite of suggestions for approaching and successfully navigating the complex landscape of intellectual property and research tools.

Historically, the current situation relates back to three key events:

1. The revolution in molecular biology, which fostered the development of wholly new branches of R&D
2. The landmark 1980 U.S. Supreme Court decision, Diamond v. Chakrabarty, which established that genetic inventions are patentable subject matter under U.S. law
3. The 1980 Bayh-Dole Act in the United States, which granted universities the right to patent inventions based on government-funded research

The more innovative developing countries, including Brazil, India, and China, have recently pursued similar policies to promote the commercialization of university research products. But developing countries, even those with a relatively well-developed scientific and medical infrastructure, face very different circumstances from those in the U.S. and other developed countries, and their approach to these issues cannot be reduced to simply imitating such policies.

To avoid potential patent thickets associated with research tools, developing countries have several approaches at their disposal, possibly in various combinations, including:

• changes in patenting policies (as permitted under TRIPS)
• research exemptions in patent law to reduce the risk of infringement in R&D
• compulsory licensing to allow access to upstream technologies
• institutional adaptations to facilitate access to needed technologies, such as guidelines to encourage or mandate patenting policies that promote innovation

Developing countries are not alone in their efforts. Various initiatives have been implemented to adapt or modify institutional practices with respect to research tools and patents. The chapter lists several diverse organizations whose examples are worth careful consideration, including CAMBIA (a non-profit organization in Australia), The Consultative Group on International Agricultural Research (CGIAR), The Public Intellectual Property Resource for Agriculture (PIPRA), The U.S. National Institutes of Health (NIH), and Stanford University. The chapter is well worth consulting for its overview of the approaches taken by these organizations.

Given the numerous, complex circumstances facing policymakers, researchers, universities, research institutions, foundations, and other organizations in developed or developing countries, specific solutions are not on offer. But the chapter does provide some guidelines for thinking through these circumstances. For example, developing countries need to think about how to implement patent legislation that is consistent with TRIPS and that meets their own objectives, particularly in respect to genetic discoveries. Legislation should be formulated to set forth appropriate research exemptions, and the laws governing compulsory licensing should be formulated to promote research that is directly relevant to the health and agricultural problems of developing countries. Indeed, patenting and licensing policies should maximize the availability of innovations—including research tools and platform technologies—in order to aid the development of urgently needed products.

Public funding bodies should introduce policies for sensible patenting and licensing practices to promote downstream innovation. And public research institutions and universities in developed countries should adopt licensing policies and practices that will ensure access to R&D outputs that are relevant to the health concerns of developing countries. By working within the global IP system, developing countries have the power to prevent patent thickets from stifling their crucial research programs. It just takes foresight and planning.

Key Implications and Best Practices

Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.

For Government Policymakers

• When considering patent legislation, the interests of private and public sector research infrastructure should be considered and incorporated into an overall national technology policy (especially as it relates to biotechnology, health, agriculture and the environment).
• It is worth analyzing whether and how policies adopted in other countries may apply or be adapted to the circumstances of another country.
• Craft legislation to minimize potential conflicts, especially conflicts between promoting innovation, affordably meeting the needs of the poor and the farming community, and promoting research-based industries.
• Encourage public funders of research and public research institutions to pursue policies that promote research and innovation.
• View patenting and licensing policies not as a way to raise revenue, but as tools for pursuing public policy goals.

For Senior Management (university president, R&D manager, etc)

• View patenting and licensing policies not as a way to raise revenue, but as tools for pursuing public policy goals. Very few universities, even in the U.S., have made significant sums from their technology transfer offices.
• Patenting may be unnecessary when publication offers the widest dissemination.
• Consider non-exclusive licensing policies to maximize the utilization of research tools.
• When exclusive licensing is essential, negotiate for freedom to use the technology in public research in your own institution and others.
• Take a strategic view of what technology transfer is seeking to achieve.

For Scientists

• When using research tools, remain aware that these tools might be covered by the IP rights of other parties. If you have any doubts about whether or not you are authorized to use specific research tools, seek the guidance of your institution’s technology transfer office.
• Conversely, the R&D work that you carry out in your program can often serendipitously lead to the invention of new research tools. Carefully document the protocols and results flowing from your program. If you believe that you have developed a new research tool or have improved a preexisting research tool, promptly contact your technology transfer office for guidance.
• Always maintain a good working relationship with your technology transfer office, so that you can readily go to them for consultation, and be sure to attend IP training sessions offered by your technology transfer office.

For Technology Transfer Officers

• Consider the strategic justification of patenting a particular invention, thinking in terms of the public good, and not just potential financial gain.
• If you are a licensor, put yourself in the position of the other party. If the roles of licensor/licensee were reversed, would your position seem unreasonable? Inflexibility may be detrimental when the licensee has technologies you may wish to utilize.
• In the case of exclusive licensing, consider whether this is the only way to pursue further research and ultimately commercialisation in this area. Could non-exclusive licensing produce a better result in promoting downstream research?