PRINCIPLES AND BEST PRACTICES FOR THE LICENSING OF GENETIC INVENTIONS
This Recommendation applies to the licensing of intellectual property rights that relate to genetic inventions used for the purpose of human healthcare. Within this Recommendation, the term “Genetic Invention” includes nucleic acids, nucleotide sequences and their expression products; transformed cell lines; vectors; as well as methods, technologies and materials for making, using or analysing such nucleic acids, nucleotide sequences, cell lines or vectors. This definition is intended to be forward looking to encompass highly related future developments.
B. Principles and Best Practices
1. Licensing Generally
1.A Licensing practices should foster innovation in the development of new genetic inventions related to human healthcare and should ensure that therapeutics, diagnostics and other products and services employing genetic inventions are made readily available on a reasonable basis.
1.B Licensing practices should encourage the rapid dissemination of information concerning genetic inventions.
1.C Licensing practices should provide an opportunity for licensors and licensees to obtain returns from their investment with respect to genetic inventions.
1.D Licensees and licensors should have reasonable certainty over their rights and the limitations to those rights in relation to genetic inventions.
1.1 License agreements should permit licensees to develop and further improve the licensed genetic inventions.
1.2 License agreements should clearly set out which parties obtain, retain, receive and maintain ownership of, grant rights to and enforce intellectual property rights, including with respect to the improvements and new genetic inventions developed from the licensed technology.
1.3 Licence agreements should clearly set out which of the parties, if any, has the right to engage in collaborative research with third parties and set out the ownership of any intellectual property rights flowing from such collaborative research.
1.4 Confidentiality provisions should be carefully drafted so as to permit the dissemination of information pertaining to genetic inventions while taking into account the need to file patent applications, to protect undisclosed information and to capitalise on the inventions in the marketplace.
1.5 License agreements should not provide the licensor with exclusive control over human genetic information, including collections of such information, derived from individuals through the use of the licensed genetic invention.
1.6 Rights holders should be encouraged to agree to licensing terms and conditions that maximize the utilisation of their genetic inventions.
1.7 License agreements should clearly stipulate the duties, obligations and responsibilities of the parties and address the rights of the parties to use the improvements to the licensed genetic invention following any, including early, termination.
1.8 License agreements should define the roles and responsibilities of the parties in the commercialisation, if any, of the products and services arising from the use of the licensed genetic invention.
2. Healthcare and Genetic Inventions
2.A Licensing practices should seek to strike a balance between the delivery of new products and services, healthcare needs, and economic returns.
2.B Licensing practices should ensure that patients benefit from the highest applicable standards with respect to privacy, safety and good laboratory methods available pursuant to the laws of their jurisdiction or those of the jurisdiction of the service provider using the genetic invention.
2.C Licensing practices should not be used to restrict the choice of other products or services by patients and their healthcare providers.
2.D Licensing practices should encourage appropriate access to and use of genetic inventions to address unmet and urgent health needs in OECD Member countries and non-member economies.
2.1 Rights holders should broadly license genetic inventions for research and investigation purposes.
2.2 Rights holders should license genetic inventions for health applications, including diagnostic testing, on terms and conditions that seek to ensure the widest public access to, and variety of, products and services based on the inventions.
2.3 Licensing practices should permit national or local providers to use genetic inventions in order to provide healthcare services, even if the rights holder is based in another jurisdiction.
2.4 Licensing agreements relating to products and services incorporating personal health information should facilitate compliance by the licensor and the licensee with the highest applicable privacy and other relevant laws.
2.5 License agreements should not restrict access by the licensee's researchers to databases generated from licensed genetic inventions in their efforts to develop new therapies, products or services.
2.6 License agreements should permit licensees, for example healthcare providers, to offer patients flexibility and choice with respect to the selection of the type and nature of healthcare products and services.
3. Research Freedom
3.A Licensing practices should increase rather than decrease access to genetic inventions for research purposes.
3.B Commercial considerations in public research activities should not unduly hinder the academic freedom of researchers.
3.C Commercial considerations in public research activities and, in particular, the need to preserve the opportunity to seek patent protection on inventions arising from these activities, should not unduly limit the ability to publish in a timely manner the results of research.
3.D Commercial considerations in public research activities should not unduly limit the educational training of students.
3.1 License agreements should clearly delineate research areas, information and time frames in which researchers and students cannot publish or present papers or theses without violating confidentiality obligations. Licensors and licensees should inform all relevant individuals, including students, of the scope of confidentiality obligations in a timely fashion.
3.2 Licensors and licensees should educate their researchers with respect to intellectual property law, especially the effects of public disclosure on the patentability of inventions, confidentiality obligations and restrictions commonly contained in agreements.
3.3 Confidentiality provisions should provide that academic research arising pursuant to the license agreement can be freely published or disclosed, with as minimum a delay as possible, subject to the need to protect proprietary information disclosed to the licensee or arising from such research.
3.4 Delays in publications of academic research necessary, for example, for the filing of patent applications, should be limited and reasonable in the circumstances.
3.5 Confidentiality provisions in licensing agreements should be drafted as narrowly as suitable and should not prevent the possibility of reasonable disclosure in exceptional public health situations, in light of the objectives of the parties and the applicable law.
4. Commercial Development
4.A Foundational genetic inventions should be licensed so as to be broadly accessible.
4.B Licensing practices should be used as an effective means to create value for licensors and licensees through the development of new products and services from genetic inventions.
4.C Licensing practices should strive to overcome co-ordination problems resulting from the need to access multiple genetic inventions.
4.1 Should several licenses be required, license agreements should include a mechanism to set a reasonable overall royalty burden for genetic invention products and services, including research tools.
4.2 License agreements should include terms that maintain low barriers for access to genetic inventions. This may mean that such agreements do not include, for example, excessive up-front fees.
4.3 License agreements should avoid reach-through rights so as to foster broad and unencumbered utilisation of the genetic invention and so as to not discourage or stifle subsequent innovations.
4.4 Private and public sector participants should develop mechanisms to decrease transaction costs in acquiring rights to use technology.
4.5 Organisations that may enter into license agreements should educate their decision-makers about the opportunities to use the least restrictive licensing practices, as appropriate, as a means to maximise the benefits from genetic inventions for society, shareholders and other stakeholders.
5.A Licensing practices pertaining to genetic inventions should foster economic growth through innovation and substantive competition, while complying with the applicable competition laws.
5.B Licensing practices should not be used to expand the breadth of exclusive rights beyond the scope of the relevant intellectual property rights.
5.1 License agreements should avoid unduly restrictive tied-selling.
5.2 License agreements should avoid non-compete clauses in areas beyond the scope of licensed genetic invention.
5.3 License agreements relating to foundational genetic inventions should generally be non-exclusive to encourage broad access for researchers and patients and broad use of the genetic invention.