Breakthrough Business Models Drug Development for Rare and Neglected Diseases and Individualized Therapies: Workshop Summary (2009) / Chapter Skim
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6 Strategies for Navigating Intellectual Property
6 Strategies for Navigating Intellectual Property
Pages 55-81
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From page 55... ...
An overview of the strategic alliance and intellectual property strategies of each of these organizations is provided in Box 6-1. OVERVIEW: Creating an Enabling Intellectual Property Environment for RARE AND Neglected Diseases The ownership and sharing of knowledge play an important role in scientific innovation, drug development, and the creation of affordable access to health technologies.
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From page 56... ...
• To identify more efficiently promising drug candidates that address significant unmet medical needs. Lessons Learned for Alliance Partners Coordinating partner (customer)
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From page 57... ...
Structure Two offices report to the Assistant Vice Chancellor for IPIRA, ensuring coordination: • The Office of Technology Licensing in IPIRA engages in "technology push," patenting and copyrighting intellectual property and licensing patent rights and copyrights to the private sector for commercial development. • The Industry Alliances Office in IPIRA is engaged in "technology pull," bringing personnel, materials, and resources back into UC Berkeley from the private sector.
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From page 58... ...
IPIRA employs a full spectrum of intellectual property management strategies, from gifting, where there are no intellectual property considerations, to spon sored research agreements, which are intellectual property–intensive. Different approaches can be applied for different purposes, and a given activity is not undertaken at the expense of another.
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From page 59... ...
The usual push solutions have included National Institutes of Health (NIH) and other research grants, as well as R&D tax credits; panelist Carol Mimura of the University of California at Berkeley illustrated an innovative approach involving "bootstrap philanthropy." Another example is licensing a drug to an entity that can produce it at reduced cost, such as a company in the developing world, rather than to a large private-sector company.
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From page 60... ...
Some universities have institutional policies supporting access for neglected diseases, and some have completed licensing agreements that offer examples of humanitarian access provisions for developing countries. In her presentation, summarized below, Carol Mimura of the University of California at Berkeley gave examples of the university's socially responsible licensing.
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From page 61... ...
Dual-Licensing Markets • Public market -- noncommercial vaccine markets and/or orphan vaccines • Private market -- commercial vaccine markets and/or nonvaccine applications Intellectual Property Approach GVI secured a license from UNC for royalty-free application and use of its vaccine technology in noncommercial or orphan vaccine markets. Concurrently, GVI can apply this technology to commercial vaccine markets or nonvaccine applications, returning licensing revenues to both GVI and the university.
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From page 62... ...
not patenting in Developing Countries, thereby allowing free access to any company to manufacture and market for no royalties; and (b) providing non-exclusive licenses to a number of companies to market these products with minimal royalties to the developers or identify a partner willing to produce the vaccines for the developing world with specific reference to the fact that the licensing party must implement the invention for the benefit of the develop ing world consistent with the Gates Foundation Charitable Objective.
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From page 63... ...
An grayscale alternative approach involving collective action is the use of patent pools to bitmapped fixed image alter the traditional one patentee–one licensee relationship by encouraging a any changes require redraw or editable original many-to-many exchange of intellectual property. So highlighted a program at Duke University that is landscape above working to conceptualize how a technology trust might create an enabling intellectual property environment for rare and scaled for portrait below neglected diseases (see Figure 6-1)
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From page 64... ...
to new benefit-sharing arrangements, and from open access to data to new platforms for supporting collaboration. Now, So said, it is essential to enable collective action by the public sector in concert with private-sector stakeholders, to pool intellectual property and cultivate collective norms, to speed innovation, and to improve the affordability of these health technologies.
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From page 65... ...
The traditional approach of a closed, internalized model of pharmaceutical R&D needs to be updated to a network approach, incorporating strategic alliances, distributed risks, and greater flexibility. In forming strategic research alliances and outsourcing, the most important criteria for success are speed, flexibility, and the right partner.
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From page 66... ...
Perceived risks are associated with alliances and licensing, including concerns about the manageability of complex projects, the internal atrophy of critical skills, the loss of hands-on experience, and the potential to lose intellectual property or be boxed in by the competition. These perceived risks collectively translate into a loss of control.
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From page 67... ...
SOURCE: Sorensen, 2008. The Myelin Repair Foundation: Accelerating Intellectual Property Sharing to Facilitate Translation Prior to establishing the Myelin Repair Foundation (MRF)
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From page 68... ...
MRF shares the relevant intellectual property -- whether materials, knowledge, or patents -- among the team, acting as an agent to pool resources for the benefit of all the participants. Through the contracts with the universities, all intellectual property that is generated through the partnership is available to the nonprofit research community on a nonexclusive, royaltyfree basis.
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Because it is a sponsored research agreement, there are annual research plans with each of the investigators. Each program sponsored by MRF has specific milestones that must be accomplished, and partners are held accountable.
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Moving Forward In the 4 years since MRF began conducting research, 19 novel targets have been identified. Some of these targets are currently undergoing a validation process, and two cellular therapies are slated to enter Phase I investigator-directed clinical trials in late 2008.
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From page 71... ...
In fact, a recent study showed that the 10 campuses within the UC system were responsible for 7 percent of the R&D activity in the state of California. his section is based on the presentation of Carol Mimura, Ph.D., Assistant Vice Chan T cellor for Intellectual Property and Industry Research Alliances, University of California at Berkeley.
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From page 72... ...
The Industry Alliances Office is engaged in "technology pull," bringing personnel, materials, and resources back into UC Berkeley from the private sector. Both offices report to the Assistant Vice Chancellor for IPIRA, ensuring coordination.
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From page 73... ...
Intellectual Property Management Strategies IPIRA employs a full spectrum of intellectual property management strategies (see Figure 6-5A) , from gifting, whereby a donor gives a gift with no contingencies and intellectual property considerations are completely moot, to sponsored research agreements, whereby a company funds a particular project and retains an exclusive license to commercialize the results.
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From page 74... ...
By applying new metrics, the goal of impact can be achieved in many ways. fully editable NOTE: IP = intellectual property; SRA = sponsored research agreement.
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Open-source licensing and patent pooling are also considered impactful end points when the goal of societal benefit is achieved through sharing of the information. The Socially Responsible Licensing Program Another IPIRA management strategy for intellectual property is UC Berkeley's Socially Responsible Licensing Program (SRLP)
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From page 76... ...
VACCINATION Tuberculosis vaccine research agreement stipulating that if a vaccine is invented with company-funded research at UC Berkeley, vaccine distribution will be royalty free in defined countries. NUTRITIONAL Development of a more nutritious and more digestible sorghum in collaboration with Africa Harvest Biotechnology Foundation International, funded by the Gates Foundation.
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From page 77... ...
in the developed world. The Institute for OneWorld Health received the reciprocal license in the developing world and is field-of-use limited to the malaria drug.
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From page 78... ...
Thus researchers who are funded by one foundation cannot use their intellectual property in a project for another foundation. Open Discussion During the open discussion, participants raised additional points regarding who pays the fees for patent applications and maintenance, and what cultural obstacles might be faced in attempting to implement a bold new intellectual property management strategy such as that of UC Berkeley.
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From page 79... ...
A patent application is necessary only if the private-sector partner needs the intellectual property right to exclude others or to justify the magnitude of its investment in the project. Cultural Obstacles In 2001, UC Berkeley convened task forces involving industry, other universities, and internal faculty to review processes for interactions with industry, particularly research contracts.
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From page 80... ...
Additional Examples An example of successful intellectual property management at the national level is the Canadian Stem Cell Program, operated under the auspices of the Canadian Genome Project. According to one participant, the program pooled the intellectual property related to stem cell biology throughout Canada, establishing a central source with which Canadian scientists can negotiate to establish a company and obtain any necessary licenses.
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From page 81... ...
When well-defined intellectual property is necessary to advance research on a given condition, this approach may be one option to consider.
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