Within each of three policy domains (data sharing, materials sharing and intellectual property rights), current conditions present serious problems for the pace of innovation, the distribution of resulting health benefits and the public accountability of stem cell research.

1. Data Sharing & Materials Sharing*

a.       The literature suggests that data and materials withholding is increasingly common and problematic

i.      Deterioration in research sharing is well-documented and will not self-correct.  e.g., Literature from 1990 forward show increasing levels of requests for data and materials not being honored; concerns about restrictions related to MTA’s; increasing lag times between presentations at conferences and publication for nonpatented work, suggesting important scientific data are maintained in secret (Taylor, 2007)

ii.      A survey of Canadian stem cell scientists found that 59% of respondents had been denied a request for research materials (Caulfield, et al., 2008)

b.      Accelerating pace of hESC and iPS research has created an urgent need for the development of cell line registries and information repositories to assist researchers by providing extensive information on hESCs

i.      Challenges for data registries

1.       Standardizing characterization tests

2.       Need to identify venues for sharing detailed methodology (not typically in journals)

3.       Securing commitments both to initial data collection and subsequent maintenance

4.       Registry standards need to be clear, concise and enforceable, based on experiences in other areas of science, e.g., from the implementation of the Minimal Information About a Microarray Experiment. “Nebulous standards and guidelines lead to alternative interpretations and non-uniform, inconsistent reporting” (Burgoon, et al., 2006)

c.       MTAs between universities have proliferated – raising concerns about the potential for restrictions in these documents, including reach-through rights and publication restrictions (Walsh et al., 2005)

2. IP rights

a.       Emergence of a patent thicket. The characteristics of the stem cell patent landscape are consistent with conditions that could give rise to a patent thicket.  Navigating and negotiating the freedom to operate within the field is likely to become increasingly difficult. (Bergman & Graff, 2007)

i.      Rapid growth in numbers of patents

ii.      Dispersal among many owners

iii.      Complex, interrelated technologies

b.      Broad patents, such as those held by WARF, might stifle innovation

i.      Control over current IP and materials by a few patent holders can lead to obstacles for scientific progress (Taylor, 2007)

ii.      The evolution/liberalization of WARF’s licensing practices shows that it is not the patents themselves, but the contracts through which patent rights are imposed that impede the advance of science. If replicated elsewhere, restrictive practices could balkanize research, causing experimental design and collaboration to be driven by legal rather than scientific choices. (Murray, 2007)

iii.      While patents can encourage innovation – they may limit further improvements and divert efforts by other researchers if the patented innovations are not available on reasonable terms (Taymor et al., 2006).

iv.      A survey of Canadian stem cell scientists found that while a significant portion of the community expressed concern about the impact of patents, there was also minimal evidence of problems associated with patenting and commercialization of research—few reported specific adverse effects  (Caulfield et al., 2008)

c.       Patenting negatively impacts collaboration patterns in published research (Bubela et al., 2010)

d.      The patent landscape is fluid; increasing funding will likely change the landscape as new technologies create new patent clusters (e.g., iPSCs) (Konski & Spielthenner, 2009)

e.      Interventions may be necessary to prevent patent policies from exacerbating existing global inequities.  Resource limited countries are less likely to offer competitive innovation infrastructure to support their scientists’ efforts.

1.       Appropriate solutions to international patent barriers are essential for the development of affordable stem cell therapies (Kiatpongsan, 2006)

2.       In a global scientific community, equalizing access by scientists across different patent systems is a community imperative – avoiding a lopsided system in which those who do not provide such patent protection are exploited by free riders within more IP-oriented systems. (and this is reflected in the ISSCR guidelines on sharing materials and reagents) (Taylor, 2007)

3.       As an outsider, exacerbating inequality seems highly likely, and would be mitigated in only a few ways

a.       Leapfrog R&D investment by China, India, Brazil, S Korea, Singapore, etc.

b.      Deliberate cultivation of resource-poor applications a la Gates, via research push or demand pull mechanisms

c.       Stem cell Rx turns out cheaper than expected (this seems particularly unlikely, but who knows?)

d.      Turns out cell Rx is best route to a particular condition faced predominantly in resource-poor regions, and we find a way to pay for it

3. Ethical/Regulatory standards

a.       Regulatory standards and ethics requirements give powerful advantages to those who control approved or sanctioned technologies

b.      Internationally, the patent landscape is complex and varied (this, in addition to the already complex and varied policy responses to stem cell research)

i.      Europe’s hESC patent landscape exists in a fractured and conflicting legal environment–A legal maze (Plomer et al., 2008)

1.       Particular uncertainty over the scope of the limitations attributable to ‘ordre public’ (prohibitions on patenting out of concern for the public order; also known as morality clauses) and the specific proscription of human embryo patents in Europe

2.       Residual uncertainty about patents in Euro region: (1) national patent offices and courts; (2) EPO versus EU/EC differences and European Parliament; and (3) truly European patents and prospect of a trans-Euro patent court

ii.      US patent landscape challenges

1.       hESC research was privately, not publicly funded, and based on companies funding academic research centers

a.       Not subject to Bayh-Dole

b.      Source of funding created company rights in resulting inventions, including access to patent rights and expectation of return on investment

2.       In the US, IP and funding policy choices have led to a concentration of research on a limited number of lines (Scott, et al., 2009)

3.       Patents and licenses in the US virtually prohibit commercially sponsored research that could otherwise be a realistic alternative to the US federal funding gap (Taylor, 2007)

4.       Restriction of public monies in some jurisdictions makes the impact of patent monopolies on the ability of researchers to access materials more pressing (Caulfield, 2003)

c.       Regulatory challenges

i.      Past and present US stem cell policies (despite the Obama administration’s court-challenged broadening of federal hESC research funding) have resulted in a policy vacuum, and a lack of enforceable oversight and data-sharing principles (Taylor 2005)

ii.      Inconsistently applied US federal policies and changing ethical frameworks across administrations increase uncertainty in the field, produced scientific inertia, and may effect international access to lines and materials  (Scott, McCormick, DeRouen, Owen-Smith, Nature Methods 2010)

iii.      State policies and IP strategies produce effects in demand and use of essential stem cell research tools (Scott, McCormick, Owen-Smith, Cell Stem Cell 2008)

* Please note: while many of the challenges raised by data and materials sharing practices apply to both domains, it may be possible to address the challenges separately.

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