While many areas of the life sciences face challenges for research and innovation due to their policies and practices governing ownership and sharing of data, materials and intellectual property, stem cell science is particularly beset with these issues for a number of reasons:
- a. Significant moral disagreement
- i. The human embryo and its destruction
- ii. High public and political profile of this area of research
- iii. Differences in ethical norms among nations, states, regions, and subgroups within jurisdictions
- iv. Litigiousness of factions concerned about cell-based research
- v. Global welfare and resource inequities and justice
- vi. Cell/tissue donors (esp. for iPSCs) and implications for justice
- vii. The rise of medical tourism, medical fraud, and calculations of benefit and risk
- viii. Launch of the first embryonic stem cell trial
- ix. International increase of stem cell clinical trials
- b. Great potential: This is possibly a game changing technology
- i. SC research has potential to dramatically advance both basic and translational research
- ii. Cell-based interventions have potential both in therapies that can be applied generally and those that are individually tailored
- iii. Platform technology – SC research provides a set of tools for scientists from different disciplines to do a wide variety of different types of work. The sharing of tools has a different history (Is it clear that we should share tools and license/patent applications?). IP can spur innovation towards better research tools, but this IP can also lead to downstream technological bottlenecks
- c. Data and materials circulation is essential for scientific progress in the stem cell field, especially with respect to cell lines and affiliated data, including characterization data, culture conditions and methods
- i. Data sharing – there are proposed (not universally adopted) standards for what info should come with ESC lines (no proposed standards yet for iPSCs)
- ii. Complicated by labs’ varying capacities to derive and distribute cells, etc.
- iii. Typical experiments utilize ‘propertized’ materials—ranging from genetic modification vectors to specialty growth factors and feeder cells.
- d. Patent thicket: Tree-like shape of cell differentiation (see figure) lends itself to blocking positions. Characteristics of the SC 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 be increasingly difficult (Bergman & Graff, 2007)
- e. Regulatory environment
- i. Patchwork of regulations, internationally and regionally. With stem cells, the complex environment includes variations in patent policy, stem cell research oversight, funding, and federal approval of treatments.
- ii. Even at level of regulation products and services (e.g., FDA and foreign equivalents), regulation of research that entails putting cells in bodies in ways that may be seen as a drug, a device, a biologic, or a procedure. Embryonic stem cell research will confront uncertainty about the pathways in the face of intense public controversy and litigiousness.
- iii. Governments at different scales have explicitly invested in stem cell research for purposes of economic growth and international competitiveness, problematizing the notion of science as a global public good
- iv. Some jurisdictions explicitly restrict stem cell research either by funding, legislation, policy, or barriers to collaboration.
Proprietary Challenges in Stem Cell Research 