A Brewing Dilemma
Optimism is the systematic tendency for people to be overly confident about the outcome of a potential event(s) but, have we forgotten the … what else(s).
Clinical trial initiations, patient enrollment, site selections, dosing levels, dilutionary effects, management’s capacity, clinical approvals and the utilization of cash to fund on-going trials, clinical results are always bandied about…
But, does this includes under-estimating the likelihood of other events. In stem cell investing: the hype usually is offset by reality. A determination of expectation should be measured against potential risks that (usually) can/could occur in this current market environment or the future. But who and what sets the bar or definition?
- It is usually the FDA and the NIH or might it be the … US PTO patent process!
Risk assessment must be derived from an objective evaluation in which ALL uncertainties are considered. Part of the difficulty of risk versus reward analysis of the stem cell universe is that measurement of all factors: potential, reality and probability of the unexpected. The chance of being right … concerning stock appreciation … is always … low but – what else is new. In theory, both are of nearly equal priority when faced with the what else(s) in which to extend viability and sustainability process focused by the regulatory environment.
A brewing dilemma could also be … very … focused to the US patent (PTO) process, filings and approvals. Specifically, referencing our posts re:
- Advanced Cell Technology (ACT or ACTC.OB) announced its being positioned to obtain significant patents relating to cellular reprogramming and the (“next”) generations of induced pluripotent stem (iPS) cells on 8/17/10 entitled “iPS Cell Patents”.
Although human iPS cells were first produced in 2007, ACTC.OB has been working on inducing pluripotency, with positive results, for more than a decade back to the 1990s, providing (through existing patent filings and continuations) some of the earliest priority dates in the field.
- ACTC.OB has filed multiple patent applications to cover reagents and processes related to induced pluripotency, as well as the resulting cell compositions,
- In 2006, Yamanaka and colleagues reported a new and less controversial method of reprogramming somatic cells to pluripotency using viral expression of transcription factors (Oct4, Sox2, Klf4, and c-Myc),
- Subsequent studies confirmed that human cells could also be reprogrammed to the pluripotent state using similar reprogramming factors,
- Unfortunately, these cells are unsuitable for human clinical use since the use of genome-integrating viruses could cause mutagenesis and unpredictable genetic dysfunction,
- “Importantly, ACT does not want to impede the development of iPS cell research by others in this field, and prefer(s) to work cooperatively to stimulate innovation and to help to drive the realization of iPS cell technology for new therapies” said William M. Caldwell IV, ACT’s Chairman and CEO,
- Interesting statement, could there be a PTO war brewing?
Recently, Cytori Therapeutics (CYTX) experienced a patent challenge that was rejected by the PTO with their ‘484 patent being validated. An “anonymous group” put the patent into re-exam; a potential competitor (no doubt). But it was summarily rejected with the best of all potential outcomes which reaffirmed CYTX’s leadership position with respect to the IP validating their longstanding belief that because they have been in this field for the longest, they continuously need to aggressively filing patents.
Given past rulings by the US PTO, future stem cell patent applications might be narrower, claiming physical but not functional (such as cell potency) characteristics. The scope of a specific stem cell patent could arguably be described by claiming unique cell surface markers, gene expression patterns or other molecular and genetic characteristics that distinguish them from lines described in the public domain.
- If the makeup of these iPS lines; whether reprogrammed directly by genes or by exogenous factors revealed through future experiments— is indeed non-obvious and useful, it nevertheless remains to be seen whether patents on iPS cells will become a central piece of stem cell IP,
- However, with the rejection of the ‘854 continuation and the decisions to uphold ‘780, ‘806 and ‘913, the iPS discoveries represented the first pluripotent cell inventions described outside the foundational hES cell patents,
- These cells will be important for deriving disease-specific lines for basic research and drug discovery.
As the debate over iPS and hES cell research continues, new questions may emerge over prior art and over which claims take priority. These questions may usher in a new battle over discoveries using direct reprogramming born from the crucible of the ES cell controversy. (USPTO)
A strong portfolio begets the competitive advantage. Expect more challenges …!
