One obstacle to forming any patent pool will always be finding incentives for the critical patent holders to provide their patents to the patent pool instead of going it alone.
The biggest incentive for the holders of essential patents, especially blocking ones, to join with other essential patent holders will occur once consensus-setting bodies like ACMG greatly expand the diseases for which they make recommendations and set standards.
If a well-established and respected entity such as ACMG deems it important enough to issue a consensus statement regarding a handful of mutations necessary to adequately predict a disease or condition, then the relevant patent holders will recognize how crucial it is that all of these mutations be tested simultaneously, and offer assistance by agreeing to participate in a patent pool.
Going at it alone will become the disfavored mode of doing business. Other incentives include a fair distribution of income generated from the pool and the ability for members to operate freely among the pooled patents.
Several commentators have raised potential problems with forming patent pools, particularly in the broad field of genomics. They have suggested that the genomics industry is too disperse, does not have common goals, advances too quickly making it difficult to identify the essential patents for a patent pool, and if there are a large number of required patentees, the pool may run afoul of antitrust laws.
While application of a patent pool to all of genomics would be difficult, if not impossible, if a patent pool is limited to diagnostic genetics for a given disease, it could circumvent several, if not all, of these potential problems.
First, the diagnostic genetics industry is not as diverse as the overall genomics industry. The genomics industry works with and patents at least three kinds of genes, i.e., those encoding therapeutic proteins, sequences with diagnostic information, or receptors useful in high throughput screening for drug discovery.
In contrast, the field of diagnostic genetics is commercially more focused and, when further limited to individual diseases such as breast cancer or CF, and to diseases that have a consensus statement on standard mutations, is ideal for a patent pool.
Unlike the varied genomics industry, the players in the market for disease-specific diagnostic geneticsregardless of whether or not they are a commercial enterprise or a nonprofit entityhave a clear common goal: to provide accurate tests and analytic devices so as to minimize false negative or false positive results for a given disease.
Furthermore, achieving a resolution of the alleged difficulty of identifying essential patents and the large number of predicted patentees that would be part of the pool would be aided by the presence of an expert committee and the selection of only essential patents, respectively.
We suggest that a patent pool created specifically with essential patents narrowly covering only the genetic diagnosis of a single polymutational disease and crafted with care so as to avoid anticompetitive effects, may well resolve potential roadblocks to the widespread use of the new genetic testing technologies.
As a result, the financial and social value of patent pools should become apparent to the diagnostic industry as their genetic testing technologies are made more broadly available.