Stem Cell companies survive or fail depending on their clinical trial advancement but, face IP risks far greater than in most other industries.
IP is not a balance sheet item other than the costs of filings and maintenance. Each day of the R&D period is another day closer to the patent expiration date, making protecting the IP extremely important.
- Discovery processes need to be secured as regulators worldwide are strictly scrutinizing IP;
- As pharmaceutical companies seek to replenish their pipelines after years of products going off-patent or failing in late-stage trials; stem cell companies seeking potential partners make IP stakes higher than ever;
- But, scientists find themselves blocked because universities or companies have already secured exclusive rights;
The rush for patents is choking US stem cell research. Scientists are busily filing for legal patents that give them exclusive IP rights for each discovery hoping for greater funding. However, stem cell experts have expressed concern that the race to secure patents for stem cell discoveries is hindering the development of the cells as treatments for various diseases.
- ”We are at a point in stem cell science where it is important that the community start to think about how intellectual property is being taken, how it is being protected and how data and material sharing are all impacting the science and the translation of science into treatments and valuable products,” one expert said.(K Sheridan)
The Bottom Line: The result has been an explosion of USPTO patent filings. In the EU, scientists cannot file patents on human embryonic stem cells because of a 2008 ruling which said it would go against the public order. Some experts believe the USPTO issues of legal rights will just make it easier for other countries to take the lead. Countries like Israel, China, (South) Korea, Singapore where stem cell science could leapfrog over European and North American science.