Patents, opportunities, and challenges: legal and intellectual property issues associated with stem cells

Making stem cell products available to customers, whether for transplantation as therapy to patients or as specific derivatives of stem cells to pharmaceutical companies for drug testing and discovery, usually requires that there is some opportunity for the manufacturer to commercialize the product and make a profit. If there is no opportunity for profit, it is unlikely that the product will be made. Stem cells clearly have many different potential applications that could be commercialized. In fact some already are. These range from offering a unique service to a customer (e.g., producing a variety of “cell-based screening platforms” for neural, cardiac, liver, vascular, blood cells etc. for drug toxicity testing by a pharmaceutical company) to a stem cell-based “drug” that is sold as a therapeutic product (e.g., vials of cells to be used for treating a particular disease). Despite the large research and development investments already made by large and small biotechnology companies to generate stem cell products, the risks of this particular market are still very high. There are no guarantees that the products will meet regulatory requirements, be marketable, or have customers by the time they can be sold. Very many stem cell companies filed for bankruptcy or stopped producing stem cell products once the initial hype at the beginning of this century on their potential in regenerative medicine declined.