Defending Stem Cells

It’s been 10 years since the discovery of human embryonic stem cells by researchers at the University of Wisconsin–Madison, and despite the efforts of scientists, no FDA-approved stem cell-based therapies have yet emerged to treat diseases such as diabetes and cancer. But stem-cell discoveries are enhancing human health. Adult and embryonic stem cells are increasingly used to test experimental drugs, often as alternatives to using animals as subjects. Pharmaceutical companies, regularly use heart stem cells to test new drugs for toxicity to the cardiovascular system.

Those growing applications have made the protection of stem cell patents at all stages of the cells’ life cycle—from discovery to commercial use—vital, says Mark Ellinger, managing principal of Fish & Richardson in Minneapolis and an expert in patent law. Ellinger, who was a tenured professor in cell and molecular biology at Southern Illinois University before getting his law degree at Harvard, says recent court cases, as well as rulings from the U.S. Patent and Trademark Office, have altered the playing field for obtaining and protecting stem cell patents.

Patents Under Pressure

Intellectual property issues weigh heavily in attracting private sector investment in stem cells, Ellinger says. Patents are among the most important assets organizations like the University of Minnesota or the Mayo Clinic have for luring venture capitalists seeking to create commercial enterprises from research breakthroughs. Biomedical com-panies such as BioE, a St. Paul–based organization that provides umbilical-cord-blood stem cell products, painstakingly pursue patents for their tools and technologies, knowing how vital they are to attracting investment and building future revenues.

Investors want to know patents have been acquired, or where they stand in the lengthy patent application process, before committing dollars to what are still, in many cases, high-risk investments. In particular, therapies that are designed to repair or regenerate damaged cells in spinal cord injuries, Parkinson’s disease, and other intractable medical problems, are still in the experimental phase. They are both highly attractive and highly risky investments.

“Patent applications themselves are heavily scrutinized by the investment community, since in the biotech industry it can take years and years to get a patent approved by the patent office,” Ellinger says.