Patents, Not Bush, The Real Impediment to ESCR Advances

Behind the CURES! CURES! CURES! facade of ESCR/SCNT research, is a mighty drive for money and fame. Nothing unusual there, nor in itself, an improper motive. Indeed, patents exist to ensure that innovators benefit from their own work.

This issue is of major consequence in the ESCR debates. ESCR has not exactly blossomed as some expected just a few years ago. President Bush’s federal funding restrictions have served as a convenient excuse for this, but a bigger issue seems to be patent restrictions that inhibit broad and robust experimentation. At least that is the opinion of a stem cell researcher named Jeanne Loring, director of the Center for Regenerative Medicine at The Scripps Research Institute. Loring is legally challenging patents that she believes inhibits the progress of ESCR. She writes in Nature Reports Stem Cells:

At 9 p.m. on 9 August, 2001, US President George W. Bush announced the first opportunity to obtain federal funding for experiments on human embryonic stem cells (ES cells). Because funding was limited to lines already established at that time, Bush’s executive order is perceived to be a constraint on this research. In fact, more restrictive decisions have already been made by another US government agency.

On 1 December, 1998, the US Patent and Trademark Office (USPTO) issued a patent that covers all primate (including human) embryonic stem (ES) cells. This patent, entitled ‘Primate Embryonic Stem Cells’ (Patent 5,843,780), was followed on 13 March, 2001 by a second (Patent 6,200,806) with the same title, but limited to human ES cells. Unlike a scientific publication, which encourages other scientists to reproduce a researcher’s work, a patent has the force of law to exclude others from working with the patented invention or material. In this case, the patents are quite broad. Through a “composition of matter” claim, the patents would cover even human ES cells that were not derived through James Thomson’s method, on whose work the patent is founded.

So what, some might ask. Loring explains:

The effects of a patent on research depend on the motives of the patent holder: the owner of a patent can sell it, mandate the terms under which it is licenced, or simply deny everyone else the chance to use the technology. In this case, the owner of the ES cell patents is the Madison-based Wisconsin Alumni Research Foundation (WARF), a technology-licencing organization associated with the University of Wisconsin, with US$1.6 billion in assets... WARF requires a licence from every academic investigator who uses human ES cells in the US, thus restricting collaboration even within the same institution, and demands large licencing fees and royalty payments from companies that wish to use human ES cells for reagent or drug development.

That expense can stifle research.

[O]nly a few companies have taken licences because they feel that WARF is demanding unreasonable licencing and royalty terms. Geron, because of their investment in Thomson’s research, retains an exclusive licence for therapeutic use of neural, pancreatic and cardiac derivatives of human ES cells.

Loring and others claim that the method of deriving ES cells is “obvious” and therefore not patentable. If they prevail, she believes research will become more robust. But perhaps it will cause a different response. If the lure of lucre fades, if the “patent or perish” paradigm that now drives this research is undermined, fewer scientists may decide to take the risks required to bring cutting edge research into fruition.

Meanwhile, as the embryonic stem cell scientists spend years fighting it out among themselves, that ethical adult and other alternative stem cell methods provide sufficient clinical benefit that the people decide that they can pay greater heed to their ethical qualms about using human life as a mere research medium and exploitable natural resource.