Remember the constant outcry against President George W. Bush’s embryonic stem cell research (ESCR) federal funding restrictions? Even though his administration issued more than $600 million in NIH grants for human ESCR, and much more than that for animal studies, Bush was castigated widely for preventing selfless scientists from creating a robust regenerative medical sector that, the critics claimed, possessed virtually unlimited potential to ameliorate suffering and cure disease.
Life isn’t that simple. To be sure, ESCR scientists do want to find efficacious treatments. But ESCR scientists also want to get rich—which is why academics often create start-up biotech companies or partner with industry before publishing their experimental findings. But in order to hit the financial jackpot, researchers and biotech companies need patent protection for the processes and products they develop in the lab. Otherwise, they could invest millions, and years of effort for the research, only to have someone else copy and market the product without risking a plug nickel.
And therein lies a very big rub. Almost from the day human embryonic stem cells were derived, legal fights have erupted over patent rights. Indeed, even as the media railed against Bush for supposedly holding back the ES cell sector, some within the science community quietly acknowledged that patent disputes constitute the real threat to the commercial viability of embryonic stem cell-industry, even if the over-hyped promise of cures ever proves medically efficacious.
The latest front in the ESCR patent wars manifested itself in Europe recently after the European Union’s highest court ruled that embryonic stem cells and products derived from are not patentable under applicable EU law.
There are a couple of interesting twists to this case. First, In the United States, most opposition to the destruction and/or creation of embryos in research comes from the starboard side of the political boat. That isn’t as true in Europe, where greens tend to distrust biotechnology more than do most Americans. Thus, the case in question—which challenged a German biotech company’s legal right to patent progenitor (a form of adult) stem cells, made from ES cells for potential use in treating Parkinson’s disease—wasn’t brought by the Catholic Church or political conservatives. Greenpeace filed the lawsuit. Yes, that Greenpeace.
Second, the court ruling interpreted a European law that forbids nations within the EU from issuing patents that involve “uses of human embryos for industrial or commercial purposes,” as “contrary to ordre public or morality.” The case reached Europe’s high court because the German judges wanted an interpretation defining the human embryo for the purposes of European patent law, and also wanted to know whether the ban on patenting “industrial applications” of products derived from embryo destruction extended to scientific research.
The court ruling constituted a complete victory for opponents of human ESCR and cloning research:
1. The definition of the embryo: Some have redefined the embryo as coming into being only after implantation in the uterus, rather than the proper embryological understanding as beginning upon completion of fertilization. The EU court rejected this view out of hand, ruling, “respect for human dignity” requires the conclusion that “any human ovum, must, as soon as fertilized, be regarded as a ‘human embryo’ . . . since that fertilization is such as to commence the process of development of a human being.”
2. Scientific research qualifies as “industrial or commercial purposes”: Who can deny that one major purpose of ESCR is commercial gain? Any time there is a research breakthrough or setback, the business press immediately focuses on whether stock values of the affected company will be impacted. The court saw the connection and ruled, “the exclusion from patentability concerning the use of human embryos for industrial or commercial purposes also covers the use of human embryos for purposes of scientific research.” The patent law does not regulate research parameters, but it does prevent any cells or other biological material derived from destroying human embryos from being patented.
3. Medical products derived from ESCR also are not patentable: The fact that the ultimate product may not consist of embryonic stem cells doesn’t make these substances any more patentable than an embryo or embryonic stem cell. “Where it concerns a product whose production necessitates the prior destruction of human embryos or a process for [sic] which requires a base material obtained by destruction of human embryos” the patent protection is unavailable under EU law.
Venture capitalists now may be unlikely to put significant money into the development of ES cell-derived products that cannot be protected from copying or imitating. The same goes for human cloning research since the ruling explicitly included somatic cell nuclear transfer (SCNT). The ruling also boosts normal adult stem cell research and induced pluripotent stem cell experiments—in which a skin cell can be reprogrammed into a stem cell—because they and products derived from these sources can be patented in Europe. American companies are not affected directly by the ruling. But they could still be materially impacted if they seek to sell their ESC-derived products in countries where the ruling applies.
The ruling conveys the same implicit moral message President Bush delivered when he restricted federal funding of ESCR: Human embryos are not chopped liver. As nascent human beings, they matter morally. Companies that use human life as a mere corn crop should not be rewarded financially for the act of destroying human life.
Wesley J. Smith is a senior fellow at the Discovery Institute’s Center on Human Exceptionalism, and a special consultant to the Center for Bioethics and Culture.
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