Big Win in Europe for Stem Cell Researchers
(CN) - Biotech companies can patent stem cell-producing eggs as long as they cannot be genetically manipulated into becoming a human embryo, an EU high court adviser held Thursday.
International Stem Cell Corp. applied to the U.K. patent office to protect its technology that produces nonembryonic stem cells from chemically or electronically activated eggs. Patent authorities rejected the applications on grounds that a 2010 European Court of Justice ruling bars patenting any biotechnology that is or could develop into a human embryo.
The company appealed, claiming that a human embryo could never develop because its technology never injects paternal DNA into the eggs. The British high court asked the Luxembourg-based Court of Justice to weigh in on whether unfertilized eggs can be considered embryos once manipulated into activity through ISC's processes, into organisms known as parthenotes.
In his preliminary opinion for the court, Advocate General Cruz Villalon said Thursday the key component of the previous ruling is whether an unfertilized egg has the inherent capacity to develop into an embryo.
With ISC's current technology the organisms that result from the manipulation of the unfertilized egg - nonembryonic tissue - cannot be considered the precursors to human life and can therefore be patented, Villalon said.
The adviser also acknowledged, however, that advances in biotechnology may soon require a different finding.
"The caveat in question concerns the eventuality that a parthenote is manipulated genetically in such a way that it can develop to term and thus into a human being," Villalon wrote. "As such manipulations have already been tried successfully on nonhuman mammalian parthenotes (namely mice), it cannot be excluded categorically that they are also possible, in the future, with respect to human parthenotes, even though these manipulations would often be illegal." [Parentheses in opinion.]
Villalon continued: "Nevertheless, the mere possibility of a posterior genetic manipulation altering the fundamental characteristics of a parthenote does not change the parthenote's character before the manipulation. As I have stated before, a parthenote as such does not, according to current scientific knowledge, have the ability to develop into a human being. Where the parthenote is manipulated in such a way that it actually obtains the respective capacity, it can no longer be considered a parthenote and it cannot be, consequently, patented."
The adviser also noted that nothing in EU law prohibits member states from denying patents for parthenotes on ethical and moral grounds.
Villalon's opinion is not binding on the Court of Justice, which has begun its own deliberations in the case.