patenting of gene sequences…

Chris Holman blogs on patent protection of gene sequences…

“…[The EU] ruling could have a substantial impact on biotechnology. Obviously, it provides an opening for growers to circumvent gene patents used to protect genetically modified crops by growing the crops in a country where the gene is not patented, such as Argentina in this case, or in a jurisdiction with weak patent enforcement, and then importing the product into a European Union member wherein the patent is in force with impunity…I personally do not think gene patents will substantially impede whole genome sequencing, in the US or elsewhere. But if I am wrong, and patents on genes pose a substantial impediment to whole genome sequencing in the US, the patents could be circumvented by exporting the process to a place like Europe. The EU court decision could substantially reduce the likelihood that whole genome sequencing in Europe will result in liability for patent infringement.”

Excerpt from the Holman blog:

Monsanto v. Cefetra: EU Court of Justice Limits Scope of Patent
Protection Available to Gene Sequences

Chris Holman

Friday, July 9, 2010

A couple of years ago I posted an article (available at:… discussing the case of Monsanto v. Cefetra. Essentially, in that case a European court held that Monsanto patents claiming the gene responsible for its Roundup Ready trait were not infringed by the importation of soy meal containing the gene, because the grinding of the soybeans to make the meal rendered the DNA incapable of expressing the encoded protein, and thus unprotectable pursuant to the 1998 European Union Directive on biotechnology.

On Tuesday, July 6, that decision was affirmed by the Court of Justice of the European Union. This is the highest judicial body of the European Union, so there will be no further appeals, and this would appear to be the final word on the subject. The decision was reported in an article posted on IPKat, a respected European IP blog, available at I am no expert on European law, but here are a few thoughts on the significance of this case.

First, my interpretation of the decision.

In a nutshell, the Court of Justice held that although the so-called Biotech Directive, promulgated by the European Union in 1998, permits the patenting of naturally occurring DNA sequences, the scope of patent protection only extends to products incorporating the DNA if the DNA is capable of performing “the function for which it was patented.” Applying this criterion to the facts of the case, the Court held that the patentable function of the gene at issue was to confer glyphosate (i.e., RoundUp) resistance upon a plant, and that since the soy meal is dead and thus incapable of expressing this function, the DNA residing in the soy meal is ineligible for patent protection.

The Court went on to hold that the Biotech Directive supersedes national law, and precludes individual European nations from enacting legislation that would permit patenting of DNA sequence per se. It also held that the prohibition against patenting DNA sequences per se applies retroactively to patents predating the EU’s adoption of Directive in 1998. In short, this unappealable ruling appears to be binding upon all 27 European Union Member States, and all DNA patents, no matter when they were issued.

See full article on Holman’s blog at:…

Is the patenting of human genes wrong? (follow up to the ‘Sweet’ judicial decision on the Myriad patents)

A case against Gene Patents
J. Stiglitz and J. Sulston
April 16, 2010
The Wall Street Journal


“Genetic sequences are naturally occurring things, not inventions. No company should be allowed to monopolize research on them.”

“Patents such as those in this case not only prevent the use of knowledge in ways that would most benefit society, they may even impede scientific progress…”

Stiglitz suggests that a ‘portfolio’ of incentives/disincentives may be the best we can do. But once this portfolio includes patents, pharma can readily use this market power to distort the portfolio choice in its favor. According to Mark Thoma’s take on the Stiglitz and Sulston article, the portfolio approach requires “countervailing power”, power that appears to be sadly lacking. Thoma remains skeptical: “Unchecked, the portfolio approach would likely end up looking much like the system we already have, so it’s not clear to me that this is the answer.”…:+EconomistsView+(Economist’s+View+(EconomistsView))&utm_content=Google+International

What do you think?

Image: Close-up for the “Segmented” Invisible College – BRCA1 & BRCA2 Gene Researchers. Highlighted square nodes are the inventors on at least one BRCA1 or BRCA2 patent assigned to Myriad Genetics…