Is Friday’s court filing by the Dept. of Justice a Trojan horse? The below article notes that the Council for Responsible Genetics wonders if the government may be “willing to throw some forms of patents under the bus to ensure that a broader range of patents remain supported in law.” The Public Patent Foundation calls it a substantial boon for the biotech industry, which itself condemns the brief. Huh?

Reactions to US Government “Bombshell” against Gene Patents

By Marcy Darnovsky

Biopolitical Times

In an unexpected reversal, the Department of Justice has come out against the US patent office’s practice of granting patents on human genes in the form of isolated DNA.

The government filed a “friend-of-the-court” brief [PDF] late Friday in a lawsuit brought by the American Civil Liberties Union and the Public Patent Foundation that challenges patents held by Myriad Genetics on the BRCA1 and BRCA2 genes associated with breast and ovarian cancer. [The DoJ brief states]:

“The United States has concluded that isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter.

“[T]he unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a ‘human-made invention.’ Nor is the fact that particular natural mutations in that unique chain increase a woman’s chance of contracting breast or ovarian cancer. Indeed, the relationship between a naturally occurring nucleotide sequence and the molecule it expresses in a human cell – that is, the relationship between genotype and phenotype – is simply a law of nature. The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolated’ from its natural environment than are cotton fibers that have been separated from cotton seeds.”

A federal district court issued a strong ruling [PDF] in March agreeing that those patents are invalid, and Myriad promptly appealed.

The government brief echoes the lawsuit’s and district court’s main argument against gene patents – that genes are products of nature, and therefore not patentable. But it differs on how broadly this argument should apply. It says that DNA that has been “isolated” and/or “purified” is not eligible to be patented, but that DNA that has been subject to “human manipulation” is.

Is this a position that the biotech industry can live with? Council for Responsible Genetics president Jeremy Gruber wonders if the government may be “willing to throw some forms of patents under the bus to ensure that a broader range of patents remain supported in law.”

Though the New York Times account of the Department of Justice move appeared on Friday, the weekend and impending elections delayed most reactions until today. Not surprisingly, they diverge. ACLU staff attorney Sandra Park said her organization is “extremely gratified,” and Public Patent Foundation executive director Daniel Ravicher said the government brief “is a substantial boon for society and the biotech industry.”

Among others greeting it as good news for both the public interest and the biotech industry is, of all places, the Science Business blog at Forbes, where the headline reads “The Feds Come Out Against Gene Patents. It’s About Time.”

Reactions from the biotech sector itself, and especially from its patent attorneys, were significantly less enthusiastic. As a Nature blog explains, the government brief is “certain to make queasy biotechnology executives reach for their Pepto Bismol.”

The Biotechnology Industry Organization, which has filed a court brief in support of Myriad, has not yet posted a press statement on its website. But the blog IPWatchdog appears to have received one, and quotes it:

“If adopted, the Department of Justice’s position would undermine U.S. global leadership and investment in the life sciences, harm U.S. economic growth and competitiveness at home and abroad, and be counterproductive to the Administration’s own initiatives to fight cancer, develop renewable sources of energy, and clean the environment by reducing dependence on fossil fuels such as petroleum.”

IPWatchdog’s own reaction is, to the say the least, less restrained. Patent lawyer Gene Quinn titles his post “Department of Justice Seeks to Cripple Biotech Industry and Fundamentally Change Patent Laws” and writes it as an anti-Obama and anti-government screed.

And over at PatentDocs, patent attorney Kevin Noonan indulges in a fit of name-calling. He begins by asserting that the government lawyers who wrote the brief have “little evident background in science, technology, or patent law,” and continues in that vein with gems including: “Insofar as it exhibits reasoning, the brief…” and “Besides their own prejudices, the brief writers do not explain why, nor do they explain (if they are even aware)….”

What supporters and opponents of the gene patent challenge agree is that the government intervention is a big deal. In the words of FierceBiotech, a blog that describes itself as the “biotech industry’s daily monitor,” its assertion that unmodified DNA should not be patentable “dropped a bombshell on the biotech industry.”

The battle lines are drawn; the fight is on. And now one of the very big guns seems to be aiming in a new direction.

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Mike Adams at Natural News celebrates the DoJ filing, concluding that “Human gene patents may be halted in USA (could end corporate monopoly)” which he sees as “gene patent enslavement of the human race.”