Judge Invalidates Human Gene Patent

[Guest guest]

http://www.nytimes.com/2010/03/30/business/30gene.html?hpw

A federal judge on Monday struck down patents on two genes linked to breast and

ovarian cancer. The decision, if upheld, could throw into doubt the patents

covering thousands of human genes and reshape the law of intellectual property

United States District Court Judge W. Sweet issued the 152-page decision,

which invalidated seven patents related to the genes BRCA1 and BRCA2, whose

mutations have been associated with cancer.

The American Civil Liberties Union and the Public Patent Foundation at the

N. Cardozo School of Law in New York joined with individual patients

and medical organizations to challenge the patents last May: they argued that

genes, products of nature, fall outside of the realm of things that can be

patented. The patents, they argued, stifle research and innovation and limit

testing options.

Myriad Genetics, the company that holds the patents with the University of Utah

Research Foundation, asked the court to dismiss the case, claiming that the work

of isolating the DNA from the body transforms it and makes it patentable. Such

patents, it said, have been granted for decades; the Supreme Court upheld

patents on living organisms in 1980. In fact, many in the patent field had

predicted the courts would throw out the suit.

Judge Sweet, however, ruled that the patents were ¡§improperly granted¡¨ because

they involved a ¡§law of nature.¡¨ He said that many critics of gene patents

considered the idea that isolating a gene made it patentable ¡§a ¡¥lawyer¡¦s

trick¡¦ that circumvents the prohibition on the direct patenting of the DNA in

our bodies but which, in practice, reaches the same result.¡¨

The case could have far-reaching implications. About 20 percent of human genes

have been patented, and multibillion-dollar industries have been built atop the

intellectual property rights that the patents grant.

¡§If a decision like this were upheld, it would have a pretty significant impact

on the future of medicine,¡¨ said Chahine, a visiting law professor at

the University of Utah who filed an amicus brief on the side of Myriad. He said

that medicine was becoming more personalized, with genetic tests used not only

to diagnose diseases but to determine which medicine was best for which patient.

Mr. Chahine, who once ran a biotechnology company, said the decision could also

make it harder for young companies to raise money from investors. ¡§The industry

is going to have to get more creative about how to retain exclusivity and

attract capital in the face of potentially weaker patent protection,¡¨ he said.

Reines, a patent lawyer who represents biotechnology firms but was not

involved in the case, said loss of patent protection could diminish the

incentives for genetic research.

¡§The genetic tools to solve the major health problems of our time have not been

found yet,¡¨ said Mr. Reines, who is with the Silicon Valley office of the firm

Weil, Gotshal & Manges. ¡§These are the discoveries we want to motivate by

providing incentives to all the researchers out there.¡¨

The lawsuit also challenged the patents on First Amendment grounds, but Judge

Sweet ruled that because the issues in the case could be decided within patent

law, the constitutional question need not be decided.

The decision is likely to be appealed. Representatives of Myriad did not return

calls seeking comment. But this month, the company¡¦s chief executive,

Meldrum, told investors that ¡§regardless of the outcome of this particular

lawsuit, it will not have a material adverse effect on the company,¡¨ or its

future revenues, according to the Pharmacogenomics Reporter, ¡§or on the future

revenues of our products.¡¨

Myriad sells a test costing more than $3,000 that looks for mutations in the two

genes to determine if a woman is at a high risk of getting breast cancer and

ovarian cancer. Plaintiffs in the case had said Myriad¡¦s monopoly on the test,

conferred by the gene patents, kept prices high and prevented women from getting

a confirmatory test from another laboratory.

Janice Oh, a spokeswoman for the United States attorney¡¦s office in Manhattan,

which represented the Patent and Trademark Office in the case, had no comment.

One of the individual plaintiffs in the suit, Genae Girard, who has breast

cancer and has been tested for ovarian cancer, applauded the decision as ¡§a big

turning point for all women in the country that may have breast cancer that runs

in their family.¡¨ Hansen, an A.C.L.U. staff lawyer, said: ¡§The human

genome, like the structure of blood, air or water, was discovered, not created.

There is an endless amount of information on genes that begs for further

discovery, and gene patents put up unacceptable barriers to the free exchange of

ideas.¡¨

, a prominent Silicon Valley venture capitalist, said the decision

could push more work aimed at discovering genes and diagnostic tests to

universities. ¡§The government is going to become the funder for content

discovery because it¡¦s going to be very hard to justify it outside of

academia.¡¨

Ball, executive vice president of the American Society for Clinical

Pathology, one of the plaintiffs in the case, called the decision ¡§a big

deal.¡¨

¡§It¡¦s good for patients and patient care, it¡¦s good for science and

scientists,¡¨ he said. ¡§It really opens up things.¡¨