Human Genes Can Be Patented

[J.A. Terranson]

IP run amok comes full circle...


//Alif

-- 
I hate Missouri.  Land of the free, home of the perjuriously deranged.

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http://www.medpagetoday.com/Genetics/GeneticTesting/27811

Court Greenlights Cancer Gene Patent
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: July 29, 2011

WASHINGTON -- An appeals court here has ruled that a company that makes 
tests for breast and ovarian cancer can patent breast cancer gene 
sequences, in effect ruling that human genes can be patented.

The U.S. Court of Appeals for the Federal Circuit -- a court that 
specializes in patent cases -- ruled that when a gene is isolated from the 
human body, it is "markedly different" and has a "distinctive chemical 
identify and nature" compared with the way it is found in nature.

Friday's 2-1 decision overturns parts of earlier decisions by a U.S. 
District Court judge in New York City who ruled that patents on the BRCA 1 
and 2 gene sequences -- and by extension all other human genes -- are 
invalid.

The company that holds the patents, Utah-based Myriad Genetics, sells 
tests that assess a woman's risk of developing breast or ovarian cancer 
based on detection of mutations in the BRCA1 and BRCA2 genes. Other 
companies, researchers, or doctors that test for the mutation would be 
violating Myriad's patent. Companies can still do whole-genome sequencing 
without violating the patent.

The American Civil Liberties Union (ACLU) and the Public Patent 
Foundation, along with a group of doctors, genetic scientists, and 
patients, first challenged Myriad's patents in 2009, arguing that 
isolating DNA from the body does not create something new and that things 
that exist in nature cannot be patented.

During oral arguments and in documents, lawyers for the ACLU likened what 
Myriad is doing to removing a person's kidney and trying to patent it.

Lawyers for Myriad, meanwhile, said it's more like making a baseball bat 
from a tree. Yes, the tree exists in nature, but the bat is an entirely 
new thing, with an entirely new use, that is made from nature.

The company argued that isolating the BRCA1/2 genes from the entire human 
genome is actually creating something new because isolated DNA isn't found 
in nature. Plus, the company is creating something with a new utility that 
goes beyond the DNA merely sitting, unseen, in the body, it argued.

The Obama Administration split with the U.S. Patent and Trademark Office 
(which originally granted Myriad its patent protection) and filed a 
friend-of-the-court brief siding with the ACLU, agreeing that "the mere 
act of isolating something" that already exists in nature is not enough to 
warrant patent protection.

The court sided with Myriad, writing that the company's patents cover 
molecules that are markedly different and have a "distinctive chemical 
identify and nature" from molecules that exist in nature. Isolated DNA has 
been cleaved to make it just a fraction of a naturally occurring DNA 
molecule.

"Thus, when cleaved, an isolated DNA molecule is not a purified form of a 
natural material, but a distinct chemical entity," wrote Judge Alan Lourie 
in the court's opinion.

The court did rule that one plaintiff, Harry Ostrer, MD, has standing to 
challenge Myriad's claims. Ostrer, director of the Human Genetics Program 
at New York University School of Medicine, in New York City, has said 
unequivocally he wants to immediately start BRCA testing, but cannot do so 
because Myriad holds the patents.

The court ruled that two other physicians do not have standing because 
they have only asserted that, hypothetically, they'd like to start BRCA 
testing.

"Simply disagreeing with the existence of a patent or even suffering an 
attenuated, non-proximate, effect from the existence of a patent does not 
meet the Supreme Court's requirement for an adverse legal controversy of 
sufficient immediacy and reality to warrant the issuance of a declaratory 
judgment," wrote Judge Alan Lourie.

Judge William Bryson, dissented, and said that "extracting a gene is akin 
to snapping a leaf from a tree."

The case may eventually make its way to the U.S. Supreme Court.