Court OKs Patent Of Breast Cancer Genes

A U.S. federal appeals court has affirmed the right of Myriad Genetics to patent two human genes that form the basis of a widely used genetic test for breast and ovarian cancers.

The ruling on Friday from a U.S. federal appeals court in New York reverses a lower court decision and backs the company's right to patent two "isolated" human genes -- BRCA1 and BRCA2 -- that account for most inherited forms of breast and ovarian cancers.

Women who test positive using Myriad's gene test, called BRACAnalysis, have an 82 percent higher risk of breast cancer and a 44 percent higher risk of ovarian cancer in their lifetimes.

Some groups have protested that patenting human DNA is immoral and unethical. But attorneys representing biotechnology companies expressed relief, saying the lower court's decision, if left standing, could have been potentially devastating to the industry.

The lawsuit filed by the American Civil Liberties Union against Myriad had sought to have gene patents revoked.

But the appeals court said the genes isolated by the company can be patented because Myriad is testing for distinctive chemical forms of the genes, and not as they appear naturally in the body.

The court also affirmed patents for the company's screening process, which is based on changes in cell growth rates, but said Myriad did not have the right to patent its method of analyzing these genes, which is based largely on abstract, mental processes.

The decision covers two "isolated" human genes -- BRCA1 and BRCA2 -- and certain genetic changes or mutations in these genes that increase the risk of breast and ovarian cancers.

"The appeals court has now held that isolated DNA is patent eligible, and it recognized that isolated DNA has a different molecular structure than DNA as it exists in the body. That is a very significant result that is very important to the biotech industry," said Bruce Wexler, a partner in the law firm Paul Hastings which was not involved in the lawsuit but represents biotech clients.

Wexler said it is not clear whether the ACLU will appeal the decision to the U.S. Supreme Court, but at the moment, he said, "It's the law of the land in patents."

Copyright 2011 Thomson Reuters. Click for Restrictions.

Comments

[OverseasVet]

07:59 AM on 08/01/2011

Since everyone carries BRCA1 and BRCA2 genes or "certain genetic changes or mutations in these genes" does that mean we all pay a royalty to use our own bodies? This ruling can have a devestating effect on scientific research and diagnostics for breast cancer. This is bad news for science and for women.

[yahooserious]

08:52 PM on 07/31/2011

This makes no sense ..... other than some corporation is trying to keep all breast cancer genetic information to themselves. Do we have to pay them if we are shown to have that gene in our body? Oh wait a minute.... We can't know the results of the genetic testing unless we pay them! Of course, it's clear now!

[lcr999]

08:45 AM on 07/30/2011

Can someone scientific explain exactly how a gene outside the body is chemically different than one inside the body. Even so, it would then seem that there might be multiple ways for that gene to exist in a different chemical state outside the body.

Basically I don't think their ruling makes sense or is good for mankind but nonetheless just trying to understand it.

[ThinkCreeps]

06:35 AM on 08/01/2011

The patent protects part of the company's test procedure that they developed for these sequences of genes, and not the sequences of genes themselves.

Others can still develop a competing test, and work with the cells, DNA or whatever they like.

[lcr999]

09:20 AM on 08/01/2011

That is not what the article says.

[Ronanyello]

03:18 PM on 08/02/2011

From what I understand after reading several sources the court allowed the patenting of the coding region of the genes because in the genome the genes have intronic regions which are not encoded into the proteins.. So if you only use the coding region of the gene for your product you can patent it because it is not a natural product. Chemically the molecule is the same (so that's the ignorance of the reuters) but the nucleotide­s are different. But this is still ridiculous­. Coding region of the gene is not an invention either it's still part of the nature. These judges are going above their understand­ing of the science and making silly decisions.

[OneManRoaring]

04:51 PM on 07/29/2011

This is part of what is wrong with health care in this country. Genes (whether they are abnormal or not) are pieces of the genetic code of individuals and should NOT be the purview of any company. Giving someone ownership over any part of my body is a form of human trafficking.

Keep your patents out of my genes!

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