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Wednesday, May 13, 2009

Courts - "Cancer Patients Challenge the Patenting of a Gene"

That is the headline to a fascinating, and lengthy, story today in the NY Times by John Schwartz. Some quotes:

When Genae Girard received a diagnosis of breast cancer in 2006, she knew she would be facing medical challenges and high expenses. But she did not expect to run into patent problems.

Ms. Girard took a genetic test to see if her genes also put her at increased risk for ovarian cancer, which might require the removal of her ovaries. The test came back positive, so she wanted a second opinion from another test. But there can be no second opinion. A decision by the government more than 10 years ago allowed a single company, Myriad Genetics, to own the patent on two genes that are closely associated with increased risk for breast cancer and ovarian cancer, and on the testing that measures that risk.

On Tuesday, Ms. Girard, 39, who lives in the Austin, Tex., area, filed a lawsuit against Myriad and the Patent Office, challenging the decision to grant a patent on a gene to Myriad and companies like it. She was joined by four other cancer patients, by professional organizations of pathologists with more than 100,000 members and by several individual pathologists and genetic researchers.

The lawsuit, believed to be the first of its kind, was organized by the American Civil Liberties Union and filed in federal court in New York. It blends patent law, medical science, breast cancer activism and an unusual civil liberties argument in ways that could make it a landmark case. * * *

Dr. Chung and others involved with the suit do not accuse Myriad of being a poor steward of the information concerning the two genes at issue in the suit, known as BRCA1 and BRCA2, but they argue that BRCA testing would improve if market forces were allowed to work.

Harry Ostrer, director of the human genetics program at the New York University School of Medicine and a plaintiff in the case, said that many laboratories could perform the BRCA tests faster than Myriad, and for less money than the more than $3,000 the company charged.

Laboratories like his, he said, could focus on the mysteries still unsolved in gene variants. But if he tried to offer such services today, he said, he would be risking a patent infringement lawsuit from Myriad.

Christopher A. Hansen, senior national staff counsel for the civil liberties union, said the problem was with the patent office, not the company. He recalled that when he first heard that the office had granted a patent for a gene, “I said that can’t be true.”

As the A.C.L.U. explored the restrictions on competition that companies like Myriad had put in place — blocking alternatives to the patented tests, and even the practice of interpreting or comparing gene sequences that involved those genes — the restrictions started to look like not just a question of patent law, Mr. Hansen said, but of the First Amendment’s guarantee of free speech as well.

“What they have really patented,” he said, “is knowledge.”

A patent was also granted to a single company for genetic testing on long QT syndrome, which can lead to heart arrhythmias and sudden death, and to the HFE gene, linked to hereditary hemochromatosis, a condition in which iron accumulates in the blood and can cause organ damage. Doctors and scientists have complained about both patents.

On the other hand, the company that owns the patent to the gene CFTR, which has been linked to cystic fibrosis, has licensed the testing to dozens of laboratories, drawing praise from the medical world. * * *

For Lisbeth Ceriani, a single mother from Newton, Mass., and a plaintiff in the case against Myriad, the biggest obstacle that gene patents present is one of cost. She has had breast cancer and a double mastectomy, but wants to have BRCA testing to determine her risk of ovarian cancer and help her decide whether to have her ovaries removed. But Myriad has refused to work with her insurance plan, Mass Health, and paying for the test herself is beyond her means.

She is reluctant to have surgery that might prove unnecessary, she said, but she also worries about her 8-year-old daughter and the inherited risk she might face. Which is why, Ms. Ceriani said, she wants to “find out if I have the mutation, so I can take the necessary steps to stay on the planet.”

Posted by Marcia Oddi on May 13, 2009 01:06 PM
Posted to Courts in general