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Cancer Patients Challenge the Corperate Patenting of a Gene

Read ArticleArticle Source: The New York Times
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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.

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Benjamin Sklar for The New York Times
Genae Girard, 39, is suing Myriad Genetics and the Patent Office over the granting of a patent on a gene. Myriad also has patented the only test that measures the risk of breast and ovarian cancer.

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The Lede: In Gene Patent Case, Company Vows to Fight 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.

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{"commentId":7147989,"authorDomain":"chrisp986"}

The coalition of plaintiffs argues that gene patents actually restrict the practice of medicine and new research.

“With a sole provider, there’s mediocrity,” said Wendy K. Chung, the director of clinical genetics at Columbia University and a plaintiff in the 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.”

{"commentId":7147989,"threadId":"581513","contentId":"2832742","authorDomain":"chrisp986"}
    Reply#1 - Mon May 18, 2009 3:46 PM EDT
    {"commentId":7148056,"authorDomain":"chrisp986"}
    In the future, genetic tests are likely to involve the analysis of many genes at once, or even of a person’s full set of genes. Some 20 percent of the human genome is already included in patent claims, amounting to thousands of individual genes, says a draft report from the National Institutes of Health. The report warns that “it may be difficult for any one developer to obtain all the needed licenses” to develop the next generations of tests.

    While I understand a company's desire to recoup costs and make a profit. Most of these genes were originally identified with puplically funded (NIH) research.

    {"commentId":7148056,"threadId":"581513","contentId":"2832742","authorDomain":"chrisp986"}
      Reply#2 - Mon May 18, 2009 3:49 PM EDT
      {"commentId":7148920,"authorDomain":"beamerab3"}

      I thought that there were checks and balances in place to protect consumers and the general populace from monopolies.

      {"commentId":7148920,"threadId":"581513","contentId":"2832742","authorDomain":"beamerab3"}
        Reply#3 - Mon May 18, 2009 4:29 PM EDT
        {"commentId":7149233,"authorDomain":"ahancock4"}

        There are checks and balances however for certain R&D projects the government will grant limited monopoly status to the patent holder in order to recoup some of the R&D costs. That way companies are more inclinded to invest billions of dollars into research and not loose it to a Chinese company or some cheap knockoff brand like Safeway select or walmart brand.

        {"commentId":7149233,"threadId":"581513","contentId":"2832742","authorDomain":"ahancock4"}
          Reply#4 - Mon May 18, 2009 4:42 PM EDT
          {"commentId":7155504,"authorDomain":"beamerab3"}

          Thanks.

          ; )

          {"commentId":7155504,"threadId":"581513","contentId":"2832742","authorDomain":"beamerab3"}
            #4.1 - Tue May 19, 2009 12:13 AM EDT
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