Saturday, November 7, 2009

Women's Health at Risk with Genetic Patents

Recognizing Far-Reaching Implications of ACLU Anti-Gene Patent Case, Court Denies Myriad’s Motion to Dismiss
November 04, 2009
By Turna Ray
A New York federal district court has denied Myriad Genetics’ motion to dismiss a lawsuit challenging its patents covering BRCA gene mutations associated with hereditary breast and ovarian cancer based on the novel circumstances presented in the case and the sweeping implications of the issues involved.
The American Civil Liberties Union filed the lawsuit in May on behalf of four scientific organizations — representing more than 150,000 medical professionals, researchers, women's health groups, and individual women — alleging that the BRCA gene patents held by the University of Utah Research Foundation and exclusively licensed to Myriad stifle research and limit women's treatment options. Additionally, the lawsuit, Association for Molecular Pathology, et al. v. US Patent and Trademark Office, et al., challenges the constitutionality of Myriad's patents on the BRCA1 and BRCA2 genes, by asserting that Myriad’s exclusive licensing practices hinder the free flow of information and therefore obstruct the First Amendment protecting free speech [see PGx Reporter 05-13-2009].
However, Myriad and other defendants challenged the plaintiff’s ability to bring the lawsuit, by filing a motion-to-dismiss memorandum, calling ACLU's case "a thinly veiled attempt to challenge the validity of patents" [see PGx Reporter 08-05-2009].
In deciding to dismiss Myriad's motion to dismiss on grounds that it lacked technical merit, Robert Sweet, the federal district court judge on the case, recognized the "uniqueness" of the plaintiffs' case with regard to "scope and significance of the issues presented, and the consequences of the remedy sought." Furthermore, the court acknowledged the right of the plaintiffs, particularly "women facing the threat of breast cancer … who are in the midst of their struggle with the illness," to challenge the practice of gene patenting.
"The challenges to the patents-in-suit raise questions of difficult legal dimensions concerning constitutional protections over the information that serves as our genetic identities and the need to adopt policies that promote scientific research," the court said in its decision.
In its decision, the court cited the example of Plaintiff Wendy Chung, a professor of molecular genetics at Columbia University who studies genetic and environmental factors linked to hereditary breast and ovarian cancer. Although Chung's lab sequences BRCA1/2 genes of research participants, researchers cannot inform subjects of their mutation status because of Myriad's patents.
Additionally, the court cited numerous examples provided by the plaintiffs where academic studies that would essentially improve BRCA sequencing methods were stopped by Myriad, who informed researchers that their work would infringe the firm's patents.
For example, according to court documents, in 2005, Yale DNA Diagnostics Laboratory asked Myriad for permission to perform genetic screening of BRCA genes looking for large rearrangement mutations correlated with cancer risk. Studies had previously shown that Myriad's full sequencing test missed some large gene rearrangements associated with disease risk. However, Myriad informed Yale that BRCA testing could not be done by the university's laboratory as it would infringe the company's patents.

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