In a 2:1 decision handed down by Judge Lourie, the United States Court of appeals of the Federal Circuit ruled that “On the merits, we reverse the district court’s decision that Myriad’s composition claims to ‘isolated’ DNA molecules cover patent-ineligible products of nature under § 101 since molecules as claimed do not exist in nature” (Association for Molecular Pathology v. Myriad Genetics, 2011, p. 8).
The ruling further states that, “We also reverse the district court’s decision that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates is directed to a patent-ineligible scientific principle” (Association for Molecular Pathology v. Myriad Genetics, 2011, p. 8).
The court acknowledged that one plaintiff had a standing challenge to the validity of Myriad’s patents due to the fact that he would like to start research on the BRCA 1/ BRCA 2 genes immediately, but couldn’t because of the patent protection of the genes.
The court upheld one decision by U.S. District Judge Robert W. Sweet stating that “that Myriad’s method claims directed to ‘comparing’ or ‘analyzing’ DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent- ineligible abstract, mental steps” (Association for Molecular Pathology v. Myriad Genetics, 2011, p. 8)
The court document has really great background information on this. Like all other genes, BRCA genes are subject to mutation. While the average risk for women in the US is around 12% to 13% of developing breast cancer in her lifetime, women with BRCA mutations face a 50% to 80% risk of developing breast cancer and a subsequent 25% to 50% risk of developing ovarian cancer (Association for Molecular Pathology v. Myriad Genetics, 2011).
Naturally, if one could test for this mutation in the BRCA 1/2 genes a patient gets a clearer picture of her risk and this could aid in decision making, such as lifestyle changes and prophylactic surgery. On the other hand BRCA 1/2 diagnostic results lead to an improved treatment plan in women with cancer because some forms of chemotherapy are more effective in BRCA related tumors than others (Association for Molecular Pathology v. Myriad Genetics, 2011).
On the other hand, a company such as Myriad holding a patent on these genes would not only benefit from the consumer end, currently Myriad charges $3,210 for a comprehensive BRCA assessment, while analysis of a single specimen costs $440 (Gever, 2011).
Why write about this on The Alternative Medicine Blog?
While the benefits of patented genes are debatable, they highlight one important aspect in healthcare. What do you do with the information gained from such genetic testing if you are cancer free?
The National Cancer Institute (n.d.) has very good information to answer this question. But as you might have guessed, many items on this list are subject to intervention with Mind-Body techniques discussed here on the Alternative Medicine Blog.
One final note, I really recommend reading the original court document (you can click on this link) Association for Molecular Pathology v. Myriad Genetics (2011) because it has great background information on the science of BRCA 1 and BRCA 2.
In a subsequent post I will make Judge Sweet’s ruling available, because it contains a very detailed discussion of the science behind the BRCA genes.
Despite the outcome of this case, or any other patent case for that matter, one thing is for certain. Healthcare consumers need to do their homework and are never ever absolved from taking charge of their own healthcare, be that in health or in disease.
Writing an essay, paper, or report? Cite this story:
APA: W Absenger. (year, month, day). Title of Blog Post [Web log post]. Retrieved from PASTE PERMALINK
MLA: Absenger, Werner. “TiTLE of BLOG POST.” The Alternative Medicine Blog. The Alternative Medicine Blog., DAY MONTH. Year. Web. Insert your date of access here.
Association for Molecular Pathology v. Myriad Genetics. (2011).
Gever, J. (2011, March 30). Medical News: Court Tosses Human Gene Patents. Retrieved July 30, 2011, from http://www.medpagetoday.com/Genetics/GeneticTesting/19294
National Cancer Institute. (n.d.). BRCA1 and BRCA2: Cancer Risk and Genetic Testing. Retrieved July 30, 2011, from http://www.cancer.gov/cancertopics/factsheet/Risk/BRCA#a16