The Implications of the BRCA Gene Patent Rulings for Individualized Medicine
ISSN: 2161-0681
Journal of Clinical & Experimental Pathology

Like us on:

Make the best use of Scientific Research and information from our 700+ peer reviewed, Open Access Journals that operates with the help of 50,000+ Editorial Board Members and esteemed reviewers and 1000+ Scientific associations in Medical, Clinical, Pharmaceutical, Engineering, Technology and Management Fields.
Meet Inspiring Speakers and Experts at our 3000+ Global Conferenceseries Events with over 600+ Conferences, 1200+ Symposiums and 1200+ Workshops on Medical, Pharma, Engineering, Science, Technology and Business
  • Editorial   
  • J Clinic Experiment Pathol 2011, Vol 1(1): e101
  • DOI: 10.4172/2161-0681.1000e101

The Implications of the BRCA Gene Patent Rulings for Individualized Medicine

Mark A. Nelson*
Professor of Pathology, University of Arizona, USA
*Corresponding Author: Mark A. Nelson, Ph. D. Professor of Pathology, University of Arizona1501 N. Campbell AvenueTucson, Arizona, USA, Tel: 520 626 2619, Fax: 520 626 1027, Email: [email protected]

Received: 11-Aug-2011 / Accepted Date: 05-Sep-2011 / Published Date: 12-Nov-2011 DOI: 10.4172/2161-0681.1000e101

According to the National Institute of health, 12 percent of women in the general population will develop breast cancer in their lifetimes, compared to 60 percent of women who have inherited a mutation in either the BRCA1 or BRCA2 genes. In regards to ovarian cancer, 1.4 percent of women may be diagnosed in their life-time, however the percentage rises to 15-40% women with a BRCA1 or BRCA2 mutation. Consequently, determining the BRCA1 and BRCA2 mutation status of women can markedly influence their risk of developing breast and or ovarian cancer.

Myraid Genetics identified these genes and subsequently built an estimated $300 million-a-year business testing women. Myriad holds 23 patents related to the BRAC1 and BRCA2 genes. Myriad's patent have been challenged on the basis that they discourage scientific research and development of new tests for ovarian and breast cancer and therefore threatened women's health. In fact no other company or commercial laboratory can perform the test, hence women cannot get second opinions.

The American Civil Liberties Union, Association of Molecular Pathologist, and the Public Patent Foundation filed a lawsuit against Myriad Genetics. The lawsuit, Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., charged that the challenged patents are illegal and restrict both scientific research and patients access to medical care, and that patents on human genes violate the First Amendment and patent law because genes are "products of nature."

The U.S. Patent & Trademark Office and Myriad Genetics have countered that the protections offered by patents create financial incentives for scientists and private enterprise to put in the time and effort it takes to come up with ground breaking tests such as the BRCA screens in the first place. But for the prospects of the patent exclusively, Myriad Genetics would not have been established and been supported by investors.

Many investigators cheered last year when a federal judge ruled that human genes couldn't be patented. However a federal appeals court upheld Myriad Genetics exclusive rights to the BRCA1 and BRCA2 genes. The appeals court decided that "isolated DNA" is not the same as the natural DNA in ones body, and that this distinction allows companies to patent genes. In fact the U.S. Patent and Trade Office has been granting gene patents for decades and there are presently over 4,000 human genes that have been patented.

It is difficult for most scientists and clinicians to understand the Federal Circuits of Appeals court decision because we know that genes are part of the genome which is part of nature (recall that Mendel eloquently demonstrated that your genotype defines your phenotype). However, the Federal Circuit Court Appeals appears to have been influenced by the fact that gene-based patents have historically been important to biotech companies in their efforts to raise venture capital. Simone Rose Professor of Law at Wake Forest University suggests that the Appeals court should have upheld the lower courts invalidation of the BRCA gene patents. "If the BRCA gene patents were invalidated, Congress could then step in and legislate a new Constitutional framework of exclusive rights for this subject matter. Congress would likely gather industry, academic, and public stakeholders together to craft a hybrid statute that would promote innovation as well as provide much-need access to these basic upstream research tool- patented gene sequences." However this issue may likely be heard by the Supreme Court.

What does it all mean? The former Chair of my Pathology Department (Ronald Weinstein, MD) once told me "Always know what the rules are once you know what the rules are, you know how to proceed." With this in mind it is clear for now interrogating breast and ovarian cancer patients for BRCA gene status must occur according to our current laws. That is suspected BRCA cases must be sent to Myriad Genetics for testing.

For those who seek to patent protection for their gene discovery it will be important for the claims to include more steps than simply "analyzing" the gene and comparing the data from the sample to other known cases. Finally, as whole genome sequencing continues to become more cost-effective, it is conceivable that gene patents like BRCA genes could become unenforceable. Presently the law is not clear if sequencing an individual's whole genome (in which genes are within "natural environment") and then providing information on mutations in the BRCA gene would violate Myriad's patent on the "isolated genes".

Citation: Nelson MA (2011) The Implications of the BRCA Gene Patent Rulings for Individualized Medicine. J Clinic Experiment Pathol 1:e101. Doi: 10.4172/2161-0681.1000e101

Copyright: © 2011 Nelson MA. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Post Your Comment Citation
Share This Article
Recommended Conferences
Article Usage
  • Total views: 13129
  • [From(publication date): 11-2011 - Apr 01, 2023]
  • Breakdown by view type
  • HTML page views: 8767
  • PDF downloads: 4362
Share This Article

Post your comment

captcha   Reload  Can't read the image? click here to refresh
Peer Reviewed Journals

Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals

Clinical & Medical Journals

Dersleri yüzünden oldukça stresli bir ruh haline sikiş hikayeleri bürünüp özel matematik dersinden önce rahatlayabilmek için amatör pornolar kendisini yatak odasına kapatan genç adam telefonundan porno resimleri açtığı porno filmini keyifle seyir ederek yatağını mobil porno okşar ruh dinlendirici olduğunu iddia ettikleri özel sex resim bir masaj salonunda çalışan genç masör hem sağlık hem de huzur sikiş için gelip masaj yaptıracak olan kadını gördüğünde porn nutku tutulur tüm gün boyu seksi lezbiyenleri sikiş dikizleyerek onları en savunmasız anlarında fotoğraflayan azılı erkek lavaboya geçerek fotoğraflara bakıp koca yarağını keyifle okşamaya başlar