Friday, July 29, 2011

Divided Appeals Court Rules That Companies May Patent Breast Cancer Genes, but Invalidates Patents on Comparing the Genes

FOR IMMEDIATE RELEASE

July 29, 2011

NEW YORK – In a 2-1 decision, a federal appeals court today partially reversed a lower court’s ruling in a case challenging patents on two human genes associated with hereditary breast cancer and ovarian cancer. The court ruled that companies can obtain patents on the genes but cannot patent methods to compare those gene sequences.

The ruling follows a lawsuit brought by a group of patients and scientists represented by the American Civil Liberties Union and the Public Patent Foundation (PUBPAT) and calls into question the validity of patents now held on approximately 4,000 human genes.

“Today’s ruling is a blow to the idea that patent law cannot impede the free flow of ideas in scientific research,” said Chris Hansen, a staff attorney with the ACLU Speech, Privacy and Technology Project. “Human DNA is not a manufactured invention, but a natural entity like air or water. To claim ownership of genetic information is to unnecessarily block the free exchange of ideas.”

The lawsuit against Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the genes, 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."

“As the dissent from today’s decision explains, pieces of the human genome are not patentable,” said Daniel B. Ravicher, executive director of PUBPAT and co-counsel in the lawsuit. “This is because no one ‘invents’ genes. Inventions are things like new genetic tools or drugs, all of which can be patented because they are not genes themselves.”

The specific patents the lawsuit challenged are on the BRCA1 and BRCA2 genes. Mutations along those genes are responsible for most cases of hereditary breast and ovarian cancers. Many women with a history of those cancers in their families opt to undergo genetic testing to determine if they have the mutations on their BRCA genes that put them at increased risk for these diseases. This information is critical in helping these women decide on a plan of treatment or prevention, including increased surveillance, preventive mastectomies or ovary removal.

One of the judges on the panel dissented in part with the decision, writing that patents on the genes should be invalid. “…[E]xtracting a gene is akin to snapping a leaf from a tree,” Judge William C. Bryson of the U.S. Court of Appeals for the Federal Circuit wrote. “Like a gene, a leaf has a natural starting and stopping point. It buds during spring from the same place that it breaks off and falls during autumn. Yet prematurely plucking the leaf would not turn it into a human-made invention.”

The lawsuit, Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., was filed on behalf of breast cancer and women’s health groups, individual women, geneticists and scientific associations representing approximately 150,000 researchers, pathologists and laboratory professionals. Because the ACLU's lawsuit challenges the whole notion of gene patenting, its outcome could have far-reaching effects beyond the patents on the BRCA genes. Approximately 20 percent of all human genes are patented, including genes associated with Alzheimer's disease, muscular dystrophy, colon cancer, asthma and many other illnesses.

The patents granted to Myriad gave the company the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes and to prevent any researcher from even looking at the genes without first getting permission from Myriad. Myriad's monopoly on the BRCA genes makes it impossible for women to access alternate tests or get a comprehensive second opinion about their results. It also allows Myriad to charge a high price for its tests.

“The court has made the wrong decision for a woman’s health,” said Sandra Park, staff attorney with the ACLU Women’s Rights Project. “No corporation should be able to claim ownership of women’s own genetic information.”

Several major organizations, including the American Medical Association, the March of Dimes and the American Society for Human Genetics, filed friend-of-the-court briefs in support of the challenge to the patents on the BRCA genes. In addition, the United States Department of Justice filed a brief arguing that many of the gene patents issued by the Patent Office are invalid.

Attorneys on the case include Hansen and Aden Fine of the ACLU Speech, Privacy and Technology Project; Park and Lenora Lapidus of the ACLU Women’s Rights Project; and Ravicher and Sabrina Hassan of PUBPAT.

Today's decision can be found online at: www.aclu.org/womens-rights/association-molecular-pathology-et-al-v-myriad-genetics-inc-appeals-court-decision - or by clicking the above light blue link.

More information about the case, including an ACLU video featuring breast cancer patients, plaintiff and supporter statements and declarations and the legal complaint, can be found online at: www.aclu.org/brca

CONTACT: Robyn Shepherd (212) 519-7829 or 549-2666; media@aclu.org Read more!

Friday, July 22, 2011

An Open Letter to Myriad Genetics

Dear Patients and Providers,

As many of you know, Myriad Genetic Laboratories holds the exclusive patent for testing for mutations within the BRCA1 and BRCA2 genes. Among individuals at "high risk", their "Comprehensive" BRCA testing currently detects ~90% of all possible mutations (genetic changes). Among individuals at "high risk", the other ~10% of mutations (called large rearrangements) are missed with this technique alone. For most patients, testing for large rearrangements is a separate $700 test (called BART) that is often not covered by insurance.

Recent data released by Myriad suggests that these large rearrangement BRCA mutations are over-represented and account for a larger percentage of mutations than previously thought in some populations including Hispanics/Latinos. In addition, data from other groups suggests Myriad's "high risk" criteria do not accurately predict which patients are likely to carry a BRCA rearrangement mutation. Therefore, we are appealing to Myriad to include BART analysis in their standard BRACAnalysis for all patients, so that it will truly be the Comprehensive testing that they advertise.

Below please find the full text of an open letter to Myriad Genetics Laboratories re: BART testing. If you would like to sign on to this letter, please send a separate e-mail with your intent, and patient/provider affiliation to karina.brierley@yale.edu.

--------------------------------------------

July 22, 2011

Richard Wenstrup, MD

Chief Medical Officer

Myriad Genetic Laboratories

Dear Dr. Wenstrup,

Thank you for your data of July 11, 2011 demonstrating that a significant proportion of BRCA1 and BRCA2 mutations are not detected by your $3340 Comprehensive BRACAnalysis, but are only detected by ordering the additional $700 BART Analysis of BRCA1 and BRCA2.1 Your data demonstrate that the proportion of mutations detected only by BART is higher in patients of Latin American/Hispanic ancestry.1 This Hispanic population is one of the most rapidly growing ethnic groups in the United States and is disproportionately uninsured, underinsured, and at or below poverty levels.2,3 Therefore, this population is less likely to be able to access and afford the necessary, expensive, additional BART testing.

Dr. Wenstrup, we, the undersigned are asking Myriad to include BART analysis as part of your Comprehensive BRACAnalysis, effective immediately. As you know, most insurance companies do not cover the extra BART Analysis and most patients do not have this important testing. This means we are missing BRCA mutations in many patients, which is costing lives. Most patients cannot afford $700 out of pocket. Recent data indicate that your high-risk criteria do not predict which patients are carrying a BART mutation.4 All patients having Comprehensive BRCA testing also need BART analysis.

We note that Myriad’s 2011 Third Quarter Revenue report indicates that your company has enjoyed its best revenue and operating income results for any period in your history, with a 3rd quarter revenue of $102.4 million (13% increase compared to last year).5 We implore you to reinvest some of your earnings into incorporating BART analysis into your standard BRACAnalysis, so that it will truly be the Comprehensive testing you advertise.

Sincerely,

Ellen T. Matloff, MS, CGC

Rachel E. Barnett, MS, CGC

Danielle C. Bonadies, MS, CGC

Karina L. Brierley, MS, CGC

Pia Banerji Summerour, M.S., CGC

Andrea Schwerdt, RN, BSN, OCN

Jayne A. Murphy, M.S., CGC

Gina Cowing, MS

Sara Goldstein, MS, CGC

Danielle Piippo, MMS, PA-C

Tina Bartell, MS

Sumedha Ghate, MS

Andrea Paal, M.S.

Maureen Flynn, MS, LGC, MPH

Nancy Cohen, MS, CGC

Kristin Kalla, M.S., CGC

Dana Kostiner Simpson, MD

Brittany Burnett, MS, CGC

Sharanya Kumaravel, MS

Erin Ash, MS, CGC

Janey Youngblom, Ph.D., M.S.

Meghan Wayne, MS, CGC

Anna Newlin, MS, CGC

Susan Mecsas-Faxon, MS, CGC

Elena Strait, MS, CGC

Jessica Heinzmann, M.S.

Katherine S. Hunt, MS, CGC

Amy Thomas, MS

Lance Grau, MS, CGC

Mohamed Khalifa, MD

Catherine Ward-Melver, MD

Cheryl Cina, MS, CGC

Jennifer Stein, MS, CGC

Rebecca Yee, MS, CGC

Shannon Morrill-Cornelius, MS, CGC

Anneliese Gonzalez, MD

Michael D. Stone, MD

Niki Armstrong, MS, CGC

Shanna Gustafson, MS, MPH, CGC

Kelly Jo Hamman, MS, CGC

Chelsy R. Jungbluth, MS, CGC

Luba Djurdjinovic, MS

Erin Houghton, MS, CGC

Lindsey Morse, MS, CGC

Alissa Bovee, ScM, CGC

Murray L. Nusbaum, MD

Gayun Chan-Smutko, MS, CGC

Kara Bui, MS, CGC

William A. Fintel, M.D.

Robin King, MS, CGC

Josephine Wagner Costalas, MS

Kerry Kingham, MS, CGC

Saun Floyd, MS, CGC

Whitney Neufeld-Kaiser, MS, CGC

Carrie Koval, MS

Bridgette Aufmuth, MS, CGC

Stacey Miller, MS, CGC

Judith A. Durcan, MS, CGC

Erin Carney, MS, CGC

Kathy Morris, MSSW, LCGC

Dawn Lee, MS

Emily Smith, MS, CGC

Melanie S. Moshier, MS

Jennifer L. Czerwinski, MS, CGC

Stephanie Kozachek, MS, CGC

Kory Jasperson, MS, CGC

Jessica Lipschutz, M.S., C.G.C.

Cristi Radford, MS, CGC

Jessica Long, MS, CGC

Taya J. Fallen, MS, CGC

Carol Brudenell, MSN, RN, AOCN, CCRP

Sherry C. Grumet, MA, MS, CGC

Laura Colello, MS, CGC

Larry R. Glazerman, MD, MBA

Valerie Loik Ramey, MS, CGC

Mollie Lyman Hutton, MS, CGC

Debbie Pencarinha, MS, CGC

Cristina Ruiz, MS, CGC

Robin C. Schwartz, M.S., C.G.C.

Susan Donlon, MS, CGC

Heather L. Shappell M.S., CGC

Heidi Beaver, MPH, CGC

Christine Laronga, MD, FACS

Christina Bittner, MS, CGC

Linda Robinson MS, CGC

Janice Berliner, MS, CGC

Michelle Gilats, M.S.

Christine Rogness, MD, FACS

Lauren Bowling, MS

Christopher E. Mason, Ph.D.

Laura Esserman MD MBA

Julie S. Mak, MS, MSc, CGC

Christine Kobelka, M.Sc., CGC, CCGC

Nicola Stewart, MS, CGC

Amie Blanco, MS, CGC

Kate Loranger, MS, CGC

Melanie Baxter, ScM, CGC

Margo Thelander, MS, CGC

LaDonna Immken, MD

Gayle Simpson Patel, MS, CGC

Katherine Schneider, MPH, LGC

Emily Brown, MS, LGC

Elaine Hiller, MS, LGC

Shelley McCormick, MS, LGC

Irene Rainville, MS, PhD, LGC

Claire Healey, MS, LGC

Anu Chittenden, MS, LGC

Monica Dandapani, MS, LGC

Judy Garber, MD, MPH

Gemma Chandratillake, MS, MPhil, PhD

Janice Rinsky, M.S.

Sarah Jane Noblin, MS, CGC

Andrea E. Harbison, MS, CGC

Justin W. Leighton, MS

Elsa Reich, MS, CGC

Cathy M. Sullivan, MS, CGC

Bobbi McGivern, MS, CGC

Kristin DePrince Mattie, M.S.

Gillian W. Hooker PhD, ScM, CGC

Nadine Dumas, M.Sc., CCGC (CGAC)

Rachel Westman, MS

Masayo Niwa-Habibi, MS

Pat Himes, MS, CGC

Niecee Singer Schonberger, MS, CGC

Carrie Prochniak, MS

Sivya Twersky, MS, GGC

Lindsey Byrne, MS, CGC

Nichole Morman, MS, CGC

Seth Marcus, MS, LCGC

Kiana Siefkas, MS, CGC

Heather Hampel, MS, CGC

Jennifer Scalia Wilbur, MS, CGC

Sidra Shapiro Boshes, MS, CGC

Fiona M. Field, MS, CGC

C├ęcile Skrzynia, MS, CGC

Jilliane Sotelo, MS, LCGC

MaryAnn W. Campion, MS, CGC

Janice O'Connell, MS, CGC

Jennifer Burton, MS, CGC

Shawnia Ryan, MS, CGC

Angela Musial Fay, MS, CGC

Kim Horton RN, MS, CGC

Lindsay Dohany, MS, CGC

Kathleen D. Valverde, MS, CGC

Peggy Cottrell, MS, CGC

Marcia Jodah, MS, CGC

Nicole Mattila, MS, CGC

Tuya Pal, MD, FABMG

Karen Brown, MS, CGC

Maegan E. Roberts, MS, CGC

Jennifer Brzosowicz, MS, CGC

Leslie Aptekar, MS CGC

Camila Shanahan, MS, CGC

Jeanne Homer, MS

Robert Pilarski, MS, CGC, MSW, LSW

Susie Ball, MS, CGC

Alexandria M. Yonker, MS, CGC

Marvin Miller, MD

Rachel Nusbaum, MS, CGC

Michelle Lyons, MS, CGC

Diana C. Darcy, M.S., C.G.C.

Cecelia A. Bellcross, PhD, MS, CGC

Faith Callif-Daley, MS, CGC

Eric Hanson MD, MPH

Diana Moglia, MS, CGC

Melissa Gilstrap, MS, CGC

Colleen Tsikerdanos, M.S., C.G.C.

Erica Ramos, MS, CGC

Molly A. Brewer, DVM, MD, MS

Kristen Dieter, MS, CGC

Sara Svendsen, MS, LCGC

Elena Infante, MS

Thea A. Johnson, MS

Rebecca A. Madore, M.S., CGC

Karen S. Metzler, MS, CGC

Erica Blouch, MS

Beth Souders, MS, CGC

Scott T. Michalski, MS, LGC

Lisa Blazejewski, MS, CGC

Jamie C. Fong, MS, CGC

Amy Crunk, MS, CGC

Zipora Eckstein MS

Thereasa A. Rich, MS, CGC

Lori Ballinger, MS, CGC

Audrey Linn Schroeder, MS, CGC

Amanda Lamb, MS

Megan E. McKenna (Hooper), M.S., C.G.C.

Erin Dola, MS, CGC

Sarah Keilman, MS, CGC

Jess Cary, MS, RN, CGC

Christina A. Seelaus, MS, MA, CGC

William Foulkes, MD

Kasia J. Bloch, MS, CGC

Nisha Isaac, M.S., CGC

Teresa M. Blake, MS, CGC, LGC

Laura M. Tripi, MS, CGC

Sara Pirzadeh-Miller, M.S., CGC

Erin H. Steed, MS, CGC

Kristen Vogel, MS, CGC

Martha Thomas, MS, CGC

Kelli Swan, MS, CGC

Denise Marty, MS, CGC

Whitney L. Ducaine, MGC, CGC

Damini Desai, MS, CGC

Maureen May, MS

Scott M. Weissman, MS, LGC

Kami Wolfe Schneider, MS, CGC

Ronald L. Bauer, M.D., FACS

Andrea M. Bauer, MSN, NP-C, ANP

Additional signatures as of August 1, 2011

Donna D. Walgenbach, MS

Toni I. Pollin, MS, PhD, CGC

Heather Sellers, MS

Andrea Forman, MS, CGC

Cathy McCann, MS, CGC

Constance Gibb, MS, CGC

Matt Mealiffe, MD

Vinaya Murthy, MPH, MS, CGC

Shelly Galasinski, MS, CGC

Darnelle L. Dorsainville, MS, CGC

Shenela Lakhani, B.Sc., M.Sc.

Wendy Chung, MD PhD

Erin Hofstatter, MD

Nadine Tung, MD

Donna Russo, MS

Kristen Shannon, MS, CGC

Stephanie Diaz, MS, CGC

Catherine A. Corman

Michelle L. Morgan

Mary-Ann Sagnella

Alison Tainter

Leslie Phillip-Kellman

Candy Goldstein

Terry Stoller

Pamela Morris Watt

References:

1. Myriad Genetic Laboratories. BRCA1 and BRCA2 Prevalence Tables for Mutations Detected by Sequencing, the 5-site Rearrangement Panel (LRP) and the BRACAnalysis® Large Rearrangement Test (BART™) in High Risk Patients. Available at: http://www.myriad.com/lib/brac/BART-table-faq.pdf . Retrieved July 14, 2011.

2. U.S. Department of Health and Human Services: Office of the Assistant Secretary for Planning and Evaluation. Overview of the Uninsured in the United States: An analysis of the 2005 Current Population Survey Available at: http://aspe.hhs.gov/health/reports/05/uninsured-cps/index.htm#race . Retrieved July 14, 2011.

3. Lloyd Runser, Sabrina Eagan and Danielle Olds. The Uninsured and Underinsured. Available at: http://www.case.edu/med/epidbio/mphp439/Safety_Nets.htm . Retrieved July 14, 2011.

4. Shannon KM, Rodgers LH, Chan-Smutko G, Patel D, Gabree M, Ryan PD. Which Individuals Undergoing BRCAnalysis Need BART Testing? Cancer Genetics (in press)

5. Myriad Genetic Laboratories. Myriad Genetics Reports Fiscal 2011 Third Quarter Results. Available at: http://investor.myriad.com/releasedetail.cfm?releaseid=574140 . Retrieved July 14, 2011.

Read more!

Wednesday, July 20, 2011

Family History Crucial In Determining Cancer Risks

Ellen Matloff, director of cancer genetic counseling at Yale Cancer Center in New Haven, recently spoke at the Hadassah Women’s Chapter at Heritage Village. Her talk focused on the ten percent of people diagnosed with a cancer that is passed down through family lines, called germline mutations; who is most at risk for these cancers; the use of genetic counseling; and who should consider counseling. While people of Jewish ancestry have an increased risk factor for cancer that makes genetic counseling and testing that much more important, there is no ethnic group that is free of cancer risks, says Ms. Matloff.

Please click on the above light blue link for the full article and a list of risk factors that help determine whether a person is a candidate for genetic counseling. Read more!