024GenePatentReading

My Medical Choice
By ANGELINA JOLIE
MY MOTHER fought cancer for almost a decade and died at 56. She held out
long enough to meet the first of her grandchildren and to hold them in her arms.
But my other children will never have the chance to know her and experience
how loving and gracious she was.
We often speak of “Mommy’s mommy,” and I find myself trying to explain the
illness that took her away from us. They have asked if the same could happen to
me. I have always told them not to worry, but the truth is I carry a “faulty” gene,
BRCA1, which sharply increases my risk of developing breast cancer and ovarian
cancer.
My doctors estimated that I had an 87 percent risk of breast cancer and a 50
percent risk of ovarian cancer, although the risk is different in the case of each
woman.
Only a fraction of breast cancers result from an inherited gene mutation. Those
with a defect in BRCA1 have a ​
65 percent​
risk of getting it, on average.
Once I knew that this was my reality, I decided to be proactive and to minimize
the risk as much I could. I made a decision to have a ​
preventive double
mastectomy​
. I started with the breasts, as my risk of breast cancer is higher than
my risk of ovarian cancer, and the surgery is more complex.
On April 27, I finished the three months of medical procedures that the
mastectomies involved. During that time I have been able to keep this private
and to carry on with my work.
But I am writing about it now because I hope that other women can benefit
from my experience. Cancer is still a word that strikes fear into people’s hearts,
producing a deep sense of powerlessness. But today it is possible to find out
through a blood test whether you are highly susceptible to breast and ovarian
cancer, and then take action.
My own process began on Feb. 2 with a procedure known as a “nipple delay,”
which rules out disease in the breast ducts behind the nipple and draws extra
blood flow to the area. This causes some pain and a lot of bruising, but it
increases the chance of saving the nipple.
Two weeks later I had the major surgery, where the breast tissue is removed
and temporary fillers are put in place. The operation can take eight hours. You
wake up with drain tubes and expanders in your breasts. It does feel like a scene
out of a science-fiction film. But days after surgery you can be back to a normal
life.
Nine weeks later, the final surgery is completed with the reconstruction of the
breasts with an implant. There have been many advances in this procedure in
the last few years, and the results can be beautiful.
I wanted to write this to tell other women that the decision to have a
mastectomy was not easy. But it is one I am very happy that I made. My chances
of developing breast cancer have dropped from 87 percent to under 5 percent. I
can tell my children that they don’t need to fear they will lose me to breast
cancer.
It is reassuring that they see nothing that makes them uncomfortable. They can
see my small scars and that’s it. Everything else is just Mommy, the same as she
always was. And they know that I love them and will do anything to be with
them as long as I can. On a personal note, I do not feel any less of a woman. I
feel empowered that I made a strong choice that in no way diminishes my
femininity.
I am fortunate to have a partner, Brad Pitt, who is so loving and supportive. So
to anyone who has a wife or girlfriend going through this, know that you are a
very important part of the transition. Brad was at the ​
Pink Lotus Breast Center​
,
where I was treated, for every minute of the surgeries. We managed to find
moments to laugh together. We knew this was the right thing to do for our
family and that it would bring us closer. And it has.
For any woman reading this, I hope it helps you to know you have options. I
want to encourage every woman, especially if you have a family history of breast
or ovarian cancer, to seek out the information and medical experts who can help
you through this aspect of your life, and to make your own informed choices.
I acknowledge that there are many wonderful holistic doctors working on
alternatives to surgery. My own regimen will be posted in due course on the
Web site of the Pink Lotus Breast Center. I hope that this will be helpful to other
women.
Breast cancer alone kills some 458,000 people each year, according to the World
Health Organization, mainly in low- and middle-income countries. It has got to
be a priority to ensure that more women can access gene testing and lifesaving
preventive treatment, whatever their means and background, wherever they
live. The cost of testing for BRCA1 and BRCA2, at more than $3,000 in the United
States, remains an obstacle for many women.
I choose not to keep my story private because there are many women who do
not know that they might be living under the shadow of cancer. It is my hope
that they, too, will be able to get gene tested, and that if they have a high risk
they, too, will know that they have strong options.
Life comes with many challenges. The ones that should not scare us are the ones
we can take on and take control of.
Natural human genes may not be patented, Supreme Court rules ­ 9 WASHINGTON — The Supreme Court ruled Thursday that naturally occurring human genes may not be patented, potentially paving the way for more genetic exploration by companies and researchers. In a unanimous decision, the court distinguished between genes found in the human body and those created in the lab. The ruling is a mixed bag for the multibillion­dollar drug and biotechnology industries. “A naturally occurring DNA segment is a product of nature," Justice Clarence Thomas wrote for the court. It cannot be patented just because scientists found it. At the same time, Thomas and his fellow justices determined that so­called “complementary DNA,” which is synthetic, can be patented because it is not found in nature. Cost Of Genetic Testing Could Drop The decision in the closely watched case rejects several patent claims filed by a company called Myriad Genetics. Myriad obtained patents on the exact location of two genes associated with a higher risk of developing breast or ovarian cancer. Having the patents gave Myriad a very profitable monopoly. Individual scientists who felt constrained by Myriad’s patents sued. So did a group called the Association for Molecular Pathology. “We are thrilled,” said American Civil Liberties Union attorney Sandra S. Park, who argued the case. “The question before the court was a simple one, but it had profound consequences.” The ruling Thursday means that competing firms now have more flexibility to develop cancer­testing tools that involve the genes for which Myriad held the patents. Park said the ruling also could call into question patents that have been issued for about 4,000 other human genes. “As a result of this, the cost of genetic testing should come down significantly,” said Dr. Harry Ostrer, a medical geneticist at the Albert Einstein College of Medicine who challenged Myriad’s patents. "I think we will see a much more level playing field. It will drive down costs and improve quality.” Genes Made In A Lab Can Be Patented Myriad officials focused on the parts of the court’s decision that it found favorable. The company stressed how the court agreed that genes made in a lab, called cDNA, still may be patented. The scientific methods used in isolating genes also can be patented. Myriad’s president and CEO Peter D. Meldrum said that “more than 250,000 patients rely upon” the company’s genetic testing. Myriad’s lawyer, Richard M. Marsh, said that the ruling would not have any major impact on its operations because of the company’s other patents and inventions. A gene is a segment of DNA. It defines physical traits, such as eye color and sex, and can influence whether an individual develops conditions such as ​
obesity​
, diabetes and Alzheimer’s disease. About 22,000 genes make up the human genome. Genes determine which traits are passed on from one generation to the next. In order to be studied and utilized, genes must be removed from the body and isolated. Scientists with Myriad used mapping tools to identify the genes associated with mutations that put women at a higher risk of breast and ovarian cancers. Scientists called these the BRCA1 and BRCA2 genes. The average American woman has a roughly 12 percent lifetime risk of developing breast cancer. Women with BRCA mutations, though, face a cumulative risk of up to 85 percent. Actress Angelina Jolie, for instance, decided to undergo surgery to have both breasts removed recently after she tested positive for the BRCA genes. Myriad obtained a number of patents relating to the isolated BRCA genes. Court Sought A Balance On Patents Supreme Court Justice Thomas said even though a discovery may be “groundbreaking, innovative or even brilliant" does not by itself mean it deserves a patent. “Myriad found the location” of the genes, that discovery by itself didn’t turn the genes into “new compositions of matter” that could be patented, he added. Myriad has been able to charge about $3,300 for its genetic­based tests for breast cancer. The company said that insurance pays for the tests for most patients. Other scientists have been limited in their ability to work with the genes. Intellectual property attorney Vernon Winters said that the court’s decision is limited. Scientists can still try to get patents for ways of working with genes and DNA. They can also try to patent new ways of using DNA sequences, he said. Barbara Rudolph, an attorney in Washington who specializes in patents, said that it was “hard to predict” how the decision would play out for companies and inventors. She did suggest that it was “a winner” for biotech firms that specialized in lab­synthesized cDNA, which could still be patented. Rudolph added that the court sought to balance whether patents serve as an incentive or a roadblock to invention. Justice Antonin Scalia, who ruled along with his fellow justices, pointed out the scientific complications of the case. He issued a one­paragraph opinion in which he noted the “fine details of molecular biology” in the court’s decision. “I am unable to affirm those details on my own knowledge or even my own belief,” Scalia said. Supreme Court rules against patents on genes found in the human body ­ 6
WASHINGTON — The Supreme Court said Thursday that no company or person can get patent rights over genes found in the human body. This decision could make it easier for scientists and businesses to do more genetic research. Genes matter because they determine things like eye color and hair color. They can also determine whether you're at risk of a disease like diabetes or cancer. All nine judges agreed on the decision. They said that nobody can get a patent on natural human genes. Patents give a person or company the right to be the only one who can make, use or sell something. The government normally gives patents to inventors for their creations. The company involved in the case is Myriad Genetics, which does research on genes. The court decision said Myriad should not have been allowed to claim a patent on two genes found in the body. The patents involved the genes that indicate a high risk of breast or ovarian cancer. Patients can get tested to see if they have the gene type related to the cancers. Having these patents helped Myriad earn big profits. Since no other company could screen for those genes, Myriad could charge a higher price for its test. Ruling Affects Gene Research The ruling was mixed for businesses that use genes to make drugs and other treatments for diseases. The court's statement that genes found naturally in the body could not be patented was bad for the businesses. But the court said there was a difference between genes found in the human body and those created in the lab. Patents may be given for genes that are made in labs and not found in nature. Justice Clarence Thomas wrote the opinion for the court. Scientists who felt limited by Myriad’s patents sued. Lawyer Sandra S. Park represented them. “We are thrilled,” Park said. “The question before the court was a simple one," but it affects lots of research in deep ways. The ruling means that it will be easier for other companies to develop cancer­testing tools. Park said the ruling also could affect patents that have been issued for about 4,000 other genes. The cost of genetic testing should fall because of the ruling, scientists said. Genes Made In Lab Can Be Patented Myriad officials focused on the parts of the court’s decision that it found favorable. The company stressed how the court agreed that genes made in a lab could still be patented. The scientific methods used in finding genes also can be patented. About 22,000 genes make up the human genome. This is how traits are passed on from one generation to the next. Genes must be removed from the body and isolated in order to be studied and used. Myriad used tools to find the genes that make women more likely to have certain cancers. Scientists called these the BRCA1 and BRCA2 genes. The average American woman has a 12 percent risk of developing breast cancer. Women with abnormal BRCA face a risk as high as 85 percent. Actress Angelina Jolie tested positive for the BRCA genes. She recently decided to have an operation to remove both breasts. The operation will greatly reduce her risk of the cancers. Myriad has been able to charge about $3,300 for its tests for breast cancer. The company said that insurance pays for the tests for most patients. The patents made it hard for other scientists to work with the genes. Finding A Balance Lawyer Vernon Winters said that the court’s decision has limits. Scientists can still try to get patents. They can get them for specific ways of working with genes. Attorney Barbara Rudolph said that it was “hard to predict” how the decision will affect companies and inventors. Patents encourage people to invent, but they can also be a roadblock to more research. The court wanted to try to find balance between the two sides. Justice Antonin Scalia's one­paragraph opinion showed how scientifically complicated the case was. He noted the “fine details of molecular biology” in the court’s decision. Scalia said he didn't have enough knowledge of his own about those details to say if they were true. Supreme Court rejects idea of patenting natural human genes ­ 12
WASHINGTON — The Supreme Court ruled Thursday that naturally occurring human genes may not be patented, potentially opening up commercial and scientific terrain to more freewheeling exploration. In a unanimous decision that is a mixed bag for the multibillion­dollar pharmaceutical and biotechnology industries, the court distinguished between genes found in the human body and those created in the lab. “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” Justice Clarence Thomas wrote for the court. At the same time, Thomas and his fellow justices determined that so­called “complementary DNA,” which is synthetic, is “patent eligible because it is not naturally occurring.” The 18­page decision in the closely watched case rejects several patent claims filed by a Utah­based company called Myriad Genetics. Myriad obtained patents, and with them a profitable monopoly, on the exact location of two genes associated with a higher risk of developing breast or ovarian cancer. Individual scientists who felt constrained by Myriad’s patents sued, along with a group called the Association for Molecular Pathology. “We are thrilled,” said American Civil Liberties Union attorney Sandra S. Park, who argued the case. “The question before the court was a simple one, but it had profound consequences.” The ruling Thursday means that competing firms now have a freer hand in developing cancer­testing tools that involve the genes for which Myriad held the patents. More broadly, Park said the ruling could call into question the validity of patents that have been issued for about 4,000 other human genes. “As a result of this, the cost of genetic testing should come down significantly,” said Dr. Harry Ostrer, a medical geneticist at the Albert Einstein College of Medicine who challenged Myriad’s patents. “I think we will see a much more level playing field. It will drive down costs and improve quality.” Park added that the court’s reasoning perhaps could be applied to challenges of patents that have been issued for non­human isolated genes as well. Myriad officials accentuated the positive in the court’s decision, stressing how the court agreed that lab­synthesized genes, dubbed cDNA, still may be patented, as may the scientific methods used in isolating genes. “We believe the court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our (gene) test moving forward,” Peter D. Meldrum, Myriad’s president and CEO, said in a statement. Meldrum added that “more than 250,000 patients rely upon” the company’s genetic testing. Myriad’s general counsel, Richard M. Marsh, elaborated in an interview that the ruling wouldn’t have any “material impact on our operations” because of the company’s reservoir of other patents and inventions. A gene is a segment of DNA. It defines physical traits, such as eye color and sex, and can influence whether an individual develops conditions such as ​
obesity​
, diabetes and Alzheimer’s disease. About 22,000 genes make up the human genome, the basis of human inheritance. Genes must be removed from the body and isolated in order to be studied and utilized. Scientists with Myriad, a company based in Salt Lake City that had revenues of $496 million last year, used mapping tools to identify the genes associated with mutations that predispose women to breast and ovarian cancers. Scientists called these the BRCA1 and BRCA2 genes. The average American woman has a roughly 12 percent lifetime risk of developing breast cancer. Women with BRCA mutations, though, face a cumulative risk of up to 85 percent. Actress Angelina Jolie, for instance, elected to have a double mastectomy recently after she tested positive for the BRCA genes. Myriad obtained a number of patents relating to the isolated BRCA genes. “Groundbreaking, innovative or even brilliant discovery does not by itself satisfy that (patent) inquiry,” Thomas said, adding that while “Myriad found the location” of the genes, that discovery by itself didn’t render the genes “new compositions of matter” that were patent eligible. Myriad has been able to charge about $3,300 for its genetic­based tests for breast cancer, although the company notes that insurance covers most patients. Other scientists, meanwhile, have been limited in their ability to work with the genes. Intellectual property attorney Vernon Winters, who is with the San Francisco Bay Area offices of the Sidley Austin law firm, stressed that the court’s decision is limited in that it doesn’t disturb “method claims for manipulating genes or DNA” or “claims for new and specific applications for DNA sequences, as opposed to the isolated sequences themselves.” Barbara Rudolph, an intellectual property attorney in the Washington office of the Finnegan law firm, said in an interview that it was “hard to predict” how the decision would play out for companies and inventors, though she suggested that it was “a winner” for biotech firms that specialized in lab­synthesized cDNA, which remained patent eligible. Rudolph added that the court sought to balance whether patents serve as an incentive or an impediment to invention. Underscoring the scientific complications of the case, Justice Antonin Scalia issued a one­paragraph concurring opinion in which he noted the “fine details of molecular biology” in the court’s decision. “I am unable to affirm those details on my own knowledge or even my own belief,” Scalia said. 
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