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What the Supreme Court ruling means for you. A patent on your DNA ?

English: DNA replication or DNA synthesis is t...

English: DNA replication or DNA synthesis is the process of copying a double-stranded DNA molecule. This process is paramount to all life as we know it. (Photo credit: Wikipedia)

Animation of the structure of a section of DNA...

Animation of the structure of a section of DNA. The bases lie horizontally between the two spiraling strands. (Photo credit: Wikipedia)

Types of chromosomal mutations

Types of chromosomal mutations (Photo credit: Wikipedia)

Heredity - autosomal dominant (AD)

Heredity – autosomal dominant (AD) (Photo credit: Wikipedia)

Can someone else patent your genes? The Supreme Court is scheduled to rule some time this month on that question – a suit filed against Myriad Genetics for its patent on the BRCA1 and BRCA2 gene mutations, which raise the risk of breast, ovarian and certain other cancers.

Opponents of patenting human DNA say a ruling in favor of Myriad will mean companies can own your genes, even though experts say it’s more complicated than that. The patents set off a cascade of effects, opponents argue: it gives the company a monopoly on the test that can identify whether patients have the BRCA mutations so other companies can’t offer their own tests as a second opinion. There’s also no one to compete with the Myriad’s $3,000 price tag on the test.

Myriad has long argued that it’s not patenting anyone’s genes. Instead, the company says, it separates them from the rest of the DNA and creates lab-made copies — and that’s what is patented and used in the test. The company has also licensed a few medical centers to run second-opinion tests.

But some say that regardless of how the court decides, it’s likely the average person won’t really be affected in any obvious, immediate way. Myriad’s first 20-year patent on the genes runs out next year, although patent experts say the company has a variety of opportunities to extend that by a few years.

“Even if the patents are thrown out today, that doesn’t make the test available” since it would take time for other companies to develop a test, said John Conley, a law professor at the University of North Carolina who’s taken a special interest in the case. “The patents are going to expire before any competitors could come into the field anyway.

“This case would have been a lot more important had it been decided 10 or 12 years ago,” he added. “A lot of things have happened in law  and science since then.”

The science has now moved far beyond the clunky, whole-gene sequencing method that Myriad uses so it’s becoming less relevant. Companies can now sequence your entire genome for you, and in a few years they might even be able to interpret the information in a meaningful way.

Others are working from the opposite end – breaking the DNA sequences up into smaller, more digestible bits for analysis.

Myriad, the University of Utah and the U.S. government’s National Institute of Environmental Health Sciences filed an application for the first patent on the BRCA gene mutations in 1994. The Patent and Trademark Office granted the patent on BRCA1 mutations in 1997. Another patent, on BRCA2, was granted in 1998.

In the years since, it’s become clear that dozens and dozens of mutations affect a person’s breast cancer risk, and each patient has his or her own combination. But Myriad’s test remains a very important one, and its role was highlighted last month when actress Angelina Jolie said she’d had both breasts removed after finding out that her genetic inheritance gave her an 83 percent chance of developing breast cancer.

Myriad’s been strict in protecting its patents and access to the test for the most significant breast and ovarian cancer mutations. The Association for Molecular Pathology and American Civil Liberties Union led a batch of lawsuits asking that no one be allowed to patent human genes. Supreme Court

“Myriad has a patent on the BRCA1 and BRCA2 genes themselves. If Myriad had simply patented a test, then other scientists and laboratories could offer alternative testing on these genes,

“But because it has patented the genes themselves, Myriad has the right to control all research and testing on or involving the BRCA genes.”

Myriad denies this. “No one can patent anyone’s genes. Genes consist of DNA that is naturally occurring in a person’s body and as products of nature are not patent able,” the company says on its website.

“In order to unravel the mysteries of what genes do, researchers have had to separate them from the rest of the DNA by producing man-made copies of only that portion of the gene that provides instructions for making proteins (only about 2 percent of the total DNA in your body). These man-made copies, called ‘isolated DNA,’ are unique chemical compositions not found in nature or the human body.”

The lawsuits say this is splitting hairs, since to do anything with human genes you first have to make copies of the DNA. “A disease-causing mutation means the same thing for the patient irrespective of whether a gene is examined inside or outside the patient’s body,” said Mary Williams, executive director of the Association for Molecular Pathology.

This is one of the decisions the Supreme Court is going to have to make.

In oral arguments in April, Supreme Court Justice Sandra Sotomayor asked if DNA was akin to the flour, sugar and other ingredients used in baking. Gregory Castanias, Myriad’s lawyer, said an analogy to a baseball bat was more like it. “A baseball bat doesn’t exist until it’s isolated from a tree,” he said. “But that’s still the product of human invention to decide where to begin the bat and where to end the bat.”

According to the ACLU, the patent office has granted patents on thousands of genes – adding up to 20 percent of all identified human genes. “A gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene. As a result, scientific research and genetic testing has been delayed, limited or even shut down due to concerns about gene patents,” it argues.

While a Supreme Court ruling against Myriad wouldn’t automatically affect the other patents, says ACLU lead attorney Sandra Park, other companies would be unlikely to try to enforce theirs any longer. “If they do seek to enforce, then that patent could be challenged in court citing to the ruling against Myriad,” she said.

A ruling against Myriad would make genetic testing cheaper and more available, says Dr. Harry Ostrer, director of the Molecular Pathology Laboratory at Montefiore Medical Center in New York, and one of the individuals involved in the suit.

“It’ll give people more choices with regard to genetic testing,” he told NBC News. “It won’t be a question of Myriad’s way or no way. I think it’ll drive down the cost of genetic testing. It will help to contain the cost of health care and hopefully will increase the utilization of genetic testing.”

Most Americans who might get genetic tests are covered by health insurance. The tests have to be ordered by doctors, and people without health insurance are far less likely to see a doctor in the first place. Few people are paying for these tests out of pocket, and few would notice any effects from the ruling.

Science is already changing how doctors use patients’ genetic information, in far more profound ways than a patent will affect.

That said, the ACLU says Myriad’s enforcement of its patent rights have held up development of lifesaving cancer therapies that target a patient’s specific genetic mutations – an experimental class of drugs called PARP inhibitors is an example. The Food and Drug Administration requires approval of the gene test that goes with the associated targeted therapy, and Myriad hasn’t sought that approval.

“Patents on the BRCA genes have stopped laboratories from providing testing that include analysis of those genes with other genes connected to breast and ovarian cancer risk. University of Washington wants to offer such testing to patients, but cannot, due to the patents,” Park adds.Ostrer says his lab is working on a comprehensive, one-step test for people wanting to know their full genetic breast cancer risk.

“We would like to develop a genetic analysis where we sequence not only BRCA1 and BRCA2 but all other genes that raise the risk of breast cancer,” Ostrer says.

Robert Cook-Deegan, a public-policy professor at Duke University’s Institute for Genome Sciences and Policy, says that’s where the market is headed, anyway. “The writing on the wall is quite clear. It makes no sense right now to be testing for just two genes,” he said.

Only a small percentage of the population needs to worry about the BRCA genes, Cook-Deegan noted. “It’s somewhere, at the most, 5 percent to 10 percent of people who get those cancers because of inherited risk,” he said.

And Cook-Deegan says other court rulings have made it clear that previous patents on genetic material were too broad. “I think it does matter what court says and how broadly it says it,” Cook-Deegan said. It will affect not patients, but business decisions about getting into the genetic testing market, he predicted.

Conley says Myriad’s made it clear that it’s moving beyond the idea of holding and guarding a patent and gene test as a business model.

“Myriad executives have made public comments about new business enterprises in Europe that are going to rely on databases, not patents,” Conley said. “There aren’t many companies that are situated just like Myriad is now, with a large business based on one or a couple of single gene patents. It’s pretty unique.”

Twenty years of exclusive rights to genetic testing have given the company a lot of data. “They built up a huge database correlating gene mutations with health effects,” Conley noted.

For now, all sides have to sit tight. The Supreme Court is due to issue its ruling before it goes on summer recess at the end of the month, and for now, rulings are scheduled to come on Mondays, and possibly on Thursday, June 13. The Court’s been known to add days to its schedule, though – last year’s ruling on the constitutionality of the 2010 health reform law came on the last possible day.

Either way, the decision may call for a drink, says Ostrer. “I am planning to go drinking with my buddies from the ACLU once the ruling comes down,” he said.


Francis gets personal: ‘I didn’t want to be pope’

English: 2008 Christmas Urbi et Orbi by Pope B...

English: 2008 Christmas Urbi et Orbi by Pope Benedict XVI, Saint Peter’s Square, Vatican City. (Photo credit: Wikipedia)

English: Pope Benedict XVI in Italy

English: Pope Benedict XVI in Italy (Photo credit: Wikipedia)

English: VATICAN. With Pope Benedict XVI. Русс...

English: VATICAN. With Pope Benedict XVI. Русский: ВАТИКАН. С Папой Римским Бенедиктом XVI. (Photo credit: Wikipedia)

English: Pope Benedict XVI in St. Peter's Squa...

English: Pope Benedict XVI in St. Peter’s Square, Rome (2007). Polski: Papież Benedykt XVI podczas Audiencji Generalnej na Placu św. Piotra w Rzymie (2007). (Photo credit: Wikipedia)

Pope Francis smiles he listens to children reading out their message during an audience with students of Jesuit schools and institutions in Italy and Albania, at the Vatican, Friday, June 8, 2013. Francis is the first pope from the Jesuit order, which is known for its missionary zeal. (AP Photo/Andrew Medichini)

Pope Francis revealed Friday that he never wanted to be pope and that he’s living in the Vatican hotel for his “psychiatric” health.

Francis showed a personal and spontaneous side as he met with thousands of children from Jesuit schools across Italy and Albania. Tossing aside his prepared remarks, Francis surprised the kids by asking them if they’d like to ask him some questions instead.

“Yes!” they shouted to cheers and applause — and the concern of teachers who fretted that no one had prepared anything.

Answering their questions one by one, Francis told them the decision to become a priest had been difficult and that he had suffered “moments of interior darkness” when “you feel dry, without interior joy.”

But he said he went ahead because he loved Christ.

One of the most touching moments came when Teresa, a bright-eyed redhead no more than six, asked Francis flat out if he had wanted to be pope.

Francis joked that only someone who hated himself would ever want to be pope. But then he became serious: “I didn’t want to be pope.”

Someone else asked him why he had renounced the papal apartments in the Apostolic Palace in favor of his spare suite in the Vatican hotel, where he has been living ever since the March conclave that elected him the first Jesuit pope and first pontiff from the Americas.

Pope Francis speaks during an audience with students …

Pope Francis speaks during an audience with students of Jesuit schools and institutions in Italy and …

It wasn’t so much a question of luxury as personality, he said. “I need to live among people,” he said. “If I was living alone, isolated, it wouldn’t be good for me. A professor asked me the same question, ‘why don’t you go and live there (in the Papal apartments)’? And I replied: ‘Listen to me professor, it is for psychiatric reasons,'” he said chuckling.

This week, the Vatican confirmed that Francis wouldn’t vacation at the papal summer retreat at Castel Gandolofo, in the hills south of Rome, and would instead remain in the Santa Marta hotel with a reduced work schedule. Francis’ predecessors have all decamped for at least a few weeks each summer to the estate, where the lush gardens, lakeside perch and cool breezes provide a welcome respite to the oppressive summer heat of Rome. The estate, which by acreage is bigger than Vatican City, is entirely walled in, making it a perfect escape for a pope who wants isolation and solitude — but not one who wants to eat breakfast each morning with a group of fellow priests, as Francis does in the communal dining room of the Vatican hotel.

Francis has shown himself to be remarkably comfortable around children, taking up to an hour each Wednesday to greet mostly young people in the crowds at his general audience: He caresses and kisses the dozens of babies handed to him by his bodyguards; and he tousles the hair of older teens and pats them on the back, asking them to pray for him.

He showed a similar ease on Friday as he engaged in a good 30 minutes of banter with the schoolchildren, casually making the points he has made in his homilies and speeches: about the “scandal” of poverty and how the world frets when the stock market dips but cares nothing when a homeless person dies, and how everyone should learn a lesson from the poor.

Once or twice a year, Pope Benedict XVI would take questions from young people, but the questions were always submitted in advance so he could prepare a response.

The questions on Friday were clearly spontaneous. One little boy from Sicily asked Francis if he had ever visited Sicily. (No, Francis said, but he recently saw a beautiful film about the island.) A teacher from Spain asked the pope about “compromised” politicians. (Francis said all Christians had an obligation to be involved in politics.)

His final message to the kid was upbeat: “Don’t let anyone rob you of hope.”