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The Supreme Court grapples Monday with the question of whether human genes can be patented. Its ultimate answer could reshape U.S. medical research, the fight against diseases like breast and ovarian cancer and the multi-billion dollar medical and biotechnology business.
"The intellectual framework that comes out of the decision could have a significant impact on other patents - for antibiotics, vaccines, hormones, stem cells and diagnostics on infectious microbes that are found in nature," Robert Cook-Deegan, director for genome ethics, law & policy at Duke University, said in a statement.
"This could affect agricultural biotechnology, environmental biotechnology, green-tech, the use of organisms to produce alternative fuels and other applications," he said.
The nine justices' decision will also have a profound effect on American business, with billions of dollars of investment and years of research on the line. The U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years.
And Myriad Genetics alone has $500 million invested in the patents being argued over in this case. Without the ability to recoup that investment, breakthrough scientific discoveries needed to combat all kind of medical maladies wouldn't happen, the company says.
"Countless companies and investors have risked billions of dollars to research and develop scientific advances under the promise of strong patent protection," said Peter D. Meldrum, the president and CEO of Myriad Genetics, in a statement.
But their opponents argue that allowing companies like Myriad to patent human genes or parts of human genes will slow down or cripple lifesaving medical research like in the battle against breast cancer.
"What that means is that no other researcher or doctor can develop an additional test, therapy or conduct research on these genes," said Karuna Jagger, executive director of Breast Cancer Action.
The Supreme Court has already said that abstract ideas, natural phenomena and laws of nature cannot be given a patent, which gives an inventor the right to prevent others from making, using or selling a novel device, process or application.
Myriad's case involves patents on two genes linked to increased risk of breast and ovarian cancer. Myriad's BRACAnalysis test looks for mutations on the breast cancer predisposition gene, or BRCA. Those mutations are associated with much greater risks of breast and ovarian cancer.
Women with a faulty gene have a three to seven times greater risk of developing breast cancer and a higher risk of ovarian cancer. Men can also carry a BRCA mutation, raising their risk of prostate, pancreatic and other types of cancer. The mutations are most common in people of eastern European Jewish descent.
Myriad sells the only BRCA gene test.
The American Civil Liberties Union challenged Myriad's patents, arguing that genes couldn't be patented, and in March 2010 a New York district court agreed. But the U.S. Court of Appeals for the Federal Circuit has now twice ruled that genes can be patented. In Myriad's case, it's because the isolated DNA has a "markedly different chemical structure" from DNA within the body.
Mark C. Capone, president of Myriad Genetics Laboratories, Inc., a subsidiary of Myriad, said some of the concerns over what they have patented are overblown and some simply incorrect.
"Myriad cannot, should not and has not patented genes as they exist in the human body on DNA," Capone said in an interview. "This case is truly about isolated DNA molecules which are synthetic chemicals created by the human ingenuity of man that have very important clinical utilities, which is why this was eligible for a patent."
But the ACLU is arguing that isolating the DNA molecules doesn't stop them from being DNA molecules, which they say aren't patentable.
"Under this theory, Hans Dehmelt, who won the Nobel Prize for being the first to isolate a single electron from an atom, could have patented the electron itself," said Christopher A. Hansen, the ACLU's lawyer in court papers. "A kidney removed from the body (or gold extracted from a stream) would be patentable subject matter."
The Obama administration seems to agree. Artificially created DNA can be patented, but "isolated but otherwise unmodified genomic DNA is not patent-eligible," Solicitor General Donald Verrilli said in court papers.
That was the ruling of the original judge who looked at Myriad's patents after they were challenged by the ACLU in 2009. U.S. District Judge Robert Sweet said he invalidated the patents because DNA's existence in an isolated form does not alter the fundamental quality of DNA as it exists in the body or the information it encodes. But the federal appeals court reversed him in 2011, saying Myriad's genes can be patented because the isolated DNA has a "markedly different chemical structure" from DNA within the body.
The Supreme Court threw out that decision and sent the case back to the lower courts for rehearing. This came after the high court unanimously threw out patents on a Prometheus Laboratories, Inc., test that could help doctors set drug doses for autoimmune diseases like Crohn's disease, saying the laws of nature are unpatentable.
But the federal circuit upheld Myriad's patents again in August, leading to the current review. The court will rule before the end of the summer.
"The key issue now for the court will therefore be whether the scientist working in the lab to isolate a particular gene innovated in a way that allows for that isolated gene to be patented," said Bruce Wexler, a lawyer with the law firm Paul Hastings, who advises pharmaceutical and biotech companies on patent issues.
The case is 12-398, Association for Molecular Pathology v. Myriad Genetics, Inc.
© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
He let out a deep sigh and struggled to contain his emotions - the thoughts of Greg Norman, the folks Down Under, the dad he hugged so tight alongside the 10th green.
It sure felt a lot different than the last time Scott was summoned to the media room at the end of a major championship.
That was Lytham, where he had to answer for throwing away a seemingly sure victory in the British Open with bogeys on the last four holes.
This was Augusta, where he reveled in the biggest win of his career Sunday evening.
Less than eight months apart, everything changed.
Now, he's Adam Scott, major champion.
"What an incredible day," he said. "Everything fell my way in the end. You just never know."
Using one of those big putters, Scott became the first Australian to win the Masters, beating Angel Cabrera on the second hole of a stirring playoff played in a steady rain and dwindling light, finally settling down in the hollow that is the 10th green, amid the towering Georgia pines.
Cabrera's 15-foot putt rolled up right next to the hole and stopped. When Scott's 12-footer dropped in the cup, he pumped his arms furiously and screamed toward the gray, darkening sky - quite a celebration for a guy who's always been accused of being a little too laid-back.
No one would've said that on this day.
"I was pumped," he said.
For Scott, this victory was sweet on so many levels.
Certainly, there was a measure of payback for what happened last July at the British Open, where Scott played beautifully for three days and 14 holes and seemed to have a stranglehold on the claret jug. Then he bogeyed the 15th hole. And the 16th. And the 17th. And, stunningly, the 18th, surrendering the title to Ernie Els.
Scott handled the staggering defeat with amazing grace, vowing to somehow "look back and take the positives from it." But no one knew if he might go the way of Ed Sneed or Jean Van de Velde, golfers who threw away majors and never came close to winning another.
For Scott, there are no such worries.
Lytham is redeemed.
"Golf gives," Cabrera said, "and golf takes."
No one knows that more than Norman, a runner-up three times at Augusta National, a third-place finisher three other times, but never a winner. This one was for him, too.
"He inspired a nation of golfers," Scott said. "Part of this is for him because he's given me so much time and inspiration and belief. I drew on that a lot."
In a grander scheme, this victory was for an entire continent. Australia has produced some greats of the game over the last half-century but never a Masters champion. Until now.
They're on top of the world Down Under.
"We are a proud sporting nation and like to think we are the best at everything," Scott said with a mischievous grin. "This is the one thing in golf that we had not been able to achieve. It's amazing that it's my destiny to be the first Aussie to win."
Norman was so nervous watching TV at his home in south Florida that he went to the gym when the final group made the turn. He returned for the last four holes and was texting with friends as his emotions shifted with every putt. Coming down the stretch, three Aussies - Scott, Jason Day and Marc Leishman - actually had a chance to win.
Scott brought it home.
"I'm over the moon," Norman told The Associated Press. "Sitting there watching Adam, I had a tear in my eye. That's what it was all about. It was Adam doing it for himself, and for the country."
For Cabrera, a burly, 43-year-old from Argentina, the majors have been a big giver. His last victory on the PGA or European tours before Sunday? The 2009 Masters. Before that? The 2007 U.S. Open.
In other words, Cabrera doesn't win often, but when he does, it's usually a pretty significant victory.
He almost got another one, trying with Scott in regulation at 9-under 279.
"I had a lot of peace of mind and I was very confident," said Cabrera, who closed with a 2-under 70. "I knew that it depended on me. I knew that (the other contenders) can make some birdies, but I still was thinking that it depended on me."
Cabrera made the turn with a two-stroke lead but stumbled on the back nine, knocking his drive behind the pine trees at the 10th and then sending his ball into Rae's Creek on the 13th, leading to bogeys at both. But a birdie at the 16th gave him a shot, and he struck what might've been the best - well, certainly the most clutch - shot of the day at the 72nd hole after Scott, playing just ahead in the penultimate group, rolled in a 20-footer for birdie and a one-stroke lead.
"For a split-second, I let myself think I could have won," said Scott, who certainly celebrated like his 69 was good enough.
Not so fast.
Cabrera stuck a 7-iron from 163 yards to 3 feet, leaving a gimme of a putt to force the playoff. Scott was watching a television in the scoring area.
"I got to see Angel hit an incredible shot," Scott said. "Then it was try to get myself ready to play some more holes."
They went back to the 18th tee box for the first playoff hole. After matching drives and approach shots, both rolling off the front of the green, Cabrera chipped over Scott's ball and nearly put it in the cup. Scott pitched to 3 feet, both made their putts and the playoff moved on to No. 10.
Again, two more booming drives and two more nifty approaches, leaving them both with a good shot at birdie.
If Cabrera's ball had turned one more time, they might've been returning to the course Monday to finish up.
When it didn't, Scott was determined to end things before nightfall.
"Had to finish it," he said.
Scott got a big assist on the winning putt from his caddie, who knows a thing or two about winning at Augusta. Steve Williams was on the bag for 13 of Tiger Woods' 14 major titles, a close friend to the world's top-ranked golfer before Woods' personal life fell apart. Williams was among those cut loose in the aftermath, a bitter split that made this victory about as satisfying to him as it was Scott.
Especially after Scott turned to Williams to get a read on the putt.
"I could hardly see the green in the darkness," the golfer said. "He was my eyes on that putt."
Scott told Williams he thought the right-to-left break would be about the width of a cup. Williams set him straight.
"It's at least two cups," the caddie said. "It's going to break more than you think."
Scott took the advice.
A short time later, he was trying on a green jacket.
"The winning putt was the highlight putt of my career," Williams said, "because he asked me to read it."
For his former boss, there was more major misery. Woods was at the center of a firestorm for an improper drop during the second round, which led to a two-stroke penalty and complaints that Woods had actually gotten off easy, because he could've been disqualified for signing an improper scorecard.
Four strokes behind going to the final round, Woods struggled with the speed of the greens on the first eight holes - they weren't nearly as quick because of the rain - and was too far behind by the time he got something going. He finished with a 70 and tied for fourth, four shots out of the playoff.
"I played well," he said. "Unfortunately, I just didn't make enough putts."
Day seized the lead with three straight birdies through the middle of the back side, but he couldn't hold on. A curious decision to putt through 12 feet of fringe behind the 16th green led to a bogey, and he surrendered another stroke after failing to get up-and-down from the bunker at the 17th. He finished with a 70 and two shots back at 281.
"I think the pressure got to me little bit," Day said.
Scott didn't let it get to him, even when he couldn't get any putts to fall early in the round with that big stick of his, which have become all the rage in the majors. He finally caught a break at the 13th, when his approach rolled back off the green, but stopped short of the creek. He wound up making a birdie, which gave him the spark he needed.
"I had no momentum on the day at that point," Scott said. "That was a great break. And everyone who wins gets those kind of breaks."
After Lytham, he sure had it coming.
--- Follow Paul Newberry on Twitter at HTTP://WWW.TWITTER.COM/PNEWBERRY1963 © 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
Too bad for them, the bullpen didn't fare so well. The Milwaukee Brewers rallied late and Jonathan Lucroy's home run in the 10th inning gave them a 4-3 win.
Garcia pitched seven innings of shutout ball, working around seven hits and two walks.
"As Jaime pitched as well as he did, it's tough to see it end that way," St. Louis manager Mike Matheny said.
The Brewers had gone a team-record 32 innings without scoring before Ryan Braun hit a two-run homer off reliever Trevor Rosenthal in the eighth that made it 3-2.
Braun's second home run of the season snapped a 39-inning shutout streak for St. Louis pitchers. The Brewers had not scored since the second inning Tuesday against the Cubs.
Matheny would have preferred to let the Cardinals closer for now, Mitchell Boggs, pitch the ninth with a cushion. But after Braun connected off Rosenthal, he did not have that luxury.
"The situations you get put into, you got to figure out a way to get out of them," Matheny said.
Milwaukee tied it in the ninth on a leadoff single by Carlos Gomez and an RBI double by Yuniesky Betancourt. Boggs left without retiring a batter and blew his second save in five chances.
"Days like today are tough," Boggs said. "I'm not going to stand here and act like it doesn't affect me, because I care. I wanted to help us win a ballgame today. I didn't do that. If you're a professional, you show up the next day and do your job."
After retiring Rickie Weeks on a fly to start the 10th, Fernando Salas (0-2) gave up Lucroy's first home run of the season.
Brandon Kintzler (1-0) pitched a scoreless ninth and got the first out in the 10th. Burke Badenhop retired pinch-hitter Carlo Beltran on a grounder for the final out and his first save.
Adams had another big day in the loss, hitting a home run and a single. He has homered in three straight games and has a hit in all five games he has played.
Adams is batting .611 (11-for-18) with three homers and eight RBI.
"I'm seeing it well, and feeling good at that plate," Adams said. "It all comes back to the work I'm getting in the cage before the game and making sure I watch the video and I'm prepared."
Matt Holliday had an RBI single and Yadier Molina an RBI double for the other St. Louis runs.
The Cardinals broke through against Marco Estrada with four consecutive two-out hits in the third, including an RBI single by Holliday and an RBI double to the gap by Molina. Allen Craig was thrown out at the plate trying to score on Molina's hit.
Adams made it five straight hits when he led off the fourth with a 419-foot homer to center that made it 3-0.
NOTES: Molina received his fifth consecutive Gold Glove award before the game. ... On Saturday, Adam Wainwright became the first St. Louis pitcher with a shutout in which he struck out at least one batter in every inning since Bob Gibson accomplished the feat on June 17, 1970, at San Diego.
© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
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