Buy or Sell: "Court to decide if human genes can be patented."

Court to decide if human genes can be patented

By By JESSE J. HOLLAND, Associated Press – 9 hours ago

WASHINGTON (AP) — The Supreme Court announced Friday it will decide whether companies can patent human genes, a decision that could reshape medical research in the United States and the fight against diseases like breast and ovarian cancer.

The justices' decision will likely resolve an ongoing battle between scientists who believe that genes carrying the secrets of life should not be exploited for commercial gain and companies that argue that a patent is a reward for years of expensive research that moves science forward.

The current case involves Myriad Genetics Inc. of Salt Lake City, which has 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.

But the American Civil Liberties Union challenged those 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 because the isolated DNA has a "markedly different chemical structure" from DNA within the body.

Among the ACLU's plaintiffs are geneticists who said they were not able to continue their work because of Myriad's patents, as well as breast cancer and women's health groups, patients and groups of researchers, pathologists and laboratory professionals. "It's wrong to think that something as naturally occurring as DNA can be patented by a single company that limits scientific research and the free exchange of ideas," said Chris Hansen, staff attorney with the ACLU Speech, Privacy and Technology Project.

A call to a Myriad spokeswoman was not immediately returned, but in court papers the company's lawyers said without being able to patent and profit from their work, they would not be able to fund the type of medical breakthroughs doctors depend on. The company also said that deciding now that genes can't be patented would throw into chaos current research and profits structures for drug-makers and medical research companies, who have gotten more than 40,000 DNA-related patents from the Patent and Trademark Office for almost 30 years, according to court papers.

"Moving the goalposts of patent eligibility for these patents now would ... undermine the interests of the investing community: Clear and certain patent protection is critical to honor the interests of past investors, such as those who funded the research behind these inventions," the company said in court papers.

In 2010, a federal judge ruled that genes cannot be patented. 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 likely will hear the case in the early spring and rule before the end of the summer.

The case is 12-398, Association for Molecular Pathology v. Myriad Genetics, Inc.

http://www.google.com/hostednews/ap/article/ALeqM5jfkCnbrfJ4ENtIWFO-v4FjiWn7Hw?docId=10563d60f57440bab057b4ea1a3a90b1

Gene Patents Draw High Court Review in Biotechnology Test
By Greg Stohr and Susan Decker on December 01, 2012

The U.S. Supreme Court agreed to consider whether human genes can be patented, taking up an issue that has split the medical community and will shape the future of personalized health care and the biotechnology industry.

The justices yesterday said they will hear a challenge to Myriad Genetics Inc. (MYGN)’s patents on genetic material used in tests for breast and ovarian cancer. Doctors, researchers and patients are opposing the patents, arguing that Myriad’s monopoly over the genes is blocking clinical testing and research.

“Myriad and other gene patent holders have gained the right to exclude the rest of the scientific community from examining the naturally occurring genes of every person in the United States,” the group argued in its appeal, filed by the American Civil Liberties Union.

Biotechnology companies say they have been getting patents on genes for 30 years -- and can’t attract investment dollars unless they can protect their research from competitors. A study published in 2005 by Science magazine found that 20 percent of human genes had some level of patent protection.

Any move to change that system, “particularly with the deeply settled reliance interests of the technology and investing communities at stake, should be addressed to Congress, not the courts,” Salt Lake City-based Myriad argued in court papers that urged rejection of the appeal.

The nation’s highest court will hear arguments, probably in March, and rule by the end of June.
Isolated DNA

The central legal question is whether isolated DNA -- genetic coding that has been removed from the body and separated from other material -- is a product of nature and thus ineligible for patent protection. In largely backing Myriad’s patents, the U.S. Court of Appeals for the Federal Circuit said isolated DNA could be patented.

“The isolated DNA molecules before us are not found in nature,” Circuit Judge Alan Lourie wrote. “They are obtained in the laboratory and are man-made, the product of human ingenuity. While they are prepared from products of nature, so is every other composition of matter.”

Genes are encoded strands of nucleotides in different sequences that are responsible for inherited traits. In isolating genes, Myriad strips out unneeded information to home in on aspects that determine whether a person has a higher risk of breast and ovarian cancer.

The challengers say isolated DNA is identical to the coding that exists naturally in the body.

“Isolation simply makes a person’s genetic information more accessible for sequencing by medical professionals,” the group argued.
Myriad Falls

Myriad fell (MYGN) after the court’s announcement, dropping $1.13, or 3.8 percent, to $28.72 in Nasdaq Stock Market trading yesterday. It was the biggest one-day drop since July 31.

The case is making its second trip to the Supreme Court, which in March ordered the Federal Circuit to reconsider an earlier ruling favoring Myriad. The high court pointed to its just-issued decision limiting patents on some types of diagnostic medical tests. The Federal Circuit, which specializes in patent cases, then said that Supreme Court ruling didn’t apply to isolated DNA.

The Supreme Court in past cases has taken a more restrictive approach toward patent coverage than the Federal Circuit. In the diagnostic-test case, Justice Stephen Breyer wrote for a unanimous court in warning against “tying up the use of the underlying natural laws.”

****Continued in link****

http://www.businessweek.com/news/2012-11-30/gene-patents-draw-high-court-review-in-biotechnology-test