Gene Ruling Could Have Broad Reach

[jimmy olsen]

Awesome. When I saw the headline I was prepared for the worst but I was pleasantly surprised.

http://online.wsj.com/article/SB10001424052702303601504575154172950757694.html?mod=googlenews_wsj

Gene Ruling Could Have Broad Reach

By SHIRLEY S. WANG, NATHAN KOPPEL And GAUTAM NAIK

A federal judge's decision Monday to strike down several patents on human genes could ultimately be a boon for genetic research and a benefit for public health, medical experts said.

The ruling adds legal weight to the argument by some geneticists and others that companies and institutions shouldn't be allowed to patent basic genetic information that makes people human.

The ruling by U.S. District Judge Robert Sweet invalidated seven patents covering the BRCA1 and 2 genes linked to hereditary forms of cancer that were licensed exclusively to Myriad Genetics Inc., Salt Lake City, by the University of Utah Research Foundation. Myriad says it plans to appeal.

The decision's near-term impact on companies that develop and market gene-based tests and treatments is likely to be limited, in part because most rely on patents that protect their drugs, not specific gene sequences.

And Peter Meldrum, Myriad's chief executive, said the litigation involves only seven of the company's 23 patents related to BRCA genes.

Patents for human genes, or DNA sequences found in the body, have been controversial since they were first issued. According to U.S. law, products of nature cannot be patented because they are pre-existing substances found in the wild.

"The idea that our ability to look at them, to analyze them, to utilize them would be constrained by the issue of a patent strikes many people viscerally," said James Evans, chairman of a federal task force on the effect of gene patents on diagnostics and patient care. "Genes represent something we see as quite fundamental to who we are."

When companies hold exclusive licenses for human genes, competition to develop gene-based applications can be restricted, prices inflated and innovation slowed, some geneticists say.

Academic research has also been impeded, though to a lesser extent, by companies who want to protect their intellectual property, they add.

"If this decision is upheld, it in the end is a win for patients and providers," said Dr. Evans, also a medical geneticist at the University of North Carolina, Chapel Hill.

Biotech companies say that if they are making a scientific advance, they should be able to protect both their intellectual property and financial investment.

Federal law does allow genes to be patented if they are isolated from the body, purified and turned into something useful. Myriad's BRCA test, for example, involves isolating the BRCA1 and 2 genes and using them as the basis for a diagnostic test to assess potential risk of breast and ovarian cancer. The test looks for alterations in a particular patient's own BRCA genes to assess the cancer risk.

While the courts have long backed the idea of gene patents, rapid advances in technology are prompting scientists and many intellectual-property experts to rethink their support for them. Modern gene-sequencers and other machines have made the task of identifying genes—and even figuring out their function—much easier than before.

In addition, science increasingly is showing that combinations of genes are critical to defining risk of disease. Exclusive licensing of gene patents may be slowing down advances in this area of medicine.

GeneDx, a Maryland-based subsidiary of Bio-Reference Laboratories Inc. that provides genetic testing for rare disorders, says getting approval from holders of exclusive gene patents makes developing multi-gene diagnostic tests especially difficult.

"We'd like to get out of the worrying about patents and licensing for diagnostics," said John Compton, GeneDx co-president. "Our stance is that exclusive licenses on genes is dramatically against the public-health interest."

Lawyers say the ruling could give rise to challenges over patents that cover the links between genetic sequences and various medical conditions, such as hearing loss and Alzheimer's disease.

Judge Sweet's ruling, lawyers say, reflects a broader trend of judges taking a more skeptical view about whether certain subject matters can be patented.

Last year, in a pending U.S. Supreme Court case, many of the justices on the court expressed skepticism about whether there should be broad patent protection for financial strategies and other methods of doing business.
—Jennifer Cummings contributed to this article.

[grumbler]

I think it is silly to suppose that one can patent things that one did not develop.  The company that was being sued was charging $3000 for tests for rare genetic defects.  The tests cost less than $300 to administer, but the patent made the testing a monopoly.  That's extortion, not commerce, in my mind.

[Jaron]

Do these genes make me look fat?

[citizen k]

Do these genes make me look fat?

It's your lifestyle. 

[DontSayBanana]

If the companies had been smart enough to, instead of trying to patent the genes themselves, patent their process for isolating them, this would be a non-issue.

[grumbler]

If the companies had been smart enough to, instead of trying to patent the genes themselves, patent their process for isolating them, this would be a non-issue.

The process for isolating them is done in universities. 
What companies can do (as they always could) is patent the process for testing and treating genetic defects.  That's all the companies actually have developed.

[The Minsky Moment]

Let's wait and see what the Federal Circuit has to say before getting too excited.

[DontSayBanana]

The process for isolating them is done in universities. 
What companies can do (as they always could) is patent the process for testing and treating genetic defects.  That's all the companies actually have developed.

I'll concede half that point.  To the other, some companies do in fact still have R&D departments.  You know what happens when you assume.

[The Minsky Moment]

Dennis Crouch at the Patently-o blog thinks that the Fed Circuit will reverse and the case will end up at the Supreme Court:

http://www.patentlyo.com/patent/2010/03/court-essentially-all-gene-patents-are-invalid.html

[jimmy olsen]

The Supreme's have ruled

Looks like a good decision.
http://usnews.nbcnews.com/_news/2013/06/13/18937571-patients-industry-both-winners-in-supreme-court-dna-ruling

Patients, industry both winners in Supreme Court DNA ruling

NBC's Pete Williams shares details on the Supreme Court's unanimous decision that says human genes cannot be patented, but Synthetic DNA is patentable.
By Maggie Fox, Senior Writer, NBC News

Patients, researchers and industry all claimed victory Thursday when the Supreme Court ruled that human DNA cannot be patented, opening the door for dozens of scientists and others trying to market newer and better tests to tell people about their risks for a range of illnesses from cancer to heart disease. 

But the unanimous ruling left in place protections for the biotechnology industry and methods used to make drugs based on engineered DNA.

The ruling clearly invalidated Myriad Genetics' most controversial patents on tests for mutations in the BRCA1 and BRCA2 genes that raise the risk of breast, ovarian and other cancers. But it did not go so far as to remove patents on artificial DNA, which is not widely used in genetic testing, but is used in other biotechnology applications.

"We just are so glad that women and our genes are not being held hostage by a private corporation any more," said Lisbeth Ceriani, a Massachusetts breast cancer survivor who is one of the plaintiffs in the suit.

The researchers whose lawsuit prompted the decision were also celebrating. They say it will make genetic tests cheaper and far more widely available in the future.

"I think it changes everything," Dr. Harry Ostrer, a genetics expert at Albert Einstein College of Medicine in New York and one of the main plaintiffs in the case, told NBC News.

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"I think this is a green light for us to go ahead with our testing."

Patients will benefit, said Dr. Ossama Tawfik an expert in breast cancer pathology at the University of Kansas Medical Center and a member of the American Society for Clinical Pathology. "I know the costs of these tests will be considerably lower without patent protection, allowing more women at risk to be tested," Tawfik said in a statement.

The American Civil Liberties Union, which backed Ostrer in the suit, said many more patents on genetic tests may also fall. "Obviously, we are thrilled with the decision, " said the ACLU's Sandra Park.

"This ruling is a victory," Park told reporters in a conference call.

Ostrer, the ACLU and others sued Myriad Genetics over the company's strict enforcement of its patents on BRCA1 and BRCA2.  Ostrer said the company's legal threats have kept researchers like himself from making and distributing DNA tests that can test multiple genes at a time to tell someone their cancer risk.

"You won't need to get prior approval from Myriad Genetics to have the BRCA1 and 2 results reported," Ostrer said.

The Court ruled that natural DNA cannot be patented, and that no matter how clever Myriad was in finding the particular gene mutations it did, or in removing and copying that DNA to make a test, it cannot claim a patent on the DNA itself.

The unanimous ruling makes a point of saying Myriad's patent was on a product, not a method.  "Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent," reads the ruling, written by Justice Clarence Thomas. But it used well-known and reported methods.

Ostrer says what the ruling does is protect other aspects of the biotech industry -- those that use artificial and engineered DNA to make drugs, for instance. "The biotech industry had expressed a lot of concern that they would lose out," Ostrer said.

Myriad claimed victory, also, saying the court's ruling on artificial DNA upheld the company's claims. "Following today's decision, Myriad has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test," the company said in a statement. Myriad also disputed that the test was too expensive.

"As a result of the Affordable Care Act, the vast majority of at-risk patients can receive BRCA analysis testing with no out-of-pocket costs — meaning no co-pays or deductibles. Additionally, more than 35,000 at-risk patients in need have participated in Myriad's patient assistance programs that provide free tests or other financial assistance," the company said.

The 2010 health care law says health insurance companies must pay for cancer screening without charging patients any co-pay.

The researchers say the ruling does leave others free to develop their own tests for breast cancer risk, however. Since the Myriad tests came out, researchers have found dozens of other genes that influence breast cancer risk, as well as the risk for other cancers.

Myriad's earliest patents were set to run out over the next year or so and the company has been preparing for this. Wall Street investors have also taken this into account, and Myriad's share rose after the decision was handed down.

Kevin Noonan, a partner at Chicago law firm McDonnell Boehnen Hulbert & Berghoff LLP, who specializes in the biotechnology industry, says many gene tests don't look at the entire gene anyway, any more. Newer tests can look at small bits of the the gene, just looking for the important mutations that affect cancer or other disease risk.

"If you don't get the whole gene isolated in a test tube, you don't infringe the claim," Noonan said.

Other companies have patented human genes, and those patents could be challenged one by one. "Perhaps a quarter or even more of human genes have been patented," Ostrer said.

But Roger Klein, of the Association for Molecular Pathology, another one of the plaintiffs in the suit, said it's more likely that researchers will just ignore the patents, knowing the companies won't be able to enforce them.
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"This testing is very, very important. People make extremely important, life-changing  decisions based on the testing," Klein said.

Among them was actress Angelina Jolie, who made headlines in May when she said she'd had both breasts removed and would have her ovaries removed soon because of her high genetic risk of both cancers.

"Having gone through the devastating experience of making life-altering decisions based on the results of one test, I believe that the Supreme Court's decision is a victory for everyone who believes that a company cannot patent parts of our body," said U.S. Rep. Debbie Wasserman Schultz, a Florida Democrat who was diagnosed with breast cancer in 2007.

"Despite the fact that we're all born with these genes, a private company had patented them. These patents had broad practical ramifications, preventing competition in testing for the gene mutations, second opinion testing, and restricting access to data on testing results for other researchers."

[11B4V]