The struggle almost certainly will reach the U.S. Supreme Court.
For now, those fighting the case are waiting for a decision from the U.S. Court of Appeals for the Federal Circuit in Washington, which decides intellectual property issues.
A three-judge panel from the Federal Circuit heard argument in the dispute last week.
Besides the overarching issues, the facts in the case are these: Myriad Genetics of Salt Lake City holds patents for isolated DNA, covering gene mutations BRCA1 and BRCA2. When present, the mutations indicate a high possibility of developing breast and ovarian cancer. The patents also cover ways of isolating the genes to test for the presence of the mutation.
DNA, or deoxyribonucleic acid, contains the genetic instructions -- or information -- that determine the development of living organisms.
A suit challenging the patents says Myriad's diagnostic analysis makes it impossible for women to confirm their test results elsewhere while others cannot afford the $3,000 cost of Myriad's test, American Medical News reported.
The genetic patents have led to $1 billion in revenue for Myriad and the University of Utah, the Patently-O blog reported.
The American Civil Liberties Union and the Public Patent Foundation filed suit in 2009 on behalf of researchers and women, saying such patents restrict science and make it difficult for women to get crucial medical care, The Salt Lake City Tribune reported. They were later joined in the suit by the U.S. Justice Department.
Last March, in a landmark opinion in New York that rocked the biotechnology world, U.S. District Judge Robert Sweet ruled Myriad Genetics' gene patent claims are invalid because they cover products of nature. The ruling said in part that because isolated DNA is not that different from DNA in nature, isolated DNA cannot be patented.
Myriad appealed Sweet's broad ruling to the Federal Circuit, which heard argument last Monday.
Acting Solicitor General Neal Katyal told the appeals court panel the Justice Department was taking a narrow position in the case, the Legal Times blog reported. Katyal argued if someone discovered pollen cures cancer, the person has discovered a cure for cancer -- "They haven't discovered pollen."
The Justice Department's position in the case reveals a split with the U.S. Patent and Trademark Office, which has allowed genomic DNA patents for more than 30 years, Legal Times said.
Myriad attorney Gregory Castanias a partner of Jones Day in Washington, argued in part there was no controversy on the table. In documents filed to the appeals court, Myriad's lawyers said there is "no adversity here -- just a complaint manufactured to serve the ends of two public-advocacy groups," Legal Times reported. In court, Castanias reinforced the jurisdictional claim, saying it takes "two to have a declaratory controversy."
"These (isolated DNA) are the products of molecular biologists, not of nature," the Tribune quoted him as arguing. "Isolated DNA does not exist in nature and never would exist in nature." Castanias said it was like fashioning a baseball bat out of a tree.
ACLU's Chris Hansen rejected that analogy, and said what Myriad did was more like a company patenting a kidney after taking it from the body of a patient: "The human gene is a product of nature and no more patentable than a human kidney."
The panel is expected to hand down a decision in the next few months, but most online analysts said they expected the dispute to be carried on to the U.S. Supreme Court.
The latest Supreme Court patent ruling -- Bilski vs. Kappos in June 2010 -- isn't encouraging for the Myriad challengers.
The Bilski case involved a patent application for a "claimed invention that explains how commodities buyers and sellers in the energy market can protect, or hedge, against the risk of price changes." A patent examiner rejected the application, saying the "invention is not implemented on a specific apparatus, merely manipulates an abstract idea, and solves a purely mathematical problem."
The Board of Patent Appeals and Interferences and the Federal Circuit agreed.
The Supreme Court agreed as well with the judgment, but said the Federal Circuit's interpretation of U.S. patent law -- how it arrived at the correct judgment -- was too constricted.
In an opinion written by Justice Anthony Kennedy, and joined either in whole or in part by all of the other justices, the high court said, citing its own precedent, "Courts 'should not read into the patent laws limitations and conditions which the Legislature has not expressed.'"
If the U.S. courts agree that isolated DNA can't be patented, it might leave the United States behind Europe in biotechnology. However the Myriad case turns out, at least one analysis says gene patents in Europe will remain relatively stable.
Genetic Engineering & Biotechnology News in a March 23 analysis said the uncertainty in the United States over Myriad's patents, and similar challenges in Australia -- where legislation is being introduced to prevent the patenting of human genes and biological materials that are substantially identical to that in nature, even if they are isolated -- should not affect the status of gene patents in Europe "even if additional requirements are imposed on patents claiming genetic material."
The analysis notes that the issues in Sweet's ruling, that isolated DNA is not that different from DNA in general and can't be patented, should "not arise in Europe."
The rules for patenting genetic material have been "harmonized" for all Europe through the "Biotech Directive," which has been included in the rules of the European Patent Office. The office sets the rules not only for the European Union, but for non-EU countries such as Norway and Switzerland.
The analysis points out the "Biotech Directive" says "biological material which is isolated from its natural environment or produced by means of a technical process" can be patented "even if it previously occurred in nature."
While the rules say that "at the various stages of (the human body's) formation and development ... the simple discovery of one of its elements including the sequence or partial sequence of a gene cannot constitute patentable inventions," the analysis reported, they also say "an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element."
The Genetic Engineering & Biotechnology News analysis says, "The law in Europe is clear -- isolated DNA is patentable subject matter."
Meanwhile, the uncertainty in the United States goes on until the courts issue a final ruling, and perhaps beyond that if the ruling is narrow. Often, the U.S. Supreme Court will rule in the narrowest way possible, leaving unresolved issues for another day.
Bottom line from United Press International: The Federal Circuit panel, looking over its shoulder at the business-friendly 5-4 majority on the Supreme Court, may hand down a ruling that will require some interpretation, but it will not overturn 35 years of precedent allowing patents for genes.
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