A case involving a Utah-based molecular diagnostic firm is getting national attention as researchers, doctors and lawyers look to the courts to define how and when the biotech industry can patent its genetics-based discoveries.
In 2009, the American Civil Liberties Union and the Public Patent Foundation sued Myriad Genetics on behalf of a group of researchers, cancer patients and others. At issue were patents Myriad received for DNA molecules isolated by the company's scientists. The plaintiffs said isolated DNA can't be patented, since federal rules bar the patenting of materials which occur naturally.
In July, the U.S. Court of Appeals for the Federal Circuit upheld the patents. Last month, the ACLU asked the court to re-hear the case, and some believe it could eventually wind up before the U.S. Supreme Court.
Hans Sauer, deputy general counsel for the Washington-based Biotechnology Industry Organization, said his industry has been closely watching the case.
"On the one hand, there was the legal novelty of it that made people watch it," Sauer said. "The other reason was some companies … did feel that the case could have commercial implications for their business," even though he said most BIO members don't work in the diagnostic space.
Myriad, which is not a BIO member, was the first to isolate two key genes in a lab — BRCA 1 and BRCA 2. That's significant because those genes are classified by the National Cancer Institute as tumor suppressors. Patients who inherit mutated forms of the genes face a higher risk of breast or ovarian cancer.
Gerard P. Norton, a partner and chair of the intellectual property department at Fox Rothschild LLP, in Lawrenceville, said the central question is whether DNA in an isolated form is a naturally occurring material, or is a product of human ingenuity.
"If you take a human being and put them in front of this magic microscope, would this DNA sequence as it is claimed (in the patent) exist?" he said.
To Norton and the court, the answer is no, but the ACLU says gene isolation doesn't constitute an invention.
"What 'isolated' means, according to the patents, is removing the genes from the body," Hansen said. "In my mind, it's still the gene."
The best proof, Hansen said, is Myriad's own use of the gene. He said the company uses its isolated gene as a control specimen against which to judge a patient's DNA for mutations.
"If the gene in the lab were different from the gene in your body, they couldn't do (the comparison)," he said. "The gene would be useless."
In a 2-1 opinion, however, the court ruled the isolated DNA was chemically different from native DNA in the body, writing that "human intervention … imparts on that isolated DNA a distinctive chemical identity from that possessed by native DNA."
The plaintiffs also challenged other Myriad patents, which cover the process of comparing a patient's genes to the isolated genes, and the process of screening potential cancer therapeutics.
The screening process was ruled patent-eligible, but the court agreed with the ACLU that the method of comparing patient DNA to the isolated DNA was not patent eligible, as it simply involved mental steps, rather than a concrete process.
Hansen said Myriad was attempting to patent "essentially proofreading."
Norton contrasts the Myriad case with another case, Mayo Collaborative Services v. Prometheus Labs Inc., which has earned a review by the U.S. Supreme Court. In that case, an appeals court ruled a diagnostic test by Prometheus was patent eligible, because it involved a chemical transformation, rather than simply an observation.
"The mere observation is not going to do it," Norton said. "That's the lesson for the patent drafter."
The larger issue for biotech companies is whether and how they'll secure intellectual property rights going forward. Sauer said disallowing patents for isolated DNA could damage medical advances — particularly for early-stage companies, which need the patents to attract investment.
"They don't have a lot of intellectual property where they can go on to raise funding and bring their technology to the next stage," he said.
But Hansen said other researchers were close behind Myriad in the race to isolate the genes. Those researchers, he said, weren't motivated by a patent and didn't plan to seek one.
"We know that this discovery would have occurred without the patent system," he said.
Hansen said allowing Myriad to have such patents could have major implications for patients. He said patients couldn't get second opinions — since the gene against which doctors could test a patient's DNA would be protected intellectual property — would allow Myriad to charge whatever it wants, and would ultimately hold back science by restricting other scientists' access to the gene.
Norton, though, believes these patents are critical to an industry that's working to further medical innovation and ultimately public health.
"It certainly pulls on your heartstrings," he said. "Companies aren't out there trying to take advantage of sick people. They're actually trying to help them."
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