The U.S. Supreme Court heard arguments Monday in a case that both sides consider absolutely vital to the future of medical research.

The case: Can a company take out a patent on a human gene? Or, as the company Myriad Genetics told the Court, not actually a patent on a gene, but a patent on isolated sections of DNA molecules that they synthetically re-create in the lab to make a test for the gene.

Patents were created 150 years ago in the Constitution as temporary protection of new inventions, thus giving economic incentive for inventors. But there is a clear rule that you cannot patent “a product of nature.”

During oral arguments on Monday, justices batted back and forth discussions of making everything from baseball bats to chocolate chip cookies, as they probed lawyers’ arguments about whether the patent was for a human gene (a product of nature)—or for “a new chemical entity,” as company argued in its legal brief, created through a complicated isolation process into a synthetic section of DNA to be used as a gene test.

Thirty years ago, scientists at the Utah biotech company Myriad painstakingly unraveled the 20,000 human genes that exist in a “6-foot-long molecule that’s coiled and compacted, and stuffed into each cell”. They beat other researchers in the race to isolate two genes, known as BRCA1 and BRCA2. Mutations in those genes greatly raise the risk of breast and ovarian cancer, and that risk that can be passed on to the next generation.

Myriad holds the patent and thus sells all tests for BRAC1 and BRAC2—at least for two more years until its patent expires. Myriad and others in the biotech industry argue that invalidating gene patents would threaten billions of dollars they’ve invested in creating genetic tests, drugs, vaccines, even genetically modified crops.

Opponents from the scientific and patient advocacy community argued that no company should hold rights to what is part of a human body, because it could hinder research and in fact has hindered patient access to lifesaving information turned up in clinical trials.

The Supreme Court justices today “seemed skeptical…that human genes can be patented,” reported National Public Radio’s long-time court reporter Nina Totenberg. She cited Justice Sonia Sotomayor’s remark that it seemed ‘the isolation [of the gene] itself is not valuable,’ but rather what’s done with the isolated gene. The government’s Solicitor General Donald Verrilli agreed that a gene cannot be patented, but he noted that the cDNA—the synthetic substance derived from DNA--could be patented, leaving the gene available for general research.

That’s when they got into making cookies, and baseball bats out of trees. Justice Stephen Breyer noted, “The patient law is filled with uneasy compromises.” If you develop a new process to extract sap from a plant that can cure cancer, he said, you could patent the process, but ‘what you can’t patent is the sap itself.”

Has the horse already left the barn….or is the barn burning

Myriad’s patents at issue will expire over the next two years, and according to an April 14^thNew York Times article. "Experts say a relatively small number of other diagnostic tests or drugs are protected by patents on single genes....It will soon be possible to sequence a person’s entire genome for less than the $4000 that Myriad charges to analyze just two genes,” and most experts believe that whole-genome sequencing might not infringe on single-gene patents.

However, two researchers reported a study in the March 25 journal Genome Medicine that there are more than 40,000 patents on DNA molecules, essentially covering the whole human genome.

“If these patients are enforced, our genomic liberty is lost,” lead author Dr. Christopher Mason of Weill Cornell Medical College told Science Daily on March 25^th, referring to the upcoming Supreme Court case. “Just as we enter the era of personalized medicine, we are ironically living in the most restrictive age of genomics. ”The research team studied two types of DNA sequence patents—for long and short fragments. They found that 41 percent of the human genome is covered by longer DNA patents often covering whole genes. But the short-fragment patents covered DNA sequences that are found in many genes, and even outside of genes, covering virtually the whole human genome. The study examined a Myriad-patented small sequence within BRCA1, which they found in at least 689 other genes; and found the company’s patents technically cover 19 other cancers plus brain development.

Dr. Mason said he undertook the study because he knew that, in his own research into brain and cancer disorders, he was studying genes or sequences actually covered under patents. “I’m extremely pro-patent,” he said, “…but I believe individuals have an innate right to their own genome…Failure to resolve these ambiguities perpetuates a direct threat to genomic liberty.”

Who owns you, and your genes? The court case is just the opening measure in this song.

  Sources:

• “Supreme Court Asks: Can Human Genes Be Patented?”, a 7-minute NPR story explaining court case, April 15, Morning Edition  
• “Justices Appear Skeptical of Patenting Human Genes,” NPR summary of court session April 15  All Things Considered,   
• "You Don't 'Own' Your Own Genes: Researchers Raise Alarm About Loss of Individual 'Genomic Liberty' Due to Gene Patents,” Mar. 25 2013 Science Daily,  
• "Justices Consider Whether Patents on Genes Are Valid,” April 14 New York Times  
• “Are Human Genes Patentable?” April 12 ScienceDaily

Disclosure: Fight Colorectal Cancer has accepted funding from Myriad Genetics in support of its patient education program. Fight Colorectal Cancer has ultimate authority over website content.