Monthly Archives: June 2013

Myriad: Designer Genes Lose A Leg of Patent Protection

“Jean, Jean, you’re young and alive. Come out of your half-dreamed dream.” Jean by Oliver.

Yesterday, a unanimous Supreme Court ruled that human genes are off-limits when it comes to patent protection. But their synthetic cousins are fair game for patenting. In a case brought by the ACLU on behalf of patients, doctors, and researchers, Justice Thomas, writing for the Court, held that a patent on so-called “isolated” genes held by biotech company Myriad Inc. was invalid because it covered “products of nature.” Myraid had focused on the genes in question, BRCA1 and BRCA2, because certain mutations of those genes have been linked to a higher risk of breast and ovarian cancer. Myriad did not “invent” those genes, since they reside in each of us. Nor did Myriad claim to have invented the link between those genes and cancer. That, of course, is a scientific and medical observation, a phenomenon of nature.

What Myriad actually claimed in its patent were two things it had indeed created through intensive effort and extensive investment–isolated, purified versions of the BRCA genes as well as synthetic versions of BRCA1 and BRCA2, which Justice Thomas refers to as cDNA. The case was rife with moral, ethical, and social issues about cost of and access to vital diagnostic tests. Those issues were magnified by Angelina Jolie’s brave sharing of her own story about carrying the mutant BRCA genes. But while those concerns added drama and fueled interest in the case, the issue before the courts was more fundamental–do Myriad’s discoveries meet the patent law’s threshold requirement that discoveries must cover patent eligible subject matter?

Over the years, the Supreme Court developed an arcane and sometimes elusive test for patent eligibility when it comes to so-called “compositions of matter.” Articles developed through significant “human intervention” make the grade, while mere “products of nature” fail the test. So altering bacteria to make it better at gobbling up oil spills than any germ found in nature is patentable. But no patent could cover the mere observation that combining certain bacteria produced a versatile fertilizer that could be used on several plants, saving farmers the cost of buying separate fertilizers.

In the Myriad gene patenting case, the trial court ruled in favor of patients and doctors, finding that Myriad’s efforts to isolate the genes had not “transformed” them into something new and different. But the patent appeals court, the Federal Circuit, disagreed. That court concluded that “isolating” and “purifying” genes does in fact transform them into something new–distinct chemical compounds that differ in structure and use than the genes as they exist in the human body. The Federal Circuit then held that the synthetic cDNA versions of BRCA1 and BRCA2–which clearly had been crafted by human hands and ingenuity–were even more solid candidates for patenting.

The Federal Circuit’s decision set the stage for the Supreme Court showdown. Industry and the patent bar lined up to side with Myriad, drawing analogies to cases from the 19th Century in the effort to extend patent protection to this cutting edge technology. On the other side, patient advocates and researchers railed against Myriad’s patent, which painted as propping up the price of breast cancer genetic screening beyond the reach of anyone without good medical insurance. All the while, the investment community, venture capital and hedge fund masters, waited on the sidelines and held their collective breaths. Myriad’s patents were just the tip of the iceberg. Thousands of other gene patents have been granted, with companies such as Myriad and its supporters insisting that those patent and the breakthrough industries they support could fall by the wayside if the Supreme Court ruled against Myriad.

When the Supreme Court announced its decision, however, it did not appear that nixing patents on isolated genes would usher in an economic apocalypse. On the contrary, Myriad’s stock soared, with investors taking solace, if not confidence, from the portion of the Court’s ruling preserving patents for cDNA. But soon, enthusiasm curbed. Throughout the day, Myriad’s stock went on a roller coaster ride, winding up down 6% for the day.

The Court’s mixed ruling, knocking out claims covering isolated genes but not synthetic ones, left both sides claiming victory. For patients, it may mean more choice and lower costs. For innovative companies such as Myriad, the Court left patent protection on cDNA intact, preserving at least one avenue for monetizing their efforts and recouping their investments. Call the decision a mixed bag or a win-win, one thing is certain, it’s good to see an issue that for once all nine justice can agree upon.

QUOTE OF THE DAY: “The scientist is not a person who gives the right answers, he’s one who asks the right questions.” Claude Lévi-Strauss

Leave a comment

Filed under Uncategorized