It looks like the courts have finally put an end to Myriad Genetics’ attempts to monopolize our genes.
Following decisions striking down its gene patents from the U.S. Supreme Court, a Utah federal district court, and a federal court of appeals, Myriad announced that it wanted to resolve lawsuits against seven other genetic testing laboratories, which would effectively end its longstanding campaign to exclusively control patients’ access to their own genetic information.
But a central question remains: Will the U.S. Patent Office listen to the courts and enforce the ban on patenting products of nature? Or will it revert back to granting patents that can prevent scientists from working with basic building blocks of nature, as urged by industry groups?
Based on how the controversy has played out thus far, the industry groups are gaining ground.
On June 13, 2013, the U.S. Supreme Court unanimously ruled that human genes cannot be patented, in a case the ACLU brought on behalf of 20 medical organizations, geneticists, women’s health groups, and patients. The court’s decision invalidated key patent claims owned by Myriad Genetics on the BRCA1 and BRCA2 genes. Because certain mutations of these genes are related to hereditary breast and ovarian cancer, it can be vital for patients to obtain genetic screening in order to make informed medical decisions. But Myriad used its gene patents for 15 years to stop all other labs from offering clinical testing of the genes to determine cancer risk, even when other labs could easily do so using different testing methods and charging lower prices. As a result, it earned roughly $2 billion in revenue from test sales.
On the same day the Supreme Court issued its decision, five labs announced that they would begin providing testing to patients. But in an attempt to hold on to its lucrative monopoly, Myriad brought suit in Utah against several labs, asserting other patent claims that were not challenged in our case, but that were clearly invalid based on the reasoning of the Supreme Court.
That litigation wound its way through the courts over the last year, and Myriad lost at every turn. First, the Utah federal district judge denied Myriad’s request to shut down the BRCA testing services of one of its new competitors in March 2014. The judge ruled that Myriad failed to establish that it was likely to win its lawsuit, because of substantial questions about the validity of its patent claims.
Myriad then appealed to the U.S. Court of Appeals for the Federal Circuit, which reviews patent appeals from across the country. We filed amicus briefs, urging it to apply the Supreme Court’s case law prohibiting patents on products of nature, laws of nature, and abstract ideas. In the opinion handed down in December, the court did just that. The court chose not only to evaluate Myriad’s likelihood of success, but also definitively found that the company’s patent claims were invalid under Section 101 of the Patent Act because they sought exclusive control over products of nature and abstract ideas.
This decision sharply contrasts with the 2011 and 2012 decisions of the Federal Circuit in the original Myriad litigation, where the court split 2-1 to uphold Myriad’s gene patents. The latest unanimous ruling demonstrates an important shift. By stepping in to shield what properly belongs in the public commons, the Federal Circuit sent a strong message to Myriad and other patentholders: Patents can’t be used to lock up products of nature, such as our genetic information. With that loss, Myriad settled six cases in recent weeks, promising not to sue again based on these patents.
Initially, the U.S. Patent Office seemed to hear the courts’ message. For decades, it had issued gene patents to those who were first to “isolate” a gene, giving patentholders like Myriad the ability to sue others who dared to examine genes we all have. But last March, it issued new guidance to patent examiners about how to review patent applications that involve products and laws of nature in light of the Supreme Court’s decisions in Myriad and another case called Mayo. It warned that isolating a natural thing (like removing naturally occurring DNA from a human cell) does not automatically create an invention. It also said that DNA claims like those asserted by Myriad in the Utah litigation were invalid. While we and other scientific associations and patient advocacy groups suggested changes to the guidance, we commended the Patent Office for making vital progress in ensuring that patents are only approved for true inventions.
But then the Patent Office backtracked.
In response to severe criticism by industry groups, patentholders, and patent attorneys, the Patent Office issued new guidance in December that watered down the standard for determining whether something is an unpatentable product of nature. It said that differences in structure or function could allow companies to patent things based in nature. Under this test, if a surgeon removed a kidney from one’s body in order to transplant it, the surgeon could argue that she should be able to patent it because it no longer has the same structure as in the body since its blood vessels were cut. The kidney, of course, would be intended to function just as it has prior to being removed in the body that receives it.
The Supreme Court has long rejected this view. For example, in 1931 the court said that a fruit treated with a preservative in its rind could not be patented, because while it has a different structure, its uses are still the same – to be eaten. The applicant could have sought a patent on a new preservative it developed, but not on the fruit itself.
The public has an opportunity to weigh in on this latest guidance. The Patent Office is seeking comments until March 16. In its next revision of the guidance, the Patent Office must require differences in both structure and function when assessing patent applications. Otherwise, the public will bear the consequences when another company, like Myriad, wields its exclusive rights on nature to stall medical and scientific advancement.