Despite the University of Utah’s defeat last month in a federal-court ruling that invalidated its patent claims on genes linked to cancer in women, some legal experts have confidently predicted its eventual victory in a case with broad implications for high-stakes academic-industry partnerships.
“I can’t see any panel upholding the lower court’s decision,” said Dennis D. Crouch, an associate professor of law at the University of Missouri who writes a blog on patent law, Patently-O.
Others, however, are less certain. Robert Cook-Deegan, director of the Center for Genome Ethics, Law and Policy at Duke University, says doubts about the ruling—issued March 29 by Judge Robert W. Sweet of the U.S. District Court in Manhattan—are based on a several factors, including a history of 11 previous cases in which the federal appeals court that handles patent cases has consistently upheld gene patent rights.
Beyond setting a different precedent from those 11 cases, the ruling by Judge Sweet, in a case known as Association for Molecular Pathology vs. United States Patent and Trademark Office, threatens patents covering thousands of other human genes identified by pharmaceutical companies and their university partners.
And yet for all that power of legal precedent, said Dr. Cook-Deegan, Judge Sweet’s ruling may prove more formidable than many appear to realize. “I’m not sure that it’s such a slam-dunk when it goes to the Court of Appeals for the Federal Circuit,” he said.
The lawsuit, filed in May 2009, challenges a claim by Myriad Genetics Inc., in Salt Lake City, to own the rights to test people for variations in two genes, known as BRCA1 and BRCA2, whose mutations are associated with elevated risks of cancer. Women with the genetic mutation are considered five times more likely than average to suffer breast cancer and 40 times more likely to develop ovarian cancer.
A co-founder of Myriad, Mark H. Skolnick, identified the significance of the BRCA1 and BRCA2 genes in detecting cancer while serving as a professor of genetic epidemiology at the University of Utah. The University of Utah Research Foundation now shares the patent rights with Myriad and was named along with Myriad and the patent office as a defendant in the case.
The plaintiffs include several scholarly societies for medical geneticists and a number of individual genetics researchers at universities, as well as cancer patients and public-interest groups.
The suit was filed on their behalf by the American Civil Liberties Union and the Public Patent Foundation at Yeshiva University’s law school. The plaintiffs contend that Myriad is using its exclusive patent right to test for mutations in BRCA1 and BRCA2 to block competitors who would offer tests that are less expensive and possibly more reliable.
Emotional and Complex
The case is complex and much of the debate surrounding it is emotional. When Myriad began enforcing its patents in 1998, nine other laboratories were forced to stop offering the tests.
Plaintiffs in the case include Lisbeth Ceriani, a single mother from Massachusetts who was diagnosed with breast cancer in May 2008 and was concerned about her risk of getting ovarian cancer, too. Myriad did not accept the coverage under her health plan, a Medicaid program in Massachusetts, and she could not pay the $3,150 testing fee charged by Myriad herself.
Myriad eventually agreed to provide Ms. Ceriani with the test under a program for low-income patients, and she had her ovaries removed after the results indicated she faced a high risk of cancer.
Another plaintiff, Genae Girard of Texas, had financial access to Myriad’s test but wished she could have a second test by another company before deciding whether to accept the recommendations of her doctors that she have a double mastectomy and have her ovaries removed.
Mr. Skolnick said he is motivated by helping such women. In a written statement to the court, he described a costly and time-consuming search for the BRCA1 and BRCA2 genes that took 30 years and dozens of collaborators. “This is seldom recognized,” Mr. Skolnick told the court, “but many medical discoveries languish without a corporate interest.”
The fate of Myriad’s various patent claims to BRCA1 and BRCA2 may rely, however, on complicated notions of what exactly the company does with the genetic information it has discovered.
One of the judge’s two main rulings is that Myriad can’t be allowed to exercise a broad claim over any possible method of comparing a patient’s genes with a standard form of the BRCA genes, Dr. Cook-Deegan said. Most experts agree that finding will be upheld on appeal, he said.
The more controversial part of the judge’s ruling concerns the specific method that Myriad is using. The Supreme Court has suggested in previous rulings that naturally occurring substances generally are not fit for patenting, meaning that a key question raised by the Myriad patents and other cases is whether extracted and purified genetic material can be considered a naturally occurring substance. In past cases before the Federal Circuit court, companies have been allowed to retain patents that cover human genetic material as part of a process for deriving a medicine, rather than a test, from the material, Dr. Cook-Deegan said. Examples include the artificial creation of human growth hormone and insulin, he said.
Human growth hormone does occur naturally, he said, but a company, Genentech, is allowed to hold a patent on it because the company is producing an engineered version, eliminating the need to extract the hormone from the pituitary glands of deceased donors. “It’s fairly obvious that there’s engineering going on, and human inventiveness is involved in that,” Dr. Cook-Deegan said.
‘Reading’ vs. ‘Making’
In the case of the BRCA genes, however, Myriad is merely growing copies of those genes so it can read the genetic information of the patient, Dr. Cook-Deegan said. “In my mind, there’s a pretty significant difference” between what Myriad is doing with its genetic material and what companies such as Genentech are doing with theirs, he said, “and this is one that Judge Sweet seizes on.”
Mr. Crouch said Dr. Cook-Deegan makes a valid observation when citing reasons why he and other patent experts should be more cautious about expecting the appeals court to overturn Judge Sweet’s decision.
Yet the judges on the federal appeals court who have scientific backgrounds “tend to be chemistry-oriented” rather than experts in information science, Mr. Crouch said. And while those judges frequently write and speak about patent-law issues, none have publicly argued that isolated DNA should not be patentable, he said.
Myriad filed for its first BRCA patent in 1995, though it may not have been first to identify the gene, says an analysis published on Wednesday in The New England Journal of Medicine and written by two Harvard University experts, Aaron S. Kesselheim, an instructor in medicine, and Michelle M. Mello, a professor of law and public health.
About 20 percent of human gene DNA sequences are now patented, and DNA patents generally last 20 years. Myriad’s patents begin expiring in 2014, and the BRCA tests in its most recent fiscal year accounted for most of the company’s $327-million in annual revenue, Dr. Kesselheim and Ms. Mello said.
The University of Utah reported receiving more than $25-million in income from inventor licenses in 2008. Its vice president for research, Thomas N. Parks, declined to give an estimate for the value of the BRCA patents. “I have no basis for predicting what its ultimate effects will be on university research,” Mr. Parks, a professor of neurobiology and anatomy, said of the court ruling.
The ruling against Myriad and the University of Utah may be part of a growing trend of questioning genetic patent rights, especially those that merely concern testing rather than actual treatment. In January, an advisory panel of the U.S. Department of Health and Human Services recommended ending all patent rights for medical tests that detect inherited diseases. Ending such rights could make the tests, often developed by universities, more widely available, according to the panel, known as the Secretary’s Advisory Committee on Genetics, Health, and Society.
Such sentiments may be gaining popularity on university campuses, even among those whose institutions may benefit financially from patent rights.
Federal policies that let universities share in the proceeds of their inventions are “better than the alternative” of letting companies keep the profits from their eventual commercial development, said David W. Leebron, president of Rice University.
Yet, Mr. Leebron said, “we have probably gone too far” in claiming patent rights on ideas.
Profit-sharing arrangements with industry are valuable if they help ensure that useful inventions get developed, said Alice P. Gast, president of Lehigh University. But, Ms. Gast said, the financial rewards from all such arrangements typically produce only about 2 percent of the research budget for universities.
“Any place can have a home run,” she said, but “it’s not money you count on.”
