Second verse, same as the first
WASHINGTON, D.C.—In a lawsuit filed by the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT), arguing that patents on breast cancer genes should be disallowed, the Federal Circuit Court substantially reiterated its prior opinion, in the case that is formally known as Association for Molecular Pathology v. U.S. Patent and Trademark Office—or commonly known as "the Myriad case."
In their suit filed on behalf of medical associations, geneticists, patients and breast cancer and women's health groups, the ACLU and PUBPAT argued that patents for two genes associated with hereditary breast and ovarian cancer (BRCA1 and BRCA2) should be invalidated. The plaintiffs claimed that the patents allow holder Myriad Genetics to stop all other laboratories from offering genetic tests that are crucial to making informed medical and treatment decisions.
"Patent law was never intended to interfere with the rights of scientists and doctors to conduct their research and exchange ideas freely," stated Chris Hansen, an ACLU staff attorney. "Human DNA occurs in nature. It cannot belong to a particular company."
Last year, a divided Federal Circuit Appeals Court ruled that companies could obtain patents on genes but invalidated patents on methods of comparing gene sequences. Earlier this year, the U.S. Supreme Court vacated the appellate court decision and sent the case back for reconsideration after ruling in Mayo v. Prometheus that patents cannot be issued on natural processes.
Myriad's monopoly on the BRCA genes allows it to set the terms and cost of testing and makes it impossible for women to access alternate tests or get a comprehensive second opinion about their results, the plaintiffs alleged. Going further, they cited two examples:
"The restrictions on examining the BRCA genes can have devastating results. Kathleen Maxian of Buffalo, N.Y., is suffering from late-stage ovarian cancer that she believes could have been prevented. Her sister, who is a breast cancer survivor, obtained a test from Myriad that did not look for all known genetic mutations associated with cancer, and was told she was negative for mutations. Years later, her sister learned that she did, in fact, have a BRCA genetic mutation—information that Maxian could have relied on to seek preventive surgery. Numerous labs across the country have stated that they are capable of providing this comprehensive screening, and would do so were it not for the patents."
The second example involved Lisbeth Ceriani, a breast cancer survivor and a plaintiff in the case, who faced having to pay for Myriad's $4,000 test to determine if she carried a genetic mutation associated with hereditary ovarian cancer because Myriad refused to enter into a contract with her insurance company.
"I had no other options available to me when I was seeking genetic testing for a potentially life-threatening health issue," Ceriani testified. "No one corporation should be able to deny me the right to look at a piece of my body."
In the introduction to its decision, the Federal Circuit took pains to set aside these issues, stating, "this appeal is not about whether individuals suspected of having an increased risk of developing breast cancer are entitled to a second opinion. Nor is it about whether the University of Utah, the owner of the instant patents, or Myriad, the exclusive licensee, has acted improperly. The question is also not whether it is desirable for one company to hold a patent or license covering a test that may save people's lives, or for other companies to be excluded from the market … that is the basic right provided by a patent."
The biggest surprise in the ruling was that "everyone stuck to their guns," says Dr. Michael R. Samardzija, a partner with Bracewell & Giuliani.
"Everyone pretty much kept to their same reasoning and positions," he says. "In all probability, the plaintiffs will go back to the Supreme Court. With its importance to personalized medicine and the larger biotech community, I don't see it not being taken up."
Bill Gaede, a partner and co-chair of the Life Sciences & Medical Products practice at the international law firm McDermott Will & Emery LLP, agrees: "The personalized medicine industry is watching the case closely because it may affect these companies' abilities to protect their intellectual property. Also, investors are asking questions where they weren't in the past," he says.
In an apt summary of the situation in a Chicago Tribune op-ed piece, "Patents are not the enemy," authors Cooper, Epstein and Haber put it this way: "A strong patent system . . . allows small companies and inventors to create and enforce intellectual property rights that drive economic growth. Indeed, a strong patent system was essential to the emergence of such modern industries as pharmaceuticals, medical devices and electronics." To which the Supreme Court need only say, "Amen."