WASHINGTON, D.C.—In a lawsuit filed by the American CivilLiberties Union (ACLU) and the Public Patent Foundation (PUBPAT), arguing thatpatents on breast cancer genes should be disallowed, the Federal Circuit Courtsubstantially reiterated its prior opinion, in the case that is formally knownas 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 andPUBPAT argued that patents for two genes associated with hereditary breast andovarian cancer (BRCA1 and BRCA2) should be invalidated. The plaintiffs claimedthat the patents allow holder Myriad Genetics to stop all other laboratoriesfrom offering genetic tests that are crucial to making informed medical andtreatment decisions.
"Patent law was never intended to interfere with the rightsof scientists and doctors to conduct their research and exchange ideas freely,"stated Chris Hansen, an ACLU staff attorney. "Human DNA occurs in nature. Itcannot belong to a particular company."
Last year, a divided Federal Circuit Appeals Court ruledthat companies could obtain patents on genes but invalidated patents on methodsof comparing gene sequences. Earlier this year, the U.S. Supreme Court vacatedthe appellate court decision and sent the case back for reconsideration afterruling in Mayo v. Prometheus thatpatents cannot be issued on natural processes.
Myriad's monopoly on the BRCA genes allows it to set theterms and cost of testing and makes it impossible for women to access alternatetests or get a comprehensive second opinion about their results, the plaintiffsalleged. Going further, they cited two examples:
"The restrictions on examining the BRCA genes can havedevastating results. Kathleen Maxian of Buffalo, N.Y., is suffering fromlate-stage ovarian cancer that she believes could have been prevented. Hersister, who is a breast cancer survivor, obtained a test from Myriad that didnot look for all known genetic mutations associated with cancer, and was toldshe was negative for mutations. Years later, her sister learned that she did,in fact, have a BRCA genetic mutation—information that Maxian could have reliedon to seek preventive surgery. Numerous labs across the country have statedthat they are capable of providing this comprehensive screening, and would doso were it not for the patents."
The second example involved Lisbeth Ceriani, a breast cancersurvivor 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 withhereditary ovarian cancer because Myriad refused to enter into a contract withher insurance company.
"I had no other options available to me when I was seekinggenetic testing for a potentially life-threatening health issue," Cerianitestified. "No one corporation should be able to deny me the right to look at apiece of my body."
In the introduction to its decision, the Federal Circuittook pains to set aside these issues, stating, "this appeal is not aboutwhether individuals suspected of having an increased risk of developing breastcancer are entitled to a second opinion. Nor is it about whether the Universityof 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 onecompany to hold a patent or license covering a test that may save people'slives, or for other companies to be excluded from the market … that is thebasic right provided by a patent."
The biggest surprise in the ruling was that "everyone stuckto their guns," says Dr. Michael R. Samardzija, a partner with Bracewell &Giuliani.
"Everyone pretty much kept to their same reasoning andpositions," he says. "In all probability, the plaintiffs will go back to theSupreme Court. With its importance to personalized medicine and the largerbiotech 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 thecase closely because it may affect these companies' abilities to protect theirintellectual property. Also, investors are asking questions where they weren'tin the past," he says.
In an apt summary of the situation in a Chicago Tribune op-ed piece, "Patents are not the enemy," authorsCooper, Epstein and Haber put it this way: "A strong patent system . . . allowssmall companies and inventors to create and enforce intellectual propertyrights that drive economic growth. Indeed, a strong patent system was essentialto the emergence of such modern industries as pharmaceuticals, medical devicesand electronics." To which the Supreme Court need only say, "Amen."