Gene Patent Case May Head to Supreme Court

  • by Washington Correspondent, MedPage Today

As part of the Year in Review series, MedPage Today reporters are revisiting major news stories and following up with an analysis of the impact of the original report, as well as subsequent news generated by the initial publication. Here's what's happened on the human gene patent front since we published the last story on the topic.

The issue of whether human genes can be patented has continued to spark debate since July, when a federal appeals court ruled that a company that makes tests for breast and ovarian cancer can patent breast cancer gene sequences.

Now that debate is one step closer to ending up in the Supreme Court.

The U.S. Court of Appeals for the Federal Circuit ruled 2-1 that when a gene is isolated from the human body, it is "markedly different" and has a "distinctive chemical identity and nature" compared with the way it is found in nature, and thus, Utah-based Myriad Genetics can continue to hold the patents for BRCA1 and BRCA2 gene sequences.

The company sells tests that assess a woman's risk of developing breast or ovarian cancer based on detection of mutations in the two genes.

The American Civil Liberties Union (ACLU), the Public Patent Foundation, and several doctors, genetic scientists, and patients who challenge Myriad's patents argue that isolating DNA from the body does not create something new and that things that exist in nature cannot be patented.

Lawyers for Myriad, meanwhile, argue that isolating the BRCA1 and BRCA2 genes from the entire human genome is actually creating something new from what exists in nature -- kind of like making a baseball bat from a tree.

The appeals court did rule that one plaintiff, Harry Ostrer, MD, has standing to challenge Myriad's claims. Ostrer, the director of the Molecular Pathology Laboratory at Montefiore Medical Center in the Bronx, N.Y., has said unequivocally that he wants to immediately start BRCA testing, but cannot do so because Myriad holds the patents.

(The appeals court ruled that two other physicians who are suing Myriad do not have standing because they have only asserted that, hypothetically, they'd like to start BRCA testing).

Interestingly, both sides of the case -- Myriad Genetics as well as the plaintiffs -- requested the full appeals court to rehear the case. Myriad didn't agree with the three-judge panel's decision that Ostrer had the right to sue, and the plaintiffs disagreed with essentially everything else.

The appeals court declined to hear the full case.

Ostrer told MedPage Today via email that he still stands ready to start BRCA testing.

"This could benefit the underserved women of the Bronx," he said.

Now for the latest update: in December, the ACLU filed a petition for the Supreme Court to take the case.

Myriad Genetics has until Jan. 13 to respond. After that, the Supreme Court will decide whether to hear the case, a process that generally takes between one and three months. If the court does decide to take the case, it likely would hear oral arguments during its next session, said Chris Hansen, a lawyer for the ACLU.

If the nation's highest court took the case, it would reopen an issue that was hotly debated a decade ago when the U.S. Patent and Trademark Office first began granting patents for human genes. The issue wasn't in the news much again until the Myriad case got started in 2009. According to the ACLU, the Patent Office has granted thousands of patents for as many as 20% of all human genes.

The Supreme Court currently is deciding another case -- Mayo Collaborative Services v. Prometheus Laboratories -- that touches on similar issues. That case involves whether a company can hold patents for tests to determine the proper dosage of drugs that treat gastrointestinal and other autoimmune diseases. Prometheus Laboratories holds the patent, but the Mayo Clinic would like to perform the tests.

The case is different from Myriad, Hansen said, because the Prometheus case is about an abstract process (a test) and the Myriad case is about something that naturally exists in the body (a genetic sequence).

The Supreme Court heard oral arguments on the Prometheus case in early December. While, the outcome won't be directly applicable to the Myriad case, it does signal the court's interest in patent cases.

"The Supreme Court doesn't decide that many patent cases and it doesn't decide that many patent cases about genetics," Hansen told MedPage Today.

In its petition to the Supreme Court, ACLU reiterated the case it laid out during its oral arguments in front of the appeals panel in April: That the genes Myriad is testing already exist in the human body and that the test the company uses to look for variants on those genes is not unique.

"The process is not unique," the ACLU wrote in its petition. "What is unique is its exclusive control over people's genetic information."

Currently, if a woman wanted to be tested for BRCA1 or BRCA2 abnormalities, she must pay about $3,000 for Myriad's test, because the company owns the patent on the two genes, so other companies cannot develop potentially cheaper tests.

Myriad said patient access to the tests is not being hindered. The company has provided tests to nearly 6,000 people at fraction of the cost of commercial testing, through research being funded by the National Cancer Institute or another institute of the National Institutes of Health.

The company also said that more than 90% of the BRCA tests ordered by doctors are covered by insurance, and that it has provided free testing in the last few years to 4,700 low-income patients without insurance.