Gene Patents Ruled Invalid
In a surprise ruling, Myriad’s controversial patents on breast and ovarian cancer susceptibility genes are struck down.
A federal
court has ruled that key patents held by Myriad
Genetics, a diagnostics company based in Salt Lake City, UT, on the BRCA 1
and 2 genes are invalid. Specific mutations in these genes are responsible for
the majority of hereditary forms of breast and ovarian cancers, and many women
with a family history of these cancers undergo screening to help them make medical
decisions around preventing the disease.
The suit, brought by the American
Civil Liberties Union (ACLU), patients and medical groups, argued that the
patents restricted research and patients’ access to healthcare. Myriad’s critics
have long argued that they give the company a monopoly over this type of genetic
screening, allowing it to keep prices high–the test costs more than $3000,
despite continual decreases in the cost of genomic analysis tools–and preventing
women from seeking confirmatory tests from other sources.
According to
a statement
from the ACLU, “The precedent-setting ruling marks the first time
a court has found patents on genes unlawful and calls into question the
validity of patents now held on approximately 2000 human genes.” That amounts
to about 20 percent of human genes, including those associated with Alzheimer’s
disease, colon cancer, asthma and other illnesses. “Because the ACLU’s lawsuit
challenges the whole notion of gene patenting, its outcome could have
far-reaching effects beyond the patents on the BRCA genes.”
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Dan Vorhaus at the Genomics Law Report discusses the ruling in more
detail:
Judge
Sweet’s ruling invalidates both Myriad’s composition of matter
claims (its patents on isolated DNA sequences to all or a portion of the
breast cancer genes) and its method claims (those
patent claims that relate to analyzing or comparing isolated DNA sequences in
order to detect mutations in a patient’s BRCA1/2 genes that might cause breast
cancer).
The overall
tone of the Court’s ruling is best captured by this passage (from page 135):
The
identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable
scientific achievement for which Myriad deserves recognition, but that is not
the same as concluding that it is something for which they are entitled to a
patent.
The ruling
follows decades of debate over gene patenting. An article
in the New York Times
points out that such patents “have been granted for decades; the Supreme Court upheld patents on living organisms in 1980,”
an argument Myriad made when asking the court to dismiss the case. The company is expected to appeal the decision
Many patent experts were surprised by the court’s decision and predict it will
have a negative impact on young start-ups in the biotech industry. It’s not yet
clear how it will affect the market for BRCA screening. “For the moment, however, we do not foresee
this decision producing any radical changes in commercial, clinical or other
activity surrounding Myriad’s BRCA patents, or gene patents more
broadly,” Vorhaus wrote in his post.
In the broader policy debate surrounding gene
and biotechnology patents, however, this decision is the latest, unmistakable
shot across the bow of gene patent holders, particularly those such as Myriad
Genetics that have developed businesses around patent-protected genetic tests
supported by exclusive rights in underlying gene patents.
