Pathologists and clinical laboratory managers will likely learn next year whether Myriad’s gene patents will stand
In the ongoing debate about gene patents, the nation’s highest legal authority is about to weigh in on the question. The Supreme Court has agreed to hear the Myriad Genetics patent case in the upcoming term. The case turns on whether human genes can be patented.
Will Clinical Labs Need to Pay Royalties for Using Human Gene Patents?
How the high court rules on this matter has significant implications for clinical laboratories and pathology groups throughout the United States. That’s because holders of patents on human genes require medical laboratories to pay royalties for the clinical testing they perform.
The Supreme Court will review an earlier decision by a federal appeals court in The Association for Molecular Pathology, et al. v. Myriad Genetics, Inc. et al., a story published by The New York Times. In that decision, the lower court declared that Myriad’s “composition of matter” claims covering isolated DNA of the BRCA1 and BRCA2 genes are patent-eligible under Section 101 of the United States Patent Act.
Determining When Human Genes Can Be Patented
As reported in the New York Times, the legal question for the justices is whether isolated genes are “products of nature” that may not be patented or “human-made inventions” eligible for patent protection. A central dispute for the federal appeals court was whether isolated genes are sufficiently different from ones in the body to allow them to be patented.
Last month, the Supreme Court agreed to hear the Association of Molecular Pathology vs. Myriad Genetics gene patent case. The central legal question is whether isolated DNA is a product of nature and ineligible for patent protection. Many pathologists and clinical laboratory administrators are following the progress of this case. (Cartoon by Chris Madden and published by Biopoliticaltimes.com.)
Myriad obtained the patents on the two genes in 1996. Since then, it has been the sole U.S. provider of tests for hereditary cancers involving the BRCA genes. In the spring of 2009, the Association for Molecular Pathology (AMP) and other plaintiffs sued Myriad Genetics, Inc. (NASDAQ: MYGN). Plaintiffs include the College of American Pathologists. The American Civil Liberties Union (ACLU) is representing the plaintiffs.
Opposing Sides Imply their Course Better Serves Patients
Opponents argue that patents on human genes stymie research, block clinical testing, and raise testing pricing. “Myriad and other gene patent holders have gained the right to exclude the rest of the scientific community from examining the naturally occurring genes of every person [in the United States],” the ACLU argued in its petition to the high court, according to the New York Times story.
Another concern critics raise is that the gene patents give Myriad an unfair monopoly over BRCA testing, a writer observed in a posting at The Pathology Blawg. The result has been higher pricing for clinical laboratory tests that incorporate human genes covered by these patents.
“As reported in The Middletown Press, before the patents were awarded to Myriad, Yale [University] offered BRCA1 and BRCA2 testing for $1,600,” the blogger observed. The posting noted that, currently, the price for the Myriad BRCA tests is $3,340. Even adjusting for inflation, noted this blogger, that is a 48% increase.
“Life’s instructions ought not be controlled by legal monopolies created at the whim of Congress or the courts,” declared James D. Watson, Ph.D., KBE, ForMemRS, in an amicus brief (friend of the court) that argued against gene patenting. Watson was a co-discoverer of the double helix structure of DNA.
On the other hand, supporters of human gene patents, such a biotechnology firms, argue that rejecting gene patents will inhibit investment and innovation. They claim denying patent protection could slow advances in personalized medicine.
Supreme Court Ruling in Prometheus
The pathology “blawgers” suggested that the Supreme’s ruling in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Prometheus) offers clues to how they might decide the Myriad case. “Many observers believe the Prometheus decision is a strong clue as to how the Supreme Court will rule on the Myriad case,” they wrote. According to the blawg, these observers had noted the fact that the Supreme Court quoted an amicus brief from two of the plaintiffs in the Myriad case in its Prometheus decision.
The high court will likely hear arguments in March of next year and rule by the end of June, according to a story published by Bloomberg.
News Story that Affects All Medical Laboratories
This is one of those news stories that, in many ways, has the potential to touch every pathologist and clinical laboratory manager. That is why, for the medical laboratory testing industry, the outcome of the Myriad case carries high stakes. Gene patents and patent royalties interfere with the ability of clinical labs to create innovative tests. New molecular tests are using tens, hundreds, and now thousands of genes. For that reason, gene patents present a challenge for all sectors of the laboratory medicine profession.
—Pamela Scherer McLeod
Related Information:
Myriad Updates: Clinical Data as Trade Secrets and a Pending Certiorari Decision
THE DARK REPORT: Lab Law Updates: Myriad Wins Federal Appeal In Important Gene Patent Suit
Supreme Court: Prometheus Decision a Harbinger for Myriad?
The Association for Molecular Pathology et al. Petition for a Writ of Certiorari
Brief for Amicus Curiae James D. Watson in Support of Neither Party
Gene Patents Draw High Court Review in Biotechnology Test
Mayo Collaborative Services v. Prometheus Laboratories, Inc.
