U.S. SC says human genes can't be patented

By Jessica M. Karmasek | Jun 13, 2013

WASHINGTON (Legal Newsline) -- The U.S. Supreme Court on Thursday ruled mostly against a Utah-based molecular diagnostic company in its attempt to patent a pair of genes linked to breast and ovarian cancer.

In its unanimous opinion, the nation's high court wrote that defendant Myriad Genetics Inc. "did not create anything."

"To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention," Justice Clarence Thomas wrote in the court's 18-page ruling.

In Association for Molecular Pathology et al. v. Myriad Genetics Inc. et al., Myriad faced claims that its patents on genes BRCA1 and BRCA2 violate intellectual property law, as well as the First Amendment.

The two human genes indicate a higher risk of breast and ovarian cancer.

In fact, BRCA1 is the gene carried by actress Angelina Jolie. Last month, Jolie wrote in a New York Times editorial that a test, like Myriad's, indicated she was at a higher risk of developing breast cancer. As a result, she decided to have a double mastectomy.

The case is the first patent case ever brought by the American Civil Liberties Union, which joined plaintiff Association for Molecular Pathology.

According to its website, AMP is an international medical professional association dedicated to the "advancement, practice, and science of clinical molecular laboratory medicine and translational research based on the applications of molecular biology, genetics and genomics."

Myriad's opponents, including AMP and the ACLU, argued that patenting human genes or other naturally occurring genetic material could have a chilling effect on scientific research.

Also, the patents on the genes allowed the company to exercise a monopoly, dictating what types of testing were offered, at what cost and the availability of second opinions, they argued.

But the company's supporters countered that the case is more about a process, and pointed to many patented procedures that work exclusively with natural materials.

"Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent," Thomas noted. "But the processes used by Myriad to isolate DNA were well understood, widely used and fairly uniform insofar as any scientist engaged in the search for a gene would likely have utilized a similar approach, and are not at issue in this case."

While the court ruled that a naturally-occurring DNA segment is a "product of nature" and not patent eligible just because it has been isolated, it concluded that complementary DNA, or cDNA, is patent eligible because it is not naturally occurring.

A federal district court had granted summary judgment to AMP, concluding that Myriad's claims were invalid because they covered products of nature.

The U.S. Court of Appeals for the Federal Circuit had reversed that ruling initially, but on remand, in light of Mayo Collaborative Services v. Prometheus Laboratories Inc., it found both isolated DNA and cDNA patent eligible.

In a blog post Thursday, the ACLU mostly praised the Supreme Court's ruling, except for its cDNA finding.

"While we disagree with that finding, the decision as a whole represents a huge shift in patent law," it said. "The Supreme Court's ruling shields parts of the human body from the assertion of private property rights. And because cDNA is not required for genetic testing, laboratories will now be able to offer testing of the BRCA genes to their patients."

And despite the court's ruling, Myriad maintained a somewhat positive outlook.

"We believe the court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward," President and CEO Peter D. Meldrum said in a statement.

"More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples' lives and lowering overall health care costs."

From Legal Newsline: Reach Jessica Karmasek by email at jessica@legalnewsline.com.

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