WASHINGTON -- Supreme Court justices lobbed hard questions Monday about whether a company could patent isolated human genes in a case that looms large in the personalized medicine arena.
During arguments before the court, several justices expressed doubt that Myriad Genetics could rightfully patent segments of human genes BRCA1 and BRCA2, genes in which mutations are indications of increased risk of breast and ovarian cancer.
Products of nature aren't patentable. Only inventions are, but Salt Lake City-based Myriad argued that because the genes have been isolated from the body, they are no longer a product of nature and can be patented.
"Now, yes, you can have a patent on the process of extracting that small part, but I don't understand how a small part of something bigger isn't obvious," Chief Justice John Roberts said.
Meanwhile, Myriad can stop others from making, using, selling, and offering to sell genetic testing to determine if an individual has such a genetic mutation.
A number of organizations including those led by physicians, researchers, clinicians, and other health professions were initially involved in the case.
"There might be a million things you can do with the BRCA genes, but nobody but Myriad is allowed to look at it and that's impeding science rather than advancing it," Christopher Hansen, who argued against Myriad, said.
A district court in 2010 ruled the patents invalid because they were products of nature. The Court of Appeals for the Federal Circuit in 2011 disagreed, setting up the case for the Supreme Court.
The Federal Circuit likened Myriad's case to that of a baseball bat. A tree isn't patent eligible, but a bat -- once extracted from the tree and carved -- is eligible.
Roberts disagreed with that analogy. "The baseball bat is quite different," Roberts said. "You don't look at a tree and say, 'well, I've cut the branch here and cut it here and all of a sudden I've got a baseball bat.' You have to invent it, if you will."
Justices repeatedly turned to the analogy of extracting a molecule from a tree leaf that is known for medicinal use. The leaf itself is a product of nature and not patentable, but the extracted molecule may be, Justice Samuel Alito said, seeming to support Myriad.
"The isolated DNA has a very different function than the DNA as it exists in your body," he added, just like the extracted molecule and the leaf. "And although the chemical composition may not be different, it certainly is in a different form."
Justice Sonia Sotomayor took a different tact and said the genes might be obvious -- not novel -- and therefore not patentable, which is a different argument from saying the genes are found in nature and not patent eligible.
Justice Stephen Breyer said he supported allowing companies like Myriad to be able to patent the process by which they find and extract certain gene segments -- just not genes themselves.
"It's important to keep products of nature free of the restrictions that patents there are," Breyer said.
The U.S. Patent and Trademark Office has issued thousand of patents similar to that of Myriad's BRCA1 and BRCA2 and the company argued that a ruling against it could mean less investment in the field if they and others can't protect their work -- an argument justices questioned.
"What does Myriad get out of this deal? Why shouldn't we worry that Myriad or companies like it will just say, well, you know, we're not going to do this work anymore?" Justice Elena Kagan asked.
The High Court could rule in the case -- Association for Molecular Pathology v. Myriad Genetics -- before its current term ends in late June.
David Pittman
David Pittman is MedPage Today’s Washington Correspondent, following the intersection of policy and healthcare. He covers Congress, FDA, and other health agencies in Washington, as well as major healthcare events. David holds bachelors’ degrees in journalism and chemistry from the University of Georgia and previously worked at the Amarillo Globe-News in Texas, Chemical & Engineering News and most recently FDAnews.
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