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Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

Citing “A Delicate Balance,” Supreme Court Overturns BRCA Patents

June 21, 2013—The U.S. Supreme Court June 13 unanimously overturned several patents relating to the BRCA1 and BRCA2 genes associated with breast cancer.  The central questions raised by the case, Association for Molecular Pathology vs. Myriad Genetics, Inc., focused on the patentability of human or other genes, under section 101 of the U.S. Patent Code, which excludes patents for “natural laws, natural phenomena, and abstract ideas.”

Justice Clarence Thomas for the Court wrote, “Myriad did not create or alter either the genetic information encoded in the BCRA1 andBCRA2 genes or the genetic structure of the DNA. It found an im­portant and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry [for patentable subject matter].”

The Court also ruled, however, that “synthetic” DNA sequences altered from their naturally occurring form, such as complementary or cDNAs, are patentable.  As such, the decision is seen as a compromise, preventing individuals or firms like Myriad from monopolizing gene-based diagnostic tests or similar activity to detect the presence of particular genes or variants, but at the same time, protecting potential proprietary research on new drugs or compounds derived from knowledge about DNA sequences.

The Court reasoned that the need for such compromise is neither new nor limited to genomics.  Justice Thomas, citing precedent, wrote, “Patent protection strikes a delicate balance between creating ‘incen­tives that lead to creation, invention, and discovery’ and ‘imped[ing] the flow of information that might permit, indeed spur, invention.’ This standard is used to determine whether Myriad’s pa­tents claim a ‘new and useful . . . composition of matter.’”

The Court ruled that Myriad’s patent claims as written did not embrace such a new composition.  The decision agreed with the position advocated by the Obama Administration, in disagreement with its own U.S. Patent and Trademark Office.  National Institutes of Health (NIH) Director Francis Collins, M.D., Ph.D., — who, earlier in his career, discovered genes for cystic fibrosis — hailed the decision, which he said, “…represents a victory for all those eagerly awaiting more individualized, gene-based approaches to medical care.”

Contact:

Stephen Heinig
Director, Science Policy
Telephone: 202-828-0488
Email: sheinig@aamc.org

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org