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Recent Ruling on Genetic Patents Leaves Many Questions

October 2011, Vol 2, No 6

On July 29, 2011, a 3-judge panel from the US Court of Appeals for the Federal Circuit invalidated some patents held by Myriad Genetics and the University of Utah Research Foundation for methods of analyzing individuals’ gene sequences for the presence of BRCA1 and BRCA2 mutations, but upheld other related patents in a reversal of a lower court ruling. The decision has left the door open to many questions.

The court ruled that Myriad’s patents remain valid for the BRCA1 and BRCA2 sequences and for the company’s methods of screening potential cancer therapies via changes in cell growth. However, experts suggest that this new ruling leaves the company open to new challenges, especially in light of the $3340 cost of the test that was developed more than a decade ago. Newer techniques for DNA sequencing are less costly and more efficient, but this decision gives the company time to upgrade its technology.

“Testing labs, or potential competitors, for deep-sequencing all 20-plus genes associated with breast or ovarian cancer, for example, might be able to do their analysis without much risk of infringement liability,” Robert Cook- Deegan, MD, Director of the Institute for Genome Sciences & Policy’s Center for Genome Ethics, Law & Policy, Duke University, Durham, NC, told Value- Based Cancer Care.

Dr Cook-Deegan added that because 1 of the 3 judges sharply dissented from the other 2 on the patentability of DNA sequences, “that would leave Myriad only with claims on specific mutations and on PCR [polymerase chain reaction] primers. So, someone doing a PCR-based gene sequencing might infringe if reporting one of the patented mutations, but there may be some space for alternative methods.”

The Controversy Continues

Commenting on the decision, Peter Meldrum, President and Chief Executive Officer of Myriad Genetics, said, “We believe this decision is in the best interests of the agriculture, biotechnology, and pharmaceutical industries, as well as the hundreds of millions of people whose lives are bettered by the products these industries develop based on the promise of strong patent protection.”

But groups that include the American Civil Liberties Union, the Public Patent Foundation, and other litigants are decrying the decision, which may well be appealed to the full Court of Appeals or to the US Supreme Court.

“Such appeals are at the discretion of the courts, but this is a high-profile case, and there is clearly disagreement to be resolved about whether DNA sequences found in nature can be patented,” noted Dr Cook-Deegan.

The dissenting judge said that patents on the BRCA1 and BRCA2 genes should be invalid. “Extracting a gene is akin to snapping a leaf from a tree,” Judge William C. Bryson wrote. “Like a gene, a leaf has a natural starting and stopping point. It buds during spring from the same place that it breaks off and falls during autumn. Yet prematurely plucking the leaf would not turn it into a human-made invention.”

Daniel B. Ravicher, Executive Director of the Public Patents Foundation and counsel for plaintiffs in the lawsuit, said, “No one ‘invents’ genes. Inventions are things like new genetic tools or drugs, all of which can be patented because they are not genes themselves.” The first 2 acts of this real-life oncology drama have taken place, the protagonists have made their positions clear, and now it remains to be seen whether the curtain will fall or the action will continue for the foreseeable future.

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