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Appeals Court Affirms Isolated DNA Patents in Myriad Case

NEW YORK (GenomeWeb News) – A federal appeals court today has for a second time reversed a lower district court's decision that isolated genes are not patentable, but it also partly affirmed the District Court's decision that certain methods patents "comparing" or "analyzing" gene sequences may not be patentable.

The Supreme Court recently asked the US Court of Appeals for the Federal Circuit to reconsider its earlier decision in the case, The Association for Molecular Pathology v. the US Patent and Trademark Office and Myriad Genetics, in light of its ruling in another lawsuit, called Mayo Collaborative Services v. Prometheus Laboratories.

AMP v USPTO focuses on the patentability of Myriad Genetics' claims on isolated gene sequences and diagnostic methods related to its BRACAnalysis test. In Mayo v Prometheus, the Supreme Court recently invalidated patents held by diagnostics firm Prometheus because they merely described laws of nature, and did not apply those laws of nature in a markedly different manner as to warrant a patent.

Despite the Supreme Court's ruling in Mayo, the CAFC in a 2-1 decision maintained that although isolated gene sequences may be derived from naturally occurring substances, their isolation requires human intervention in order to make them useful in medical care and so are deserving of patent protection.

"We are very pleased with the favorable decision the Court rendered today which again confirmed that isolated DNA is patentable," Myriad Genetics President and CEO Peter Meldrum said in a statement. "Importantly, the court agreed with Myriad that isolated DNA is a new chemical matter with important utilities which can only exist as the product of human ingenuity."

The decision was met with disappointment by those opposing gene patenting.

"It is extremely disappointing that despite the Supreme Court's ruling, the appeals court has failed to fully re-consider the facts of this case," Chris Hansen, a staff attorney with the ACLU Speech, Privacy and Technology Project, said in a statement.

The case against Myriad was filed in 2009 by the Public Patent Foundation, American Civil Liberties Union, AMP, and others who claim that patents cannot cover natural phenomena and that Myriad's patents, and others like them, will hinder genetics research and keep some people from accessing tests and second opinions.

"This ruling prevents doctors and scientists from exchanging their ideas and research freely," Hansen added the ACLU statement today. "Human DNA is a natural entity like air or water. It does not belong to any one company."

Myriad said again today what it has argued all along, that gene patents have not thwarted research, that the cost of its BRACAnalysis test is not prohibitive and is covered through most insurance for "appropriate" patients, and that second opinion testing is available in many US labs.

"Certainly, you could hear a collective sigh of relief from the biotech industry, as of this decision," Jennifer Camacho, an attorney and shareholder with law firm Greenberg Traurig, told GenomeWeb Daily News today.

"Isolated DNA patents remain intact. We still have patent eligibility for isolated DNA," Camacho said, explaining that the court's decision to uphold the patentability of isolated DNA may be seen by the biotech industry as more important than its reading of the reach of the Prometheus decision.

"They did actually take [the Prometheus decision] into consideration," Camacho said, adding that it did not change the judges' analysis.

"This puts a narrow interpretation of Prometheus in the books, as being limited to the 'laws of nature' exclusion, she added.

Camacho told GWDN that she was struck by how similar today's CAFC ruling was to the original. She pointed out that part of one judge's opinion, which argued that whether some patents should or should not be awarded are policy questions that are best left to Congress, was the same language as in the first opinion.

For Myriad, the ruling provided mixed results, Goldman Sachs Investment Research analyst Isaac Ro said in a note today.

On the positive side for Myriad, the patent eligibility of its BRCA1 and BRCA2-based tests was upheld again based on its isolated DNA claims and screening method claims. But a potential negative is that the CAFC also upheld the District Court's opinion that Myriad's method claims for comparing DNA sequences are not eligible.

"The outcome is modestly disappointing," Ro stated, adding that the critical question now is whether or not the Supreme Court will agree to hear the case next year.

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