Court Rules Genetic's DNA Analysis Method Patent Invalid

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By Peter Leung

April 8 — Genetic Technologies Ltd.'s patent on methods for analyzing DNA sequences is invalid because the invention doesn't cover patentable subject matter, the U.S. Court of Appeals for the Federal Circuit ruled April 8.

The patent seeks to cover a law of nature and fails to do significantly more than describe a natural phenomenon, the court said (Genetic Technologies Ltd. v. Merial LLC, 2016 BL 110883, Fed. Cir., 2015-1203, 4/8/16).

Under the two-step framework the U.S. Supreme Court outlined in Mayo Collaborative Servs. v. Prometheus Labs Inc., this means the invention covers unpatentable subject matter.

The decision highlights why some patent lawyers dislike the Mayo framework. Under it, they say, courts can deny patent protection for even useful medical advances. This newest case may raise the bar even higher.

Robert L. Stoll, partner at Drinker Biddle & Reath LLP in Washington and previously commissioner of patents at the Patent and Trademark Office, told Bloomberg BNA in an e-mail that this case is further evidence that the Mayo ruling is being too broadly applied in a way that hurts the medical diagnostic and personalized medicine industries.

“The Supreme Court needs to clarify their holding or the legislature will need to change the law of 35 U.S.C. §101,” he said, referring to the statute concerning what is patentable subject matter.

Genetic's invention relates to a discovery that certain coding DNA sequences are correlated with non-coding sequences. U.S. Patent No. 5,612,179 describes methods of using what the court described as well-established techniques to amplify and analyze the non-coding sequences to read the coding sequences.

In 2011, Genetic sued Merial LLC and Bristol-Myers Squibb Co., alleging patent infringement.

Laws of Nature

In applying the Mayo test, the court first found that the patent is directed to the correlation between the coding and non-coding DNA sequences, a law of nature.

The court said that the patent is very similar to one invalidated in Sequenom Inc. v. Ariosa Diagnostics Inc., 2015 BL 185953 (Fed. Cir. 2015), which involved prenatal detection methods .

The court said that like that invention, Genetic's patent relates to a law of nature because it covers newly discovered facts about human biology without creating or altering the DNA or describing new detection techniques.

In the second part of the Mayo test, an invention covering a law of nature may still be patentable if it contains an inventive concept, but the court found that Genetic's invention does not.

In applying that part of the test, the court first looked at the physical steps described in the patent. The first step calls for amplifying the genomic DNA with a primer pair, which the court said does not provide an inventive concept because it was already well known and conventional when the patent application was filed.

The patent's second step, which calls for analyzing the amplified DNA, was also routine and conventional, the court found. Furthermore, the patent's instructions to analyze the DNA by detecting the coding region allele does not create an inventive concept, because this step can be performed completely in the human mind.

Calling for Intervention

The Ariosa decision highlighted concerns about the Supreme Court's patent eligibility test, because the invention there was unpatentable even though it appeared to be a significant improvement over previous diagnosis methods.

The Supreme Court is considering a petition to review the Federal Circuit's decision in Ariosa. To some practitioners, Genetic's case again emphasizes the need for more guidance .

Courtenay C. Brinckerhoff, IP partner at Foley & Lardner LLP in Washington, told Bloomberg BNA that she thinks this decision is another blow for patent eligibility that goes beyond Ariosa. She said the technology in Ariosa was simpler, while the claims at issue here appear to be more about something new.

“This invention is really more about a new way of detecting something, as opposed to discovering a correlation between a DNA sequence and a disease,” she said. “To me, it exploits a law of nature, rather than just describing it.”

An Even Higher Bar?

Brinckerhoff also said that she was concerned about the court saying that mental steps in a patent cannot support patentability. While the court tied this analysis to its decision in CyberSource Corp. v. Retail Decisions, Inc., 2011 BL 211283, 654 F.3d 1366 (Fed. Cir. 2011), this new decision appears to go even further.

While held that methods that can be entirely performed in the mind aren't patentable, the court here seems to say that even individual steps within a method—that are purely mental steps—also can't support patentability, she explained. This approach would make it even harder to prove that an invention is patentable subject matter.

Judges Sharon Prost, Timothy B. Dyk and Richard G. Taranto heard the case, with Dyk writing the decision. Sheridan Ross PC represented Genetic. Jones Day represented Merial, while Wilmer Cutler Pickering Hale & Dorr LLP represented Bristol-Myers Squibb.

To contact the reporter on this story: Peter Leung in Washington at

To contact the editor responsible for this story: Mike Wilczek in Washington at

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