Federal Circuit Affirms Patent Ineligibility of Sequenom's Prenatal Test Methods

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By Tony Dutra

June 12 — Life sciences patent stakeholders' hopes that the Federal Circuit would rescue method claims from the implications of the Supreme Court's Mayo v. Prometheus decision were dashed June 12 as the court found Sequenom's prenatal detection methods ineligible under 35 U.S.C. §101.

The court acknowledged the scientific value of the patentees' discovery of detecting paternity-identifying DNA in a serum or plasma sample from a pregnant female. However, it said, “even such valuable contributions can fall short of statutory subject matter, as it does here.”

The court determined that the methods begin and end with an unpatentable natural phenomenon, with steps of amplification and detection “well-understood, routine, and conventional activity”—insufficient under Mayo to save a claim from patent ineligibility—at the time of the invention.

A concurring opinion lambasted—but conceded that the court was bound by—that “sweeping language of the test set out” in Mayo.

Judge Richard Linn distinguished the activities here, where “no one was amplifying and detecting paternally-inherited cffDNA using the plasma or serum of pregnant mothers,” from those in Mayo, which covered “the very steps that doctors were already doing—administering the drug at issue, measuring metabolite levels, and adjusting dosing based on the metabolite levels.”

However, Linn said, “the Supreme Court did not limit its ruling to those particular facts and circumstances.”

Stakeholders Disappointed.

“This decision is going to have a ripple effect across the diagnostic and personalized medicine industry,” according to Courtenay C. Brinckerhoff of Foley & Lardner LLP, Washington.

“Although the Supreme Court justifies the judicial exception on the basis that ‘manifestations of laws of nature' should be ‘free to all men and reserved exclusively to none,' ” she said, “new diagnostic methods may be available to none if the lack of patent protection discourages investment in these important technologies.”

Jennifer Lane Spaith of Dorsey & Whitney, Seattle, went back to the constitution.

“Given that the patent system finds its roots in the Constitutional mandate to ‘promote the Progress of Science and the Useful Arts,' many will no doubt find it disappointing that the law has developed in such a way as to deny patent protection outright to technology that even the court recognizes as a ‘positive and valuable contribution to science,' ” she told Bloomberg BNA.

‘No Opinion' on §101 First Time Through

San Diego-based Sequenom Inc. is the exclusive licensee of U.S. Patent No. 6,258,540, which relates to methods performed on a maternal serum or plasma sample from a pregnant female that comprise detecting the presence of a paternally inherited nucleic acid of fetal origin.

Ariosa Diagnostics Inc. of San Jose, Calif., and Natera Inc. of San Carlos, Calif., filed separate complaints seeking a declaration that their Harmony Test and Non-Invasive Paternity Test, respectively, do not infringe any claims of the '540 patent.

The case was before the Federal Circuit previously, in Sequenom's appeal of a denial of a preliminary injunction by the U.S. District Court for the Northern District of California.

The court faulted the lower court for its eBay injunction factor analysis, and in its remand, said it would offer “no opinion as to whether there is or is not a substantial question regarding the subject matter eligibility of the asserted claims.” Aria Diagnostics, Inc. v. Sequenom, Inc., 726 F.3d 1296, 1304, 107 U.S.P.Q.2d 1879 (Fed. Cir. 2013).

On remand, Judge Susan Y. Illston held in favor of the challengers on that issue. Sequenom appealed again.

The Biotechnology Industry Organization submitted an amicus brief arguing that “the development and commercialization of genetic and other diagnostic technologies will be hampered if not precluded, should this Court affirm the district court’s decision below.”

Mayo Rules

Judge Jimmie V. Reyna wrote the opinion of the court, joined by Linn and Judge Evan J. Wallach. Reyna was the only one of the three also on the panel that remanded the case in 2013.

The opinion cited other Section 101 decisions by the Supreme Court, but its reasoning ultimately was drawn almost exclusively from Mayo Collaborative Servs. v. Prometheus Labs. Inc., 132 S. Ct. 1289, 2012 BL 66018, 101 U.S.P.Q.2d 1961 (2012).

Each of the asserted claims here begins with cell-free fetal DNA, known as “cffDNA,” taken from the sample—a patent-ineligible naturally occurring phenomenon—the court said. And the result at the end of each claim, it said, is “paternally inherited cffDNA, which is also a natural phenomenon.”

The claims thus failed the first step of Mayo, the court said, because “[t]he method therefore begins and ends with a natural phenomenon.”

To overcome that Section 101 failing, a party claiming patent rights must show, in the second step of the analysis, “an inventive concept sufficient to ‘transform' the claimed naturally occurring phenomenon into a patent-eligible application,” the court said.

The amplifying and detecting steps to get from the starting natural phenomenon to the ending natural phenomenon, the court said, “amount[ ] to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA.”

The court seemingly addressed the complaint of many stakeholders that this second step conflates the obviousness analysis under Section 103. The court framed the question instead in terms of the “new and useful” text from Section 101.

“For process claims that encompass natural phenomenon, the process steps are the additional features that must be new and useful,” it said, but the process steps here were not.

“The only subject matter new and useful as of the date of the application was the discovery of the presence of cffDNA in maternal plasma or serum,” it said.

Pre-Emption Arguments Put Aside.

Most Section 101 cases feature a patent owner's separate argument that its specific application of the natural phenomenon (or abstract idea) merits patent eligibility because it does not pre-empt all commercially viable uses of the phenomenon. In this case, the court said, that issue was irrelevant.

The court said that “questions on preemption are inherent in and resolved by the §101 analysis.”

“While preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility,” the court said. And limiting claim breadth here did not save Sequenom, it said.

“Where a patent’s claims are deemed only to disclose patent ineligible subject matter under the Mayo framework, as they are in this case, preemption concerns are fully addressed and made moot,” the court concluded.

Gass: Still Some Wiggle Room.

“I would not view this decision—alone or in combination with any other decision—as the death of diagnostic patent claims,” David A. Gass of Marshall, Gerstein & Borun LLP, Chicago, said in an e-mail message to Bloomberg BNA. “However, it is now one more hurdle that the industry and the biotechnology patent bar must deal with.”

Gass saw one area where the claims here were lacking, where other diagnostic claims might still succeed.

“It is possible that claims with some additional specificity with regard to how to practice the invention (e.g., machines, reagents, or steps to achieve the goals of the method) would have been analyzed differently,” he said. “In patent cases, the wording of the patent claims matters and usually is the focus of intense scrutiny.”

Brinckerhoff: Please Grant Cert.

Given Linn's reasoning in the concurrence, though, Gass said, “I was a surprised that the Court could not also articulate a legal basis for distinguishing the two cases and reaching a different result. There has long been a recognition that these ‘judicial exception' cases can be fact-specific in nature.”

“Judge Linn’s concurring opinion places blame for the result here squarely on the shoulders of the Supreme Court, and urges the Court to reconsider the Mayo framework, and at least permit the consideration of ‘post-solution activity' when that activity is novel,” Brinckerhoff said in an e-mail.

“Even if the Supreme Court grants certiorari, it will be another year before we could have a different decision,” she said, though. “In the meantime, patent applicants who do not have the resources to appeal the rejections of their patent applications may decide to abandon those applications, and may decide not to develop the underlying technology.”

David I. Gindler of Irell & Manella LLP, Los Angeles, represented Ariosa. William P. Schuck of Bartko, Zankel, Bunzel & Miller, San Francisco, represented Natera and its licensee, Diagnostics Center Inc. Michael J. Malecek of Kaye Scholer LLP, Palo Alto, Calif., represented Sequenom. Kevin E. Noonan of McDonnell, Boehnen Hulbert & Berghoff LLP, Chicago, submitted the BIO amicus brief.

To contact the reporter on this story: Tony Dutra in Washington at adutra@bna.com

To contact the editor responsible for this story: Anandashankar Mazumdar in Washington at amazumdar@bna.com

Full text at http://www.bloomberglaw.com/public/document/Ariosa_Diagnostics_Inc_v_Sequenom_Inc_Docket_No_1401139_Fed_Cir_D.

Brinckerhoff is a member of this journal's advisory board.