High Court Must Review Sequenom Test Decision, Attorneys Say

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By John T. Aquino

March 21 — The Supreme Court should review an appeals court decision to clear up uncertainty about patenting natural discoveries that is chilling innovation, attorneys told Bloomberg BNA.

Sequenom Inc. asked the Supreme Court March 21 to review a decision by the U.S. Court of Appeals for the Federal Circuit to invalidate claims directed to methods for detecting paternally inherited cell-free fetal DNA in a mother’s blood . The decision has had a seismic effect on the life sciences industry.

At a session of the 2015 Biotechnology Innovation Organization International Convention dedicated to the decision, which had just been issued, there were suggestions that the Federal Circuit's ruling reflecting the Supreme Court's increasing restrictions on patent eligibility should lead companies to consider shifting to trade secret protection rather than relying on patents and/or to lobby Congress to clarify patent law.

Chance Court Will Review?

In its petition, Sequenom wrote, “This is as straightforward a certiorari candidate as any patent case can be,” noting that judges on the Federal Circuit as well as companies and people filing amicus briefs had said that only the Supreme Court could resolve the problems.

Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, said that Sequenom had put together a petition that gives the Supreme Court a reason to review the patent eligibility question.

“Rather than criticizing the court’s recent cases, the petition criticized the way those cases have been applied by the inferior courts. This argument is aided by being able to quote statements by several Federal Circuit judges who believed the decision to be wrong but that the court’s hands were tied due to the Mayo decision, and by Judge Pauline Newman’s argument that the decision was wrong but that [the case on which the Federal Circuit relied] could be distinguished,” he said. Noonan was referring to the Supreme Court's decision in Mayo Collaborative Servs. v. Prometheus Labs. Inc. that particular diagnostic method claims recited a law of nature and weren't patentable subject matter .

Noonan added, “In view of Judge Newman’s seniority and at least hints from recent cases that the Supreme Court appreciates her perspective, it is possible that the court could see a way clear to set out a better distinction between what is and isn’t patent eligible.”

Court Review Needed

Other attorneys contacted by Bloomberg BNA said that they agreed with Sequenom that the Supreme Court should grant review to clarify its ruling in Mayo, on which the Federal Circuit in Sequenom relied.

Howard E. Levine of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, New York, who had moderated the 2015 BIO session, told Bloomberg BNA in a March 22 e-mail, “If accepted, the cert. petition will provide the Supreme Court with the opportunity to reconsider its decision in Mayo and explain whether the federal courts have correctly interpreted the decision or have taken some of the language of the Mayo opinion that was applicable to a particularized set of facts out of context to create a rigid test that may not be relevant to all situations.”

Levine added, “Thus, the Supreme Court’s decision in this case could have a profound effect on the ability to patent important life sciences inventions, particularly in the diagnostic field and in the burgeoning area of personalized medicine.”

Neeta Thakur of Sheppard Mullin Richter & Hampton, Palo Alto, Calif., said in a March 22 phone interview that the Federal Circuit's decision suggests there are significant hurdles to obtain patent protection of new diagnostic methods, which can significantly affect the personalized medicine industry.

“It is clear that any further guidance on patent eligibility under 35 USC §101 will now come from the Supreme Court. I hope the Supreme Court does review it,” she said.

Carl Gulbrandsen, managing director of the Wisconsin Alumni Research Foundation, told Bloomberg BNA in a March 22 e-mail, “The uncertainty that exists today over whether newly discovered and non-obvious natural products or natural principles can be patented continues to seriously threaten innovation in this country. The focus of a Supreme Court review of this case would be whether there remains some exception for pharmaceutical, medical and biotechnology inventions under the judicial exclusion from 35 U.S.C. §101 eligibility for natural principles and products of nature.”

Gulbrandsen said the European patent environment continues to look more attractive than the one in the U.S. because of the hard line taken by the courts regarding the natural product/natural principles exceptions to patent eligibility.

“Add to this the weakening of the patent system by legislation and it becomes a perfect storm for small start-up companies trying to develop what otherwise are lifesaving inventions,” Gulbrandsen said.

Test Found Natural Phenomenon

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 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, don't infringe any claims of the '540 patent. The case before the Federal Circuit was Sequenom's appeal of the U.S. District Court for the Northern District of California's denial of a preliminary injunction.

Applying the Mayo test, the panel found that the claims were directed to a natural phenomenon, lacked an inventive step and were therefore patent ineligible .

Judge Richard Linn wrote in a concurrence that if it hadn't been for the “sweeping language” of Mayo, he would have found the claims patent eligible.

“This case represents the consequences—perhaps unintended—of that broad language in excluding a meritorious invention from the patent protection it deserves and should have been allowed to retain,” Linn wrote.

One Question

At the BIO 2015 convention, attorneys told Bloomberg BNA that the Federal Circuit's decision was difficult to accept because Sequenom's discovery had been so revolutionary and life-changing.

“These inventors replaced a long needle invading the amniotic sac—and a terrifying moment for expectant parents—with a simple and safe blood draw, solving a problem that had frustrated their field for years,” Sequenom said in its petition for Supreme Court review.

In its petition, Sequenom presented a single question for the court's consideration: “Whether a novel method is patent-eligible where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery?”

Medical Breakthroughs Undermined

The petition also said that the Supreme Court should grant review because “the decision below has dangerously overextended Mayo, and the court needs to clarify that its precedents permit patenting meritorious inventions like this one.”

The petition added that “the Federal Circuit’s version of Mayo undermines just about any biomedical breakthrough you can conceive. Vaccines? They combine the natural fact of immune response with known methods of drug administration. Even for previously unstudied diseases like Zika? Yes. Aspirin—perhaps the world’s most successful patented medicine? It combined a natural plant product with basic chemistry techniques.”

As a consequence, Sequenom concluded, “anyone who would invest in making, validating, or commercializing inventions like these for human medical use must invite others along for the free ride, with predictably unfortunate results.”

Noonan told Bloomberg BNA that Sequenom had also made a strong argument for error in the Federal Circuit’s disregard for the preemption question, which the Supreme Court has said motivates its worries in this area and which is a concern that the use of a natural phenomenon will preempt others from obtaining the benefit of the natural phenomenon.

“If only for this reason, the court may grant cert, to examine the role of the preemption analysis in deciding eligibility,” Noonan said.

The case is (U.S., No. not assigned, petition for certiorari 3/21/16).

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Lee Barnes at lbarnes@bna.com

For More Information

The text of the Sequenom petition is at http://src.bna.com/dtb.