Eyes on Supreme Court after Sequenom rejection

There were no surprises, but plenty of alarms yesterday following the US Court of Appeals for the Federal Circuit’s decision to reject Sequenom’s request for a re-hearing of its dispute with Ariosa Diagnostics en banc.

The dispute concerns Sequenom’s patent covering the method of detecting foetal abnormalities in a pregnant mother and performing a prenatal diagnosis. In July, a three-judge panel on the federal circuit revoked the patent on the grounds it covered natural phenomenon, citing the US Supreme Court’s decision 2012 in the Mayo v Prometheus case.

Yesterday, December 2, that decision was upheld.

Judge Alan Lourie wrote: “It is not disputed that before this invention, the amplification and detection of cffDNA from maternal blood, and use of these methods for prenatal diagnoses, were not routine and conventional. But applying Mayo, we are unfortunately obliged to divorce the additional steps from the asserted natural phenomenon to arrive at a conclusion that they add nothing to the process.”

Lourie was joined by 12 other circuit judges in administering his opinion.

Judge Kimberely Moore lamented her decision to uphold the invalidation of patent, stating in her concurring opinion that the decision “may discourage development and disclosure of diagnostic and therapeutic methods”.

Many feel that Sequenom’s patent is genuinely inventive; the kind that should be rewarded by the US Patent and Trademark Office (USPTO).

Courtenay Brinckheroff, partner at law firm Foley & Lardner, said that because of the Mayo decision it is now increasingly difficult for companies to obtain patents covering diagnostic methods.

“Right now it is very difficult to obtain a US patent on a diagnostic method,” she told LSIPR.

“While not impossible, most USPTO examiners are only willing to grant somewhat specific claims that implement the inventive diagnostic method using specific techniques, while previously it was possible to obtain broader protection.

“This is leading innovators to consider whether they should patent their inventions or retain them as trade secrets, and some are even considering whether they should continue investing in the development of certain types of diagnostic methods,” she added.

No surprises

Counsel for both Sequenom and Ariosa told LSIPR yesterday, December 03, that they were not surprised by the federal circuit’s decision.

Lisa Haile, partner at law firm DLA Piper, but who did not counsel either company, said yesterday’s rejection is “consistent” with the legal precedent set out by the Supreme Court in Mayo.

“The courts and the USPTO are consistently saying that if method claims do no more than recite routine or conventional methods and steps, and the claims do not provide significantly more, then they will be found to be invalid, or patent ineligible, under section 101 [of the US Code]."

Eyes now turn to role of the US Supreme Court on whether it will feel compelled to correct the precedent.

Tom Goldstein, partner at law firm Goldstein & Russell and representing Sequenom, confirmed it will appeal against the decision and said there a number of diagnostic companies will be watching the development closely.

Kevin Noonan, partner at law firm McDonnell Boehnen Hulbert & Berghoff, said Lourie and Moore’s opinions “send a clear signal to the Supreme Court that the application of Mayo is problematic, that the court’s concerns can be better addressed by other portions of the statute, and that the broad sweeping language used in Mayo and other decisions prevents the inferior courts from developing the law as the court may have intended”.

Judge Pauline Newman was the only judges to reject the application of Mayo.

In her dissenting opinion, she noted that the patent is novel and should therefore qualify for protection under the current legal precedent.

“Precedent does not require that all discoveries of natural phenomena or their application in new ways or for use are ineligible for patenting; the Supreme Court has cautioned against such generalisations.”

Many have noted that Sequenom’s discovering of a method to detect foetal abnormalities in a pregnant mother is the type of invention that the patent system should be rewarding.

In his opinion, Lourie said that natural formulas such as Ohm’s law and Newton’s laws of motion are not patentable formulas, but noted that “all physical steps of human ingenuity utilise natural laws or involve natural phenomenon”.

Sequenom’s sense of injustice is perhaps only matched by its bombastic rhetoric in its petition for an en banc rehearing.

It decried the “existential threat” to patents if the patent remains revoked on the grounds it covers natural phenomenon. Sequenom’s argument has the sympathy of some in the intellectual property profession who believe the very purpose of a patent system is to reward genuine innovations like the one at dispute.