LSPN 19: Mayo has led us down the rabbit hole, says lawyer

There’s alarm in the scientific community because of how broadly the principles of the Mayo test for section 101 are being used to strike down patents on profound innovations and discoveries.

“We have gone down a rabbit hole, which has caused a fair amount of consternation in the life sciences patent community,” warned David Gindler, managing partner at Irell & Manella, based in Los Angeles.

Gindler delivered the keynote speech at the Life Sciences Patent Network yesterday, April 25, in Boston.

“Mayo v Prometheus was a profound change in the law,” said Gindler.

In its 2012 decision in Mayo, the US Supreme Court established a two-part test for patent eligibility under section 101. First, courts determines whether a claim is directed to a law of nature and, if so, the court then determines whether the claim recites an inventive concept that transforms the claim into a patent-eligible application of the law of nature.

“Setting up the enquiry in this way disconnects the inventive concept of law of nature. You are no longer doing what you were told to do a long time ago, which was to consider the claim as a whole,” said Gindler.

He added: “What’s somewhat worse is that the Supreme Court didn’t give a definition of inventive concept, they gave a negative definition of inventive concept.”

Repeated throughout the Mayo decision is the statement that: “[W]ell-understood, routine, conventional activity previously engaged in by researchers in the field is not an inventive concept”.

This language, said Gindler, has been relied upon by many later cases to support the division of the inventive concept from the law of nature.

However, Gindler warned that this language doesn’t have very much support in any prior precedent from the Supreme Court, making it a “dramatic extension” of the principle.

He went on to say that in looking at the Court of Appeals for the Federal Circuit’s precedent, there isn’t really a two-step test as the steps have collapsed into one.

“In answering the first question, is the claim directed to a natural law, they have looked at what else is in the claim and is what else is in the claim a conventional activity understood by scientists at the time? If the answer to that question winds up being yes, then you answer question one yes, and the answer to question two follows to the first answer,” said Gindler.

Post-Mayo, Gindler said the Federal Circuit has “laboured mightily” to defend method of treatment claims, while repeatedly striking down diagnostic and detection methods.

“Diagnostic tests are basically under assault,” said Gindler, who explained that this began with the Sequenom  v. Ariosa Diagnostics case, where “a claim that has many problems, wound up making the case law that set the future”.

He added: “If it’s just a routine diagnostic procedure, it doesn’t matter how profound this breakthrough is [it will not be patentable].”

This may create a potential crisis in funding.

“Venture capitalists are going to wonder, should I put my money in an innovative technique that may have zero protection, or put my money on the technology side where there could be patent protection?”

Finally, Gindler concluded: "It isn’t clear that there will be a legislative solution to this problem. The question will be will the Federal Circuit look back at the history of Supreme Court precedent and understand that what it has done has collapsed it in a way that is no longer rewarding true to its foundation and that no longer is rewarding innovation?”

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