Several weeks ago, the United States Court of Appeals for the Federal Circuit issued a decision in Rapid Litigation Management LTD v. Cellzdirect, Inc. The patent owner appealed the decision of the district court, which had concluded that claims of U.S. Patent No. 7,604,929 were patent ineligible under the “law of nature” doctrine. The unanimous Federal Circuit panel, which was made up of Chief Judge Prost (writing for the majority), Judge Moore and Judge Stoll, vacated and remanded the case for further proceedings. The Federal Circuit ruled that the ‘929 patent claims in question were not directed to a patent-ineligible concept.
This decision could well mark a significant turning point and give real relief to innovators in the life sciences arena. Up until now, the Federal Circuit has avoided a narrow reading of the Supreme Court’s recent precedents in Mayo v. Prometheus and AMP v. Myriad Genetics. It is difficult to know exactly why that has been the case, but one strong possibility is that the Federal Circuit was looking to the Supreme Court to clarify and narrow the expansive language that they used in Mayo and Myriad.
Judge Dyk, who has been on the wing of the Federal Circuit much more likely to find patent claims to be ineligible, shared concerns of the other Judges, writing in Sequenom that the Supreme Court’s test in Mayo was too broad. Dyk concluded, however, that it was for the Supreme Court, not the Federal Circuit, to set the record straight. See CAFC denies Sequenom en banc petition.
With the Supreme Court recently denying certiorari in Sequenom, perhaps at least some of the Judges on the Federal Circuit believe it is time for them to start to apply their own independent judgment and not blindly follow the extraordinarily broad language of the Supreme Court that has led to truly bizarre rulings on patent eligibility in the life sciences sector – where groundbreaking innovations have been ruled patent ineligible despite everyone agreeing that the innovation was of extreme importance.
Mayo/Alice Step One
The Federal Circuit explained:
At step one… it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is “directed to.” Here, the plain claim language shows that it is not. The ’929 patent does not simply claim hepatocytes’ ability to survive multiple freeze-thaw cycles. The ’929 patent instead claims a “method of producing a desired preparation of multi-cryopreserved hepatocytes.” ’929 patent col. 19 l. 56-col. 20 l. 20. This new and improved technique, for producing a tangible and useful result, falls squarely outside those categories of inventions that are “directed to” patent-ineligible concepts.
Step Two
Notwithstanding, the Federal Circuit went on to say that, even if they were to agree that the claims were directed to a patent-ineligible concept, the claims would still be patent eligible under the second step. Prost explained that the claims covered an invention that provided a significant improvement for a variety of reasons, and also because the discovery was used to achieve a new and useful preservation process.
The Best Part
The Court explained, “patent-eligibility does not turn on ease of execution or obviousness of application. Those are questions that are examined under separate provisions of the Patent Act.” Interestingly, the Court cited Mayo for that proposition, which is really a stretch. Mayo conflates novelty and obviousness on the one hand with patent eligibility on the other, and turns the patentability inquiry into a nearly one-inquiry test for software and life-sciences related innovations. This statement by Chief Justice Prost is an important one that seems to signal that the Federal Circuit may be ready to apply the statute and allow the different sections of the Patent Act to do the work for which they were designed, as required by the Supreme Court in Diamond v. Diehr, and ignore the conflation by the Supreme Court in Mayo.
Tags: CAFC, Federal Circuit, life sciences, life sciences patents, patent, Patent eligibility, patents
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