Method Steps Must Be New and Useful to Be Patent Eligible Under Mayo: Federal Circuit

Practical Law Legal Update 1-616-4853 (Approx. 6 pages)

Method Steps Must Be New and Useful to Be Patent Eligible Under Mayo: Federal Circuit

by Practical Law Intellectual Property & Technology

Background

In 1996, Doctors Dennis Lo and James Wainscoat discovered cell-free fetal DNA (cffDNA) in maternal plasma and serum, which had previously been discarded as medical waste. The doctors applied a combination of known laboratory techniques to their discovery and implemented a method for detecting paternally inherited cffDNA in maternal plasma or serum to detect certain fetal characteristics. Sequenom, Inc. packaged and sold the invention as its MaterniT21 tests, which were used as an alternative for risky prenatal tests of fetal DNA. Ultimately, Drs. Lo and Wainscoat obtained US Patent No. 6,258,540 ('540 patent) in 2001 on behalf of Sequenom.

While the '540 patent does not claim cffDNA or paternally inherited cffDNA, the patent does claim certain methods of using cffDNA, including amplifying the cffDNA contained in a sample of maternal plasma or serum to detect the paternally inherited cffDNA.

Ariosa Diagnostics, Inc. makes and sells a non-invasive prenatal test that tests for certain fetal characteristics. Natera, Inc. also makes and sells a non-invasive fetal paternity test. After receiving letters claiming patent infringement from Sequenom, Ariosa and Natera (collectively Ariosa) filed declaratory judgment actions alleging their tests did not infringe the '540 patent. When Sequenom sought to preliminarily enjoin Ariosa from selling its prenatal test, the district court denied the motion, finding that there was a substantial question as to whether the '540 patent claimed patent eligible subject matter. Sequenom appealed. In 2013, the Federal Circuit vacated and remanded the matter on other grounds not relevant to this appeal. After the case was remanded to the district court, the parties filed cross motions for summary judgment regarding invalidity under 35 U.S.C. § 101.

The district court found in favor of Ariosa, agreeing that the '540 patent was directed towards the naturally occurring phenomenon of paternally inherited cffDNA present in a mother's plasma and serum. The district court further determined that there was no additional inventive concept because the claimed steps of amplifying and detecting were well-understood, routine or conventional tasks at the time the patent application was filed. Accordingly, the district court concluded that the '540 patent was not directed to patentable subject matter because the only inventive component of the claimed process was the application of those well-understood and routine tasks to the naturally occurring phenomenon of paternally inherited cffDNA.

Outcome

On appeal, the Federal Circuit affirmed the district court's decision, holding that:

For process patents directed to an application of an underlying natural phenomenon, the method steps themselves must supply the inventive concept in order to be patent eligible under 35 U.S.C. § 101.
Where a patent's claims are found only to disclose patent ineligible subject matter under the Mayo framework, preemption concerns are fully addressed and rendered moot.

Patent Eligibility Under Mayo

The Federal Circuit began its analysis by noting that the US Supreme Court has supplied the following framework for distinguishing between patents that claim patent ineligible laws of nature, natural phenomena and abstract ideas and those that claim patent-eligible applications of those ideas:

First, determine whether the claims at issue are directed to a patent-ineligible concept.
If yes, consider the elements of each claim both individually and as an ordered combination to determine whether there are additional elements that transform the nature of the claim into a patent-eligible application.

(Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)).

When the Federal Circuit applied the first step of the Mayo test to the '540 patent, it found that:

The claims of the '540 patent are method claims, which are usually eligible subject matter.
The claims of the '540 patent are directed to a multi-step method that starts with cffDNA taken from the mother's plasma or serum, which is a naturally occurring phenomenon. The method ends with paternally inherited cffDNA, which is also a naturally occurring phenomenon.
Because the method begins and ends with a natural phenomenon, the claims are directed to matter that is naturally occurring, which is a patent-ineligible concept.

Under the second step of the Mayo framework, the court concluded that:

The method at issue is little more than a set of general instructions directing doctors to apply routine, conventional techniques when seeking to detect cffDNA.
Because the individual method steps were well-understood, conventional and routine, the claimed method is not new and useful.
The only subject matter that was new and useful was the discovery of the presence of cffDNA in maternal plasma and serum.
Expert testimony confirmed that the methodology for amplifying DNA in the '540 patent was already well known in science at the time of the application.

The Federal Circuit emphasized that applying routine, conventional steps to a natural phenomenon is not enough to supply an inventive concept under the Mayo framework. Accordingly, the Federal Circuit concluded that the claims of the '540 patent are not directed to patent-eligible subject matter and are invalid.

Preemption

The Federal Circuit also addressed the preemption principle. In its summary judgment decision, the district court noted that because the '540 patent claimed a method for detecting the naturally occurring phenomenon of cffDNA, there was a risk that allowing the claims would preempt all practical uses of cffDNA. On appeal, the Federal Circuit:

Acknowledged the Supreme Court's explanation that preemption is the basis for judicial exceptions to patentability (Alice Corp. v. CLS Bank Int'l, 134 S. Ct. 2347, 2354 (2014)).
Clarified that although preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility.
Held that where a patent's claims are deemed only to disclose patent ineligible subject matter under Mayo, any preemption concerns are fully addressed and rendered moot.

Concurring Opinion (Linn)

Circuit Judge Linn issued a concurring opinion, stating that he was joining the court's opinion invalidating the '540 patent because he was bound to do so by the broad language of the Mayo decision. Judge Linn emphasized that the '540 patent's invention was clearly meritorious and that it was only Mayo's blanket dismissal of conventional post-solution activities that required the court to find the invention patent ineligible. Otherwise, Judge Linn would have found the fact that no one was amplifying and detecting paternally inherited cffDNA before Drs. Lo and Wainscoat discovered it as sufficiently new and inventive as to warrant patent protection.

Practical Implications

The Federal Circuit's decision may have a significant impact on the patent eligibility of many patents in the biotechnology field and others that result from a new discovery, like the discovery of cffDNA in this case. Unless the Supreme Court weighs in on this issue and modifies the test for patent eligibility as it relates to natural phenomenon, it may remain difficult for patent owners to successfully defend against patent eligibility challenges unless the invention includes individual method steps that rise to the level of an inventive concept.

Method Steps Must Be New and Useful to Be Patent Eligible Under Mayo: Federal Circuit | Practical Law