Locke Lord QuickStudy: Method for Separating Fetal and Maternal DNA Held Ineligible for Patent Protection

Locke Lord LLP
January 23, 2019

On December 24, 2018, Judge Susan Illston of the United States District Court for the Northern District of California granted a motion for summary judgment of invalidity on several claims of U.S. Patent Nos. 9,850,751 (“’751 patent”) and 9,738,931 (“’931 patent”) filed by accused infringers Ariosa Diagnostics, Inc., Roche Sequencing Solutions, Inc., and Roche Molecular Systems, Inc. (collectively, “Defendants”). The arguments made by Illumina, Inc. and Sequenom, Inc. (collectively, “Plaintiffs”) were not found persuasive, as Judge Illston ruled that the claims were “directed towards patent-ineligible concepts, namely naturally occurring phenomena,” and further that the claims were not inventive because they called for the application of routine, conventional techniques that were well-known in the art. Illumina, Inc. v. Ariosa Diagnostics, Inc., No. 18-CV-02847-SI, 2018 WL 6735143, at *5, *8 (N.D. Cal. Dec. 24, 2018).

The ’751 patent is directed to “prenatal detection methods performed on a maternal serum or plasma samples from a pregnant female,” the claims being focused on “procedures to separate fetal and maternal DNA in a maternal blood sample.” Id. at *1. The ’931 patent is likewise directed to “prenatal detection methods performed on a maternal serum or plasma samples from a pregnant female,” the claims being similarly focused on “procedures to separate fetal DNA from a maternal sample through size discrimination methods.” Id. at *2. Both patents emphasized the “surprising finding[s]” that “fetal DNA has a relatively small size of approximately 500 base pairs or less” (’751 patent) and “fetal DNA has a relatively small size of approximately 300 base pairs or less” (’931 patent). Id. at *1-*2. Both patents shared substantially the same specification.

The District Court’s decision was made at the summary judgment stage. Summary judgment can only be granted “if the pleadings, the discovery and disclosure materials on file, and any affidavits show that there is no genuine dispute as to any material fact and that the movant is entitled to judgment as a matter of law.” Id. at *3.

Defendants had argued that the ’751 and ’931 patents were invalid under 35 U.S.C. § 101 because they were not directed to patent-eligible subject matter. Patent-eligible subject matter includes “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Id. at *3 (quoting Bilski v. Kappos, 561 U.S. 593, 601 (2010)). Importantly, however, “[l]aws of nature, natural phenomena, and abstract ideas are not patentable” because “they are the basic tools of scientific and technological work” and are “free to all men and reserved exclusively to none.” Id. (quoting Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014) and Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 70 (2012), respectively.)

The Supreme Court has established a two-step framework for determining whether a patent is impermissibly directed to laws of nature, natural phenomena, or abstract ideas:

The first step looks to determine whether claims are directed to patent-ineligible concept. If they are, the second step is to consider whether the additional elements recited in the claim transform the nature of the claim into a patent-eligible application by reciting an inventive concept that is sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.

Id. (quoting Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1380 (Fed. Cir. 2015)). If those “additional elements” include only “well-understood, routine, conventional activity previously engaged in by researchers in the field,” then they are “insufficient to transform a patent-ineligible concept into a patent-eligible application.” Id. at *4 (quoting Mayo, 566 U.S. at 73).

With respect to the first step of the framework, Defendants argued that the ’751 and ’931 patents claimed natural phenomena: “[t]he claimed method begins with a sample of cell-free DNA and ends with an analysis of it.” Id. at *4. Plaintiffs, on the other hand, argued that “the patent claims are directed to a laboratory method for preparing new and useful DNA fractions that do not exist in nature and are thus not a natural phenomenon.” Id.

Judge Illston agreed with Defendants—“[b]oth patents claim results from a test of naturally occurring fetal DNA and do not transform the naturally occurring product into something new. Instead the patents lay claim to test results obtained from the use of fetal DNA.” Id. at *5. Both patents claim “a testable quantity of genetic information found in nature.” Id. at *6.

With respect to the second step of the framework, Defendants argued that the ’751 and ’931 patents “do nothing more than list a series of conventional steps to detect and analyze DNA fragments.” Id.  Plaintiffs responded by arguing that “the inventors present a novel process that exploits the discovery that in a maternal cell free DNA sample from a pregnant woman, the fetal DNA is on average smaller than the maternal DNA.” Id. The court responded to the parties’ arguments as follows:

“To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately,” then there is no inventive concept.

Id. at *7 (quoting Mayo, 5666 U.S. at 79-80).

Judge Illston again sided with Defendants, stating that the ’751 and ’931 patents “extend only to isolation and analysis of a naturally occurring phenomenon and employ routine, well-known laboratory techniques” and finding that the asserted claims of each patent were not inventive. Id. at *7.

After finding in favor Defendants on both prongs of the Supreme Court’s section 101 framework, Judge Illston ruled that Plaintiffs had not raised any genuine issue of material fact and awarded summary judgment to Defendants. The judge summarized: “[t]he ‘novelty’ of an idea is not enough in itself to confer patentability, where the novelty does not exceed the ‘inventive concept’ limitations,” and “[t]he claimed combination of elements lacks an inventive concept because the combination was well-understood, routine and conventional at the time of invention.” Id. at *8.

This case is an important piece of a yet-evolving picture of section 101 jurisprudence. Plaintiffs filed an appeal of Judge Illston’s decision on January 16, 2019. Locke Lord will update this post pending the outcome of that appeal.