Court: District Court, N.D. California; December 23, 2018; Federal District Court
On May 15, 2018, Illumina, Inc. and Sequenom, Inc. filed a lawsuit against Ariosa Diagnostics, Inc. and Roche Sequencing Solutions, Inc., alleging infringement of U.S. Patent Nos. 9,580,751 and 9,738,931. The case was assigned to Judge Susan Illston on June 6, 2018. Roche filed an answer and counterclaim for declaratory judgment of noninfringement and invalidity on July 9, 2018, with Ariosa submitting similar responses the same day. Both defendants later amended their responses on August 9, 2018, and plaintiffs replied to these amended counterclaims on August 23, 2018. On August 31, 2018, the defendants moved for summary judgment, claiming certain patent claims were invalid as not patent-eligible under 35 U.S.C. § 101. The court granted a stipulated enlargement of time for plaintiffs to respond, and oral arguments occurred on December 21, 2018.
The '751 patent, titled "Non-Invasive Detection of Fetal Genetic Traits," was issued to inventors on February 28, 2017, and is assigned to Sequenom, with Illumina as the exclusive licensee under a 2014 agreement. This patent pertains to prenatal detection methods using maternal serum or plasma to separate fetal and maternal DNA, leveraging the discovery that fetal DNA fragments are smaller (approximately 500 base pairs or less) than maternal DNA. The patent outlines a method involving the extraction of DNA from a pregnant woman’s blood sample, size discrimination to isolate fetal DNA, and subsequent analysis of genetic loci associated with fetal chromosomal abnormalities. The independent claim details the process of preparing a DNA fraction suitable for this analysis.
Illumina is the exclusive licensee of U.S. Patent No. 9,738,931 ('931 patent), which was assigned to Sequenom, Inc. and relates to non-invasive prenatal detection methods for fetal genetic traits. The patent, issued on February 28, 2017, was established under a 2014 Pooled Patents Agreement between Illumina and Sequenom. It focuses on separating fetal DNA from maternal serum or plasma samples using size discrimination methods, specifically targeting DNA fragments of approximately 300 base pairs or less. This approach is based on the discovery that fetal DNA is typically smaller than maternal DNA, allowing for enrichment of fetal sequences. The '931 patent shares substantial specifications with U.S. Patent No. 9,738,751 ('751 patent), differing mainly in its focus on smaller DNA fragment sizes. The independent claim of the '931 patent outlines a method involving the extraction of DNA from a maternal sample, size discrimination to isolate DNA fragments of 300 base pairs or smaller, and subsequent analysis of these DNA fragments.
A summary judgment may be granted when there is no genuine dispute over material facts, as per Federal Rule of Civil Procedure 56(a). The moving party must initially demonstrate the absence of such disputes but is not required to produce evidence of this absence. Instead, they can shift the burden to the non-moving party by indicating a lack of evidence supporting their claims. The non-moving party must then provide specific facts showing a genuine issue for trial, surpassing mere speculation about the facts.
A scintilla of evidence is inadequate to support a jury's finding for the non-moving party; there must be sufficient evidence that enables a reasonable conclusion in their favor (Anderson v. Liberty Lobby, Inc.). In summary judgment motions, the non-movant's evidence is presumed credible, and all reasonable inferences must be drawn in their favor. However, conclusory or speculative affidavits do not create genuine issues of fact sufficient to defeat summary judgment (Thornhill Publ'g Co. Inc. v. Gen. Tel. Elec. Corp.). Evidence presented must also be admissible (Fed. R. Civ. P. 56(c)(4)).
Regarding patent eligibility under § 101 of Title 35 of the U.S. Code, patentable subject matter includes any new and useful process, machine, manufacture, or composition, but excludes laws of nature, natural phenomena, and abstract ideas (Bilski v. Kappos). This exclusion exists because such concepts are fundamental tools for scientific and technological work and should remain free for public use (Mayo Collaborative Servs. v. Prometheus Labs. Inc.). The Supreme Court has cautioned that granting patents on these concepts would hinder rather than promote innovation. The Alice decision established a two-step framework for assessing patent eligibility: first, determine if claims are directed to a patent-ineligible concept; second, evaluate whether additional elements in the claims transform them into a patent-eligible application by demonstrating an inventive concept that significantly surpasses the ineligible concept itself (Ariosa Diagnostics, Inc. v. Sequenom, Inc.).
Additional elements that merely represent "well-understood, routine, conventional activity" by researchers do not suffice to convert a patent-ineligible concept into a patent-eligible application, as established in Mayo. Determining whether an element is well-understood, routine, and conventional is a factual inquiry, according to Berkheimer. Summary judgment on § 101 eligibility is appropriate when no genuine disputes of fact exist regarding the conventionality of claim elements. If a court must address underlying factual questions related to eligibility, they must be supported by clear and convincing evidence.
In the current case, defendants seek summary judgment, claiming that the '931 and '751 patents encompass patent-ineligible subject matter. They argue that the patents are directed to natural phenomena, asserting that the claimed method—from a sample of cell-free DNA to its analysis—fits this category. They reference Genetic Techs and Ariosa, where similar claims were deemed directed to naturally occurring phenomena. Conversely, plaintiffs contend that their patents pertain to a laboratory method that generates new, useful compositions of cell-free DNA, specifically enriched for fetal DNA, thus not classifying as a natural phenomenon.
The inquiry into whether the patents are directed to patent-ineligible concepts involves analyzing their overall character in light of the specification. The courts acknowledge the challenge in distinguishing between abstract ideas and patent-eligible subject matter. The Supreme Court has maintained a rule against patents on naturally occurring phenomena, underscoring the complexity in delineating patentable processes from unpatentable principles.
The Supreme Court established that laws of nature, natural phenomena, and abstract ideas are not patentable. In support of a patent application, Mathias Ehrich of Sequenom, Inc. argued that claimed methods do not target a natural phenomenon, asserting that the differences in size of maternal and fetal DNA in maternal blood plasma do not constitute a natural phenomenon. He claimed that the DNA extracted through size discrimination exhibits structural differences and new utility, as the ratio of fetal to maternal DNA changes post-discrimination, allowing for the detection of specific fetal genetic loci. The initial rejection by the Patent and Trademark Office (PTO) cited that the techniques used for selecting nucleic acids were routine and conventional, while the plaintiffs contended that the complex mixture of DNA made isolation difficult. The court concluded that the patents in question are directed at patent-ineligible concepts—naturally occurring phenomena—because they claim results derived from naturally occurring fetal DNA without transforming it into something new. The plaintiffs' reliance on a Federal Circuit case regarding the patentability of a cryopreservation technique was deemed insufficient, as that case involved a laboratory technique rather than a natural product.
The court determined that the inventors of the patented process for preserving hepatocyte cells developed a novel method to address significant limitations in using fresh hepatocytes, which can only be sourced from liver resections or organ donors and have a limited viability. Prior cryopreservation techniques damaged the cells, resulting in low recovery rates, and were inadequate for creating multi-donor hepatocyte pools, which are valuable for research. The inventors discovered that certain hepatocytes could endure multiple freeze-thaw cycles, leading to an improved preservation method involving density gradient fractionation and refreezing of viable cells. The resulting preparation could be thawed and used immediately.
In contrast to previous cases like Ariosa, where the claims involved natural concepts, the court recognized CellzDirect as a unique artisan technique producing cryogenically frozen liver cells not found in nature. The court concluded that the claims in the current case were directed at naturally occurring genetic information, rendering them patent ineligible.
Regarding the inventive concept, defendants argued that the claims merely outlined conventional steps for DNA analysis, lacking novelty beyond the natural phenomenon. Plaintiffs contended that their process capitalized on the discovery that fetal DNA in maternal samples is typically smaller than maternal DNA, offering improved detection of fetal genetic traits. They highlighted that the selection of specific DNA fragment sizes and certain laboratory techniques, such as PCR and chromatography, demonstrated human ingenuity. The court emphasized that claims must exceed mere drafting efforts to monopolize abstract ideas and should show improvement over existing technological processes to qualify as inventive.
Well-understood, routine, and conventional activities do not suffice to convert an unpatentable law of nature into a patent-eligible application. Claims that merely inform about laws of nature, along with additional steps that are routine and conventional within the scientific community, fail to demonstrate an inventive concept. The court referenced the case of CellzDirect, where the patent was distinguished from Myriad because it involved a new and useful method rather than just an observation of naturally occurring phenomena. In contrast, the patents in question here align more closely with those in Ariosa, as they involve the isolation and analysis of naturally occurring phenomena using conventional techniques. The independent claims require phases of extraction, size production, and selective removal, all described as well-known activities. The plaintiffs argued that their invention's novelty lies in the application of these conventional steps, but the court found no inventive concept present. The claims were deemed to lack patentability as the combination of elements was routine at the time of invention. Consequently, the court granted the defendants' motion for summary judgment, directing the parties to file a joint statement regarding remaining issues by January 9, 2019. Additionally, a minor specification in the '931 patent regarding a Sequence Listing was noted, which is also included in the '751 patent.
