Illumina, Inc. v. Ariosa Diagnostics, Inc.
Illumina, Inc. v. Ariosa Diagnostics, Inc.
Opinion of the Court
On May 15, 2018, plaintiffs Illumina, Inc. and Sequenom, Inc. (collectively "plaintiffs") filed this action against Ariosa Diagnostics, Inc. ("Ariosa"), Roche Sequencing Solutions, Inc., and Roche Molecular Systems, Inc., (collectively "Roche"), alleging infringement of U.S. Patent Nos. 9,580,751 ("the '751 patent") and 9,738,931 ("the '931 patent"). Dkt. No. 1. This case was assigned to this Court on June 6, 2018. Dkt. No. 16.
Roche answered the complaint on July 9, 2018 and counterclaimed against plaintiffs, seeking declaratory judgment of noninfringement and invalidity of both asserted patents. Dkt. No. 21. Ariosa responded to the complaint with substantially the same answer and counterclaims on July 9, 2018. Dkt. No. 25. On August 9, 2018, both defendants modified their responses and submitted amended answers and counterclaims *928against plaintiffs. Dkt. Nos. 40, 41. Plaintiffs answered the amended counterclaims on August 23, 2018. Dkt. Nos. 46, 47.
On August 31, 2018 all defendants moved for summary judgment, seeking a finding that claims 1, 2, 4, 5, and 9-10 of
I. The '751 Patent
Illumina is the exclusive licensee of the '751 patent pursuant to an amended 2014 Pooled Patents Agreement between Illumina and Sequenom. Dkt. No. 1 ¶ 7. The '751 patent is titled "Non-Invasive Detection of Fetal Genetic Traits," and was issued to inventors Sinuhe Hahn, Wolfgang Holzgreve, Bernhard Zimmermann, and Ying Lim on February 28, 2017 and assigned to Sequenom, Inc.
According to the patent, "the presence of circulatory extracellular DNA in the peripheral blood is a well established phenomenon" and it has been shown that "fetal DNA is present in the maternal circulation."
The only independent claim of the '751 patent is as follows:
1. A method for preparing a deoxyribonucleic acid (DNA) fraction from a pregnant human female useful for analyzing a genetic locus involved in a fetal chromosomal aberration, comprising:
(a) extracting DNA from a substantially cell-free sample of blood plasma or blood serum of a pregnant human female to obtain extracellular circulatory fetal and maternal DNA fragments;
(b) producing a fraction of the DNA extracted in (a) by:
(i) size discrimination of extracellular circulatory DNA fragments, and
(ii) selectively removing the DNA fragments greater than approximately 500 base pairs,
wherein the DNA fraction after (b) comprises a plurality of genetic loci of the extracellular circulatory fetal and maternal DNA; and
(c) analyzing a genetic locus in the fraction of DNA produced in (b).
II. The '931 Patent
Illumina is the exclusive licensee of the '931 patent pursuant to an amended 2014 Pooled Patents Agreement between *929Illumina and Sequenom. Dkt. No. 1 ¶ 7. Like the '951 patent, the '931 patent is entitled "Non-Invasive Detection of Fetal Genetic Traits," and was issued to inventors Sinuhe Hahn, Wolfgang Holzgreve, Bernhard Zimmermann, and Ying Lim on February 28, 2017 and assigned to Sequenom, Inc.
The '931 patent has substantially the same specification as the '751 patent discussed above.
1. A method, comprising:
(a) extracting DNA comprising maternal and fetal DNA fragments from a substantially cell-free sample of blood plasma or blood serum of a pregnant human female;
(b) producing a fraction of the DNA extracted in (a) by:
(i) size discrimination of extracellular circulatory fetal and maternal DNA fragments, and
(ii) selectively removing the DNA fragments greater than approximately 300 base pairs,
wherein the DNA fraction after (b) comprises extracellular circulatory fetal and maternal DNA fragments of approximately 300 base pairs and less and a plurality of genetic loci of the extracellular circulatory fetal and maternal DNA fragments; and
(c) analyzing DNA fragments in the fraction of DNA produced in (b).
LEGAL STANDARD
I. Summary Judgment
Summary judgment is proper 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. See Fed. R. Civ. P. 56(a). The moving party bears the initial burden of demonstrating the absence of a genuine issue of material fact. Celotex Corp. v. Catrett ,
Once the moving party has met its burden, the burden shifts to the non-moving party to "designate 'specific facts showing that there is a genuine issue for trial.' "
*930
In deciding a summary judgment motion, the evidence of the non-movant is to be believed, and all justifiable inferences are to be drawn in his favor.
II. Subject Matter Eligibility Under § 101
Under Section 101 of Title 35 of the United States Code, the scope of patentable subject matter encompasses "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." Bilski v. Kappos ,
In Alice , the leading case on patent-eligible subject matter under § 101, the Supreme Court refined the "framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts" originally set forth in Mayo . Alice ,
The first step looks to determine whether claims are directed to a 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.
Ariosa Diagnostics, Inc. v. Sequenom, Inc. ,
DISCUSSION
Defendants seek summary judgment on the grounds that both the '931 and '751 patents claim patent-ineligible subject matter. Defendants assert that both patents are directed toward patent-ineligible subject matter and that there are no additional elements that transform the patents' claims into patent-eligible concepts. See Dkt. No. 48. Plaintiffs contest defendants' characterization of its patents, arguing the patents cover a laboratory technique for preparing a new and useful composition of cell-free DNA that is enriched for fetal DNA. See Dkt. No. 56.
Whether the patents are directed towards ineligible subject matter and whether there is nonetheless an inventive concept that transforms otherwise unpatentable subject matter are discussed in turn below.
I. Directed Towards a Patent-Ineligible Concept
Defendants argue that the asserted claims are directed to natural phenomena. Dkt. No. 48 at 7. Specifically, defendants argue that "[t]he claimed method begins with a sample of cell-free DNA and ends with an analysis of it," meaning that it is directed to patent-ineligible subject matter. Id. at 8:12-18. Defendants compare this case to both Genetic Techs. Ltd. v. Merial LLC ,
Plaintiffs argue 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. Dkt. No. 56. Plaintiffs argue the patents are directed to a process that yields a non-natural composition of cell-free DNA fragments that is enriched for fetal DNA.
The " 'directed to' inquiry applies a stage-one filter to claims, considered in light of the specification, based on whether 'their character as a whole is directed to excluded subject matter.' " Enfish, LLC v. Microsoft Corp. ,
Regarding patent-ineligible concepts, the Supreme Court has held that there is a "rule against patents on naturally occurring things ..." Ass'n for Molecular Pathology v. Myriad Genetics, Inc. ,
During prosecution (application no 13/757, 637) Mathias Ehrich, the Senior Vice President of Research and Development at Sequenom, Inc. filed a declaration in support of the patent. Dkt. No. 48-3 ("Ex. 2") ¶ 2. He stated that "[t]he claimed methods are not directed to a natural phenomenon - a difference in size of the maternal and fetal DNA in maternal blood plasma do not result in a natural phenomenon." He claimed that "the DNA in maternal blood plasma is not the size discriminated fraction produced by the claimed methods" and that "[t]he fetal and maternal DNA found in nature is structurally different and does not exhibit the discussed new utility." Id. ¶ 20. After size discrimination, "the ratio" of fetal DNA to maternal DNA "changes and has a new value that does not exist in nature." Id.
The fetal and maternal DNA in maternal blood plasma were subject to size discrimination based on a chosen fragment length (e.g., less than approximately 500 base pairs) to produce a fraction of the maternal and fetal DNA useful for a specific purpose (e.g., detection of a fetal genetic locus that is present in the maternal DNA and that is related to fetal chromosomal aneuploidy ). The size distribution of the DNA from maternal blood plasma substantially changed after this size discrimination was performed: certain DNA fragments mostly of maternal origin were preferentially removed and were no longer present in the sample. The difference in structure is directly related to and demonstrated by the new utility for the altered DNA of maternal blood plasma in the claimed methods: detection of certain fetal genetic loci.
Id.
In sum, plaintiffs contend that changing the concentration of fetal DNA relative to maternal DNA in the sample creates a "difference in structure" which is not naturally occurring.
The PTO originally rejected plaintiffs' applications stating:
Nothing is added by identifying the techniques to be used in selecting nucleic acids based on size because such techniques were the well-understood, routine and conventional techniques that a scientist would have thought of when instructed to enrich fetal DNA from a cell-free sample of maternal blood plasma or serum.
Id. ¶ 21.
Plaintiffs responded that "it was thought the similarity of the fetal and maternal genomes and the complex mixture of fetal and maternal fragments, in terms of fragment sizes and diversity of sequences exhibited for a given fragment size, were insurmountable" in isolating fetal DNA. Id. ¶ 21. However, plaintiffs' representations to the patent office conflate the two prongs of the Alice test. Changing the ratio of two natural products in a mixture and analyzing one of those products does not impact whether an invention is directed towards a natural phenomenon.
*933Here, the Court finds that both the '931 and '751 patents are directed towards patent-ineligible concepts, namely naturally occurring phenomena. Both 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. This use alone is insufficient to overcome the "directed to" inquiry.
Plaintiffs cite to Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc. ,
In CellzDirect , the inventors created a patent to solve a systemic issue with hepatocytes, namely that "certain factors limit their use: fresh hepatocytes can only be obtained from liver resections or non-transplantable livers or organ donors, and their life space is short."
In distinguishing CellzDirect from prior precedent, the Federal Circuit noted the difference between the claims in CellzDirect and the patent ineligible concepts amounting to nothing more than observing or identifying the ineligible concept in Ariosa and In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig. ,
The Court finds the facts at hand more analogous to Ariosa than to CellzDirect . In CellzDirect , the end result was cryogenically frozen useful liver cells that did not occur in nature. In Ariosa , as is the case here, the claims are directed to a testable quantity of genetic information found in nature. Unlike CellzDirect , the end result is naturally occurring. Accordingly, the Court finds plaintiffs' arguments unpersuasive and holds that the patents are directed to patent ineligible concepts.
II. Inventive Concept
Defendants argue the asserted claims do nothing more than list a series of conventional *934steps to detect and analyze DNA fragments. Defendants argue that nothing in the patent specifications or prosecution history identifies novelty or inventiveness beyond the natural phenomenon itself. Plaintiffs counter that, analyzing the claims as a whole, 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. Plaintiffs argue the composition of DNA presents new and useful utility in allowing for improved detection of fetal genetic traits, such as aneuploidy. Plaintiffs also argue the selection of 300 to 500 base pairs is human ingenuity and scientific judgment. In addition, plaintiffs argue that dependent claims include several laboratory steps that do not occur in nature, including PCR and ligase chain reactions for amplification, as well as the use of chromatography and electrophoresis. See Dkt. No. 56.
An inventive concept occurs when the claims are "more than a drafting effort designed to monopolize the [abstract idea]" and "claims may be read to 'improve[ ] an existing technological process.' " Bascom Glob. Internet Servs., Inc. v. AT & T Mobility LLC ,
"To put the matter more succinctly, [where] 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 incentive concept. Mayo ,
Plaintiffs rely on CellzDirect in support of their argument.
This Court finds the facts at hand far closer to those in Ariosa and distinguishable from CellzDirect . The invention in CellzDirect went beyond applying a known laboratory technique to a newly discovered natural phenomenon, and instead created an entirely new laboratory technique that "is not simply an observation or detection" based on the natural phenomenon. Id. Here, as in Ariosa , the claims extend only to isolation and analysis of a naturally occurring phenomenon and employ routine, well-known laboratory techniques. See Roche Molecular Sys., Inc. v. CEPHEID ,
The Court finds that the claims of each patent are not inventive. The independent claims require three phases: extraction, size production, and selective removal. Each of the steps is described as well-known and conventional. See Dkt. No. 61. Plaintiffs suggest that the novelty of their invention is in the use of routine and conventional steps to isolate and analyze smaller DNA fragments. However, the Court finds that the 'inventive concept' is the application of the well-known routine and conventional techniques for extraction and removal. For example, the patents require "extracting DNA," "producing a fraction of DNA", and discuss "discrimination" and "removal steps." These broad terms are "well-understood, routine, conventional activities previously known to the industry," particularly given that the claims provide them no more explicit definition. Broadband iTV, Inc. ,
Accordingly, the Court finds that plaintiffs' evidence does not raise genuine issues of material fact sufficient to defeat summary judgment. The "novelty" of an idea is not enough in itself to confer patentability, where the novelty does not exceed the "inventive concept" limitations. See, e.g., Diamond v. Diehr ,
In addition, the Court finds that the dependent claim limitations do not add enough to render the patents eligible. The claimed combination of elements lacks an inventive concept because the combination was well-understood, routine and conventional at the time of invention. Exergen Corp. v. Kaz USA, Inc. ,
CONCLUSION
For the foregoing reasons and for good cause shown, the Court hereby GRANTS defendants' motion for summary judgment. The parties are directed to file a joint statement identifying the issues which remain to be decided in this case and proposing a schedule for same. Such joint statement must be filed no later than January 9, 2019.
IT IS SO ORDERED .
There is an additional paragraph in the specification of the '931 patent that is not in the specification of the '751 patent. This paragraph merely highlights that a Sequence Listing is included in the specification. See id. at 1:25-30. The Sequence Listing is included in both patents.
Reference
- Full Case Name
- ILLUMINA, INC. v. ARIOSA DIAGNOSTICS, INC.
- Cited By
- 3 cases
- Status
- Published