SUSAN ILLSTON, United States District Judge.
Cross-motions for summary judgment by plaintiff/counterdefendant Ariosa Diagnostics, Inc. and defendant/counterclaimant Sequenom, Inc. came on for oral argument on October 11, 2013. Having considered the parties' motion papers, pleadings and arguments, and for good cause shown, the Court GRANTS Ariosa's motion for summary judgment and DENIES Sequenom's motion for summary judgment.
In this declaratory judgment action, plaintiff Ariosa, formerly known as Aria Diagnostics, Inc., seeks a declaration that its non-invasive prenatal test, the Harmony test, using cell-free fetal DNA circulating in the blood of a pregnant woman does
Sequenom is the exclusive licensee of the '540 patent, which Sequenom licensed from Isis Innovation Limited ("Isis"). See Docket No. 37, Tatman Decl. ¶¶ 3-4. The '540 patent is entitled "Non-Invasive Prenatal Diagnosis," and was issued to inventors Yuk-Ming Dennis Lo and James Stephen Wainscoat on July 10, 2001 and assigned to Isis. U.S. Patent No. 6,258,540 The '540 patent relates to prenatal detection methods performed on a maternal serum or plasma sample from a pregnant female, which methods comprise detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample. Id. at 2:1-4. "This invention enables non-invasive prenatal diagnosis, including for example sex determination, blood typing and other genotyping, and detection of pre-eclampsia in the mother." Id. (Abstract).
According to the patent, conventional pre-natal diagnostic DNA tests such as amniocentesis and chorionic villus sampling involved invasive procedures with risks to the mother and the pregnancy. '540 Patent at 1:12-17; see also Docket No. 35, Evans Decl. ¶¶ 34-37. Therefore, non-invasive techniques began to be developed that used maternal blood or serum. '540 Patent at 1:18-20. Prior non-invasive DNA research had focused on detecting fetal cells in a mother's bloodstream, because the presence of cell-free fetal DNA was not known. Id. at 1:28-36; see also Docket No. 35, Evans Decl. ¶ 21. However, these techniques were time-consuming or required expensive equipment. '540 Patent at 1:36-37; see also Docket No. 35, Evans Decl. ¶¶ 39-41 ("Ultimately, neither approach, using fetal cells or the other noninvasive screening measurements described above, has proved sufficiently successful or reliable to replace invasive testing.").
The '540 patent is based on the discovery in 1996-1997 by Drs. Lo and Wainscoat that cell-free fetal DNA (sometimes referred to as "cffDNA") is detectable in maternal serum or plasma samples.
The three independent claims of the '540 patent are as follows:
'540 Patent at 23:60-67; 26:20-36.
Ariosa filed this declaratory relief action against Sequenom on December 19, 2011, seeking a declaration that its Harmony Test does not infringe any claims of the '540 patent.
On July 5, 2012, the Court denied Sequenom's motion for a preliminary injunction. Docket No. 121. In the order, the Court found that Ariosa had raised a substantial question with regard to the validity of the '540 patent based on Ariosa's argument that the '540 patent does not cover patent eligible subject matter. Id. at 16-19. Sequenom appealed the Court's denial of its motion for a preliminary injunction. Docket No. 123.
On August 9, 2013, the Federal Circuit vacated the Court's order denying the preliminary injunction and remanded the case for further proceedings. Aria Diagnostics, Inc. v. Sequenom, Inc., 726 F.3d 1296, 2013 U.S.App. LEXIS 16506 (Fed.Cir. 2013). In vacating the order, the Federal Circuit rejected this Court's initial claim construction, but offered no opinion as to whether there is or is not a substantial question regarding the subject matter eligibility of the asserted claims of the '540 patent. Id. at *16-17. Rather, the Federal Circuit remanded with directions that this Court examine subject matter eligibility of the asserted claims in the first instance in light of the Supreme Court's recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc., ___ U.S. ___, 133 S.Ct. 2107, 186 L.Ed.2d 124 (2013) and the Federal Circuit's claim construction holdings. Id. at *16.
By the present cross-motions for summary judgment, the parties move for summary adjudication of whether claims 1, 2, 4, 5, 8, 19-22, 24, and 25 of '540 patent are drawn to patent-eligible subject matter.
Summary judgment is proper "if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter
Once the moving party has met its burden, the burden shifts to the nonmoving party to "set forth, by affidavit or as otherwise provided in Rule 56, `specific facts showing that there is a genuine issue for trial.'" T.W. Elec. Service, Inc. v. Pacific Elec. Contractors Ass'n, 809 F.2d 626, 630 (9th Cir.1987) (citing Celotex, 477 U.S. at 324, 106 S.Ct. 2548). To carry this burden, the non-moving party must "do more than simply show that there is some metaphysical doubt as to the material facts." Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 586, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). "The mere existence of a scintilla of evidence... will be insufficient; there must be evidence on which the jury could reasonably find for the [non-moving party]." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).
In deciding a summary judgment motion, the Court must view the evidence in the light most favorable to the non-moving party and draw all justifiable inferences in its favor. Id. at 255, 106 S.Ct. 2505. "Credibility determinations, the weighing of the evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a judge ... ruling on a motion for summary judgment." Id. However, conclusory, speculative testimony in affidavits and moving papers is insufficient to raise genuine issues of fact and defeat summary judgment. Thornhill Publ'g Co., Inc. v. GTE Corp., 594 F.2d 730, 738 (9th Cir.1979). The evidence the parties present must be admissible. Fed. R. Civ. P. 56(c)(2).
Under § 101 of the Patent Act, "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title." 35 U.S.C. § 101. "In choosing such expansive terms... modified by the comprehensive `any,' Congress plainly contemplated that the patent laws would be given wide scope." Diamond v. Chakrabarty, 447 U.S. 303, 308, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980).
However, the Supreme Court has long held that there is an important exception to § 101: "`[L]aws of nature, natural phenomena, and abstract ideas' are not patentable." Mayo Collaborative Servs. v. Prometheus Labs., Inc., ___ U.S. ___, 132 S.Ct. 1289, 1293, 182 L.Ed.2d 321 (2012); see also id. ("[T]he [Supreme] Court has written that a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc
Patent eligibility under § 101 is an issue of law that may involve underlying factual issues. Accenture Global Servs. v. Guidewire Software, Inc., 728 F.3d 1336, 2013 U.S.App. LEXIS 18446, at *10 (Fed.Cir.2013). Moreover, under 35 U.S.C. § 282, patents are presumed to be valid. Therefore, an alleged infringer must prove invalidity by clear and convincing evidence. See Microsoft Corp. v. i4i L.P., ___ U.S. ___, 131 S.Ct. 2238, 2242, 180 L.Ed.2d 131 (2011); see also Ultramercial, 722 F.3d at 1339 (explaining that an accused infringer must prove ineligible subject matter under § 101 by clear and convincing evidence). In this connection, it is the factual evidence itself which must be clear and convincing. See Buildex, Inc. v. Kason Indus., Inc., 849 F.2d 1461, 1463 (Fed.Cir.1988) (clear and convincing evidence is evidence "which produces in the mind of the trier of fact an abiding conviction that the truth of [the] factual contentions are highly probable" (alteration in original) (citation and internal quotation marks omitted)).
The Supreme Court has issued several recent decisions articulating standards for the subject matter eligibility, building on cases decided over the last half-century. Several of these cases are briefly reviewed below.
The patent in Funk Brothers claimed an inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria of the genus Rhizobium, where the strains are unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific.
The Supreme Court held that the claims were not patentable because "patents cannot issue for the discovery of the phenomena of nature." Id. at 130, 68 S.Ct. 440. The Supreme Court explained that discovery of the fact that certain strains of each species of these bacteria can be mixed without harmful effect to the properties of either is no more than the discovery of
The patent application in Benson "claimed a method for converting binary-coded decimal (BCD) numerals into pure binary numerals." Gottschalk v. Benson, 409 U.S. 63, 64, 93 S.Ct. 253, 34 L.Ed.2d 273 (1972). The Supreme Court noted that "[t]he claims were not limited to any particular art or technology, to any particular apparatus or machinery, or to any particular end use," and "[t]hey purported to cover any use of the claimed method in a general-purpose digital computer of any type." Id.; see also id. at 68, 93 S.Ct. 253 ("Here the `process' claim is so abstract and sweeping as to cover both known and unknown uses of the BCD to pure binary conversion").
The Supreme Court held that the claims were ineligible subject matter because the formula for converting BCD numerals to pure binary numerals was an abstract idea. See id. at 71, 93 S.Ct. 253. The Court explained: "The mathematical formula involved here has no substantial practical application except in connection with a digital computer, which means that if the judgment below is affirmed, the patent would wholly pre-empt the mathematical formula and in practical effect would be a patent on the algorithm itself." Id. at 71-72, 93 S.Ct. 253.
The patent application in Flook claimed a method of updating alarm limits,
The patent application in Diehr claimed "a process for molding raw, uncured synthetic rubber into cured precision products." Diamond v. Diehr, 450 U.S. 175, 177, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981). The process involved constantly determining the actual temperature inside the mold, then automatically feeding the temperatures into a computer which would repetitively calculate the necessary cure time using a mathematical formula known as the Arrhenius equation, and opening the press whenever the elapsed cure time equaled the calculated necessary cure time. See id. at 178-79 & n. 5, 101 S.Ct. 1048.
The Supreme Court found the invention to be patentable. The Court held that "a physical and chemical process for molding precision synthetic rubber products falls within the § 101 categories of possibly patentable subject matter." Id. at 184, 101 S.Ct. 1048. The Court distinguished the invention at issue from the inventions found unpatentable in Benson and Flook. See id. at 185-88, 191-92 & n. 14, 101 S.Ct. 1048. The Court recognized that "the process admittedly employs a well-known mathematical equation, but [the patentees] do not seek to pre-empt the use of that equation. Rather, they seek only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process." Id. at 187, 101 S.Ct. 1048. "[W]hen a claim containing a mathematical formula implements or applies that formula in a structure or process which, when considered as a whole, is performing a function which the patent laws were designed to protect (e. g., transforming or reducing an article to a different state or thing), then the claim satisfies the requirements of § 101." Id. at 192, 101 S.Ct. 1048. In addition, unlike in Flook, the patentees contended that there were novel aspects of the invention other than the use of the mathematical formula. See id. at 178-79, 101 S.Ct. 1048.
The patent application in Bilski claimed a procedure for instructing buyers and sellers of commodities in the energy market
The Supreme Court held that the claims were unpatentable under Benson, Flook, and Diehr because the claims "are attempts to patent abstract ideas." Id. at 3230. The Court explained that claims 1 and 4 in the patentees' application explain the basic concept of hedging, or protecting against risk, and the concept of hedging is an unpatentable abstract idea. Id. at 3231. "Allowing petitioners to patent risk hedging would preempt use of this approach in all fields, and would effectively grant a monopoly over an abstract idea." Id. The Court also rejected the remaining claims of the application because they were "broad examples of how hedging can be used in commodities and energy markets." Id. "Flook established that limiting an abstract idea to one field of use or adding token postsolution components d[o] not make the concept patentable." Id.
The patents in Prometheus claimed processes that help doctors using thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level is too low or too high. Prometheus, 132 S.Ct. at 1294. Too high a dosage would risk harmful side effects, but too low a dosage might be ineffective. Id. at 1295. At the time of the invention, scientists already understood that the levels of certain metabolites in a patient's blood were correlated with the likelihood that a particular dosage of a thiopurine drug could cause harm or prove ineffective. Id. The patents' claims set forth processes embodying researchers' findings that identified the precise correlations between metabolite levels and likely harm or ineffectiveness. Id.
The Supreme Court held that the claims were invalid under § 101. Id. at 1305. The Court explained that "Prometheus' patents set forth laws of nature — namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm." Id. at 1296. "If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. A patent, for example, could not simply recite a law of nature and then add the instruction `apply the law.'" Id. at 1297. Therefore, the Court concluded that although the patents recited additional steps in addition to the law of nature, the additional steps were insufficient to transform the character of the claims. See id. at 1297-98 ("[T]he 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.").
The patentees in Myriad discovered the precise location and sequence of two human genes, the BRCA1 and BRCA2 genes,
The Supreme Court held that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring." Id. at 2111. The Court noted that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes and did not create or alter the genetic structure of DNA. Id. at 2116. "Instead, Myriad's principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13." Id. "To be sure, [Myriad] found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention." Id. at 2117. In contrast, the Court found that cDNA is not a "product of nature" and, therefore, is patent eligible under § 101. Id. at 2119.
Ariosa argues that claims 1, 2, 4, 5, 8, 19-22, 24, and 25 of the '540 patent are not drawn to patent eligible subject matter because paternally inherited cffDNA is a natural phenomenon and the claims of the '540 patent merely add well-understood, routine, conventional activity in the field to that natural phenomenon. Docket No. 219 at 7-20. In response, Sequenom argues that the claimed methods are patentable because they are novel uses of a natural phenomenon, rather than a patent on the natural phenomenon itself. Docket No. 223 at 7-18. In addition, Sequenom argues that the claims are patentable because the claims do not preempt all uses of cffDNA. Id. at 18-22.
The parties agree that neither cffDNA nor the discovery of cffDNA in maternal plasma or serum is patentable, because the presence of cffDNA in maternal plasma or serum is a natural phenomenon. Docket No. 219 at 1-2; Docket No. 223 at 1, 8; see Myriad, 133 S.Ct. at 2116; Prometheus, 132 S.Ct. at 1293; see also Funk Bros., 333 U.S. at 130, 68 S.Ct. 440 ("He who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes."). This is true even if the discovery of cffDNA in maternal plasma or serum was considered groundbreaking, innovative, and brilliant. See Myriad, 133 S.Ct. at 2117. However, the '540 patent does not claim as an invention the discovery of cffDNA in maternal plasma or serum. The '540 patent claims methods of detecting paternally inherited cffDNA in maternal plasma or serum. See '540 Patent at 2:1-5, 23:60-26:40. Therefore, the issue before the Court is whether the steps of the claimed methods in the '540 patent, applied to that natural phenomenon, are sufficient to render the claims patentable. See Prometheus, 132 S.Ct. at 1297 ("[D]o the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent eligible processes that apply natural laws").
A process or method is not unpatentable simply because it contains a law of nature, a natural phenomenon, or an abstract idea. Prometheus, 132 S.Ct. at 1293; Flook, 437 U.S. at 590, 98 S.Ct. 2522. But, to be patentable, a process that focuses
Here, Ariosa argues that the method steps contained in claims 1, 2, 4, 5, 8, 19-22, 24, and 25 of the '540 patent do not add enough to the natural phenomenon of paternally inherited cffDNA to make these claims patentable under § 101. Docket No. 219 at 10-20. Specifically, Ariosa argues that the additional limitations in the claims either apply well-understood, routine, and conventional activity to the natural phenomenon or limit the natural phenomenon to specific types of the natural phenomenon, which are also unpatentable. See id. The Court agrees. For example, claim 1 of the '540 patent claims a method for detecting cffDNA, comprising the following two steps: "amplifying a paternally inherited nucleic acid from the serum or plasma sample [from a pregnant female] and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample." '540 Patent at 23:64-67. Ariosa has presented the Court with evidence, including the specification and prosecution history of the '540 patent and testimony by Sequenom's own expert, Dr. Evans, stating that the amplification and detection of DNA sequences in plasma or serum was well known by 1997. Docket No. 219 at 10-14 (citing evidence); Docket No. 238 at 6-7 (citing evidence). For example, the specification of the '540 patent states that "[t]he preparation of serum of plasma from the maternal blood sample is carried out by standard techniques" and also states "[s]tandard nucleic acid amplification systems can be used." '540 Patent at 2:26-27, 2:44-45; see also Docket No. 219-7, Gindler Decl. Ex. 5 ¶ 7. In addition, the inventors during the prosecution history stated that any of the well-known, routine techniques for detection of DNA could be used to detect fetal DNA in maternal serum or plasma. Docket No. 219-4, Gindler Decl. Ex. 2 at 5, 7-8, 10, 12; see also '540 Patent at 1:38-43. Sequenom's expert Dr. Evans acknowledged that traditional DNA diagnostics, prior to the invention, commonly involved sample preparation, amplification, and detection. Docket No. 219-6, Gindler Decl. Ex. 4 at 188:5-13; see also id. at 150:18-151:7, 152:4-15. Dr. Evans also acknowledged that others before the inventors had amplified and detected nucleic acid in plasma or serum. Id. at 188:15-17; Docket No. 35, Evans Decl. ¶ 58; see also Docket No. 238-7, Gindler Decl. Ex. 16 at 485 ("There has been much interest in the use of DNA derived from plasma or serum for molecular diagnosis."). Sequenom does not contest that these steps and other steps in the
Sequenom argues that the claims are patentable because although cffDNA is not patentable, the use of cffDNA is patent eligible. Docket No. 223 at 7-10. The Court disagrees. The Supreme Court has never stated that any use of a natural phenomenon is patentable. To the contrary, the Supreme Court has held that "simply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable." Prometheus, 132 S.Ct. at 1300. It is only an innovative or inventive use of a natural phenomenon that is afforded patent protection. See Myriad, 133 S.Ct. at 2119 ("Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent."); Flook, 437 U.S. at 594, 98 S.Ct. 2522 ("[A]n inventive application of the principle may be patented."). Sequenom attempts to argue that its patent claims an inventive method of using cffDNA. But, based on the undisputed facts before the Court, the
The Court's conclusion conforms with the relevant Supreme Court case law, in particular Flook and Myriad. The patent in Flook, like the present patent, claimed methods that utilized an abstract idea or a natural phenomenon — a mathematical algorithm in Flook, paternally inherited cffDNA in the present case.
Sequenom cautions that the Court should not engage in a step-by-step dismantling of the claims. Docket No. 223 at 22-24 (citing Diehr, 450 U.S. at 188, 101 S.Ct. 1048 ("In determining the eligibility of respondents' claimed process for patent protection under § 101, their claims must be considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. This is particularly true in a process claim because a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made."); Ultramercial, 722 F.3d at 1344)). In evaluating the patentability of the claims, the Court has not
In addition, in determining whether a claim is patentable, a court should consider whether the claim poses a risk of preempting a law of nature, natural phenomenon, or abstract idea.
Further, the articles cited by Sequenom were published after the issuance of the patent and well after the date of the invention. See Docket No. 223-1, Root Decl. Ex. A at A2102-05 (2003), A2273-80 (2012), Ex. F (2002). Therefore, even assuming that the articles disclose alternative methods of detecting cffDNA, Sequenom has failed to show that any alternative methods existed at the time of the invention or at the time of issuance of the patent. Thus, it appears that the effect of issuing the '540 patent was to wholly preempt all known methods of detecting cffDNA at that time. Accordingly, the Court concludes that the claims at issue pose a substantial risk of preempting the natural phenomenon of paternally inherited cffDNA and that the preemption inquiry supports the Court's conclusion that the claims are not drawn to patent eligible subject matter.
In sum, the Court concludes that, based on the undisputed facts before the Court, Ariosa has met its burden of proving by clear and convincing evidence that claims 1, 2, 4, 5, 8, 19-22, 24, and 25 of the '540 patent are not drawn to patent eligible subject matter and are invalid under 35 U.S.C. § 101.
For the foregoing reasons, the Court GRANTS Ariosa's motion for summary judgment and DENIES Sequenom's motion for summary judgment. Docket Nos. 219, 223.
Dependent Claims 5, 8, 19, and 20 merely limit the natural phenomenon of paternally inherited cffDNA to specific types of that natural phenomenon, such as requiring that the cffDNA is from a Y chromosome or requiring that the cffDNA is at least a certain percentage of the total DNA. See '540 Patent at 25:1-3, 25:8-10, 25:39-26:3. A specific type of a natural phenomenon is still a natural phenomenon and, thus, is not patentable. See Myriad, 133 S.Ct. at 2116; Prometheus, 132 S.Ct. at 1293.
Dependent claims 21 and 22 add the limitations of fractionating the blood sample and providing a diagnosis based on the cffDNA. See id. at 26:4-26:16. Independent claims 24 and 25 contain — in addition to the limitations in claim 1 — limitations related to fractionating a blood sample. See id. at 26:20-36. Ariosa has presented the Court with evidence that fractionating blood and providing a diagnosis based on fetal DNA were well-understood, routine, conventional activity engaged in by those in the field at the time of the invention. See id. at 2:26-27; Docket No. 219-2, Gindler Decl. Ex. 3 at 6, Ex. 4 at 152:4-15, Ex. 5 ¶ 7.
In addition, the Court rejects Sequenom's argument that Myriad's holding that cDNA is patent eligible supports the patentability of the claims of the '540 patent. Docket No. 223 at 11; Docket No. 240 at 5. In Myriad, the Supreme Court held that cDNA was patent eligible because it was not a naturally occurring phenomenon. 133 S.Ct. at 2119. Here, Sequenom has failed to provide any evidence or argument stating that the methods claimed in the '540 patent produce a non-naturally occurring phenomenon. To the contrary, Sequenom concedes that cffDNA is a naturally occurring phenomenon. See Docket No. 223 at 1, 8.
