DCT

3:11-cv-06391

Ariosa Diagnostics Inc v. Sequenom Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:11-cv-06391, N.D. Cal., 12/19/2011
  • Venue Allegations: Venue is alleged to be proper in the Northern District of California because a substantial part of the events giving rise to the claim, including clinical studies of the plaintiff's test, occurred in the district, and the defendant is subject to personal jurisdiction there.
  • Core Dispute: Plaintiff seeks a declaratory judgment that its non-invasive prenatal test, which analyzes cell-free fetal DNA from maternal blood, does not infringe Defendant's patent related to the same field.
  • Technical Context: The technology concerns non-invasive prenatal testing (NIPT), which allows for the diagnosis of fetal genetic characteristics, such as chromosomal abnormalities, by analyzing small fragments of fetal DNA circulating in the mother's bloodstream, avoiding the risks of invasive procedures.
  • Key Procedural History: The complaint alleges that Defendant Sequenom made public statements and sent a cease-and-desist letter to Plaintiff Aria asserting its patent against competitors in the NIPT market. An Inter Partes Review (IPR) certificate attached to the patent-in-suit, issued in 2018, indicates that several claims, including the primary independent claim at issue in the complaint (Claim 1), were subsequently cancelled.

Case Timeline

Date Event
1997-03-04 ’540 Patent Priority Date
2001-07-10 ’540 Patent Issue Date
2008-11-12 Aria Diagnostics, Inc. incorporated
2010-05-01 Aria Diagnostics, Inc. commenced operations
2011-07-27 Sequenom statement to investment analyst
2011-09-07 Sequenom executive interview published on GenomeWeb
2011-11-03 Sequenom statement during earnings call
2011-11-14 Sequenom executive statement at investor conference
2011-12-06 Sequenom's counsel sends letter to Aria
2011-12-19 Complaint for Declaratory Judgment filed
2012-01-01 Planned commercial launch of the Aria Test (Early 2012)
2018-02-08 U.S. Patent Office issues IPR Certificate cancelling claims

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 6,258,540 - "Non-Invasive Prenatal Diagnosis"

  • Patent Identification: U.S. Patent No. 6,258,540, "Non-Invasive Prenatal Diagnosis," issued July 10, 2001.

The Invention Explained

  • Problem Addressed: The patent addresses the risks associated with conventional prenatal screening methods like amniocentesis and chorionic villus sampling, which are invasive and pose a danger to both the mother and fetus (’540 Patent, col. 1:11-18).
  • The Patented Solution: The invention is based on the discovery that cell-free fetal DNA is present and detectable in a pregnant woman's blood serum or plasma (’540 Patent, col. 1:49-52). The patent describes methods to detect this fetal DNA—specifically, paternally inherited sequences not found in the mother's genome—by amplifying and analyzing it, thereby enabling non-invasive prenatal diagnosis for various conditions (’540 Patent, col. 2:1-18).
  • Technical Importance: This discovery established a foundation for non-invasive prenatal testing, offering a way to obtain fetal genetic information from a simple maternal blood draw, which was previously only possible through risky, invasive procedures (’540 Patent, col. 1:29-34).

Key Claims at a Glance

  • The complaint focuses on creating a controversy regarding infringement of the ’540 patent, with particular attention given to Claim 1, which was quoted in its entirety in a letter from Defendant's counsel to Plaintiff (Compl. ¶¶ 19-20, 22).
  • Independent Claim 1 (since cancelled):
    • A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises:
    • amplifying a paternally inherited nucleic acid from the serum or plasma sample and
    • detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.
  • The complaint seeks a declaration of non-infringement for all claims of the patent (Compl. ¶24).

III. The Accused Instrumentality

  • Product Identification: The "Aria Test" (Compl. ¶2).
  • Functionality and Market Context:
    • The complaint describes the Aria Test as a non-invasive prenatal test that "employs a novel way of analyzing cell-free DNA circulating in the blood of a pregnant woman to determine whether a fetus is at risk of having an abnormal number of chromosomes (sometimes referred to as 'aneuploidy')" (Compl. ¶10).
    • It is positioned as a more accurate alternative to existing maternal serum screening techniques and a safer alternative to invasive procedures like amniocentesis (Compl. ¶10). Aria states it has made an "extraordinary investment" to prepare for the commercial launch of the test in early 2012 and is using it in the district for clinical validation studies (Compl. ¶¶ 11-12).
  • Visual Evidence: No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint, being for declaratory judgment of non-infringement, does not contain a detailed, element-by-element infringement theory from the Plaintiff. Instead, it summarizes the infringement allegations it attributes to the Defendant, Sequenom, to establish that a substantial controversy exists between the parties (Compl. ¶¶ 16-22).

The complaint alleges that Sequenom has publicly and repeatedly asserted that the ’540 Patent is foundational to the entire field of non-invasive prenatal testing using cell-free DNA (Compl. ¶17). According to the complaint, Sequenom's position is that "anybody [who is] developing, an approach that interrogates the circulating [cell-free] DNA is infringing this key patent in the field" (Compl. ¶17). This broad assertion forms the basis of the alleged infringement threat. The complaint further notes that Sequenom's counsel sent a letter that quoted Claim 1 of the ’540 Patent and implied its relevance to Aria's activities (Compl. ¶20). Aria, in turn, asks the court to declare that its Aria Test does not and will not infringe any claim of the patent, thereby directly challenging Sequenom's alleged infringement theory (Compl. ¶24). The complaint does not, however, provide sufficient technical detail about the Aria Test's specific steps to allow for a direct comparison against the claim elements of the ’540 Patent.

V. Key Claim Terms for Construction

  • The Term: "paternally inherited nucleic acid of fetal origin"
  • Context and Importance: This term appears in independent Claim 1 and is fundamental to the claimed method, as it defines the specific material being amplified and detected. The construction of this term is critical because it determines the scope of what the patent covers. If construed broadly, it could cover any fetal genetic material that differs from the mother's; if narrowly, it might be limited to specific types of sequences. Practitioners may focus on this term because the heart of the invention was the discovery of this material in maternal plasma, and its definition is central to any infringement or validity analysis.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the term generally as "any paternally-inherited sequences which are not possessed by the mother" (’540 Patent, col. 2:60-62). This language suggests the method is applicable to a wide range of genetic differences, not just specific named examples.
    • Evidence for a Narrower Interpretation: The specification provides specific, enabling examples, such as detecting a Y-chromosome sequence for sex determination or the Rhesus D gene for RhD status determination (’540 Patent, col. 2:50-52, col. 3:1-3). A party could argue the claims should be limited to the types of single-gene or chromosomal markers disclosed, rather than more complex quantitative analyses for conditions like aneuploidy, which Aria's test is designed to detect (Compl. ¶10).

VI. Other Allegations

  • Indirect Infringement: The complaint seeks a declaration that Aria's activities do not and will not "contribute to or induce the infringement" of any claim of the ’540 patent (Compl. ¶24). The factual basis for a potential indirect infringement claim by Sequenom is not detailed, but would presumably relate to Aria providing its test to healthcare providers and laboratories with instructions for use.
  • Willful Infringement: Willfulness is not alleged by Sequenom in this complaint. However, Aria's complaint establishes that Sequenom put Aria on notice of the ’540 patent through a letter from counsel dated December 6, 2011 (Compl. ¶19). This documented pre-suit knowledge could form the basis for a willfulness claim by Sequenom if it were to file a counterclaim for infringement.

VII. Analyst’s Conclusion: Key Questions for the Case

  1. Patent-Eligible Subject Matter: A primary issue, foreshadowed by the subsequent IPR cancellation of Claim 1, is one of patent eligibility: does the claimed method of detecting a naturally occurring phenomenon (the presence of cell-free fetal DNA in maternal plasma) by applying conventional techniques (amplification via PCR) represent a patent-eligible application of that discovery, or is it an impermissible attempt to claim the natural phenomenon itself?
  2. Definitional Scope: Assuming the claims were valid, a central question would be one of claim scope: can the term "detecting a paternally inherited nucleic acid," as taught in the context of identifying specific genes like the SRY or RhD gene, be construed to cover the quantitative analysis methods allegedly used by the Aria Test to determine the risk of chromosomal aneuploidies?
  3. Evidentiary Mismatch: A key evidentiary question will be whether there is a functional mismatch between the accused Aria Test and the patented method. The complaint describes the Aria Test as a "novel way of analyzing" DNA (Compl. ¶10), raising the question of whether its specific technical steps are the same as or equivalent to the simple "amplifying" and "detecting" steps required by the patent's claims.