Ariosa Diagnostics, Inc. v. Sequenom, Inc., s. 2014–1139

Citation115 U.S.P.Q.2d 1152,788 F.3d 1371
Decision Date12 June 2015
Docket Number2014–1144.,Nos. 2014–1139,s. 2014–1139
PartiesARIOSA DIAGNOSTICS, INC., Natera, Inc., Plaintiffs–Appellees DNA Diagnostics Center, Inc., Counterclaim Defendant–Appellee v. SEQUENOM, INC., Sequenom Center for Molecular Medicine, LLC, Defendants–Appellants Isis Innovation Limited, Defendant.
CourtUnited States Courts of Appeals. United States Court of Appeals for the Federal Circuit

David Isaac Gindler, Irell & Manella LLP, Los Angeles, CA, argued for plaintiff-appellee Ariosa Diagnostics, Inc. Also represented by Andrei Iancu ; Amir Naini, Russ August & Kabat, Los Angeles, CA.

William Paul Schuck, Bartko, Zankel, Bunzel & Miller, San Francisco, CA, for plaintiff-appellee Natera, Inc., counterclaim defendant-appellee DNA Diagnostics Center, Inc.

Michael J. Malecek, Joseph M. Lipner, Kaye Scholer LLP, Palo Alto, CA, argued for defendants-appellants. Also represented by Peter E. Root, Menlo Park, CA; Aton Arbisser, Los Angeles, CA.

Richard L. Blaylock, Pillsbury Winthrop Shaw Pittman LLP, San Diego, CA, for amicus curiae Invitae Corporation. Also represented by Kirke M. Hasson, Colin Travers Kemp, San Francisco, CA.

Kevin Edward Noonan, McDonnell, Boehnen Hulbert & Berghoff, LLP, Chicago, IL, for amicus curiae Biotechnology Industry Organization.

William Larry Respess, I, Sheppard, Mullin, Richter, & Hampton LLP, San Diego, CA, for amicus curiae The San Diego Intellectual Property Law Association.

Before REYNA, LINN, and WALLACH, Circuit Judges.

Opinion

Opinion for the court filed by Circuit Judge REYNA. Concurring Opinion file by Circuit Judge LINN.

REYNA, Circuit Judge.

This appeal is from a grant of summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (“the '540 patent”). The United States District Court for the Northern District of California found that the asserted claims of the '540 patent are not directed to patent eligible subject matter and are therefore invalid under 35 U.S.C. § 101. For the reasons explained below, we affirm.

I

In 1996, Drs. Dennis Lo and James Wainscoat discovered cell-free fetal DNA (“cffDNA”) in maternal plasma and serum, the portion of maternal blood samples that other researchers had previously discarded as medical waste. cffDNA is non-cellular fetal DNA that circulates freely in the blood stream of a pregnant woman. Applying a combination of known laboratory techniques to their discovery, Drs. Lo and Wainscoat implemented a method for detecting the small fraction of paternally inherited cffDNA in maternal plasma or serum to determine fetal characteristics, such as gender. The invention, commercialized by Sequenom as its MaterniT21 test, created an alternative for prenatal diagnosis of fetal DNA that avoids the risks of widely-used techniques that took samples from the fetus or placenta. In 2001, Drs. Lo and Wainscoat obtained the '540 patent, which relates to this discovery.

The parties agree that the patent does not claim cffDNA or paternally inherited cffDNA. Instead, the '540 patent claims certain methods of using cffDNA. The steps of the method of claim 1 of the '540 patent include amplifying the cffDNA contained in a sample of a plasma or serum from a pregnant female and detecting the paternally inherited cffDNA. Amplifying cffDNA results in a single copy, or a few copies, of a piece of cffDNA being multiplied across several orders of magnitude, generating thousands to millions of copies of that particular DNA sequence. In the amplification step, DNA is extracted from the serum or plasma samples and amplified by polymerase chain reaction

(“PCR”) or another method. PCR exponentially amplifies the cffDNA sample to detectable levels.

In the detecting step, the lab technician adds the amplified cffDNA to an agarose gel containing ethidium bromide to stain and visualize the paternally inherited cffDNA.

The '540 patent also provides for making a diagnosis of certain fetal characteristics based on the detection of paternally inherited cffDNA. The specification explains that analysis of cffDNA permits more efficient determination of genetic defects and that a pregnant woman carrying a fetus with certain genetic defects will have more cffDNA in her blood than will a woman with a normal fetus. '540 patent col. 3 ll. 30–43.

Claims 1, 2, 4, 5, 8, 19–22, 24, and 25 of the '540 patent are at issue in this appeal.1 Independent claim 1 requires:

1. 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 comprisesamplifying 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.

'540 patent col. 23 l. 61–67.

For comparison, independent claims 24 and 25 require:

24. A method for detecting a paternally inherited nucleic acid on a maternal blood sample, which method comprises: removing all or substantially all nucleated and anucleated cell populations from the blood sample,
amplifying a paternally inherited nucleic acid from the remaining fluid and subjecting the amplified nucleic acid to a test for the Paternally [sic] inherited fetal nucleic acid.
25. A method for performing a prenatal diagnosis on a maternal blood sample, which method comprises
obtaining a non-cellular fraction of the blood sample
amplifying a paternally inherited nucleic acid from the non-cellular fraction
and performing nucleic acid analysis

on the amplified nucleic acid to detect paternally inherited fetal nucleic acid.

Id. at 26 ll. 20–36.

The remaining claims explain how the method of detection occurs or how it can be used. For example, claim 2 depends from claim 1 and claims amplification by polymerase chain reaction

. Id. at col. 24 ll. 60–61. Claim 4 similarly depends from claim 1 and claims detection via a sequence specific probe. Id. col. 24 ll. 65–67. Claim 21 also depends from claim 1, but instead of focusing solely on a method for detecting, it focuses on a method for performing a prenatal diagnosis, using claim 1's method for detecting. Id. col. 26 ll. 4–14.

II

Appellee Ariosa Diagnostics, Inc. (formerly known as “Aria Diagnostics, Inc.) makes and sells the Harmony Test, a non-invasive test used for prenatal diagnosis of certain fetal characteristics. Natera, Inc. makes and sells the Non–Invasive Paternity Test, which is intended to confirm the paternity or non-paternity of a gestating fetus from genetic information in fetal DNA available in the blood of the pregnant female. Diagnostics Center, Inc. is a licensee of Natera.

In response to letters threatening claims of infringement, Ariosa Diagnostics, Inc., Natera, Inc. and Diagnostics Center, Inc. each filed separate declaratory judgment actions from December 2011 through early 2012 against Sequenom alleging that they did not infringe the '540 patent. Sequenom counterclaimed alleging infringement in each case. The district court related the three actions for pretrial purposes.

In the Ariosa action, Sequenom filed a motion seeking to preliminarily enjoin Ariosa from selling the accused Harmony Prenatal Test. In July 2012, the district court issued an order denying Sequenom's motion for a preliminary injunction. In the context of doing so, the district court found that there was a substantial question over whether the subject matter of the asserted claims was directed to eligible subject matter. Sequenom appealed to this court.

On August 9, 2013, this court vacated and remanded the case, holding that the district court erred in certain respects not relevant to this appeal. Aria Diagnostics, Inc. v. Sequenom, Inc., 726 F.3d 1296, 1305 (Fed.Cir.2013). In addition, this Court noted that it 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, but remanded “for the district court to examine subject matter eligibility.... in light of [Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ––––, 133 S.Ct. 2107, 2117, 186 L.Ed.2d 124 (2013) ].” Id. at 1304.

After remand, the parties filed cross motions for summary judgment regarding invalidity under 35 U.S.C. § 101. The district court agreed with Ariosa's argument that the claims of the '540 patent were directed to the natural phenomenon of paternally inherited cffDNA and that the claims did not add enough to the natural phenomenon to make the claims patent eligible under § 101. The district court determined that the steps of amplifying and detecting were well-understood, routine, or conventional activity in 1997, when the application for the '540 patent was filed. The district court concluded that the '540 patent was not directed to patentable subject matter because “the only inventive component of the processes of the '540 patent is to apply those well-understood, routine processes to paternally inherited cffDNA, a natural phenomenon.” J.A. 18. The district court also found that the claimed processes posed a risk of preempting a natural phenomenon. Sequenom appeals.

We have jurisdiction under 28 U.S.C. § 1295(a)(1).

III

We review the grant of summary judgment under the law of the regional circuit, in this case the Ninth Circuit. Charles Mach. Works, Inc. v. Vermeer Mfg. Co., 723 F.3d 1376, 1378 (Fed.Cir.2013). The Ninth Circuit reviews the grant or denial of summary judgment de novo. Leever v. Carson City, 360 F.3d 1014, 1017 (9th Cir.2004). We also review de novo the question of whether a claim is invalid under section 101. In re BRCA1– and BRCA2–Based Hereditary Cancer Test Patent Litig., 774 F.3d 755, 759 (Fed.Cir.2014).

Section 101 of the Patent Act defines patent eligible subject matter:

Whoever 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. The Supreme Court has long held that there are certain exceptions to this...

To continue reading

Request your trial
2739 cases
  • In re Biogen 755 Patent Litig.
    • United States
    • U.S. District Court — District of New Jersey
    • September 7, 2018
    ...categories of patent-ineligible subject matter apply. 6/6/18 Tr. at 224:21-225:8.28 For the same reasons, Ariosa Diagnostics, Inc. v. Sequenom, Inc. , 788 F.3d 1371 (Fed. Cir. 2015) and Genetic Technologies Limited v. Merial L.L.C. , 818 F.3d 1369 (Fed. Cir. 2016), which, like Mayo , involv......
  • Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC
    • United States
    • U.S. Court of Appeals — Federal Circuit
    • February 6, 2019
    ...Cir. 2017) ; Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc. , 827 F.3d 1042, 1047–49 (Fed. Cir. 2016) ; Ariosa Diagnostics, Inc. v. Sequenom, Inc. , 788 F.3d 1371, 1376 (Fed. Cir. 2015) ; see also McRO, Inc. v.Bandai Namco Games Am. Inc. , 837 F.3d 1299, 1314–15 (Fed. Cir. 2016) ; Elec. Power......
  • AuthWallet, LLC v. Block, Inc.
    • United States
    • U.S. District Court — Southern District of New York
    • May 3, 2022
    ...eligibility," Return Mail, Inc. v. U.S. Postal Serv. , 868 F.3d 1350, 1370 (Fed. Cir. 2017) (quoting Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015) ), rev'd on other grounds , ––– U.S. ––––, 139 S. Ct. 1853, 204 L.Ed.2d 179 (2019).Further factual developmen......
  • Affinity Labs of Tex., LLC v. DirecTV, LLC
    • United States
    • U.S. District Court — Western District of Texas
    • July 7, 2015
    ...1348–49. The Federal Circuit has even disposed of claims without even a conclusory supporting analysis. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1378 (Fed.Cir.2015) ("None of the remaining asserted dependent or independent claims differ substantially from [the claims expli......
  • Request a trial to view additional results
4 firm's commentaries
  • Federal Circuit's Ariosa Decision, Good Chance For Rehearing En Banc
    • United States
    • Mondaq United States
    • November 5, 2015
    ...Circuit panel in Ariosa Diagnostics, Inc. v. Sequenom, Inc. invalidated a patent on the grounds of patent-ineligible subject matter. 788 F.3d 1371 (Fed. Cir. 2015). While the case is one of many since the Supreme Court's Mayo decision involving patent invalidation under Section 101 of the P......
  • IP Newsflash - February 12, 2016
    • United States
    • Mondaq United States
    • February 26, 2016
    ...'transform' the claimed naturally occurring phenomenon into a patent-eligible application." Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1376 (Fed. Cir. 2015) (quoting Judges Lourie and Dyk each wrote concurring opinions that agreed with the court application of the Mayo frame......
  • Federal Circuit Denies En Banc Review Of Ariosa v. Sequenom
    • United States
    • Mondaq United States
    • December 11, 2015
    ...Linn) applied the two-part test set forth in Mayo and affirmed the district court's ruling.3 Ariosa Diagnostic, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). Under the first part of the test (whether the claims are directed to a patent-ineligible concept), the court concluded that......
  • Strong Support For Sequenom's Petition For Rehearing En Banc
    • United States
    • Mondaq United States
    • September 15, 2015
    ...Ariosa Diagnostics Inc. v. Sequenom Inc., 788 F.3d 1371 (Fed. Cir. 2015), a Federal Circuit panel held that Sequenom Inc.'s prenatal diagnosis patent claims patent ineligible subject matter under the two-step test of Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012......
24 books & journal articles
  • The Evolving Landscape of Disparaging and Scandalous Trademarks: Historical and Public Relations Perspectives
    • United States
    • ABA General Library Landslide No. 11-6, July 2019
    • July 1, 2019
    ...29. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 90–92 (2012). 30. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, ©2019. Published in Landslide ® , Vol. 11, No. 6, July/August 2019, by the American Bar Association. Reproduced with permission. All rights rese......
  • Debunking Copyright Myths
    • United States
    • ABA General Library Landslide No. 11-6, July 2019
    • July 1, 2019
    ...29. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 90–92 (2012). 30. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, ©2019. Published in Landslide ® , Vol. 11, No. 6, July/August 2019, by the American Bar Association. Reproduced with permission. All rights rese......
  • All Patents Are Not Created Equal: Sovereign Immunity
    • United States
    • ABA General Library Landslide No. 10-3, January 2018
    • January 1, 2018
    ...Patent App. No. 00/027,220 (filed Oct. 3, 2000). 28. U.S. Patent. App. No. 15/234,814 (filed Aug. 11, 2016). 29. Id. 30. Id. 31. Id. 32. 788 F.3d 1371, 1376, 1379 (Fed. Cir. 2015). 33. Id. 34. Id. at 1377. 35. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014) (citing May......
  • CERTIORARI, UNIVERSALITY, AND A PATENT PUZZLE.
    • United States
    • Michigan Law Review Vol. 116 No. 8, June 2018
    • June 1, 2018
    ...[https://perma.cc/LN2S-AFlYD]; Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1380 (Fed. Cir. 2015) (Linn, J., concurring); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1284 (Fed. Cir. 2015) (Lourie, J., concurring in the denial of the petition for rehearing en ban......
  • Request a trial to view additional results

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT