DCT

3:11-cv-00056

Troll Busters LLC v. Roche Diagnostics GmbH

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:11-cv-00056, S.D. Cal., 04/08/2011
  • Venue Allegations: Venue is alleged as proper because Defendants' products are advertised, marked, offered for sale, or sold within the Southern District of California.
  • Core Dispute: Plaintiff, a relator in a qui tam action, alleges that Defendants have violated the false patent marking statute, 35 U.S.C. §292, by marking, advertising, and selling products with expired U.S. patent numbers for the purpose of deceiving the public.
  • Technical Context: The technology relates to foundational methods and products for polymerase chain reaction (PCR), a ubiquitous technique for amplifying nucleic acid sequences that is critical to molecular diagnostics, genetic research, and biotechnology.
  • Key Procedural History: The complaint is a First Amended Complaint, and it alleges that Defendants have continued to falsely mark their products on their websites even after being served with the original complaint, which Plaintiff asserts is evidence of a continuing intent to deceive the public. Several of the patents at issue are noted to have expired due to terminal disclaimers filed during prosecution.

Case Timeline

Date Event
1985-03-28 Earliest Priority Date for U.S. Patent 4,683,195 and U.S. Patent 4,683,202
1986-02-07 Earliest Priority Date for U.S. Patent 4,965,188
1987-07-28 Issue Date for U.S. Patent 4,683,195 and U.S. Patent 4,683,202
1987-10-23 Earliest Priority Date for U.S. Patent 5,079,352
1988-06-17 Earliest Priority Date for U.S. Patent 4,889,818
1988-08-03 Earliest Priority Date for U.S. Patent 4,952,496
1988-08-22 Earliest Priority Date for U.S. Patent 5,869,320
1988-10-21 Earliest Priority Date for U.S. Patent 5,001,050 and U.S. Patent 5,198,543
1988-12-02 Earliest Priority Date for U.S. Patent 5,047,513 and U.S. Patent 4,877,830
1989-10-31 Issue Date for U.S. Patent 4,877,830
1989-12-26 Issue Date for U.S. Patent 4,889,818
1990-03-23 Earliest Priority Date for U.S. Patent 5,173,418 and U.S. Patent 5,168,062
1990-08-06 Earliest Priority Date for U.S. Patent 5,210,015 and U.S. Patent 5,487,972
1990-08-06 Earliest Priority Date for U.S. Patent 5,219,727 and U.S. Patent 5,476,774
1990-08-28 Issue Date for U.S. Patent 4,952,496
1990-10-23 Issue Date for U.S. Patent 4,965,188
1990-12-07 Earliest Priority Date for U.S. Patent 5,035,996 and U.S. Patent 5,945,313
1991-03-19 Issue Date for U.S. Patent 5,001,050
1991-07-30 Issue Date for U.S. Patent 5,035,996
1991-07-30 Issue Date for U.S. Patent 5,035,936
1991-09-10 Issue Date for U.S. Patent 5,047,513
1991-11-19 Issue Date for U.S. Patent 5,066,584
1991-12-24 Issue Date for U.S. Patent 5,075,216
1992-01-07 Issue Date for U.S. Patent 5,079,352
1992-12-01 Issue Date for U.S. Patent 5,168,062
1992-12-22 Issue Date for U.S. Patent 5,173,418
1993-03-30 Issue Date for U.S. Patent 5,198,543
1993-05-11 Issue Date for U.S. Patent 5,210,015
1993-06-15 Issue Date for U.S. Patent 5,219,727
1995-12-19 Issue Date for U.S. Patent 5,476,774
1996-01-30 Issue Date for U.S. Patent 5,487,972
1999-02-09 Issue Date for U.S. Patent 5,869,320
1999-08-31 Issue Date for U.S. Patent 5,945,313
2004-03-30 Expiration Date for U.S. Patent 5,869,320
2004-07-28 Expiration Date for U.S. Patent 4,683,195
2005-03-28 Expiration Date for U.S. Patent 4,683,202 and U.S. Patent 4,965,188
2006-12-26 Expiration Date for U.S. Patent 4,889,818
2007-07-13 Expiration Date for U.S. Patent 4,877,830
2007-08-28 Expiration Date for U.S. Patent 4,952,496
2008-09-10 Expiration Date for U.S. Patent 5,047,513
2008-11-19 Expiration Date for U.S. Patent 5,066,584
2008-12-24 Expiration Date for U.S. Patent 5,075,216
2009-01-07 Expiration Date for U.S. Patent 5,079,352
2009-02-08 Expiration Date for U.S. Patent 5,035,936
2009-03-24 Expiration Date for U.S. Patent 5,001,050
2009-06-01 Expiration Date for U.S. Patent 5,035,996 and U.S. Patent 5,945,313
2009-12-01 Expiration Date for U.S. Patent 5,168,062
2009-12-22 Expiration Date for U.S. Patent 5,173,418
2010-03-30 Expiration Date for U.S. Patent 5,198,543
2010-06-15 Expiration Date for U.S. Patent 5,219,727 and U.S. Patent 5,476,774
2010-08-06 Expiration Date for U.S. Patent 5,210,015 and U.S. Patent 5,487,972
2011-04-08 First Amended Complaint Filing Date

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

This analysis pertains to the 22 patents the complaint alleges have been used for false marking. Full analysis is provided for the first two patents listed; the remaining patents are summarized in capsules.

U.S. Patent No. 5,210,015 - *"Homogeneous assay system using the nuclease activity of a nucleic acid polymerase"*

The Invention Explained

  • Problem Addressed: The patent's background describes prior methods for detecting specific nucleic acid sequences as being "heterogeneous," often requiring separation of a probe-target hybrid from unhybridized probe, which can be complex and time-consuming (’015 Patent, col. 1:29-37).
  • The Patented Solution: The invention provides a "homogeneous" assay where detection can occur without such separation steps. It utilizes the 5' to 3' nuclease activity of a nucleic acid polymerase (like Taq polymerase) to cleave a labeled oligonucleotide probe that has annealed to the target sequence during a primer extension reaction, thereby releasing a detectable labeled fragment (’015 Patent, Abstract; col. 4:5-24). This process is foundational to modern real-time PCR assays, such as the TaqMan® assay.
  • Technical Importance: This approach enabled the quantitative measurement of nucleic acid amplification in real-time within a single, closed reaction vessel, a significant advance in molecular diagnostics (’015 Patent, col. 1:19-28).

Key Claims at a Glance

The complaint does not assert any claims for infringement, as the core allegation is false marking with expired patents (Compl. ¶¶ 2-3).

U.S. Patent No. 5,487,972 - *"Nucleic acid detection by the 5'-3'exonuclease activity of polymerases acting on adjacently hybridized oligonucleotides"*

The Invention Explained

  • Problem Addressed: The patent addresses the need for specific, sensitive, and simple methods for detecting nucleic acid sequences, particularly in the context of amplification reactions like PCR (’972 Patent, col. 1:11-20).
  • The Patented Solution: The invention discloses a process where a primer and a labeled probe hybridize to a target nucleic acid in adjacent positions. As a polymerase extends the primer, its inherent 5' to 3' nuclease activity cleaves the downstream probe, releasing labeled fragments that can be detected as an indication of the target sequence's presence (’972 Patent, Abstract; col. 2:60-3:12).
  • Technical Importance: This method provides a basis for homogeneous detection assays where the signal is generated concurrently with nucleic acid amplification, enhancing the efficiency and specificity of diagnostic tests (’972 Patent, col. 2:28-36).

Key Claims at a Glance

The complaint does not assert any claims for infringement (Compl. ¶¶ 2-3).

Multi-Patent Capsules

  • U.S. Patent 5,079,352: "Purified thermostable enzyme," issued Jan. 7, 1992. This patent describes a purified thermostable DNA polymerase isolated from Thermus aquaticus (Taq), which is stable at high temperatures, making it a critical component for automating PCR by eliminating the need to add fresh polymerase after each denaturation cycle (Compl. ¶49).
  • U.S. Patent 5,035,996: "Process for controlling contamination of nucleic acid amplification reactions," issued Jul. 30, 1991. This patent discloses a method to prevent carry-over contamination from previous PCR reactions by substituting dUTP for dTTP during amplification and then treating subsequent reaction mixtures with uracil DNA glycosylase (UNG) to degrade any contaminating dU-containing DNA (Compl. ¶50).
  • U.S. Patent 5,945,313: "Process for controlling contamination of nucleic acid amplification reactions," issued Aug. 31, 1999. This patent relates to similar methods for controlling PCR contamination as described in the ’996 Patent (Compl. ¶51).
  • U.S. Patent 4,683,202: "Process for amplifying nucleic acid sequences," issued Jul. 28, 1987. One of the foundational patents for the polymerase chain reaction, it describes a method for amplifying a target DNA sequence by using a pair of primers and a DNA polymerase through repeated cycles of denaturation, annealing, and extension (Compl. ¶52; '202 Patent, Abstract).
  • U.S. Patent 4,683,195: "Process for amplifying, detecting, and/or-cloning nucleic acid sequences," issued Jul. 28, 1987. A related foundational PCR patent, it describes processes for amplifying and detecting specific nucleic acid sequences using primers and polymerization agents (Compl. ¶53; '195 Patent, Abstract).
  • U.S. Patent 4,965,188: "Process for amplifying, detecting, and/or cloning nucleic acid sequences using a thermostable enzyme," issued Oct. 23, 1990. This patent describes the use of a thermostable DNA polymerase, such as Taq polymerase, in PCR, which allows the reaction to be performed at higher temperatures for greater specificity and enables automation (Compl. ¶54).
  • U.S. Patent 5,001,050 & 5,198,543: "PHphi29 DNA polymerase," issued Mar. 19, 1991 and Mar. 30, 1993, respectively. These patents relate to the DNA polymerase from bacteriophage phi29, known for its high processivity and strand displacement activity (Compl. ¶¶ 55, 56).
  • U.S. Patent 4,877,830 & 5,047,513: "Metal chelate resins," issued Oct. 31, 1989 and Sep. 10, 1991, respectively. These patents describe resins used in affinity chromatography for purifying proteins, particularly those with histidine tags (Compl. ¶¶ 57, 58).
  • U.S. Patent 5,173,418: "Production in Escherichia coli of extracellular Serratia spp. hydrolases," issued Dec. 22, 1992. This patent relates to methods for producing enzymes in E. coli (Compl. ¶59).
  • U.S. Patent 5,219,727 & 5,476,774: "Quantitation of nucleic acids using the polymerase chain reaction," issued Jun. 15, 1993 and Dec. 19, 1995, respectively. These patents describe methods for quantifying the amount of a target nucleic acid in a sample by co-amplifying the target with a known amount of an internal standard (Compl. ¶¶ 60, 61).
  • U.S. Patent 5,066,584: "Methods for generating single stranded DNA by the polymerase chain reaction," issued Nov. 19, 1991. This patent describes "asymmetric PCR," a method for preferentially amplifying one strand of a DNA target by using an unequal ratio of primers (Compl. ¶62).
  • U.S. Patent 4,889,818: "Purified thermostable enzyme," issued Dec. 26, 1989. This patent describes a purified thermostable DNA polymerase from Thermus aquaticus with a molecular weight of about 86,000-90,000 daltons (Compl. ¶63).
  • U.S. Patent 4,952,496 & 5,869,320: "Cloning and expression of the gene for bacteriophage T7 RNA polymerase," issued Aug. 28, 1990 and Feb. 9, 1999, respectively. These patents relate to the gene for T7 RNA polymerase and its use in expressing target genes (Compl. ¶¶ 64, 65).
  • U.S. Patent 5,075,216: "Methods for DNA sequencing with thermus aquaticus DNA polymerase," issued Dec. 24, 1991. This patent describes using Taq DNA polymerase for dideoxy sequencing, enabling the reaction to be performed at high temperatures to resolve secondary structures (Compl. ¶66).
  • U.S. Patent 5,035,936: "Loose fill insulation product comprising mineral wool nodules," issued Jul. 30, 1991. The complaint alleges this patent was improperly marked on products when the '996 contamination control patent was intended (Compl. ¶67).
  • U.S. Patent 5,168,062: "Transfer vectors and microorganisms containing human cytomegalovirus immediate-early promoter-regulatory DNA sequence," issued Dec. 1, 1992. This patent relates to genetic vectors using a strong viral promoter (Compl. ¶68).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are numerous products related to nucleic acid amplification sold by the 15 defendant companies (Compl. ¶45). These include, but are not limited to, DNA polymerases (e.g., Taq DNA Polymerase), PCR and RT-PCR kits (e.g., PCR Core Kit), probes, and other reagents used for PCR and real-time PCR applications (Compl. ¶43).

Functionality and Market Context

The complaint alleges these products are used to practice polymerase chain reaction ("PCR") and real time PCR (Compl. ¶43). The products are marketed and sold through online catalogs and product literature (Compl. ¶46). The complaint alleges that the false marking of these products with expired patents has been "effectively discouraging competitors from entering the relevant market segments" and has prevented price reductions that would normally occur after patent expiration (Compl. ¶¶ 19, 43).

IV. Analysis of False Marking Allegations

The complaint does not allege patent infringement; it alleges false marking under 35 U.S.C. §292 by marking products with expired patent numbers (Compl. ¶¶ 2-3). A traditional claim chart comparing patent claims to accused products is therefore not applicable. The central allegations are that Defendants associated their products with one or more of the 22 expired patents listed in the complaint for the purpose of deceiving the public (Compl. ¶45).

The complaint provides a detailed table itemizing dozens of Roche’s products, such as "Tth DNA Polymerase" and "Titan One Tube RT-PCR Kit," and alleges that they are marked with or require licenses for expired patents including the ’015, ’972, and ’352 Patents (Compl. ¶71). Similar allegations and product lists are provided for the other fourteen defendants (Compl. ¶¶ 73-93). The complaint alleges that by marking products with these expired patents, Defendants represent that the products are protected by patent rights that no longer exist (Compl. ¶¶ 10, 109).

  • Identified Points of Contention:
    • Factual Question: A primary factual question will be whether the Defendants marked, advertised, or required licenses for their products using the specific expired patent numbers after the patents' respective expiration dates. The complaint alleges this occurred through "websites and product literature" (Compl. ¶43, 46).
    • Legal Question (Intent): The central legal issue of the case will likely be one of deceptive intent. The analysis will focus on whether the plaintiff can establish that any such marking was done "for the purpose of deceiving the public," as required by 35 U.S.C. §292, or whether Defendants can demonstrate that any continued marking was the result of mistake, administrative oversight, or another reason lacking deceptive purpose.

V. Allegations of Deceptive Intent

The complaint alleges that Defendants acted with the intent to deceive the public, which is a required element for a false marking claim (Compl. ¶3). The specific facts alleged to support this intent include:

  • Sophistication and Knowledge: The Defendants are alleged to be large, sophisticated companies with experience in patenting and litigation, and they retain experienced patent counsel (Compl. ¶¶ 97-99).
  • Licensor/Licensee Awareness: The complaint alleges that as licensors and/or licensees of the expired patents, Defendants were "acutely aware" of the patent expiration dates, as those dates would terminate the obligation to pay or the right to receive royalties (Compl. ¶¶ 101-102).
  • Post-Suit Conduct: It is alleged that Defendants continued to mark their websites with the expired patents even after being served with the original complaint in this action, which the plaintiff characterizes as "additional evidence of defendants' intent to deceive the public" (Compl. ¶104, 72, 74, 80, 83).
  • Industry Knowledge: The complaint claims that industry publications had described the expiration of key patents, making it "common knowledge in the industry" that the patents had expired (Compl. ¶105).

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

This case appears to turn on the statutory requirements for a false marking claim under 35 U.S.C. §292, rather than on technical issues of patent infringement. The central questions for the court will likely be:

  • A primary evidentiary question will be one of proof of marking: can the Plaintiff demonstrate, for each Defendant, that specific "unpatented articles" were marked with expired patent numbers through online catalogs, product literature, or other means, after the patents' expiration dates?
  • The case will likely turn on the question of deceptive intent: can the Plaintiff prove that any established false marking was done for the purpose of deceiving the public and stifling competition, or will Defendants be able to argue successfully that any such markings were the result of administrative oversight, clerical error, or another reason lacking the requisite statutory intent?