3:11-cv-00056
Troll Busters LLC v. Roche Diagnostics GmbH
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Troll Busters® LLC (Washington)
- Defendant: Roche Diagnostics GMBH, Roche Molecular Systems, Eurogentec North America Inc., Clontech Laboratories Inc., Integrated DNA Technologies (IDT), Life Technologies Corporation, Qiagen NV., Thermo Fisher Scientific, Inc., Quanta Biosciences, Inc., Gene Link Inc., GenScript USA Inc., EMD Chemicals Inc., TriLink BioTechnologies Inc., and Cepheid (collectively, "Defendants")
- Plaintiff’s Counsel: Kendall Law Group, LLP; Nix Patterson & Roach LLP; Bracewell & Giuliani LLP
- Case Identification: 3:11-cv-00056, S.D. Cal., 04/08/2011
- Venue Allegations: Venue is alleged to be proper in the Southern District of California because the Defendants' products are advertised, marked, offered for sale, and sold within the district.
- Core Dispute: Plaintiff brings this qui tam action on behalf of the public, alleging that Defendants have intentionally marked and advertised products with expired U.S. patents related to Polymerase Chain Reaction (PCR) technology with the purpose of deceiving the public, in violation of the false marking statute, 35 U.S.C. §292.
- Technical Context: The patents at issue relate to Polymerase Chain Reaction (PCR), a foundational and commercially significant technology for amplifying DNA, which is central to molecular biology, genetic testing, and clinical diagnostics.
- Key Procedural History: This filing is a First Amended Complaint. The complaint alleges that several defendants continued to mark products with expired patents on their websites even after being served with the original complaint, which the Plaintiff asserts is evidence of a continuing intent to deceive the public.
Case Timeline
| Date | Event |
|---|---|
| 1985-03-28 | Earliest Priority Date for U.S. Patents 4,683,195 and 4,683,202 |
| 1987-07-28 | U.S. Patents 4,683,195 and 4,683,202 Issue Date |
| 1988-10-21 | Earliest Priority Date for U.S. Patent 4,877,830 |
| 1989-08-01 | Earliest Priority Date for U.S. Patent 4,952,496 |
| 1989-08-04 | Earliest Priority Date for U.S. Patents 4,965,188 and 4,889,818 |
| 1989-10-31 | U.S. Patent 4,877,830 Issue Date |
| 1989-12-26 | U.S. Patent 4,889,818 Issue Date |
| 1990-03-12 | Earliest Priority Date for U.S. Patent 5,035,936 |
| 1990-04-03 | Earliest Priority Date for U.S. Patent 5,001,050 |
| 1990-06-27 | Earliest Priority Date for U.S. Patent 5,075,216 |
| 1990-07-03 | Earliest Priority Date for U.S. Patent 5,079,352 |
| 1990-08-28 | U.S. Patent 4,952,496 Issue Date |
| 1990-10-23 | U.S. Patent 4,965,188 Issue Date |
| 1990-11-13 | Earliest Priority Date for U.S. Patent 5,066,584 |
| 1991-03-19 | U.S. Patent 5,001,050 Issue Date |
| 1991-05-15 | Earliest Priority Date for U.S. Patent 5,173,418 |
| 1991-07-30 | U.S. Patents 5,035,936 and 5,035,996 Issue Date |
| 1991-09-10 | U.S. Patent 5,047,513 Issue Date |
| 1991-11-19 | U.S. Patent 5,066,584 Issue Date |
| 1991-12-24 | U.S. Patent 5,075,216 Issue Date |
| 1992-01-07 | U.S. Patent 5,079,352 Issue Date |
| 1992-03-05 | Earliest Priority Date for U.S. Patent 5,210,015 |
| 1992-06-05 | Earliest Priority Date for U.S. Patent 5,219,727 |
| 1992-08-07 | Earliest Priority Date for U.S. Patent 5,198,543 |
| 1992-12-01 | U.S. Patent 5,168,062 Issue Date |
| 1992-12-22 | U.S. Patent 5,173,418 Issue Date |
| 1993-03-30 | U.S. Patent 5,198,543 Issue Date |
| 1993-05-11 | U.S. Patent 5,210,015 Issue Date |
| 1993-06-15 | U.S. Patent 5,219,727 Issue Date |
| 1993-08-06 | Earliest Priority Date for U.S. Patent 5,487,972 |
| 1995-12-19 | U.S. Patent 5,476,774 Issue Date |
| 1996-01-30 | U.S. Patent 5,487,972 Issue Date |
| 1997-03-25 | Earliest Priority Date for U.S. Patent 5,869,320 |
| 1997-06-02 | Earliest Priority Date for U.S. Patent 5,945,313 |
| 1999-02-09 | U.S. Patent 5,869,320 Issue Date |
| 1999-08-31 | U.S. Patent 5,945,313 Issue Date |
| 2004-03-30 | U.S. Patent 5,869,320 Expiration Date |
| 2004-07-28 | U.S. Patent 4,683,195 Expiration Date |
| 2005-03-28 | U.S. Patents 4,683,202 and 4,965,188 Expiration Date |
| 2006-12-26 | U.S. Patent 4,889,818 Expiration Date |
| 2007-07-13 | U.S. Patent 4,877,830 Expiration Date |
| 2007-08-28 | U.S. Patent 4,952,496 Expiration Date |
| 2008-09-10 | U.S. Patent 5,047,513 Expiration Date |
| 2008-11-19 | U.S. Patent 5,066,584 Expiration Date |
| 2008-12-24 | U.S. Patent 5,075,216 Expiration Date |
| 2009-01-07 | U.S. Patent 5,079,352 Expiration Date |
| 2009-02-08 | U.S. Patent 5,035,936 Expiration Date |
| 2009-03-24 | U.S. Patent 5,001,050 Expiration Date |
| 2009-06-01 | U.S. Patents 5,035,996 and 5,945,313 Expiration Date |
| 2009-12-01 | U.S. Patent 5,168,062 Expiration Date |
| 2009-12-22 | U.S. Patent 5,173,418 Expiration Date |
| 2010-03-30 | U.S. Patent 5,198,543 Expiration Date |
| 2010-06-15 | U.S. Patents 5,219,727 and 5,476,774 Expiration Date |
| 2010-08-06 | U.S. Patents 5,210,015 and 5,487,972 Expiration Date |
| 2011-04-08 | First Amended Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
The complaint alleges false marking with respect to twenty-two expired U.S. patents related to Polymerase Chain Reaction (PCR) and associated molecular biology technologies Compl. ¶¶ 46, 69
U.S. Patent No. 4,683,195 - "Process for amplifying, detecting, and/or-cloning nucleic acid sequences"
- Issued: July 28, 1987
The Invention Explained
- Problem Addressed: The patent's background describes the difficulty in detecting very small quantities of specific nucleic acid sequences within a sample, a common challenge in diagnostic applications and molecular research ʼ195 Patent, col. 1:29-44 Existing methods for synthesizing or cloning nucleic acids were described as laborious, time-consuming, and inefficient ʼ195 Patent, col. 2:1-12
- The Patented Solution: The invention provides a process for exponentially amplifying a specific target nucleic acid sequence ʼ195 Patent, abstract The process involves treating the sample with two oligonucleotide primers that are complementary to opposite strands of the target sequence. Through repeated cycles of separating the DNA strands, annealing the primers, and extending the primers with a DNA polymerase, the target sequence is replicated exponentially, generating a large number of copies from a small initial amount ʼ195 Patent, col. 3:3-15; ʼ195 Patent, col. 4:45-59
- Technical Importance: This process, known as the Polymerase Chain Reaction (PCR), was a revolutionary development that enabled the rapid detection and analysis of minute amounts of genetic material, transforming diagnostics, genetics, and forensics.
Asserted Claims
The complaint does not assert specific claims for infringement. The cause of action is based on the allegation that the entire patent is expired and therefore cannot be used to mark any product Compl. ¶ 53
U.S. Patent No. 4,683,202 - "Process for amplifying nucleic acid sequences"
- Issued: July 28, 1987
The Invention Explained
- Problem Addressed: Similar to the ʼ195 Patent, the ʼ202 Patent addresses the technical challenge of producing large amounts of a specific nucleic acid sequence from a small starting sample ʼ202 Patent, col. 1:12-23
- The Patented Solution: The patent describes a process for amplifying a desired specific nucleic acid sequence contained in a nucleic acid or mixture thereof ʼ202 Patent, abstract It comprises treating separate complementary strands with a molar excess of two oligonucleotide primers and extending them to form extension products that act as templates for subsequent synthesis, leading to exponential amplification ʼ202 Patent, col. 4:48-59 The process is described as a "chain reaction for producing, in exponential quantities... at least one specific nucleic acid sequence" ʼ202 Patent, col. 7:24-29
- Technical Importance: As one of the foundational patents for PCR, this invention provided a core methodology for the exponential amplification of DNA, which has become a fundamental tool in modern biotechnology.
Asserted Claims
The complaint does not assert specific claims for infringement. The cause of action is based on the allegation that the entire patent is expired and therefore cannot be used to mark any product Compl. ¶ 52
U.S. Patent No. 4,965,188 - "Process for amplifying, detecting, and/or cloning nucleic acid sequences using a thermostable enzyme"
- Issued: October 23, 1990
Technology Synopsis
This patent describes an improvement to the PCR process by using a thermostable DNA polymerase (e.g., from Thermus aquaticus). This eliminates the need to add fresh enzyme after each high-temperature denaturation step, making the automation of PCR feasible and more efficient.
Asserted Claims
No specific claims asserted; the action is based on the patent's expired status Compl. ¶ 54
Accused Features
The complaint alleges various Defendants, including Roche and Eurogentec, have marked products such as DNA polymerases and PCR kits with the expired '188 Patent Compl. ¶¶ 71, 73
U.S. Patent No. 5,219,727 - "Quantitation of nucleic acids using the polymerase chain reaction"
- Issued: June 15, 1993
Technology Synopsis
This patent describes a method for quantifying the amount of a target nucleic acid in a sample using PCR. It involves the simultaneous amplification of the target sequence and a known amount of an internal standard sequence, allowing for the determination of the initial amount of the target.
Asserted Claims
No specific claims asserted; the action is based on the patent's expired status Compl. ¶ 60
Accused Features
The complaint alleges that Defendant Roche has marked or required licenses for products such as its "LightCycler®" systems with the expired '727 Patent Compl. ¶ 71, p. 23
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are numerous molecular biology reagents and kits for performing PCR sold by the various Defendants Compl. ¶¶ 71, 73, 75, 77, 79, 81, 82, 84, 86, 88, 89, 90, 92, 93 Examples include Taq DNA Polymerase, PCR Core Kits, Master Mixes, oligonucleotide probes, and integrated systems like the LightCycler® Compl. ¶ 71, pp. 20-24
Functionality and Market Context
- The accused products are reagents, enzymes, and kits used by researchers and clinicians to perform PCR for applications such as DNA amplification, sequencing, and quantitation Compl. ¶ 6 The complaint alleges that the Defendants' websites and product literature indicate that a license is needed to use these products to practice PCR with the now-expired patents Compl. ¶ 43
- The complaint alleges that these products are part of a "lucrative PCR and molecular diagnostics market" and that the Defendants are "dominating companies" in this market Compl. ¶ 106 It is further alleged that the false marking has stifled competition and prevented price reductions that would normally occur after patent expiration Compl. ¶¶ 4, 107
IV. Analysis of False Marking Allegations
This is a qui tam action for false marking under 35 U.S.C. §292, not a direct patent infringement suit. The central allegation is that Defendants have marked products with expired patents with the "purpose of deceiving the public" Compl. ¶ 3 Therefore, a standard claim chart analysis is not applicable. The core of the Plaintiff's factual allegations is presented in a series of tables that list accused products and the expired patents with which they are allegedly marked.
The complaint provides a table summarizing the 22 expired patents, their corresponding exhibit letters, and their expiration dates Compl. ¶ 69, p. 19 For each of the 13 defendant groups, the complaint then presents extensive tables listing specific products alongside the expired patents allegedly used to mark them. For example, the complaint includes a multi-page table asserting that Defendant Roche marked or required licenses for over 100 products, including its "FastStart Taq DNA Polymerase" and "LightCycler® 480 Probes Master," with expired patents such as the ʼ015 Patent and ʼ972 Patent Compl. ¶ 71, pp. 20-24 Similarly, another table alleges Defendant Eurogentec marked products like "GoldStar DNA polymerase" and "Diamond Taq®" with expired patents including the ʼ015, ʼ972, and ʼ352 patents (Compl. ¶ 73, p. 24). These tables constitute the primary visual evidence supporting the false marking claims.
The complaint also alleges a specific instance of mistake, noting that Defendant Eurogentec improperly marked products with the '936 Patent when it allegedly intended to mark them with the '996 Patent, and points out that the '996 Patent was also expired Compl. ¶ 67
The primary point of contention will not be technical claim scope, but rather a question of fact and law regarding scienter: whether the Defendants' marking activities were undertaken with the specific "purpose of deceiving the public" required to establish liability under 35 U.S.C. §292.
V. Other Allegations
The central cause of action in the complaint is the allegation of intentional false marking, which requires proof of a "purpose of deceiving the public" Compl. ¶ 3 The complaint presents several categories of evidence to support this required element of intent.
- Knowledge of Expiration: The complaint alleges that Defendants knew or should have known when the patents expired because they are large, sophisticated companies with experienced patent counsel and, in many cases, are licensors or licensees of the patents Compl. ¶¶ 97-99, 101 As parties to license agreements, they would have been "acutely aware" of expiration dates, as those dates would terminate royalty obligations Compl. ¶ 101 The complaint also asserts that the expiration of key PCR patents was common knowledge in the industry Compl. ¶ 105
- Post-Filing Conduct: A key allegation supporting intent is that many Defendants did not change their websites to remove the expired patent markings even after being served with the original complaint in this lawsuit Compl. ¶¶ 72, 74, 76, 78, 80, 83, 85, 87, 91 Plaintiff contends this "indicat[es] a continuing intent to deceive the public and chill competition" Compl. ¶ 72
- Qui Tam Action: The complaint is brought as a qui tam action under 35 U.S.C. § 292, which permits a person to sue on behalf of the government for statutory penalties for false marking Compl. ¶¶ 2, 7 The Plaintiff, Troll Busters®, seeks monetary damages of up to $500 for each offense, half of which would be paid to the United States Compl. ¶¶ 8, 95
VI. Analyst’s Conclusion: Key Questions for the Case
This case does not concern patent infringement but rather alleges false marking with expired patents. The dispute will likely center on the high standard of proof for deceptive intent required by 35 U.S.C. §292. The key questions for the court will be:
- A core issue will be one of scienter: can the Plaintiff prove by a preponderance of the evidence that the Defendants' marking of products with expired patents was done with the specific "purpose of deceiving the public," or can the Defendants demonstrate that the continued markings were the result of inadvertence, mistake, or a lack of systematic review rather than a deliberate effort to mislead?
- A key evidentiary question will be one of conduct: what weight will the court give to the allegations that several Defendants failed to update their online product markings after being served with the original complaint? Does this post-filing conduct serve as sufficient evidence of a pre-existing deceptive intent, or could it be viewed as simple administrative delay?
- A central legal and factual question will be the definition of an "offense": if false marking with deceptive intent is found, how will the court calculate the number of "offenses" subject to the statutory penalty of up to $500? Does each individually marked item constitute an offense, or is the offense the single decision to mark a product line?