DCT
3:11-cv-00056
Troll Busters LLC v. Roche Diagnostics GmbH
Key Events
Amended Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: TROLL BUSTERS®, LLC (Washington)
- Defendant: Roche Diagnostics GmbH (German), ROCHE MOLECULAR SYSTEMS (United States), and numerous other entities in the molecular diagnostics field.
- 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 based on allegations that Defendants' products are advertised, marked, offered for sale, and sold within the Southern District of California.
- Core Dispute: Plaintiff, acting as a relator in a qui tam action, alleges that Defendants have violated the false patent marking statute (35 U.S.C. §292) by intentionally marking and advertising molecular biology products with expired U.S. patent numbers for the purpose of deceiving the public and stifling competition.
- Technical Context: The technology at issue is the Polymerase Chain Reaction (PCR), a foundational method for amplifying specific DNA sequences that is a cornerstone of modern molecular biology, diagnostics, and life sciences research.
- Key Procedural History: This is a First Amended Complaint in a qui tam action brought on behalf of the public. The complaint alleges that many defendants have continued to falsely mark their products on their websites even after being served with the original complaint, which the plaintiff offers as evidence of a continuing intent to deceive.
Case Timeline
| Date | Event |
|---|---|
| 1985-03-28 | Earliest Priority Date for U.S. Patent 4,683,195 & 4,683,202 |
| 1987-07-28 | Issue Date: U.S. Patent 4,683,202 |
| 1987-07-28 | Issue Date: U.S. Patent 4,683,195 |
| 1989-10-31 | Issue Date: U.S. Patent 4,877,830 |
| 1989-12-26 | Issue Date: U.S. Patent 4,889,818 |
| 1990-08-28 | Issue Date: U.S. Patent 4,952,496 |
| 1990-10-23 | Issue Date: U.S. Patent 4,965,188 |
| 1991-03-19 | Issue Date: U.S. Patent 5,001,050 |
| 1991-07-30 | Issue Date: U.S. Patent 5,035,936 |
| 1991-07-30 | Issue Date: U.S. Patent 5,035,996 |
| 1991-09-10 | Issue Date: U.S. Patent 5,047,513 |
| 1991-11-19 | Issue Date: U.S. Patent 5,066,584 |
| 1991-12-24 | Issue Date: U.S. Patent 5,075,216 |
| 1992-01-07 | Issue Date: U.S. Patent 5,079,352 |
| 1992-12-01 | Issue Date: U.S. Patent 5,168,062 |
| 1992-12-22 | Issue Date: U.S. Patent 5,173,418 |
| 1993-03-30 | Issue Date: U.S. Patent 5,198,543 |
| 1993-05-11 | Issue Date: U.S. Patent 5,210,015 |
| 1993-06-15 | Issue Date: U.S. Patent 5,219,727 |
| 1995-12-19 | Issue Date: U.S. Patent 5,476,774 |
| 1996-01-30 | Issue Date: U.S. Patent 5,487,972 |
| 1999-02-09 | Issue Date: U.S. Patent 5,869,320 |
| 1999-08-31 | Issue Date: U.S. Patent 5,945,313 |
| 2004-03-30 | Expiration Date: U.S. Patent 5,869,320 |
| 2004-07-28 | Expiration Date: U.S. Patent 4,683,195 |
| 2005-03-28 | Expiration Date: U.S. Patent 4,683,202 |
| 2005-03-28 | Expiration Date: U.S. Patent 4,965,188 |
| 2006-12-26 | Expiration Date: U.S. Patent 4,889,818 |
| 2007-07-13 | Expiration Date: U.S. Patent 4,877,830 |
| 2007-08-28 | Expiration Date: U.S. Patent 4,952,496 |
| 2008-09-10 | Expiration Date: U.S. Patent 5,047,513 |
| 2008-11-19 | Expiration Date: U.S. Patent 5,066,584 |
| 2008-12-24 | Expiration Date: U.S. Patent 5,075,216 |
| 2009-01-07 | Expiration Date: U.S. Patent 5,079,352 |
| 2009-02-08 | Expiration Date: U.S. Patent 5,035,936 |
| 2009-03-24 | Expiration Date: U.S. Patent 5,001,050 |
| 2009-06-01 | Expiration Date: U.S. Patent 5,035,996 |
| 2009-06-01 | Expiration Date: U.S. Patent 5,945,313 |
| 2009-12-01 | Expiration Date: U.S. Patent 5,168,062 |
| 2009-12-22 | Expiration Date: U.S. Patent 5,173,418 |
| 2010-03-30 | Expiration Date: U.S. Patent 5,198,543 |
| 2010-06-15 | Expiration Date: U.S. Patent 5,219,727 |
| 2010-06-15 | Expiration Date: U.S. Patent 5,476,774 |
| 2010-08-06 | Expiration Date: U.S. Patent 5,210,015 |
| 2010-08-06 | Expiration Date: U.S. Patent 5,487,972 |
| 2011-04-08 | First Amended Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
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 section describes the difficulty in detecting a specific nucleic acid sequence when it is only a small portion of the DNA or RNA in a sample (Compl. ¶43; ’195 Patent, col. 1:31-39). Existing methods for synthesizing large amounts of a specific sequence were described as "laborious and time-consuming" or required complex molecular cloning procedures (’195 Patent, col. 2:1-12).
- The Patented Solution: The invention provides a process for amplifying a target nucleic acid sequence by treating separate complementary strands with two oligonucleotide primers, extending the primers to form new complementary strands which then act as templates for subsequent synthesis, and repeating the process (’195 Patent, Abstract). This cyclical amplification, known as the Polymerase Chain Reaction (PCR), allows for the exponential production of a specific DNA segment from a minute starting quantity (’195 Patent, col. 8:23-40).
- Technical Importance: This process, for which inventor Kary Mullis was awarded the Nobel Prize, created a foundational method for exponentially amplifying DNA, enabling significant advances in fields from medical diagnostics to forensics and basic research (Compl. ¶43).
Key Claims at a Glance
The complaint does not assert any claims for infringement, as this is a false marking action. The independent claims of the patent are summarized to provide context for the technology that the defendants allegedly represent as covering their products.
- Claim 1 (Independent): A process for detecting a specific nucleic acid sequence in a sample, comprising the essential steps of:
- Treating the sample with oligonucleotide primers under hybridizing conditions to synthesize an extension product of each primer.
- Separating the primer extension products from their templates.
- Treating the separated strands with primers to synthesize further extension products, thereby amplifying the sequence.
- Adding a labeled probe to the amplified product.
- Determining whether hybridization has occurred.
- The complaint does not reserve the right to assert dependent claims for infringement purposes.
U.S. Patent No. 4,683,202 - "Process for amplifying nucleic acid sequences"
- Issued: July 28, 1987
The Invention Explained
- Problem Addressed: The patent's background addresses the same general problem as the ’195 patent: the need for a practical method to produce large amounts of a specific, desired nucleic acid sequence from a complex mixture where it may be present in only small quantities (’202 Patent, col. 1:12-24).
- The Patented Solution: The patent describes a process for amplifying a nucleic acid sequence by treating separate complementary strands with two primers and an agent for polymerization, separating the newly synthesized strands from their templates, and using these new strands as templates for subsequent synthesis cycles (’202 Patent, col. 2:37-53). This method results in the exponential accumulation of the specific sequence defined by the primers (’202 Patent, col. 9:44-48).
- Technical Importance: As with the related ’195 patent, this invention provided the fundamental methodology for PCR, which has become an indispensable tool in molecular biology (Compl. ¶43).
Key Claims at a Glance
The complaint does not assert any claims for infringement. The independent claims of the patent are summarized to provide context for the technology that the defendants allegedly represent as covering their products.
- Claim 1 (Independent): A process for amplifying at least one specific nucleic acid sequence in a mixture of nucleic acids, comprising the essential steps of:
- Treating the strands with two oligonucleotide primers under conditions where an extension product complementary to each strand is synthesized.
- Separating the primer extension products from the templates.
- Treating the separated strands with the primers so that they serve as templates for further synthesis.
- The complaint does not reserve the right to assert dependent claims for infringement purposes.
Twenty additional expired patents are listed in the complaint. A full analysis for each is not provided due to the repetitive nature of the technology and allegations. The patents generally relate to various aspects of PCR and molecular biology, including specific enzymes (e.g., U.S. 5,079,352 "Purified thermostable enzyme"), processes for contamination control (e.g., U.S. 5,035,996), and methods for quantitation (e.g., U.S. 5,219,727).
III. The Accused Instrumentality
Product Identification
- The complaint identifies a wide range of products across fifteen defendants, primarily related to molecular diagnostics and PCR (Compl. ¶¶ 71, 73, 75, 77, 79, 82, 84, 86, 88, 89, 90, 92, 93). These include, but are not limited to, DNA polymerases (e.g., Taq DNA Polymerase, Pwo DNA Polymerase), comprehensive PCR kits (e.g., PCR Core Kit, Titan One Tube RT-PCR System), specialized master mixes (e.g., FastStart PCR Master), and oligonucleotide probes (Compl. ¶¶ 71, 73).
Functionality and Market Context
- The accused products are reagents and kits used to perform PCR, a process for amplifying DNA for research and diagnostic purposes (Compl. ¶43). The complaint alleges that these products are sold into a "lucrative PCR and molecular diagnostics market" and that the defendants are "dominating companies" in this market segment (Compl. ¶106). It further alleges that the false marking of these products with expired patents has wrongfully quelled competition and maintained high prices by deterring new entrants and chilling investment (Compl. ¶¶ 20-21, 106, 107).
IV. Analysis of False Marking Allegations
The complaint does not allege patent infringement; rather, it alleges false patent marking under 35 U.S.C. §292. The core of the action is the accusation that defendants, with intent to deceive the public, marked products with patents that had already expired (Compl. ¶¶ 3, 9).
The complaint provides extensive tables cataloging the alleged false marking for each defendant. For example, a table in the complaint lists dozens of Roche's products, such as 'Tth DNA Polymerase' and the 'PCR Core Kit,' and indicates with an 'X' that they are marked with or require a license under expired patents including the '015, '972, and '352 Patents (Compl. ¶71). Similar tables are provided for other defendants, such as Eurogentec's "GoldStar DNA polymerase" (Compl. ¶73) and Clontech's "TITANIUM Taq DNA Polymerase" (Compl. ¶75). The complaint alleges this marking occurs on product literature and websites, which require customers to obtain a license to use the products under the now-expired patents (Compl. ¶¶ 43, 45, 46). The plaintiff contends this conduct discourages competitors from entering the market, as it creates uncertainty about freedom to operate (Compl. ¶¶ 20, 106).
V. Other Allegations
Intent to Deceive
- The central legal element of a false marking claim is the "purpose of deceiving the public" (Compl. ¶ 3). The complaint alleges this intent is demonstrated by several factors:
- Sophistication: The defendants are described as large, sophisticated companies with experienced patent counsel who know or should have known the patents were expired (Compl. ¶¶ 97-99, 110).
- Knowledge: The complaint alleges defendants, as licensors and licensees of the patents, were "acutely aware of when the patents expired" for purposes of royalty payments (Compl. ¶¶ 101, 102). It is also alleged that industry publications had announced the expiration of key PCR patents years prior to the complaint (Compl. ¶105).
- Post-Suit Conduct: The complaint alleges that numerous defendants, including Roche, Eurogentec, and Clontech, did not change their websites to remove the expired patent markings even after being served with the original complaint in this action, which the plaintiff asserts is "additional evidence of defendants' intent to deceive the public" (Compl. ¶¶ 72, 74, 76, 104).
VI. Analyst’s Conclusion: Key Questions for the Case
This case does not turn on claim construction or technical infringement analysis, but on the statutory requirements for false marking. The central questions for the court will likely be:
- A Factual Question of Marking: Did the defendants mark their products, product literature, and online catalogs with the numbers of U.S. patents that had expired at the time of the marking? The complaint provides extensive documentary evidence in the form of product tables that will be the primary basis for this factual determination.
- A Legal Question of Intent: Can the plaintiff prove, by a standard of clear and convincing evidence, that the alleged marking was done with the "purpose of deceiving the public"? The court will likely focus on the defendants' knowledge, sophistication, and any post-suit conduct, weighed against potential defenses of mistake, inadvertence, or clerical error, to determine whether the necessary deceptive intent was present.