DCT

3:10-cv-00281

Promega Corp v. Life Tech Corp

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:10-cv-00281, W.D. Wis., 02/24/2011
  • Venue Allegations: Venue is based on allegations that Defendants transact business within the Western District of Wisconsin, including through a local office, giving the court personal jurisdiction.
  • Core Dispute: Plaintiff alleges that Defendant’s genetic testing kits infringe five patents related to the simultaneous amplification and analysis of multiple Short Tandem Repeat (STR) loci in DNA.
  • Technical Context: The technology involves multiplex polymerase chain reaction (PCR) for DNA profiling, a foundational technique in forensic science, paternity testing, and clinical genetics for human identification.
  • Key Procedural History: The complaint details a complex and contentious history between the parties and their corporate predecessors, centered on a 1996 License Agreement and a 2006 Cross License. Plaintiff alleges Defendants are infringing the asserted patents by selling products outside the fields permitted by these licenses. The dispute also involves a demand for arbitration by Defendants over royalty obligations, which Plaintiff contests.

Case Timeline

Date Event
1988-10-11 ’984 Patent Priority Date
1994-09-30 ’660, ’598, and ’235 Patent Priority Date
1996-04-15 ’771 Patent Priority Date
1996-06-19 Promega/Research Genetics 1996 License Agreement executed
1998-12-01 U.S. Patent No. 5,843,660 Issues
2000-02-02 Research Genetics acquired by Invitrogen
2001-04-24 U.S. Patent No. 6,221,598 Issues
2002-11-12 U.S. Patent No. 6,479,235 Issues
2003-02-11 U.S. Patent No. Re. 37,984 Issues
2006-03-07 U.S. Patent No. 7,008,771 Issues
2006-08-29 Promega/Applied Biosystems Cross License Agreement executed
2008-11-01 Applied Biosystems acquired by Invitrogen (approx. date)
2009-10-20 Life Technologies sends letter to Promega regarding royalty obligations
2010-01-01 Promega meets with Life Technologies executives and raises issue of infringement (approx. date)
2010-05-04 Life Technologies delivers demand for arbitration to Promega
2011-02-24 Second Amended Complaint Filing Date

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

U.S. Patent No. 5,843,660 - Multiplex Amplification of Short Tandem Repeat Loci

The Invention Explained

  • Problem Addressed: The patent's background section describes the need to minimize labor, materials, and analysis time in genetic testing by analyzing multiple genetic loci simultaneously in a single reaction (’660 Patent, col. 1:13-18).
  • The Patented Solution: The invention provides methods and materials for "multiplex" amplification, which involves simultaneously amplifying multiple distinct Short Tandem Repeat (STR) loci in a single polymerase chain reaction (PCR). The solution is based on selecting specific sets of loci and corresponding primer pairs that are compatible, do not interfere with one another, and produce amplified DNA fragments (alleles) that can be distinguished from one another, typically by size, after electrophoretic separation (’660 Patent, Abstract; col. 3:54-64). The result is a genetic profile from multiple locations on the genome generated in a single test.
  • Technical Importance: This technology significantly increased the efficiency and statistical power of DNA typing, making it a cornerstone of modern forensic science and paternity testing by allowing robust profiles to be generated from small amounts of DNA (’660 Patent, col. 8:1-14).

Key Claims at a Glance

  • The complaint asserts infringement of claims 2-5, 16-17, 19-21, 23-25, and 27-31 (Compl. ¶172). These dependent claims appear to stem from independent claims 1, 16, and 23. Independent claim 1 is representative of the asserted method claims.
  • Essential Elements of Independent Claim 1:
    • A method of simultaneously determining the alleles present in at least four short tandem repeat loci from one or more DNA samples.
    • Obtaining at least one DNA sample to be analyzed.
    • Selecting a set of at least four short tandem repeat loci of the DNA sample which can be amplified together, wherein the loci are selected from a large specified group.
    • Co-amplifying the loci in the set in a multiplex amplification reaction to produce a mixture of amplified alleles.
    • Evaluating the amplified alleles in the mixture to determine the alleles present at each locus.
  • The complaint asserts numerous dependent claims but does not explicitly reserve the right to assert others.

U.S. Patent No. 6,221,598 - Multiplex Amplification of Short Tandem Repeat Loci

The Invention Explained

  • Problem Addressed: The patent, which is a continuation of the application leading to the ’660 Patent, addresses the same technical problem: the need for efficient and simultaneous analysis of multiple polymorphic genetic markers to simplify DNA typing and improve its precision (’598 Patent, col. 1:13-19).
  • The Patented Solution: The invention builds on the same multiplex PCR concept by disclosing additional specific combinations of STR loci and primer pairs suitable for co-amplification. It provides new sets of genetic markers that can be analyzed together in a single reaction, expanding the toolkit for creating robust and discriminating DNA profiles for human identification (’598 Patent, Abstract; col. 3:52-60).
  • Technical Importance: The invention provided the field with more validated sets of markers for multiplex analysis, which is critical for standardizing DNA profiling across different laboratories and for increasing the statistical power to identify individuals or determine kinship (’598 Patent, col. 8:1-11).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-2, 4-5, 7-10, 12, 15, 19, 21-24, 27-28 and 31-33 (Compl. ¶178).
  • Essential Elements of Independent Claim 1:
    • A method of simultaneously determining the alleles present in at least three short tandem repeat loci from one or more DNA samples.
    • Selecting a set of at least three loci which can be co-amplified, with at least one locus selected from a first specified group (HUMCSF1PO, HUMTPOX, HUMTH01, HUMVWFA31).
    • Co-amplifying the loci in the set in a multiplex amplification reaction.
    • Evaluating the amplified alleles in the mixture.
  • The complaint asserts a mix of independent and dependent claims.

U.S. Patent No. 6,479,235 - Multiplex Amplification of Short Tandem Repeat Loci

  • Technology Synopsis: Continuing the work of the ’660 and ’598 patents, this patent discloses further methods, kits, and specific sets of STR loci for use in multiplex PCR. The invention focuses on providing robust combinations of markers, including the thirteen core loci later adopted by the FBI's Combined DNA Index System (CODIS), for standardized and highly discriminating human identification (’235 Patent, col. 1:11-17; col. 5:9-15).
  • Asserted Claims: Independent claim 1 and dependent claims 4, 6-13, 15-19, and 21-23 are asserted (Compl. ¶184, 187).
  • Accused Features: The AmpFℓSTR® Identifiler® PCR Amplification Kit is accused of infringement (Compl. ¶63, 70).

U.S. Patent No. 7,008,771 - Multiplex Amplification of Short Tandem Repeat Loci

  • Technology Synopsis: This patent, also in the same family, is directed to specific kits for simultaneously analyzing a set of STR loci. It claims kits containing oligonucleotide primers designed to co-amplify at least sixteen specified loci, including the thirteen CODIS core loci plus additional markers, to provide an even higher degree of discrimination for forensic and paternity analysis (’771 Patent, col. 5:1-12; col. 59:1-10).
  • Asserted Claims: Claim 5 is asserted (Compl. ¶190, 193).
  • Accused Features: The AmpFℓSTR® Identifiler® PCR Amplification Kit is accused of infringement (Compl. ¶79, 86).

U.S. Patent No. Re. 37,984 - Process for Analyzing Length Polymorphisms in DNA Regions

  • Technology Synopsis: This patent claims a foundational process for analyzing length variations in DNA regions containing simple or cryptically simple sequences (like STRs). The process involves using PCR with primers that flank such a region to create amplified products whose length corresponds to the number of repeats, and then separating those products to determine the polymorphism. This is a core technique underlying all modern STR-based DNA typing (’984 Patent, col. 2:5-16).
  • Asserted Claims: Claims 15-16, 18, 23, 25, 27-28 and 41 are asserted (Compl. ¶196, 199).
  • Accused Features: A range of kits, including AmpFℓSTR® Profiler Plus®, COfiler®, Profiler®, Identifiler®, Yfiler®, and Green™ I PCR Amplification Kits, are accused of infringement (Compl. ¶97, 104).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are primarily DNA amplification kits sold by Defendants under the AmpFℓSTR® brand, including the Identifiler®, Profiler Plus®, COfiler®, Profiler®, Yfiler®, and Green™ I PCR Amplification Kits (Compl. ¶31, 47, 63, 79, 97).

Functionality and Market Context

  • These products are commercial kits that contain the necessary reagents, including DNA polymerase and locus-specific oligonucleotide primers, to perform multiplex PCR (Compl. ¶31, 47). They are designed to be used by laboratories to simultaneously amplify multiple defined STR loci from a human DNA sample. The resulting amplified DNA fragments are then analyzed to generate a genetic profile for use in "clinical diagnostics, clinical research and research markets," particularly forensic identification and paternity testing (Compl. ¶30, 46). The complaint alleges these products are sold into markets where Promega holds exclusive rights through license agreements (Compl. ¶46, 53).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint makes general allegations of infringement without providing detailed claim charts. The following charts summarize the infringement theory for the lead independent claims based on the complaint's description of the accused products' functionality.

’660 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of simultaneously determining the alleles present in at least four short tandem repeat loci from one or more DNA samples, comprising: (a) obtaining at least one DNA sample to be analyzed The accused kits are designed for use with human DNA samples to generate genetic profiles. ¶30, 31 col. 23:5-8
(b) selecting a set of at least four short tandem repeat loci of the DNA sample to be analyzed which can be amplified together, wherein the at least four loci in the set are selected from the group of loci consisting of: [list of loci] The accused kits allegedly contain primers and reagents for co-amplifying a set of at least four STR loci covered by the patent. ¶31 col. 23:40-54
(c) co-amplifying the loci in the set in a multiplex amplification reaction...to produce a mixture of amplified alleles from each of the co-amplified loci The accused kits are PCR amplification kits whose function is to perform a multiplex reaction to co-amplify STR loci. ¶31, 38 col. 24:30-34
(d) evaluating the amplified alleles in the mixture to determine the alleles present at each of the loci analyzed The kits are sold for the purpose of enabling end-users to perform this evaluation to generate a DNA profile. ¶30, 32 col. 24:30-46

’598 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of simultaneously determining the alleles present in at least three short tandem repeat loci from one or more DNA samples, comprising: (a) selecting a set of at least three loci of the DNA sample which can be co-amplified, wherein at least one of the loci in the set is selected from the group consisting of: [list of loci] The accused kits, such as the COfiler® and Profiler® kits, allegedly contain primers for co-amplifying sets of loci including those specified in the claim. ¶47, 54 col. 6:50-65
(b) co-amplifying the loci in the set in a multiplex amplification reaction...to produce a mixture of amplified alleles from each of the co-amplified loci The accused kits are designed to perform a multiplex PCR reaction to simultaneously amplify the specified loci. ¶47, 54 col. 13:50-54
(c) evaluating the amplified alleles in the mixture to determine the alleles present at each of the loci analyzed The kits are sold with instructions and for the purpose of enabling end-users to analyze the reaction products to determine a genetic profile. ¶46, 48 col. 15:1-12
  • Identified Points of Contention:
    • Scope Questions: A primary issue will be whether the specific sets of STR loci amplified by Defendants' various AmpFℓSTR® kits fall within the literal scope of the combinations claimed in the patents. The patents claim particular groupings of loci (e.g., ’660 Patent, col. 23:40-54). The infringement analysis will likely require a detailed comparison of the genetic markers targeted by each accused kit against the specific sets recited in the asserted claims.
    • Technical Questions: The asserted claims are for methods, not for the kits themselves. The complaint alleges direct infringement by Defendants (Compl. ¶30, 46). A key factual question will be what evidence exists that Defendants themselves perform all steps of the claimed methods. The allegations of induced and contributory infringement (Compl. ¶33-34, 49-50) may present a more direct path to liability, raising the question of whether Defendants' product manuals and marketing materials instruct and encourage end-users to perform the patented methods.

V. Key Claim Terms for Construction

  • The Term: "a set of...loci...selected from the group of loci consisting of..." (e.g., ’660 Patent, Claim 1)
  • Context and Importance: This term defines the universe of genetic markers covered by the claims. The infringement determination for the ’660, ’598, and ’235 patents will depend entirely on whether the loci targeted by the accused kits are considered "selected from" the groups recited in the claims. Practitioners may focus on this term because it is the primary technical limitation distinguishing the invention from the prior art.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The use of the phrase "selected from the group consisting of" could be argued to encompass kits that amplify any subset of four or more loci from the larger recited list, rather than requiring all of them.
    • Evidence for a Narrower Interpretation: The specification provides numerous specific combinations of loci in its examples and preferred embodiments (e.g., ’660 Patent, col. 23:55-65). A defendant may argue that the claims should be limited to these specific disclosed combinations, and that kits targeting different combinations, even if they draw from the same master list of loci, do not infringe.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants have induced infringement by selling the accused kits to unlicensed end-users and causing them to use the kits to perform the patented methods (Compl. ¶33, 40, 49). It further alleges contributory infringement on the basis that Defendants sell the kits knowing they are especially made for use in an infringing manner and are not staple articles of commerce suitable for substantial non-infringing use (Compl. ¶34, 41, 50).
  • Willful Infringement: Willfulness is alleged based on Defendants acting "despite an objectively high likelihood that its actions constituted infringement...when it knew or should have known" of Promega's rights (Compl. ¶35, 51). The complaint alleges that Promega put Defendants on notice of infringement during a meeting in January 2010, which may serve as evidence of pre-suit knowledge (Compl. ¶5).

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

  • A core issue will be one of claim scope versus product composition: does the precise combination of STR loci targeted by each of the accused AmpFℓSTR® kits literally read on the specific sets of loci recited in the asserted claims, or will the analysis turn on whether different combinations fall outside the scope of the patents?
  • A central legal question will be the theory of liability: given that Defendants sell kits while end-users practice the claimed methods, the case will likely depend less on proving direct infringement by Defendants and more on establishing the knowledge and intent elements required for induced and contributory infringement.
  • The outcome may be significantly influenced by the interpretation of prior agreements: the court must first navigate the complex licensing and corporate history between the parties to determine what activities, if any, were authorized under the 1996 License Agreement and the 2006 ABI Cross License, as any licensed sales would not constitute infringement.