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`Case 2:20-at-01217 Document 1 Filed 12/09/20 Page 1 of 36
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`DURIE TANGRI LLP
`DARALYN J. DURIE (SBN 169825)
`ddurie@durietangri.com
`EUGENE NOVIKOV (SBN 257849)
`enovikov@durietangri.com
`217 Leidesdorff Street
`San Francisco, CA 94111
`Telephone: 415-362-6666
`Facsimile: 415-236-6300
`
`Attorneys for Plaintiffs
`ANTECH DIAGNOSTICS, INC. and CHRISTIAN LEUTENEGGER
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF CALIFORNIA
`
`
`Case No.
`
`COMPLAINT FOR DECLARATORY RELIEF
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`
`
`ANTECH DIAGNOSTICS, INC. and
`CHRISTIAN LEUTENEGGER,
`
`Plaintiffs,
`
`v.
`IDEXX LABORATORIES, INC.,
`
`Defendant.
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`Case 2:20-at-01217 Document 1 Filed 12/09/20 Page 2 of 36
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`Plaintiffs Antech Diagnostics, Inc. (“Antech”) and Christian Leutenegger (“Dr. Leutenegger”)
`(collectively, “Plaintiffs”), for their Complaint against Defendant IDEXX Laboratories, Inc. (“IDEXX”),
`allege as follows:
`
`PRELIMINARY STATEMENT
`1.
`Plaintiffs Antech Diagnostics (“Antech”) and Dr. Christian Leutenegger bring this case to
`protect Dr. Leutenegger’s right to earn a living in his field.
`2.
`Dr. Leutenegger has spent the entirety of his career—over twenty-five years—as a
`veterinary scientist specializing in molecular diagnostics, and specifically in the use and development of
`quantitative polymerase chain reaction tests, also known as “qPCR” or “real-time PCR.” The primary
`use of a qPCR test in veterinary medicine is to detect and measure the presence of infectious pathogens
`in animals. qPCR tests can also be used to identify other information, for example, animal parentage or
`the presence of genes that can cause heritable diseases. Today, qPCR tests are commonplace in
`veterinary science.
`3.
`Dr. Leutenegger helped pioneer the use of qPCR tests for diagnostic purposes in
`veterinary medicine. His doctoral research—performed in the 1990s—involved the earliest versions of
`qPCR tests for Feline Immunodeficiency Virus (FIV). After receiving his PhD in 1998, Dr. Leutenegger
`joined University of California, Davis School of Veterinary Medicine for his postdoctoral work. By the
`end of 1999, he helped create the Real-Time PCR Research and Diagnostics Core Facility. Over the next
`nearly seven years, he designed and validated more than 1,500 qPCR tests for research and diagnostic
`applications. He then joined Defendant IDEXX Laboratories (“IDEXX”) in West Sacramento,
`California, where he continued his work designing and validating qPCR tests for veterinary use. After 13
`years at IDEXX, Dr. Leutenegger resigned in 2019 and joined Antech in Fountain Valley, California.
`4.
`It is this last career move that IDEXX now tries to obstruct. After learning of Dr.
`Leutenegger’s employment at Antech, IDEXX sent a series of letters threatening litigation against both
`Plaintiffs for alleged misappropriation of trade secrets and against Dr. Leutenegger for breach of
`contract. But IDEXX has no basis to do so.
`5.
`IDEXX’s threats boil down to the fact that Antech launched a new qPCR panel for
`ringworm—the FastPanel® Ringworm PCR—in September 2020, after Dr. Leutenegger came on board.
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`Case 2:20-at-01217 Document 1 Filed 12/09/20 Page 3 of 36
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`IDEXX points to the release of the FastPanel® Ringworm PCR to insinuate that Antech and/or Dr.
`Leutenegger may have misappropriated its trade secret information. But IDEXX’s letters fail to identify
`with any specificity any confidential material Dr. Leutenegger supposedly took or used. Instead,
`IDEXX’s letters identify as “trade secrets” standardized and public aspects of the qPCR process that are
`routinely used in the field of veterinary science and cite to materials that IDEXX itself published in an
`academic journal.
`6.
`Both Dr. Leutenegger and Antech repeatedly assured IDEXX that Dr. Leutenegger has not
`disclosed any proprietary information, and that both Plaintiffs implemented additional safeguards to
`protect against even inadvertent disclosure. But IDEXX continues to insist, without basis, that Dr.
`Leutenegger either has misappropriated or will misappropriate trade secrets simply by virtue of his
`employment at Antech.
`7.
`IDEXX also threatens to pursue breach of contract claims against Dr. Leutenegger,
`asserting that Dr. Leutenegger’s employment at Antech violates the non-competition and non-disclosure
`clauses in his employment contract with IDEXX. But IDEXX’s efforts to enforce the non-competition
`clause contravene California law, which staunchly protects an employee’s right to mobility. California’s
`policy against employee non-competition clauses must apply to any claim brought by IDEXX against Dr.
`Leutenegger: Dr. Leutenegger has worked in California—and only California—since 1999. Indeed,
`IDEXX itself employed Dr. Leutenegger along with numerous other employees in California at an
`IDEXX laboratory in West Sacramento for thirteen years. And any claim of breach of the non-disclosure
`clause fails for the same reason as does IDEXX’s trade secret claim: Dr. Leutenegger has not disclosed
`or used any IDEXX confidential information in his role at Antech, and the information IDEXX takes
`issue with in its letters is and has been public.
`8.
`California law does not allow IDEXX to use threatened litigation as a sword to bar Dr.
`Leutenegger—a former and current California employee—from earning a living in his field of expertise.
`Dr. Leutenegger has spent his entire career in the field of veterinary diagnostics. Long before he began
`his work with IDEXX, he developed thousands of qPCR tests at the University of Zurich and the
`University of California, Davis, advancing the field from his role at one of the most prominent and
`prestigious veterinary programs in the country. He now seeks to continue his life’s work at Antech—and
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`Case 2:20-at-01217 Document 1 Filed 12/09/20 Page 4 of 36
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`Antech seeks to continue its business operations—without the specter of litigation.
`9.
`Plaintiffs thus file this lawsuit to clarify their rights. Plaintiffs seek a declaration that Dr.
`Leutenegger and Antech have not misappropriated or threatened misappropriation of any trade secrets
`under either the federal Defend Trade Secrets Act (“DTSA”) or the California Uniform Trade Secrets Act
`(“CUTSA”). Dr. Leutenegger further seeks a declaration that the non-competition clause in his
`employment contract with IDEXX is unenforceable, and that the non-disclosure clause in his
`employment contract with IDEXX has not been breached.
`THE PARTIES
`10.
`Plaintiff Antech Diagnostics, Inc. is a subsidiary of VCA, Inc. Antech is a corporation
`organized and existing under the laws of the State of California, having its principal place of business at
`17620 Mount Hermann St., Fountain Valley, CA 92708. Antech has been a leader in veterinary
`diagnostics in the United States and Canada for nearly thirty years.
`11.
`Plaintiff Dr. Christian Leutenegger is a resident of California. He has continuously lived
`and worked as a veterinary scientist in California since 1999.
`12.
`Upon information and belief, Defendant IDEXX is a corporation incorporated in
`Delaware with a principal place of business at One IDEXX Drive, Westbrook, ME 04092. IDEXX
`employed Dr. Leutenegger from 2006 until March 2019 at its laboratory at 2825 Kovr Dr., West
`Sacramento, CA 95605. Upon information and belief, IDEXX employs approximately 250 veterinarians
`and technicians at its West Sacramento laboratory, which is the only laboratory in which IDEXX
`performs qPCR testing.
`
`NATURE OF THE ACTION
`13.
`This is an action for declaratory judgment pursuant to 28 U.S.C. § 2201 regarding trade
`secret disputes arising from Dr. Leutenegger’s employment with Defendant IDEXX followed by his
`subsequent employment with Plaintiff Antech, and contract disputes arising from non-competition and
`non-disclosure clauses signed by Dr. Leutenegger as a condition of his employment with Defendant
`IDEXX.
`///
`///
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`Case 2:20-at-01217 Document 1 Filed 12/09/20 Page 5 of 36
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`JURISDICTION, VENUE & INTRADISTRICT ASSIGNMENT
`14.
`This Court has subject matter jurisdiction over Antech’s claims for declaratory relief
`relating to IDEXX’s federal trade secret claims pursuant to 18 U.S.C. § 1836, et seq., 28 U.S.C. § 1331,
`and 28 U.S.C. §2201. This Court has supplemental jurisdiction over Antech’s claims for declaratory
`relief relating to IDEXX’s state law claims as detailed in this Complaint pursuant to 28 U.S.C. § 1367.
`15.
`A substantial part of the events or omissions giving rise to the claims alleged in this
`Complaint occurred in this Judicial District. Dr. Leutenegger has resided in California both before and
`throughout his employment with IDEXX and Antech. The contract and trade secret claims arise from Dr.
`Leutenegger’s employment with IDEXX in West Sacramento, California. Upon information and belief,
`IDEXX employed approximately 250 employees at its reference laboratory in West Sacramento
`throughout the time it employed Dr. Leutenegger there. Upon information and belief, IDEXX has
`operated that laboratory in West Sacramento since at least 2006, and continues to do so to this day. The
`technology IDEXX contends is confidential and proprietary was developed at that facility, and upon
`information and belief is still used and kept at that facility. The Court has personal jurisdiction over
`IDEXX, and IDEXX resides in this District for venue purposes pursuant to 28 U.S.C. § 1391(c)(2).
`Venue lies in the United States District Court for the Eastern District of California pursuant to 28 U.S.C.
`§ 1391(b)(1)–(2).
`16.
`A substantial part of the events giving rise to the claims alleged in this Complaint
`occurred in the City and County of Sacramento. For purposes of intradistrict assignment under Civil
`Local Rule 120 and Appendix A, this Intellectual Property Rights action will be assigned on a district-
`wide basis.
`
`A.
`
`STATEMENT OF FACTS
`Dr. Leutenegger’s work at Antech builds on his lengthy career in the field of
`veterinary molecular diagnostics.
`
`17.
`The mere fact that Dr. Leutenegger now develops real-time PCR tests for Antech does not
`constitute evidence of misappropriation of IDEXX’s proprietary information. Rather, Dr. Leutenegger
`has worked in the research and design of qPCR tests for nearly as long as they have been in existence,
`and he began his work relating to ringworm qPCR tests well before he joined IDEXX.
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`Case 2:20-at-01217 Document 1 Filed 12/09/20 Page 6 of 36
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`18.
`Dr. Leutenegger’s work in real-time PCR test development at Antech continues the work
`he has done since 1995, when he began his Ph.D. in molecular virology and immunology at the
`Department for Internal Veterinary Medicine at the University of Zurich. There, Dr. Leutenegger
`researched a method of using one of the earliest real-time PCR tests to detect feline immunodeficiency
`virus (FIV), a disease similar to the human immunodeficiency virus (HIV). 1
`19.
`After receiving his PhD in 1998, Dr. Leutenegger joined the University of California,
`Davis School of Veterinary Medicine (“UC Davis”) for his post-doctoral studies. By the end of 1999, he
`had helped to implement UC Davis’s new Real-time PCR Research and Diagnostics Core Facility, which
`he directed for the next seven years. There, he created novel DNA services for real-time PCR testing for
`researchers and clinicians. Leading a team of nine technicians, Dr. Leutenegger designed and validated
`more than 1,500 tests, and was included on more than 50 peer-reviewed publications relating to qPCR
`testing in animals, humans, and plants.
`20.
`It was at UC Davis that Dr. Leutenegger first engaged with real-time PCR testing in
`animals for ringworm. As early as 2002 or 2003, Dr. Leutenegger conceived of a real-time PCR
`ringworm panel. But at that time, not enough was known about the genetic make-up of a common
`ringworm strain—Trichophyton mentagrophytes—to design an accurate real-time PCR test.
`21.
`Dr. Leutenegger remained at UC Davis for seven years. He then joined IDEXX in 2006
`as the Director of Molecular Diagnostics at IDEXX’s laboratory in West Sacramento, California. Upon
`joining IDEXX, Dr. Leutenegger signed agreements containing the clauses at issue in this action. Dr.
`Leutenegger was not represented by counsel when he signed his employment agreement with IDEXX.
`During his time at IDEXX, including in 2017 and 2018, Dr. Leutenegger received annual 3% raises to his
`salary.
`22.
`At IDEXX, Dr. Leutenegger’s work focused on validating and scaling up certain qPCR
`tests. Much of this work built on Dr. Leutenegger’s earlier research at UC Davis described in paragraphs
`19–20, supra, and on information in the public domain.
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`1 Christian Leutenegger et. al, Rapid feline immunodeficiency virus provirus quantitation by polymerase
`chain reaction using the TaqMan® fluorogenic real-time detection system, J. of Virological Methods 78,
`105–116 (1999).
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`23.
`Around 2010, the genetic sequence data for ringworm Dr. Leutenegger needed to
`complete his qPCR panel design became publicly available in NCBI GenBank, a database widely used in
`the industry. Dr. Leutenegger used this new genetic sequence data to complete the ringworm panel he
`conceived years earlier at UC Davis. IDEXX publicized Dr. Leutenegger’s research and findings.2
`24.
`In September 2014, IDEXX announced the launch of the Ringworm RealPCRTM Panel,
`which Dr. Leutenegger designed.3
`B.
`IDEXX began threatening Dr. Leutenegger and Antech with litigation almost
`immediately after Dr. Leutenegger commenced his new employment.
`
`25.
`Dr. Leutenegger joined Antech in March 2019. As Antech’s Director of Molecular
`Diagnostics, Dr. Leutenegger develops diagnostic tests that detect a wide range of infectious diseases and
`other harmful pathogens in animals. As one example, Dr. Leutenegger recently helped to develop a
`SARS-CoV-2 real-time PCR test to detect the first two cases of Covid-19 in cats from New York. Dr.
`Leutenegger also helped to develop a new real-time PCR panel to detect several strains of ringworm in
`animals.
`26.
`Shortly after Dr. Leutenegger’s departure from IDEXX, IDEXX began sending a series of
`letters to both Dr. Leutenegger and Antech claiming that Dr. Leutenegger had breached his prior
`employment contract with IDEXX and misappropriated “trade secrets.” But IDEXX failed to
`substantiate its claim that any misappropriation or improper disclosure took place, and instead identified
`the following as its proprietary “trade secrets”:
`a.
`“development of Quantitative Leishmania, Equine Diarrhea, FIV, FIPv,
`Ringworm, canine influenza and Respiratory tests;” Ex. 1 at 1.
`b.
` “reverse transcription, amplification and detection;” id.
`c.
`“the IDEXX methodology of operating RealPCRs within a single set of conditions
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`2 Karen A. Moriello and Christian M. Leutenegger, Use of a commercial qPCR assay in 52 high risk
`shelter cats for disease identification of dermatophytosis and mycological cure, Veterinary Dermatology
`29(1), 66–e26 (2018); Linda S. Jacobson et. al, Comparison of real-time PCR with fungal culture for the
`diagnosis of Microsporum canis dermatophytosis in shelter cats: a field study, J. of Feline Medicine and
`Surgery, 20(2), 103–107 (2018).
`3 IDEXX Laboratories Announces Two New Innovative Tests to Aid Veterinarians in the Diagnosis and
`Management of Itchy Pets, IDEXX Website (Sep. 8, 2014), https://www.idexx.com/en/about-
`idexx/news/newsroom-archive/idexx-announces-two-new-innovative-tests-itchy-patients/.
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`Case 2:20-at-01217 Document 1 Filed 12/09/20 Page 8 of 36
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`for extraction;” id.
`d.
`
`service;” id.
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`“the cost position and internal cost structure of every IDEXX product and
`
`e.
`
`“the pricing and product positioning strategy of all related IDEXX products and
`
`services;” id.
`
`f.
`“information about the most attractive disease franchises for new menu
`development and IDEXX’s strategies for competing with them;” id.
`g.
`“IDEXX’s genetic testing strategy;” id. and;
`h.
`“the value and strategic focus on decentralization and IDEXX’s new product focus
`areas (including but not limited to antibiotic resistance testing, demodex and UTI) and service
`development pipeline.” Id.
`C.
`Dr. Leutenegger and Antech provided IDEXX with multiple written assurances that
`he has not disclosed IDEXX’s proprietary information.
`
`27.
`In a response to IDEXX’s first letter, Dr. Leutenegger assured IDEXX that he did not and
`would not disclose or use any trade secrets or proprietary information owned by IDEXX in his work with
`Antech:
`
`I assured IDEXX in my resignation letter that I would not disclose any
`confidential business information and/or trade secrets belonging to IDEXX
`and am hereby reaffirming this position. My new position as Director of
`Molecular Diagnostics for Antech Diagnostics does not require or cause
`me to use any sensitive, proprietary information belonging to IDEXX. In
`fact, both Antech and I have taken extra precautions to ensure that I do not
`disclose IDEXX’s trade secrets or confidential business information,
`including but not limited to having me sign a statement prior to the
`commencement of employment affirming that I would not disclose any
`such information to Antech. (Please see attached).
`
`Ex. 2 at 1.
`28.
`Dr. Leutenegger even provided IDEXX with an affidavit, signed under the penalty of
`perjury on July 31, 2020, stating:
`On or about September 26, 2006, I executed an Invention and Non-
`Disclosure Agreement with IDEXX (the “Agreement”). I recognize my
`obligations and responsibilities to IDEXX as set forth in the Agreement
`and I agree to abide by the terms and conditions set forth in the Agreement
`that are legally enforceable and remain in effect.
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`Case 2:20-at-01217 Document 1 Filed 12/09/20 Page 9 of 36
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`I recognize and acknowledge that, in my role with IDEXX, I was allowed
`access to, and was involved in developing, certain of IDEXX’s proprietary
`and trade secret information. In particular, I recognize that the specific
`primer, probe, synthetic positive controls and re-sequencing primer
`sequence information of all real-time PCR tests I developed are
`confidential, proprietary information belonging to IDEXX (“IDEXX
`Proprietary Information”). I also recognize that IDEXX has asserted that
`its market-based analyses of such tests and products and its planned release
`and marketing strategies and initiatives and platforms relating thereto are
`IDEXX Proprietary Information. Since I have left IDEXX’s employ, I
`have not used or disclosed, nor has it ever been my intention to use or
`disclose, or to assist others to use or disclose, any IDEXX Proprietary
`Information or trade secrets—including in my capacity as an employee of
`Antech Diagnostics.
`I am not in possession of any IDEXX equipment, including any IDEXX
`thumb drives, and I have returned all such equipment to IDEXX.
`Ex. 3 ¶¶ 4–5, 7.
`29.
` Antech also provided IDEXX with its own affirmations that Dr. Leutenegger’s
`employment with Antech would not involve the disclosure or use of any trade secrets or confidential
`information owned by IDEXX, stating:
`I am Vice President and Co-General Counsel for Antech Diagnostics Inc. .
`. . Dr. Leutenegger has affirmed in writing that he has not and shall not use
`IDEXX’s confidential information or trade secrets in his role at Antech.
`Antech shares this same position. Dr. Leutenegger has also reviewed with
`me in detail that information IDEXX alleges is proprietary is already in the
`public domain.
`
`Ex. 4 at 1; see also Ex. 5 at 3 (“To the best of my knowledge and belief, Antech has not induced and
`shall not induce or encourage Dr. Leutenegger to violate the promises and covenants set forth in the
`Agreement”); Ex. 6 at 3.
`30.
`Despite these assurances, when Antech announced its FastPanel® Ringworm PCR test on
`September 17, 2020, IDEXX again threatened Antech and Dr. Leutenegger with litigation. Ex. 5. In that
`letter, IDEXX alleged that the Antech FastPanel® Ringworm PCR “create[d], at a minimum, the
`suspicion that Antech has misappropriated and used IDEXX’s confidential/proprietary information
`and/or trade secrets, and is now using that information at Antech.” Id. at 1. As support for its accusation,
`IDEXX stated that Dr. Leutenegger “was integral to the design and implementation of the IDEXX
`RealPCR system, a novel approach to PCR testing that optimizes tests to a standard set of lab protocols
`(versus optimizing protocols to each individual test),” and that he played a “critical role” in the research
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`and development of IDEXX’s testing portfolio including the ringworm qPCR panel that IDEXX
`launched six years earlier, in 2014. Id.
`31.
`In response, Antech again reassured IDEXX that it and Dr. Leutenegger developed the
`Antech FastPanel® Ringworm PCR independently, and that Dr. Leutenegger neither disclosed nor used
`any of IDEXX’s proprietary or confidential information in doing so:
`Your letters make a number of contentions and assumptions concerning
`Antech’s alleged use of IDEXX’s trade secrets and confidential/proprietary
`information. Antech believes that such contentions and assumptions are
`unfounded, and that it and Dr. Leutenegger have complied fully with the
`affidavits referenced in your letters. Antech takes these obligations very
`seriously, and is amenable to providing additional information confirming
`its compliance.
`
`Ex. 7.
`
`32.
`But IDEXX continued to threaten litigation, asserting that Antech’s letter “raises more
`questions than it answers.” Ex. 8 at 1. IDEXX’s continued threats compelled Antech and Dr.
`Leutenegger to file this Complaint to clarify their rights and resolve these issues.
`D.
`The core steps of qPCR tests are standardized and public, and the fact that Antech
`used them in its FastPanel® Ringworm PCR does not constitute evidence of
`misappropriation.
`33.
`IDEXX claims that Dr. Leutenegger and Antech misappropriated or will misappropriate
`“reverse transcription, amplification and detection” and “the IDEXX methodology of operating
`RealPCRs within a single set of conditions for extraction.” Ex. 1 at 1. But these are in fact the core
`components of real-time PCR tests, and are both public and standardized in the industry.
`34. Modern technology allows scientists and clinicians to analyze genetic material in the form
`of DNA and RNA. The presence of foreign DNA or RNA in an animal sample (meaning DNA or RNA
`other than the animal’s own) can indicate the presence of a pathogen. Identifying that foreign pathogen
`can enable the diagnosis of a disease.
`35.
`DNA and RNA in their naturally occurring states, however, are present in only trace
`amounts. Thus, to detect and analyze foreign pathogens using the genes that indicate their presence (the
`“target” DNA), a laboratory instrument must be used to increase the amount of DNA or RNA available
`for analysis and simultaneously track the rate at which it accumulates. The faster the target DNA or
`RNA accumulates, the more target DNA or RNA that was initially present in the sample, and the more
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`Case 2:20-at-01217 Document 1 Filed 12/09/20 Page 11 of 36
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`severe the infection.
`36.
`This laboratory process, known as quantitative PCR (qPCR), “real-time” PCR, or as
`IDEXX has branded it, “RealPCR,” has become a standard technique in diagnostic molecular biology
`since its invention in 1991.
`37. When performed on a sample of DNA, qPCR can be broken down into three main steps:
`(i) extraction; (ii) amplification; and (iii) detection. In the case of RNA, qPCR involves an additional step
`of reverse transcription between steps (i) and (ii). This is because the qPCR process can only amplify
`DNA and not RNA. Reverse transcription converts RNA to complementary DNA (“cDNA”), which then
`can be amplified and detected.
`38.
`IDEXX asserts that each of these steps reflects use of its trade secrets. But as set forth
`below, the steps of extraction, reverse transcription, amplification, and detection are standardized and
`public—indeed, IDEXX itself has published that it performs these steps in the standardized ways
`described below. Thus, the mere fact that Antech, like IDEXX, uses these standard steps cannot be
`evidence of misappropriation of IDEXX’s trade secrets.
`1.
`Extraction: removing genetic material from a sample.
`39.
`Real-time PCR involves analyzing genetic material—DNA or RNA. In veterinary
`diagnostics, a clinician obtains from the animal a sample—typically blood, saliva, hair, or tissue. That
`sample is then sent to a reference laboratory such as IDEXX or Antech for testing. The extraction
`process removes the DNA or RNA from that sample and then purifies the DNA or RNA to ready it for
`qPCR testing.
`40.
`IDEXX claims as a trade secret “the IDEXX methodology of operating RealPCRs within
`a single set of conditions for extraction.” Ex. 1 at 1. However, as set forth in more detail below, both the
`process of extracting DNA and RNA from animal samples and the chemical formulations used to
`effectuate each step in the extraction process are both public and standardized. Indeed, IDEXX’s own
`“RealPCR* Technical Guide,” which is available online, describes IDEXX’s method of extraction. Ex. 9
`at 7.
`///
`///
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`41.
`
`Extracting DNA and RNA from animal samples involves the following steps:
`
`
`
`a.
`Cells from the sample are ruptured or “lysed” by placing them into a solution
`known as a lysis buffer solution. This process of “lysis” releases the contents of the cells—including the
`cells’ genetic material—into the solution. The lysis buffer solution Dr. Leutenegger developed at Antech
`is based on a formulation that is widely used and has been in the public domain for over 20 years.
`b.
`The proteins from the solution of ruptured cells are then removed, leaving behind
`the dissolved DNA and RNA. This is accomplished by adding a solution of phenol and chloroform—a
`formulation also widely known in the industry, and originally published in 1967.4 After the proteins
`have been removed, the DNA or RNA is converted from its dissolved state into its solid form by a well-
`known technique of adding a solution containing ethanol or isopropanol.
`c.
`The solid DNA or RNA is then purified by binding the molecules to glass or silica
`particles and washing away any remaining contaminants using different wash solutions. It is well known
`that either glass or silica can accomplish this goal. The methods of such purification and the wash
`solution formulations used are widely known and routinely used in the field.5
`IDEXX’s reference to operating the extraction process under “a single set of conditions”
`42.
`merely refers to the idea of standardizing the above method of extraction across different sample types
`and for different real-time PCR tests. Standardizing the method of extraction is commonplace in the
`field. Indeed, Dr. Leutenegger proposed, published, and implemented a method of qPCR standardization
`for veterinary applications in 2001, while working at the University of California, Davis—well before his
`
`
`4 K. S. Kirby and E. A. Cook, Isolation of deoxyribonucleic acid from mammalian tissues, Biochem J.
`104(1):254–257 (1967).
`5 See, e.g., Bert Vogelstein and David Gillespie, Preparative and analytical purification of DNA from
`agarose, Proc Natl. Acad. Sci. U.S.A. 76(2):615–619 (1979) (describing a method of binding DNA to
`glass using what’s now known as the “Patterson Protocol”).
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`employment at IDEXX began.6 Indeed, one of the sample types submitted for various qPCR panels Dr.
`Leutenegger commercialized while at UC Davis was capable of being extracted simultaneously for use in
`qPCR to detect feline immunodeficiency virus (FIV) as well as other infectious pathogens. IDEXX has
`not identified any specific “set of conditions” governing the method of extraction for its RealPCR tests
`that could be proprietary.
`43. Moreover, Antech’s method of extraction and the conditions under which it is performed
`were developed from scratch based on a reagent kit and protocol first made commercially available by a
`third-party manufacturer in 2016—two years after IDEXX launched its RealPCR ringworm panel.
`2.
`Reverse transcription: converting RNA to DNA.
`44.
`As mentioned above, before the qPCR process can be performed on RNA, that RNA must
`be converted into cDNA. The process of converting RNA to cDNA is called “reverse transcription.” To
`convert RNA to cDNA, a scientist will use a naturally occurring enzyme called “reverse transcriptase.”
`This process and the reverse transcriptases that can be used in the laboratory, too, have been well known
`for decades.7
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`RNA
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`cDNA
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`6 Christian M. Leutenegger, The Real-Time TaqMan PCR and Applications in Veterinary Medicine,
`Veterinary Sciences of Tomorrow, Issue 1 (Jan. 2001),
`https://pcrlab.vetmed.ucdavis.edu/sites/g/files/dgvnsk6571/files/inline-files/Real-Time-Taq-Man-PCR-
`Applications-Veterinary-Medicine.pdf; see also N. Pusterla, J.E. Madigan, and C.M. Leutenegger, Real-
`Time Polymerase Chain Reaction: A Novel Molecular Diagnostic Tool for Equine Infectious Diseases, J.
`Vet. Intern. Med. Vol. 20, 3–12 (2006).
`7 See e.g., Marc S. Krug and Shelby L. Berger, First-strand cDNA synthesis primed with oligo(dT), Meth.
`Enzymol. 152, 316–25 (1987).
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`3.
`
`Amplification: multiplying genetic material so that it can be detected and
`measured.
`
`45.
`The next step in the real-time PCR process is amplification of the portion of the nucleic
`acid to be tested (referred to as the “target sequence”—for example, in ringworm, DNA from the fungus
`that causes ringworm). “Amplifying” a piece of DNA means increasing the number of occurrences of
`that piece of DNA in the sample so that it may be more easily analyzed or detected. Amplification
`occurs by precisely heating and cooling a sample of DNA with certain reagents. As with extraction and
`reverse transcription, both the method and the chemicals used to amplify DNA are standardized and
`known in the industry.
`a.
`First, the DNA is heated to a specific temperature for several seconds to break the
`hydr