DCT
2:17-cv-00108
Genetic Veterinary Sciences Inc v. Laboklin GmbH & Co KG
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Genetic Veterinary Sciences, Inc. d/b/a Paw Prints Genetics (Washington)
- Defendant: LABOklin GmbH & Co. KG (Germany); The University of Bern (Switzerland)
- Plaintiff’s Counsel: Venable LLP; Lowe Graham Jones
- Case Identification: 2:17-cv-00108, E.D. Va., 02/22/2017
- Venue Allegations: Venue is asserted under 35 U.S.C. § 293, which applies to foreign patent owners who have not designated a domestic representative for service of process.
- Core Dispute: Plaintiff, a genetic testing company, seeks a declaratory judgment that Defendants' patent is invalid under 35 U.S.C. § 101 for claiming a natural phenomenon, and is therefore not infringed by Plaintiff's genetic testing services for dogs.
- Technical Context: The lawsuit concerns genetic testing to identify a specific mutation in Labrador Retrievers that causes Hereditary Nasal Parakeratosis (HNPK), a non-lethal but chronic skin condition.
- Key Procedural History: The action was precipitated by a cease and desist letter sent by Defendant LABOklin to Plaintiff on January 24, 2017, which accused Plaintiff of infringing the patent-in-suit. The complaint alleges that Defendant The University of Bern is the patent owner and has granted an exclusive license to Defendant LABOklin, including the right to enforce the patent.
Case Timeline
| Date | Event |
|---|---|
| 2012-05-25 | '114 Patent Priority Date |
| 2015-10-13 | '114 Patent Issue Date |
| 2017-01-24 | LABOklin sends cease and desist letter to Plaintiff |
| 2017-02-22 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 9,157,114, Method of Determining the Genotype Relating to Hereditary Nasal Parakeratosis (HNPK) and Nucleic Acids Usable in Said Method, issued October 13, 2015.
U.S. Patent No. 9,157,114 - Method of Determining the Genotype Relating to Hereditary Nasal Parakeratosis (HNPK) and Nucleic Acids Usable in Said Method
The Invention Explained
- Problem Addressed: The patent's background section describes a "long felt need" among breeders of Labrador Retrievers for a genetic test to identify dogs that are healthy but carry the recessive gene for HNPK. Without such a test, breeders cannot reliably distinguish "carriers" from dogs that are genetically "free" of the trait, leading to unintentional breeding that perpetuates the disease. ('114 Patent, col. 2:36-52).
- The Patented Solution: The invention is an in vitro diagnostic method based on the discovery that a specific genetic mutation—a T-to-G substitution at position 972 in the SUV39H2 gene—is the cause of HNPK. The method involves obtaining a biological sample from a dog and testing it to determine the presence or absence of this specific mutation, thereby identifying the dog's genotype as "free," "carrier," or "affected." ('114 Patent, col. 3:35-42, col. 7:22-31).
- Technical Importance: This genetic test provides a definitive way to discriminate between the three possible genotypes, allowing breeders to eliminate the disease from their breeding programs through informed selection. ('114 Patent, col. 2:42-52).
Key Claims at a Glance
- The complaint challenges all claims of the '114 patent as invalid (Compl. ¶¶ 9, 14, 26). The independent claims are 1 and 5.
- Independent Claim 1: An in vitro method for genotyping a Labrador Retriever, comprising the steps of:
- obtaining a biological sample from the Labrador Retriever;
- genotyping a SUV39H2 gene; and
- detecting the presence of a replacement of a nucleotide T with a nucleotide G at position 972 of SEQ ID NO: 2.
- Independent Claim 5: An in vitro method for genotyping a Labrador Retriever, comprising the steps of:
- obtaining a biological sample from the Labrador Retriever;
- contacting the nucleic acid from the sample with an isolated nucleic acid probe corresponding to the mutated gene sequence; and
- detecting the presence of a hybridized nucleic acid.
III. The Accused Instrumentality
Product Identification
- The "accused instrumentality" is the service offered by Plaintiff Paw Prints Genetics ("PPG") (Compl. ¶18).
Functionality and Market Context
- The complaint states that "PPG is in the business of testing for a variety of genetic variations and mutations known to cause diseases in dogs" (Compl. ¶18). Specifically, the activity that prompted the cease and desist letter is PPG's test for "the presence or absence of the single nucleotide mutation in the SUV39H2 gene known to cause HNPK in homozygotes" (Compl. ¶18). The complaint frames this activity as central to PPG's business interests, which are now at risk due to the Defendants' infringement allegations (Compl. ¶21). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain a formal infringement claim chart from the patentee. The following table summarizes the plaintiff's (PPG's) own description of its activities that form the basis for the declaratory judgment action, mapped to the elements of the asserted patent claim.
'114 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An in vitro method for genotyping a Labrador Retriever comprising: a) obtaining a biological sample from the Labrador Retriever; | The complaint does not specify how samples are obtained, but this is an inherent prerequisite for PPG's testing service. | ¶18 | col. 15:4-6 |
| b) genotyping a SUV39H2 gene encoding the polypeptide of SEQ ID NO: 1 and | PPG's service is described as "testing for the presence or absence of the single nucleotide mutation in the SUV39H2 gene." | ¶18 | col. 15:7-9 |
| c) detecting the presence of a replacement of a nucleotide T with a nucleotide G at position 972 of SEQ ID NO: 2. | PPG's service specifically tests for the single nucleotide mutation that causes HNPK, which the patent identifies as the T-to-G replacement at position 972. | ¶18 | col. 15:10-12 |
- Identified Points of Contention: The central dispute is not over whether PPG's activities meet the claim limitations, but whether the claims are valid in the first place.
- Legal Question (§ 101): The primary point of contention, and the sole basis for the declaratory judgment action, is patent eligibility. The complaint alleges that the '114 Patent's claims are directed to a natural phenomenon—"the discovery that HNPK is caused by a single nucleotide mutation in the SUV39H2 gene" (Compl. ¶14).
- Technical Question: The complaint asserts that the claims fail to add an "inventive concept" because the method steps for detecting the mutation are "well-known, routine, or conventional" (Compl. ¶16). The key technical question for the court will be whether the claimed method steps represent a transformation of the natural law into a patent-eligible application, or if they are merely instructions to apply conventional techniques to a newly discovered natural correlation.
V. Key Claim Terms for Construction
The dispute centers on the validity of the claims as a whole under 35 U.S.C. § 101, rather than on the specific meaning of individual terms. However, the interpretation of the action-oriented steps is foundational to that analysis.
- The Term: "genotyping a SUV39H2 gene" (Claim 1)
- Context and Importance: The plaintiff's invalidity argument hinges on this step being a "well-known, routine, or conventional" activity (Compl. ¶16). Practitioners may focus on this term because if "genotyping" is construed as simply referring to any conventional data-gathering activity, it may not supply the "inventive concept" required by the Supreme Court's Mayo framework to transform a patent-ineligible law of nature into a patent-eligible application.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader (Conventional) Interpretation: The patent specification explicitly lists a wide array of standard laboratory techniques that can be used for the genotyping step, such as "PCR, real-time PCR, melting point analysis... mass spectroscopy, direct DNA sequencing, restriction fragment length polymorphism (RFLP), single strand conformation polymorphism (SSCP), high performance liquid chromatography (HPLC), or single base primer extension." ('114 Patent, col. 4:27-33). This extensive list could support an interpretation that the claim covers any conventional method of genetic analysis.
- Evidence for a Narrower (Specific Application) Interpretation: The patentee may argue that the term must be read in the context of the full claim, which limits the genotyping to a specific gene (SUV39H2), for a specific purpose (diagnosing HNPK), in a specific species (dog) and breed (Labrador Retriever). This context, it could be argued, cabins the term to a concrete application of the inventors' discovery, not just the abstract idea of genotyping. ('114 Patent, Claim 1).
VI. Other Allegations
- Indirect Infringement: The complaint does not contain allegations of indirect infringement.
- Willful Infringement: As a declaratory judgment complaint filed by the accused infringer, there is no allegation of willfulness against the plaintiff. However, the complaint does allege that the defendants "know or should know that the '114 Patent is invalid" (Compl. ¶23) and seeks a declaration that the case is "exceptional" under 35 U.S.C. § 285, which could entitle the plaintiff to attorney's fees (Compl. Prayer for Relief ¶D).
VII. Analyst’s Conclusion: Key Questions for the Case
This case appears to be a direct test of the patent eligibility of a genetic diagnostic method patent following the Supreme Court's decisions in Mayo and Myriad. The resolution will likely depend on the court's answers to two central questions:
A core issue will be one of patentable subject matter: Is the '114 patent's claim to a method of detecting a specific, newly-discovered genetic mutation a patent-ineligible "natural phenomenon," or is it a patent-eligible "application" of that discovery?
A key legal question will be one of inventive concept: Do the claimed method steps—such as "obtaining a biological sample" and "genotyping a SUV39H2 gene"—add enough to the underlying discovery to transform the claim into something "significantly more" than the natural law itself, or are they merely the "well-understood, routine, conventional activity" that the Mayo framework holds is insufficient to confer patent eligibility?