Earlier this month, in Genetic Veterinary Sciences, Inc. v. LABOklin GmbH, Senior District Judge Henry Coke Morgan, Jr. of the U.S. District Court for the Eastern District of Virginia granted a motion for judgment as a matter of law under Rule 50 of the Federal Rules of Civil Procedure filed by Plaintiff Genetic Veterinary Sciences, Inc. (doing business as Paw Prints Genetics) that claims 1-3 of U.S. Patent No. 9,157,114, which is assigned to Defendant University of Bern, are invalid under 35 U.S.C. § 101.  Genetic Veterinary Sciences ("GVS") had initiated the dispute between the parties by filing a complaint for declaratory judgment of invalidity and noninfringement of the '114 patent.

The '114 patent, which is entitled "Method of determining the genotype relating to hereditary nasal parakeratosis (HNPK) and nucleic acids usable in said method," is directed to in vitro methods for genotyping a Labrador Retriever in order to determine whether the Labrador Retriever is a genetic carrier of Hereditary Nasal Parakeratosis ("HNPK"), which causes fissures to appear on a dog's nose.  Claims 1-3, which were at issue in this case, recite:

1.  An in vitro method for genotyping a Labrador Retriever comprising:
    a) obtaining a biological sample from the Labrador Retriever;
    b) genotyping a SUV39H2 gene encoding the polypeptide of SEQ ID NO: 1 and
    c) detecting the presence of a replacement of a nucleotide T with a nucleotide G at position 972 of SEQ ID NO: 2.

2.  The method according to claim 1, wherein the genotyping is achieved by PCR, real-time PCR, melting point analysis of double-stranded DNA, 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.

3.  The method of claim 1, wherein the genotyping utilizes a primer pair comprising a first primer and a second primer, each comprising a contiguous span of at least 14 nucleotides of the sequence SEQ ID NO: 2 or a sequence complementary thereto, wherein:
    a) said first primer hybridizes to a first DNA strand of the SUV39H2 gene;
    b) said second primer hybridizes to the strand complementary to said first DNA strand of the SUV39H2 gene; and
    c) the 3' ends of said first and second primers are located on regions flanking the position 972 of SEQ ID NO: 2, or of nucleotide positions complementary thereto.

Prior to trial, GVS filed a motion for summary judgment regarding validity of the '114 patent, which the District Court denied.  GVS then filed a motion for reconsideration of the Court's denial of its motion for summary judgment, which the District Court also denied.  At trial, following the close of GVS' evidence, LABOklin moved for judgment as a matter of law, arguing that no reasonable juror could find claims 1-3 of the '114 patent invalid.  The District Court denied LABOklin's motion.  After the close of LABOklin's evidence, GVS moved for judgment as a matter of law that claims 1-3 were invalid as not patent eligible, which the District Court granted.

In assessing the patent eligibility of claims 1-3 of the '114 patent, the District Court noted that the analysis follows the two-step framework set forth by the Supreme Court in Alice Corp. Ptv. Ltd. v. CLS Bank Int'l (2014).  Pursuant to that framework, courts first determine whether the claims at issue are directed to a patent-ineligible concept, and if so, then consider the elements of each claim both individually and as an ordered combination to determine whether the additional elements transform the claim into a patent-eligible application.  The District Court noted that this second step "represents a 'search for an 'inventive concept''—i.e., an element or combination of elements that is 'sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.'"

In applying the Alice two-step framework to the claims at issue, the District Court "[r]eview[ed] Claim one (1) individually, and then as an ordered combination with Claims two (2) or three (3)," and determined that "Claim one (1) of the '114 Patent, even in combination with Claims two (2) and three (3), is directed to patent ineligible subject matter, namely the discovery of the genetic mutation that is linked to HNPK."  The Court noted that as in Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015), "[s]imilarly here, the methods claimed in the '114 patent begin and end with the discovery of a natural phenomenon," adding that "[t]he fact that the research to which the patent refers is conducted in a lab [i.e., noting that claim 1 recites an in vitro method] does not form a basis for transforming the discovery of a law of nature into patent eligible subject matter."  According to the Court, "[p]arts (a), (b), and (c) of Claim 1, which break down how the mutation is discovered, do not provide anything apart from the scientific designation of the mutation," and "the mutation of the SUV39H2 gene at position 972 in a Labrador Retriever arises through a natural process."

In response to GVS' motion, LABOklin argued that claims 1-3 were patent eligible in view of the Federal Circuit's decisions in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int'l Ltd., and Rapid Litigation Management Ltd. v. CellzDirect, Inc.  The District Court noted that in Vanda, the Federal Circuit reasoned that the patent claim at issue "was distinguishable from a patent claim that was aimed at a natural phenomenon because the claim did more than simply recite how to discover the correlation between CYP2D6 and iloperidone, it additionally applied that discovery to a particular regimen of treatment."  According to the Court, however, "Vanda is distinguishable from this case because the '114 Patent does not claim a method of applying the discovery—the presence a point mutation in the SUV39H2 gene—to a new method of treating Labrador Retrievers."

As for LABOklin's reliance on CellzDirect, the District Court indicated that this too was "misplaced."  The Court noted that in CellzDirect, "the Federal Circuit held that a claim was not directed to natural law when it claimed a 'new and useful laboratory technique for preserving hepatocytes,'" and that "[t]he Federal Circuit was careful to distinguish its ruling from other cases where claims amounted to nothing more than 'observing or identifying the ineligible concept itself.'"  According to the Court, "Claim 1 of the '114 Patent is not a new and useful laboratory technique," and "amounts to nothing more than 'observing or identifying' the natural phenomenon of a mutation in the SUV39H2 gene, which has been rejected by the Federal Circuit as a basis for satisfying Step 1 of Alice."

The opinion concludes by finding that contrary to the testimony of LABOklin's expert that claim 1 of the '114 patent recites a patentable method of discovery, "the evidence does not support Dr. Friedenberg's opinion that paragraphs (a), (b), and (c) of Claim 1 constitutes a method."  In particular, the District Court determined that:

[P]aragraphs (a) through (c) merely provide the supplying of Labrador DNA in part (a), point to the location of the mutation in dog's DNA in (b), and in (c) describe and locate the point mutation.  These three paragraphs constitute a discovery of a natural phenomenon, not a method.

With respect to claims 2 and 3, the District Court noted these claims "only contain a number of alternative methods to locate the mutation, all of the methods are well known and have been around for decades."

The Court indicated that "after translating the complex scientific jargon used in the patent, the result is that it contains a valuable scientific discovery of a natural phenomenon without any inventive concept which transforms it from patent ineligible subject matter to patent eligible subject matter."  The Court therefore granted GVS' motion for judgment of invalidity as a matter of law.

Genetic Veterinary Sciences, Inc. v. LABOklin GmbH (E.D. Va. 2018)
Opinion & Order by Senior District Judge Morgan, Jr.