United States District Court, D. Minnesota
GENETIC VETERINARY SCIENCES, INC., doing business as PAW PRINT GENETICS, Plaintiff,
CANINE EIC GENETICS, LLC, Defendant
For Plaintiff: Mark P. Walters, LOWE GRAHAM JONES, Seattle WA; and Jonathan D. Jay, HELLMUTH & JOHNSON PLLC, Edina, MN.
For Defendant: Frank S. Farrell, Jr. and Alexander Farrell, F S FARRELL, LLC, Edina, MN.
MEMORANDUM OPINION AND ORDER GRANTING PLAINTIFF'S MOTION FOR PARTIAL SUMMARY JUDGMENT
JOHN R. TUNHEIM, United States District Judge.
Canine Exercise-Induced Collapse causes dogs to lose control of their legs after strenuous exercise. Defendant Canine EIC Genetics (" Canine EIC" ) discovered a genetic mutation in dogs that is tied to EIC. Canine EIC subsequently secured a patent (" the '297 Patent" ) that identifies this mutation and lists eight claims, all of which describe slightly different methods for detecting whether a dog has the mutation and therefore has EIC. Plaintiff Genetic Veterinary Science, doing business as Paw Print Genetics (" PPG" ), also tests dogs for EIC.
Anticipating patent litigation, PPG filed this action, accusing Canine EIC of telling its customers that PPG was violating Canine EIC's patent; and claiming that the '297 Patent is invalid because it protects a patent-ineligible natural law. PPG then filed a motion for partial summary judgment, seeking a declaratory judgment as to the invalidity of the '297 Patent. Because the '297 Patent is directed at a natural law and because it does not introduce any additional inventive concept beyond well-understood, routine, and conventional methods for determining whether the EIC mutation exists in a dog, the Court will find that the patent is invalid and will grant PPG's motion for partial summary judgment.
I. THE PARTIES AND THE '297 PATENT
This case involves Canine Exercise-Induced Collapse (" EIC" ), " a genetic syndrome" that causes dogs -- especially Labrador Retrievers -- " to lose coordination," develop " a wobbly gait," and eventually lose " control of the[ir] hind legs." (First Am. Compl. ¶ 9, Jan. 17, 2014, Docket No. 9.) Dogs who suffer from EIC usually experience these effects " five to fifteen minutes after initiation of strenuous exercise." ( Id.) An EIC " collapse period" usually lasts five to ten minutes and the dog generally recovers fully within thirty minutes. ( Id.)
Canine EIC is based in St. Paul, Minnesota. (Decl. of Dr. Edward Earl Patterson in Supp. of Def.'s Resp. to Pl.'s Mot. for Partial Summ. J. (" Patterson Decl." ) ¶ 2, Sept. 29, 2014, Docket No. 50.) Canine EIC co-founder Dr. Edward Earl Patterson, along with Drs. James R. Mickelson and Susan Taylor, and Katie Minor, RN, developed a genetic test to detect EIC in dogs. ( Id. ¶ 5.) They were issued a United States patent for that development, Patent No. 8,178,297, titled " Method of Detecting Canine Exercise-Induced Collapse." ( Id.; Decl. of Mark P. Walters in Supp. of Mot. for Partial Summ. J. (" First Walters Decl." ), Ex. A. ('297 Patent (" '297 Patent" )), Aug. 29, 2014, Docket No. 44.) The '297 Patent is dated May 15, 2012. ('297 Patent.)
PPG is a Washington state company, founded in 2012 in Spokane by Dr. Lisa Shaffer. (First Am. Compl. ¶ 12.) PPG has developed numerous tests for canine genetic disorders, including for EIC. ( Id. ¶ ¶ 13-14.) The company has been conducting tests for EIC since August 2013. ( Id. ¶ 18.)
According to PPG, Canine EIC has filed two lawsuits to enforce the '297 patent, both in the District of Minnesota. ( Id. ¶ 28.) In both cases, Canine EIC " characterized the infringing services as 'DNA testing services to detect whether a dog has or is predisposed to developing Canine [EIC].'" ( Id. ¶ 29.) In June 2013, principals from both PPG and Canine EIC met, and Canine EIC officials offered to license PPG's EIC testing under its patent, in exchange for a 50% royalty. ( Id. ¶ ¶ 31-32.) PPG did not accept the offer and consequently concluded it was under a genuine threat of being sued by Canine EIC for patent infringement. ( Id. ¶ 33.) Indeed, PPG alleges that Canine EIC has been informing PPG customers that PPG is not legally authorized to conduct DNA testing for canine EIC. ( Id. ¶ ¶ 35-37.) This litigation soon followed.
II. THE '297 PATENT
The '297 Patent essentially covers assays, or tests, for determining whether a dog has, or might develop, EIC. ('297 Patent, col. 1, l. 55-60.) This sort of genetic testing ascertains whether the dog has mutations -- also called, at least at a broad level of generality, " alleles" or " polymorphisms" -- " that either cause a disease state or[, at a minimum,] are 'linked' to the mutation causing a disease state." ( Id. col. 6, l. 60-65.)
" Genes form the basis for hereditary traits in living organisms." Ass'n for Molecular Pathology v. Myriad Genetics, Inc. ( Myriad ), 133 S.Ct. 2107, 2111, 186 L.Ed.2d 124 (2013). Genes are " encoded as DNA [deoxyribonucleic acid], which takes the shape of the familiar 'double helix' . . . first described in 1953." Id. " Each 'cross-bar' in the DNA helix consists of two chemically joined nucleotides. The possible nucleotides are adenine (A), thymine (T), cytosine (C), and guanine (G), each of which binds naturally with another nucleotide." Id.
Polymorphism, a term used throughout the '297 Patent, refers " to the coexistence of more than one form of gene or portion (e.g., allelic variant) thereof. A portion of a gene of which there are at least two forms, i.e., two different nucleotide sequences, is referred to as a 'polymorphic region of a gene.'" ('297 Patent, col. 12, l. 11-15.) A polymorphic region can be a single nucleotide or several nucleotides long. ( Id. col. 12, 1. 11-19.)
The term " allele" refers to a specific genetic sequence at a polymorphic region of a gene. ( Id.) Alleles can have different sequence variants at different polymorphic regions. ( Id. col. 10, l. 33-35.) When multiple alleles co-exist at a genetic locus, it is called " genetic polymorphism." ( Id. col. 10, l. 42-44.)
In developing the invention underlying the '297 Patent, Dr. Patterson and his colleagues first searched for the genetic source of canine EIC in order to, at a minimum, discover an allele that correlates with EIC to allow genetic testing. ( Id. col. 8, l. 10-32.) In other words, whether or not they could discover the definitive cause of EIC, they wanted to discover a biomarker for the disease that could be identified in dogs in order to determine whether dogs have, or are susceptible to, EIC. They discovered a locus for the EIC gene on canine chromosome 9, and further discovered four positional candidate genes in that region -- dynamin 1 or DNM1, PTGES2, AK1, and SLC2A8. ( Id.) While the latter three were ruled out, " a G to T nucleotide mutation at position 767 of the DNM1 gene was identified." ( Id.) This led to the conclusion that " EIC is . . . caused by a point mutation at nucleic acid 767" of the DNM1 gene on canine chromosome 9. ( Id. col. 26, l. 42-44; see also id. col. 8, l. 13.) Dr. Patterson refers to this mutation as the T allele of the dynamin 1 gene at location 767. (Patterson Decl. ¶ 6.) A dog is susceptible when it has two copies of the T allele and is consequently homozygous for " 767T." ( Id.)
When using the term " DNM1 allele," the '297 Patent refers to both a normal allele of the DNM1 locus and an allele " carrying a variation(s) that predispose a dog to develop EIC." ('297 Patent, col. 10, l. 35-45.) The latter allele is the one associated with EIC (i.e., the " T allele" Dr. Patterson describes in his declaration). ( Id.)
Given these discoveries, the patent notes that DNA testing can now " more accurately determine if a dog with clinical signs of EIC has the heritable and 'classic' form of [the] disease that can be specifically attributed to this DNM1 gene mutation." ( Id. col. 9, l. 53-60.) Indeed, the '297 Patent describes its invention as providing " a method for detecting the presence of a biomarker associated with canine" EIC. ( Id. col. 2, l. 49-51.) The patent notes that all the test requires is a tissue sample of the dog, followed by an " appropriate PCR and sequence analysis technology to detect the G to T single nucleotide change." ( Id. col. 9, l. 53-60.) Nevertheless, the '297 Patent includes several embodiments, describing different ways to determine whether a single nucleotide mutation at position 767 exists. ( Id. col. 2, l. 50-65; id. cols. 3-4; see also id. col. 22, l. 28-30 (" The present invention, therefore, provides methods and kits for determining whether a subject has or is likely to develop EIC." ).
Specifically, the '297 Patent includes eight claims:
1. A method for determining whether a dog has or is predisposed to develop Exercise Induced Collapse (EIC) comprising:
a) detecting in a nucleic acid sample the allele in the dynamin 1 gene at position 767 of SEQ ID NO: 1, and
b) identifying that the dog has or is predisposed to the development of EIC when the dog is homozygous for the T767 allele.
2. The method of claim 1, wherein prior to or in conjunction with detection, the nucleic acid sample is subject to an amplification step.
3. The method of claim 2, wherein dynamin 1 or a portion thereof is amplified.
4. The method of claim 1, wherein the detecting step is by a) allele specific hybridization; b) size analysis; c) sequencing; d) hybridization; e) 5' nuclease digestion; f) single-stranded conformation polymorphism; g) primer specific extension; and/or h) oligonucleotide ligation assay.
5. The method of claim 4, wherein the detecting step is by size analysis, and the size analysis is preceded by a restriction enzyme digestion.
6. The method of claim 1, wherein the detecting step is by hybridization of the nucleic acid sample from the dog to at least one oligonucleotide probe specific for the dynamin 1 ...