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 from the dog 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.
Motion for partial summary judgment on invalidity under 35 U.S.C. § 101.
Exception Category: Law of Nature
Like those in Myriad, the claims “are directed at identifying and observing a natural law—a genetic mutation that is tied to a disease in a living organism.”
Even if some of the claims “involve non-natural processes or materials, those claims are still directed at identifying a genetic biomarker that exists in nature.”
“Unlike the cDNA patent in Myriad, the patent claims at issue here are not directed at creating entirely new, non-natural genetic material. Instead, the ’297 Patent uses non-natural processes to serve its purpose of identifying a natural law.”
Significantly More: No
“Outside of the natural law relationship between the T767 allele and EIC, the techniques or methods identified in the claims, whether viewed individually or in the aggregate, were at the time the patent was issued ’well-understood, routine, and conventional techniques that a scientist would have thought of when instructed to’ test whether a certain allele exists at a specific genetic location.”
“Claim one simply states the natural law at the heart of the ‘297 Patent (i.e., the biomarker—the T767 allele—that is tied to EIC), and then describes detecting that biomarker through “a nucleic acid sample” and, if that nucleic acid sample shows that the dog is homozygous for the T767 allele, then identifying the dog as having or being predisposed to EIC. Simply detecting a patent-ineligible concept—in this case a natural law—and then identifying the law once it is detected, is not enough to render the subject matter patentable.”
The dependent claims “offer nothing more, beyond routine and conventional processes.” These are simply “generalized steps that essentially tell experts about the natural law; the claims simply tell someone treating a canine to detect whether the natural law—the specific allele tied to EIC—exists or is implicated in the dog being treated.”
With regard to breadth and preemption, the court stated that while Plaintiff “argues that its patent claims are much more narrowly drawn, patenting only one test that identifies one mutation that is tied to one disease,” … “It has not shown that the [claims are simply] narrowly wading into a deep ocean of research and innovation around dogs, genetics, and EIC. Instead, the ‘297 Patent broadly seeks to control all the ties between the 767T allele and EIC, which renders it ineligible for patent protection.”