Genetic Technologies Ltd. v. Bristol-Myers Squibb Co.
72 F. Supp. 3d 521
D. Del.2014Background
- Plaintiff Genetic Technologies Ltd. (GTG) sued defendants (Bristol-Myers Squibb and Merial) for infringement of U.S. Patent No. 5,612,179 (’179) (and also asserted U.S. Patent No. 5,851,762 (’762) in related cases).
- The ’179 patent claims a method to detect a coding-region allele by amplifying genomic DNA with a primer pair spanning a non-coding region in linkage disequilibrium with the allele, then analyzing the amplified sequence.
- Defendants moved to dismiss under Fed. R. Civ. P. 12(b)(6) arguing claim 1 of the ’179 patent is patent-ineligible under 35 U.S.C. § 101 as directed to a natural phenomenon with only conventional steps added.
- The court evaluated the claim under the Mayo/Alice two-step framework: (1) whether the claims are directed to a law of nature/natural phenomenon, and (2) whether the claim elements add an ‘‘inventive concept’’ sufficient to transform it into patent-eligible subject matter.
- The court concluded the claimed correlation (linkage disequilibrium between non-coding variants and coding alleles) is a natural phenomenon and that the additional steps (amplifying with primers and analyzing) are routine, conventional laboratory techniques that do not supply an inventive concept.
- Result: defendant motions to dismiss were granted as to claim 1 of the ’179 patent; challenges to other asserted claims (including claims of the ’762 patent) were left for further briefing.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether claim 1 of the ’179 patent is directed to patent-ineligible subject matter under § 101 | GTG: The claim is an applied laboratory method; amplifying non-coding sequences with primer pairs to detect linked alleles is novel and unconventional and thus patent-eligible | Defs: The claim is directed to a natural phenomenon (genetic linkage/linkage disequilibrium); the claim’s steps are routine and conventional and add nothing inventive | Held: Claim 1 is directed to a natural phenomenon and the additional steps are routine; claim 1 is § 101-ineligible and dismissed |
| Whether the additional claim steps supply an ‘‘inventive concept’’ under Mayo/Alice | GTG: Application of conventional amplification to newly-discovered linkage is unconventional because the primers target introns linked to alleles | Defs: Amplification and analysis (e.g., PCR, primers, RFLP) were well-known and conventional; those steps cannot make a natural law patentable | Held: The amplification/analysis steps are routine/conventional and do not transform the natural correlation into a patent-eligible application |
| Whether the machine-or-transformation test is satisfied | GTG: Amplification uses machines, primers are man-made tools, and amplified DNA is a ‘‘man-made’’ transformed product (like cDNA) | Defs: Claim does not tie to a particular machine; primers are conventional tools; amplified sequence mirrors natural genetic information and the claim does not rely on chemical differences | Held: Test not satisfied — no particular machine, and amplified DNA’s chemical differences are not claimed or relied upon to confer eligibility |
| Prematurity of § 101 dismissal at Rule 12(b)(6) stage | GTG: Factual disputes and claim-construction issues make dismissal premature | Defs: Even accepting GTG’s allegations, the only plausible reading shows ineligibility | Held: Dismissal not premature as to claim 1 — no factual disputes or claim-construction issues would change the outcome |
Key Cases Cited
- Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012) (established two-step framework and held routine post-solution steps insufficient to transform natural law into patentable application)
- Alice Corp. v. CLS Bank Int'l, 573 U.S. 208 (2014) (reaffirmed Mayo framework for abstract ideas/natural laws and requirement of inventive concept)
- Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 689 F.3d 1303 (Fed. Cir. 2012) (application of Mayo principles to DNA-related method claims)
- Diamond v. Diehr, 450 U.S. 175 (1981) (distinction between patent-eligible applications and patent-ineligible laws of nature/abstract ideas)
- Bilski v. Kappos, 561 U.S. 593 (2010) (machine-or-transformation test is a useful clue but not dispositive)
- Laboratory Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124 (2006) (correlations that preexist in the human body are natural phenomena)