Genetic Technologies Limited v. Merial L.L.C., 818 F.3d 1369

GTG (Genetic Technologies Ltd.) sued Merial and Bristol-Myers Squibb, alleging infringement of U.S. Patent No. 5,612,179, which claims methods of detecting coding-region alleles by amplifying and analyzing linked non-coding DNA sequences.
Claim 1 (representative) recites: (a) amplifying genomic DNA with a primer pair that spans a non-coding region in genetic linkage with a multi-allelic locus, and (b) analyzing the amplified sequence to detect the allele.
The asserted technique relies on the natural phenomenon of linkage disequilibrium: certain non-coding sequences are predictive of nearby or linked coding-region alleles.
District court dismissed GTG’s complaint under Rule 12(b)(6), holding claims 1–25 and 33–36 ineligible under 35 U.S.C. § 101 as directed to a law of nature; parties stipulated claim 1 is representative on appeal.
The Federal Circuit applied the Mayo/Alice two-step framework, finding claim 1 directed to the natural law of linkage disequilibrium and that the claimed steps (PCR amplification and routine sequence analysis plus a mental comparison to detect an allele) were conventional and not an inventive application.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether claim 1 is directed to patent-eligible subject matter under 35 U.S.C. § 101	GTG: Claim 1 is an application of laboratory techniques to analyze man-made amplified DNA to detect alleles; novelty lies in using non-coding sequences as surrogates for coding alleles, providing an inventive application.	Appellees: Claim 1 claims a natural law (linkage disequilibrium) and adds only routine, conventional lab steps and a mental comparison; thus ineligible under Mayo/Alice.	Held: Claim 1 is directed to a law of nature (linkage disequilibrium) and is therefore ineligible under § 101.
Whether the claimed additional steps supply an "inventive concept" sufficient to transform the natural law into a patent-eligible application	GTG: Amplifying and analyzing man-made amplified non-coding DNA to detect coding alleles was not previously done and supplies the inventive concept.	Appellees: Amplification (PCR) and sequence analysis were well-known, and the mental step of "detecting" the allele is a routine comparison/mental process; together they do not add an inventive concept.	Held: The amplification and analysis steps were routine and conventional; the mental comparison is not patent-eligible. The claim lacks the required inventive concept under step two.

Mayo Collaborative Servs. v. Prometheus Labs., 566 U.S. 66 (2012) (establishes that a claim directed to a law of nature must include an inventive concept beyond routine, conventional steps)
Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014) (articulates the two-step test for patent eligibility)
Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) (distinguishes patent-eligible cDNA from ineligible claims directed to naturally occurring DNA information)
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015) (similar genetic-detection claims invalidated under Mayo/Alice)
Gottschalk v. Benson, 409 U.S. 63 (1972) (laws of nature and mental processes are not patentable)
Diamond v. Diehr, 450 U.S. 175 (1981) (process claims that apply a law of nature may be patent-eligible when they include an inventive application)
Bilski v. Kappos, 561 U.S. 593 (2010) (limits abstract ideas as patentable subject matter)
CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366 (Fed. Cir. 2011) (mental processes performed by the human mind are not patentable)
In re BRCA1- & BRCA2-Based Hereditary Cancer Test, 774 F.3d 755 (Fed. Cir. 2014) (claims combining routine implementation with a simple comparison were ineligible)
In re Roslin Inst. (Edinburgh), 750 F.3d 1333 (Fed. Cir. 2014) (distinguishes claims to newly created organisms/altered material from claims directed to naturally occurring information)