IP Law Daily Genetic variation detection patent invalid as directed to law of nature
Friday, April 8, 2016

Genetic variation detection patent invalid as directed to law of nature

By Jody Coultas, J.D.

Genetic Technologies Limited (GTG) was unable to state patent infringement claims against Merial L.L.C. and Bristol-Myers Squibb Company, according to the U.S. Court of Appeals for the Federal Circuit (Genetic Technologies Limited v. Merial L.L.C., April 8, 2016, Dyk, T.). A district court properly held that the patent asserted by GTG was invalid as directed to ineligible subject matter.

A GTG doctor discovered that certain DNA sequences in coding regions (exons) of certain genes are correlated with non-coding regions (introns) within the same gene, non-coding regions in different genes, or non-coding regions of the genome that are not part of any gene. U.S. Patent No. 5,612,179 (the ’179 patent) claims methods of analyzing sequences of genomic deoxyribonucleic acid (DNA) to detect genetic variations. Claim 1 covers a method of detecting a coding region of a person’s genome by amplifying and analyzing a linked non-coding region of that person’s genome.

In an infringement suit against Merial and Bristol-Myers, a district court held that claim 1 was invalid for claiming patent-ineligible subject matter and dismissed the suit. GTG appealed.

To determine whether a patent is invalid as claiming an abstract idea, the court looks first at whether the claims are directed to a patent-ineligible concept. If so, the court must determine whether the claims include an inventive concept sufficient to transform the claims into a patent-eligible invention. A claim directed to a newly discovered law of nature cannot rely on the novelty of that discovery to meet the inventive concept element. Rather, the application must provide something beyond “well-understood, routine, conventional activity.”

Claim 1 is directed to a patent-ineligible law of nature, according to the court. The claim covers the relationship between non-coding and coding sequences in linkage disequilibrium and the tendency of such non-coding DNA sequences to be representative of the linked coding sequences. Also, Claim 1 covered essentially all applications, via standard experimental techniques, of the law of linkage disequilibrium to the problem of detecting coding sequences of DNA. Therefore, the patent covers the natural law principle that certain non-coding and coding sequences are in linkage disequilibrium with one another.

The physical steps of claim 1 did not provide an inventive concept necessary to render the claim patent-eligible, according to the court. Claim 1 covers “amplifying genomic DNA with a primer pair” and “analyzing the amplified DNA sequence to detect the allele.” Those two steps were well known, routine, and conventional in the field of molecular biology. The background section of the ’179 patent acknowledged as prior art the claimed two-step combination of amplification of DNA and subsequent analysis of its sequence.

GTG was unable to show that the ‘179 patent contained an inventive concept, according to the court. After the noncoding DNA has been amplified and sequenced, the patent directs users to “analyz[e] the amplified DNA sequence to detect the [coding region] allele.” GTG argued that no one had ever analyzed man-made non-coding DNA in order to detect a coding region allele.” However, the term “to detect the allele” did not create the requisite inventive concept, because it merely sets forth a routine comparison that can be performed by the human mind. Diagnostic and therapeutic method claims that combined routine and conventional physical implementation of a law of nature with a simple mental process step do not transform the law of nature into patent-eligible subject matter. The novelty of looking to non-coding DNA to detect a coding region allele of interest resided in the novelty of the newly discovered natural law of linkage disequilibrium between coding and non-coding regions and was merely a restatement of the natural law itself.

The court noted that GTG’s attempts to distinguish this case on the ground that the method of claim 1 is useful had no basis in case law or in logic.

The cases are Nos. 2015-1202 and 2015-1203.

Attorneys: Benjamin B. Lieb (Sheridan Ross, PC) for Genetic Technologies Limited. Gregory A. Castanias (Jones Day) for Merial L.L.C. Amy K. Wigmore (Wilmer Cutler Pickering Hale and Dorr LLP) for Bristol-Myers Squibb Company.

Companies: Genetic Technologies Limited; Merial L.L.C.; Bristol-Myers Squibb Company

MainStory: TopStory Patent FedCirNews

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