Another Diagnostic Patent Falls Under 101

Another Diagnostic Patent Falls Under 101

In Genetic Techs Limited v Merial LLC (Given. Cir., April 8, 2016), the government Circuit invalidated another diagnostic patent for neglecting to satisfy 35 U.S.C. § 101 on the floor the claims recite simply legislation of nature. The claim’s recitation from the term “to identify the allele” was inadequate to qualify the claims for eligibility since the clam element “merely asks the consumer to check the non-coding sequences … amplified and examined having a library of non-coding sequences….” Slip Op. at 17.

Detecting “Junk” DNA

Genetic Technologies, Limited. (“GTG”) sued Merial L.L.C. (“Merial”) and Bristol-Myers Squibb (together “Merial”) for infringing U.S. Patent No. 5,612,179 (“the ‘179 patent”) entitled “Intron Sequence Analysis Way of Recognition of Adjacent and Remote Locus Alleles as Haplotypes.” The district court granted Merial’s motions to dismiss to fail to condition claims and joined final judgment that claims 1-25 and 33-36 were ineligible for patenting under 35 U.S.C. § 101.

Claim 1 was stipulated through the parties to become representative:

  1. A method for detection of at least one coding region allele of a multi-allelic genetic locus comprising: a) amplifying genomic DNA with a primer pair that spans a non-coding region sequence, said primer pair defining a DNA sequence which is in genetic linkage with said genetic locus and contains a sufficient number of non-coding region sequence nucleotides to produce an amplified DNA sequence characteristic of said allele; and b) analyzing the amplified DNA sequence to detect the allele.

Emphasis added.

In 1980, inventor Dr. Malcolm J. Simons learned that certain DNA in coding regions correlated with non-coding regions between genes, which these regions are usually inherited together, “more frequently than probability would dictate.” Slip Op. 4. This linkage (termed linkage disequilibrium) can happen although the two sequences are far apart around the chromosome. Id. Dr. Simons created that you could identify the coding parts of certain genes by trying to find the non-coding regions from the coding regions. He exploited this discovery and based on GTG, the claimed methods provided advantages within the methods known within the art at that time the invention is made, e.g., the claimed methods permitted case study of huge coding sequences. Slip Op. at 5.

Applying the Alice Two-Part Test

The court focused on the “two-part” test to analyze subject matter eligibility under 35 U.S.C. § 101, and as set forth by the Supreme Court in Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2355 (2014):

“First, we determine whether the claims at issue are directed to one of those patent-ineligible concepts. If so, we then ask, what else is there in the claims before us? . . . We have described step two of this analysis as a search for an inventive concept – i.e., an element or combination of elements that is sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself.”

Slip Op. at 8.

A legal court first figured that the claim did recite legislation of nature – discovering a coding region of the genome by “amplifying and analyzing a linked non-coding region of this person’s genome.” Slip Op. at 8-9. Citing the similarity from the claims that unsuccessful in Mayo and Alice, and also the court’s newer ruling in Ariosa Diagnostics, Corporation. v. Sequenom, Corporation., 788 F.3d 1371 (Given. Cir. 2015), a legal court mentioned the claim centered on “a recently discovered fact about human biology (the linkage of coding and non-hyphen coding parts of DNA), involves no creation or difference in DNA sequences, and doesn’t purport to recognize novel recognition techniques.” Slip Op. at 11.

Getting figured that the claim was forwarded to unpatentable subject material, a legal court then began to step two from the test, i.e., if the claim provides some thing than just describing the ineligible concept. GTG contended the step of analyzing the amplified DNA sequence to identify the allele satisfied the “something more” step from the test. A legal court could not agree, noting the “amplifying” step was well-known within the art at that time the invention is made. The step of “analyzing” the amplified DNA to supply details about the DNA seemed to be known, based on the court, which noted that Applicants, during examination, accepted that no new techniques to evaluate DNA came to be. Slip Op. at 14.

GTG further contended claiming 1 provided more since the analysis limitation of claim 1 mandates that case study step is conducted on amplified, man-made non-coding DNA. This, GTG mentioned, was new because “no you before examined man-made non-coding DNA to be able to identify a coding region allele.” Slip Op. at 16. The Government Circuit could not agree, proclaiming that case study step would be a mental process step that may be performed within the human mind. Citing Cyborsource Corp. v. Retail Decisions, Corporation., 654 F.3d 1366 (Given. Cir. 2011), a legal court noted that methods that may be performed entirely within the human mind are unpatentable since they’re the kinds of “basic tools and scientific and technical work which are to stay liberated to all men and reserved to none.” Slip Op. at 16. In summing up their decision a legal court mentioned:

“To be sure, it seems to be true, as GTG alleges, that at the time the ‘179 patent was filed, no one was ‘using the non-coding sequence as a surrogate marker for the coding region allele’. . . But the novelty of looking to non-coding DNA to detect a coding region allele of interest resides in the novelty of the newly discovered natural law of linkage disequilibrium between coding and non-coding regions and adds little more than a restatement of the natural law itself.”

Slip Op. at 18-19.

Lessons Learned

As the court here held unpatentable another diagnostic method patent that embodies a brand new, helpful and valuable use of a substantial scientific discovery, the court’s opinion provides several helpful strategies for figuring out if your diagnostic method claim could pass the Alice two-part test. A legal court is more prone to look for a method patent qualified when the claim recites using a “new” technology, not just the use of a known method to a recently discovered natural phenomenon. A legal court also shows that when the method necessitates the modification or development of a brand new naturally-derived product, the claim may also be patent qualified.




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1 Response

  1. disqus_fj2dk8g7Bm says:

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