Thursday, December 6, 2012

ArcticDx v. Sequenom: A Human Gene Patent Litigation Settles

On November 16, a court in the Eastern District of Texas issued a consent judgment and dismissal with prejudice in the case of ArcticDx v. Sequenom.   The patents at issue are what I would classify as gene patents - all of the patents include claims directed towards methods of identifying specific genetic variations associated with disease, particularly age-related macular degeneration (AMD). These method claims are analogous to the Myriad claims directed toward methods of identifying mutations in the BRCA genes, which the Federal Circuit recently held to be patent ineligible in Association for Molecular Pathology v. USPTO, i.e., the Myriad case. 
I think ArcticDx v. Sequenom illustrates some point I have raised in earlier posts to this blog, including a post earlier this week reporting on the Supreme Court's decision to grant certiorari in the Myriad case, i.e., claims to isolated DNA sequences are probably not that big of a deal, and gene patent claims are generally not nearly so preemptive of genetic testing as the ACLU and other critics of gene patents would have us believe.
The lawsuit was filed by ArcticDx earlier this year, alleging infringement of one of its patents, and seeking a declaratory judgment of non-infringement of five Sequenom patents.  None of the patents at issue in this case include a composition of matter claim, there are only method claims. Thus, the classic gene patent claim most people think about, i.e., the isolated DNA claim, is not represented in any of these patents. This is consistent with my view that, at least moving forward, isolated DNA claims are probably not that big of a deal. As I have explained on this blog, in articles I have published in venues such as Nature Biotechnology, and an Amicus brief I filed with the Federal Circuit in the Myriad case, there is good reason to think that few isolated DNA claims would be infringed by most genetic testing activities. Ironically, the Supreme Court granted certiorari solely for the purpose of assessing the patent eligibility of isolated DNA claims.
The five Sequenom patents are numbers 8,053,190; 7,867,727; 7,695,909; 7,351,524; and 8,088,579. The ArcticDx patent is number 8,114,592.
To provide a sense of the nature of the patent claims, claim 1 of the ‘579 patent recites:
A method of screening for susceptibility to developing age-related macular degeneration (AMD) in a subject by determining whether or not the subject's genome encodes a haplotype in the Complement Factor H (CFH) gene associated with reduced susceptibility to developing AMD, comprising determining whether or not a sequence encoding isoleucine at position 62 of the CFH protein is present at the polymorphic site rs800292 (SEQ ID NO:12) in the subject's genome, wherein the presence of said haplotype indicates the subject has reduced susceptibility to developing AMD.

Claim 1 of the 727 patent recites:
A screening method for determining a human subject's propensity to develop an abdominal aortic aneurysm and/or age-related macular degeneration (AMD) comprising: analyzing a biological sample from the subject to detect the presence or absence of a deletion of at least 1000 bp in the region of chromosome 1 between the 3' end of exon 22 of the complement factor H (CFI-1) gene and the 5' end of exon 1 of complement Factor H-related 4 (CFHR4) gene wherein the presence of a deletion indicates the subject is at increased risk of developing an abdominal aortic aneurysm and is at decreased risk of developing AMD.
For comparison, one of the Myriad method claims that was found patent ineligible is claim 1 of US patent number 6,033,857, which recites:
A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequence identifies a mutant BRCA2 nucleotide sequence.

Note that the Sequenom claims are much narrower than Myriad’s, restricted to specific genetic variations like 1000 base deletion and isoleucine substitution recited in the exemplary claims. In contrast, the Myriad claim purports to cover detection of any mutation in the BRCA2 nucleotide sequence, including mutations that were not identified at the time the patent was filed. This scope, and particularly the apparent inclusion within the claim of genetic variations which had not been identified at the time the patent was filed, has been one of the primary criticisms of Myriad’s method claims.
The consent judgment and settlement between ArcticDx and Sequenom is based upon the parties’ agreement that ArcticDx's AMD testing products and related activities, including “Macula Risk,” do not test for the specific genetic variations recited in Sequenom’s claims, e.g., the specific 1000 base pair deletion or the isoleucine substitution.
I think it is worth noting the scope of the patent claims at issue in this case. In contrast with the Myriad claims, the ArcticDx and Sequenom claims appear to be quite narrow (and perhaps not overly preemptive of genetic testing). These two companies are currently competing in the market for AMD genetic testing, but based on the consent judgment the parties agree that ArcticDx does not need to test for any of the claimed genetic creations in order to provide services. Once again, I think this is consistent with the idea that gene patents, and particularly this sort of method of genetic diagnostic testing claim, is not necessarily as preemptive of genetic testing as some would have us believe.
As another observation, all of the patents at issue in the case are University patents – Sequenom’s patents were all assigned to the University of Iowa or the University of Pittsburgh, and ArcticDx's patent was assigned to Cambridge University. This is consistent with what I have found in studying gene patents, i.e., most of the gene patents which could have an impact on genetic testing come out of universities, including some of Myriads patents.




Anonymous said...

'579 patent is invalid. Issued pre-Mayo.

Anonymous said...

You are too confident that isolated DNA doesn't affect molecular diagnostics. The fact that a majority of isolated nucleic acid claims are cDNA ones is not the point. The ones that are gene related (EGFR, BRAF, JAK2, FLT3 etc etc) cover millions of dollars of testing every year. Primers covered by isolated nucleic acids are also very problematic--PCR is still the workhorse of all these assays

Anonymous said...

The Sequenom and ArcticDx patents, if valid, are of course preemptive of genetic testing. That is why you obtain a genetic diagnostic patent. However, they are all invalid in light of Mayo v. Prometheus, you could forget Myriad.

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