A bid by Natera Inc. to short-circuit inter partes review of its oncologic testing patent should be denied, petitioner NeoGenomics Laboratories told the US Patent Trial and Appeal Board yesterday, because Natera’s enforcement efforts could jeopardize the health of cancer patients.
NeoGenomics Laboratories is urging the US Patent and Trademark Office to turn down a request for a discretionary denial of its petition for inter partes review of a patented method for tracking the progression of certain head and neck cancers.The opposition brief filed yesterday (see here) accuses Natera Inc. of attempting to put its patented technology “out of the public’s reach” via US Patent No. 11,319,596, as applied to NeoGenomics’ “RaDaR 1.1” assay.
To that end, NeoGenomics notes Natera previously sought and won a preliminary injunction in the parties’ parallel district court litigation over its “RaDaR 1.0,” on the basis it likely infringes US Patent No. 11,519,035.
The relief was affirmed by the US Court of Appeals for the Federal Circuit last summer.
Review by the Patent Trial and Appeal Board “is thus important to ensure that the public has access to Petitioner’s new assay,” which is currently being studied for clinical equivalency, NeoGenomics maintains.
Titled “Detecting Mutations and Ploidy in Chromosomal Segments,” the ‘596 patent covers a method of preparing biological samples whereby a tumor biopsy sample is sequenced for single nucleotide variant, or SNV, mutations.
Those results can then be used to determine molecular markers which span the SNVs, and cell-free DNA obtained from a patient over time is tested for the same markers through the use of targeted multiplex polymerase chain reaction amplification and high throughput sequencing.
In seeking IPR in January, just five weeks after the ‘596 patent was added to the district court case, NeoGenomics said Natera was only able to secure protection by persuading a patent examiner that an SNV mutation “present in less than or equal to 0.015% of the cell-free DNA having the SNV locus is detected from the sequence read” is novel.
But printed publications like “Evaluation of DNA from the Papanicolaou Test to Detect Ovarian and Endometrial Cancers” (Kinde 2013) and “Detection of Circulating Tumor DNA in Early and Late-Stage Human Malignancies” (Bettegowda) both “disclose error corrected sequencing methods that detect rare ‘somatic mutations’ at detection levels below the 0.015% limitation and are compatible with multiplex amplification,” according to the petitioner.
There has been no shortage of arguments both for and against discretionary denials since the USPTO updated its guidance on the matter earlier this year.
Most notably, discretionary denials are no longer addressed in petitions for IPR and preliminary patent owner responses; instead, parties in an IPR brief the question separately, and directly, to USPTO Acting Director Coke Morgan Stewart.
Natera lodged its request on April 14.
In the filing, the patent owner notes a jury trial before US District Judge Catherine M. Eagles of the Middle District of North Carolina will take place 10 months before any final written decision by the PTAB, rendering IPR “unnecessary, burdensome, and [a] wasteful duplication of effort.”
Natera says neither party has moved for a stay of the litigation, and Eagles has given no indication she would be inclined to grant such a request, if one is made.
What’s more, NeoGenomics allegedly relies on four of the same five prior art references it raises in North Carolina, and a “Sotera stipulation” by the patent challenger — so-named for Sotera Wireless v. Masimo — doesn’t foreclose the possibility of “substantially overlapping invalidity arguments” being made in both venues.
Each of the aforementioned factors support a discretionary denial under Apple v. Fintiv, Natera asserts.
NeoGenomics countered yesterday, however, that the petition presents “particularly strong” merits — reiterating its position that the recitation of a 0.015% or less SNV was taught by prior art not considered by an examiner, that the same limitation is replicable in the context of multiplex amplification and that Natera has advanced inconsistent interpretations of the ‘596 patent claims before the district court.
But there are other reasons to allow the IPR to move forward, according to NeoGenomics, including that Natera’s allegedly invalid technology stands in the way of RaDaR 1.1 being made available to the public.
That RaDaR 1.0 was enjoined is of no consequence because the relief relates to the ‘035 patent, which NeoGenomics says “claims an earlier priority date and has a different claim scope.” Moreover, NeoGenomics continues, “RaDaR 1.0’s approval for head and neck cancers also was not before the District Court at the time of the preliminary injunction, and there is no indication that the Federal Circuit considered this evidence.”
Lastly, the petitioner asserts that because the USPTO’s new discretionary denial procedure was enacted without notice-and-comment rulemaking, it runs afoul of the Administrative Procedure Act.
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