In Natera Inc. v. NeoGenomics Laboratories, Inc. the Federal Circuit affirmed the District Court’s grant of a preliminary injunction in opposition to NeoGenomics in patent infringement litigation involving Natera’s U.S. Patent Nos. 11,519,035 and 11,530,454 directed to strategies for amplifying focused genetic materials and strategies for detecting variations in genetic materials indicative for illnesses and issues, respectively.
Claim 1 of the ‘035 is consultant and recites:
1. A technique for amplifying and sequencing DNA, comprising:
tagging remoted cell free DNA with a number of common tail adaptors to generate tagged merchandise, whereby the remoted cell-free DNA is remoted from a blood pattern collected from a topic who just isn’t a pregnant ladies;
amplifying the tagged merchandise a number of occasions to generate ultimate amplification merchandise, whereby one of many amplification steps includes focused amplification of a plurality of single nucleotide polymorphism (SNP) loci in a single response quantity, whereby one of many amplifying steps introduces a barcode and a number of sequencing tags; and
sequencing the plurality of SNP loci on the cell free DNA by conducting massively parallel sequencing on the ultimate amplification merchandise, whereby the plurality of SNP loci includes 25-2,000 loci related to most cancers.
The opinion explains that cell-free DNA (cfDNA) fragments are present in human blood and {that a} subset of those fragments are derived from tumor cells (termed ctDNA); detection of those latter species can present a strategy to detect relapse in most cancers sufferers as “molecular residual illness.” These fragments have been detected utilizing Natera’s Signatera product, and in its infringement go well with Natera accused NeoGenomics of infringing by promoting its competing RaDaR product. Both merchandise “determine ctDNA throughout the bloodstream to evaluate the efficacy of most cancers therapy and the chance of most cancers recurrence” (i.e., “they’re designed from a affected person’s genetic info primarily based on a tissue biopsy of the affected person’s tumor”).
The District Court granted Natera’s movement for preliminary injunction as a result of it held that Natera happy the four-prong take a look at, particularly 1) there being a probability of success on the deserves (infringement of at the least one asserted declare of the ‘035 patent); 2) irreparable hurt to Natera brought on by NeoGenomics’ infringement; 3) that the injunction could be within the public’s curiosity; and 4) that the stability of the hardships have been in Natera’s favor. The particulars of the injunction not solely prohibited NeoGenomics from making, utilizing, promoting or providing to promote its competing RaDaR product, but additionally from “selling, promoting, advertising and marketing, servicing, distributing, or supplying the RaDaR assay to allegedly induce infringement”; the injunction exempted sufferers already utilizing RaDaR in addition to “finalized or in-process analysis tasks, research, and medical trials.” The District Court granted NeoGenomics’ motions to allow three not-yet-initiated medical testing contracts to proceed (regardless of testing of samples not having but begun however for which third events had designed the experiments and testing protocols utilizing RaDaR), primarily based on the general public curiosity on this analysis and the destructive impact that the injunction may have on these third events. The Court additionally permitted NeoGenomics to check affected person samples it had acquired however not but examined on the time of the injunction. Finally, the District Court permitted NeoGenomics to make use of its RaDaR product in three “negotiation-stage” analysis contracts (however that had finalized protocols and approvals) as a result of implementing the injunction below these circumstances would trigger “delay and hardship.” On the opposite hand, the Court didn’t allow one other potential contract to go ahead as a result of the proof for this contract was “solely a conclusory assertion that the sponsoring group had completed vital work designing the examine.” NeoGenomics appealed.
The Federal Circuit affirmed in an opinion by Chief Judge Moore, joined by Judges Taranto and Chen, expressly assessing three of the 4 prongs of the take a look at in flip (the opinion doesn’t handle the “stability of the hardships” prong). With regard to the probability of success on the deserves for infringement of at the least one asserted declare of the ‘035 patent, the opinion units out the proof for the probability that Natera would prevail on the query of infringement, and individually the probability that NeoGenomics could be unable to ascertain invalidity. On the infringement query, NeoGenomics argued that the District Court erred by not partaking in specific declare building, however the Federal Circuit rejected this argument, noting that “[a] district court docket has no obligation to definitively construe claims on the preliminary injunction stage,” citing Sofamor Danek Grp., Inc. v. DePuy-Motech, Inc., 74 F.3d 1216, 1221 (Fed. Cir. 1996) (whereas definitely a choice directed to the preliminary injunction customary Sofamor it is usually curiously one handed down by the Court just a few months earlier than the Supreme Court rendered its determination in Markman v. Westview, which determination altered the declare building panorama significantly). Here, the events didn’t current a declare building dispute to the District Court and for its half NeoGenomics didn’t increase the problem regardless of having a number of alternatives to take action (“in its opposition transient earlier than the district court docket, on the expertise tutorial, or on the preliminary injunction listening to,” solely lastly doing so in its movement to remain the injunction). The Federal Circuit didn’t disagree with the District Court’s building nor that NeoGenomics’ RaDaR product infringed the expressly recited steps of declare 1 of the ‘035 patent. The Court additionally distinguished the info in Amgen Inc. v. Sandoz Inc., 923 F.3d 1023 (Fed. Cir. 2019), asserted by NeoGenomics as being analogous and, as in that case, non-infringing, the Court discovering no clear error within the district court docket’s dedication thereof.
On the invalidity query, the opinion rejected NeoGenomics’ argument that the District Court utilized an incorrect authorized customary relating to their obviousness contentions, and that “mere vulnerability” to invalidation is sufficient to defeat a preliminary injunction movement, citing Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1358–59 (Fed. Cir. 2001). While the Court acknowledged that an accused infringer “needn’t make out a case of precise invalidity” below Amazon the correct customary is to indicate a “substantial query” of invalidity, and “[t]he related inquiry is subsequently whether or not the patentee has proven it’s extra possible than to not prevail over an invalidity problem.” On the deserves, NeoGenomics argued that the ‘035 patent claims have been apparent over a poster introduced by Fiona Kaper and colleagues and reproduced within the 2010 PROC. OF THE 101ST ANN. MEETING OF THE AM. ASS’N FOR CANCER RES. entitled “Parallel Preparation of Targeted Resequencing Libraries From 480 Genomic Regions Using Multiplex PCR on the Access Array System,” which disclosed “a system for tagging, amplifying, and including barcodes to DNA areas of curiosity” termed the “Fluidigm Access Array.” The opinion finds no error within the District Court’s determination primarily based largely by the Court’s evaluation that NeoGenomics’ assertions have been “little greater than conclusory argument with no significant supporting documentation” set forth in [only] “4 paragraphs.” Citing KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418–19 (2007), the Federal Circuit asserted that “[i]t just isn’t ample to merely allege that the person components of the claimed invention have been every recognized within the prior artwork,” and that “NeoGenomics didn’t articulate a motive why a talented artisan would have been motivated to make use of the Fluidigm Access Array system with cfDNA for most cancers detection as claimed by the ‘035 patent.” The Court additional held that the District Court didn’t commit clear error in rejecting NeoGenomics’ allegations of ample motivation to mix the Fluidigm Access Array system with cfDNA and an inexpensive expectation of success thereof within the face of Natera’s “vital proof of obstacles to utilizing cfDNA within the current setting that may have been recognized to a talented artisan.” Nor was NeoGenomics persuasive in arguing that the District Court erred in assessing the obstacles raised by Natera primarily based on having the ability to amplify and sequence ctDNA “with precision” as a result of the ‘035 patent claims contained no such precision requirement. The Federal Circuit held that whereas “[u]nclaimed components related to the feasibility of making a helpful claimed invention can influence the motivation to mix evaluation,” citing Auris Health, Inc. v. Intuitive Surgical Operations, Inc., 32 F.4th 1154, 1159 (Fed. Cir. 2022), right here the District Court didn’t abuse its discretion in deciding in opposition to NeoGenomics on whether or not a talented employee would have anticipated the strategy to be practiced with some degree of “precision.”
Turning to the problem of irreparable hurt, the Court opined that the usual is whether or not Natera may present a “causal nexus” between infringement and the hurt alleged, citing Luminara Worldwide, LLC v. Liown Elecs. Co., 814 F.3d 1343, 1352 (Fed. Cir. 2016). Such proof can embody “head-to-head” competitors and “misplaced market share” and may come up the place the harm alleged just isn’t quantifiable (the previous bromide being “no ample treatment at regulation”). Natera’s proof of direct competitors between the events in a “two-player” market meant to the Court that “any progress skilled by NeoGenomics would subsequently end in misplaced gross sales to Natera” which was ample to fulfill the usual for irreparable hurt. The Federal Circuit rejected NeoGenomics’ argument that the District Court had misinterpreted Presidio Components, Inc. v. American Technical Ceramics Corp., 702 F.3d 1351 (Fed. Cir. 2012), to create a per se customary for competitors within the two-player market state of affairs. According to the opinion, the District Court assessed the circumstances, together with the potential for “biopharmaceutical partnerships, enterprise relationships, medical alternatives, and market share” to be misplaced by Natera due to competitors from NeoGenomics if permitted to proceed to compete (recognizing that in Presidio, as right here, the patentee was unwilling to grant a license to the accused infringer). Other components thought of by the Court have been the need for most cancers sufferers for “continuity of care” which might inhibit sufferers utilizing a distinct diagnostic take a look at as soon as NeoGenomics’ take a look at was used as a substitute of Natera’s take a look at (leading to lack of present gross sales plus lack of repeat enterprise/future gross sales). Regarding one other NeoGenomics’ argument the Federal Circuit rejected the facet of each the Signatura and RaDaR checks as being tumor-informed testing, which was not a claimed limitation of the ‘035 patent, primarily based in Natera’s proof that the strategy claimed within the ‘035 patent was “essential to overcoming challenges related to efficiently amplifying and sequencing cfDNA within the claimed ctDNA context” and “could be unimaginable to realize with out practising the actual strategies claimed within the ‘035 patent.” Finally the Court rejected NeoGenomics’ argument that Natera delaying in bringing go well with, primarily based on its involvement with different infringement circumstances and Natera having introduced go well with inside days (Medicare protection) of NeoGenomics acquiring regulatory approval and or months of NeoGenomics attaining business availability.
Regarding the general public curiosity, the Court famous that the District Court thought of proof that Natera’s Signatura and NeoGenomics’ RaDaR merchandise have been authorized to be used with sufferers having the identical most cancers diagnoses and that Natera had business capability to fulfill any elevated demand brought on by imposition of the injunction. The Federal Circuit famous that the District Court had carved out gross sales to current sufferers or these concerned in “ongoing medical trials or analysis tasks.” The Federal Circuit additionally rejected NeoGenomics’ claims that the general public was harmed as a result of their RaDaR product was superior to Natera’s Signatura product within the face of controverting proof from Natura. Nor was the Court satisfied by testimony of NeoGenomics’ skilled that their product was superior for sure particular cancers, discovering that “the [expert’s] letter gives no scientific foundation for its broad and conclusory assertions” nor does it “level to any proof that RaDaR is efficient for extra sorts of cancers than Signatera” (whereas quite the opposite Natera offered proof that its product was authorized for all of the most cancers indications that the RaDaR product was authorized for). And whereas NeoGenomics offered testimony from a “key opinion chief” in addition to market stories and different proof of its RaDaR product being superior to Natera’s Signatura product, none of this proof was ample to persuade the panel that the District Court had erred relating to the general public curiosity prong of the preliminary injunction customary.
Finally, the opinion doesn’t set forth its overview of the District Court’s consideration of the stability of the hardships (or equities, as termed within the opinion) being in Natera’s favor, merely stating that “[w]e have thought of NeoGenomics’ remaining arguments and discover them unpersuasive.”
Natera, Inc. v. NeoGenomics Laboratories, Inc. (Fed. Cir. 2024)
Panel: Chief Judge Moore and Circuit Judges Taranto and Chen
Opinion by Chief Judge Moore
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