7,297,485 B2 11/2007 Bomar et al.
6,270,970 Bl 8/2001 Smith et al. …proceeding on U.S. Patent Nos. 10,619,187 (the
’187 patent) and 11,002,646 (the ’646 patent) owned by DNA …/2023
patent about an embodiment in the ancestral patent application to the ’187 patent. In
that …infringes U.S. Patent Nos. 10,619,187 (“the ’187 Patent”)
23
and 11,002,646 (“the ’646 Patent”) (collectively… by assignment of the ’187 Patent and the ’646 Patent.
10 See U.S. Patent No. 10,619,187, at [73] (issued
Litigation summary and analysis for: DNA Genotek Inc. v. Spectrum Solutions LLC (Fed. Cir. 2023)
The patent dispute between DNA Genotek Inc. (Genotek) and Spectrum Solutions LLC (Spectrum) centered on allegations of infringement related to Spectrum's saliva collection devices. Below is a detailed summary and analysis of the litigation, including key rulings and implications.
Case Overview
Genotek accused Spectrum of infringing U.S. Patent Nos. 10,619,187 ('187 Patent) and 11,002,646 ('646 Patent), which cover devices for preserving nucleic acids in biological samples[1][12]. Spectrum’s SDNA-1000, SDNA-2000, and SDNA-3000 products—critical for COVID-19 testing under FDA Emergency Use Authorization—were at issue[3][8]. Spectrum denied infringement and counterclaimed for fraud and antitrust violations[3][8].
Key Procedural Developments
Summary Judgment (May 2023):
The U.S. District Court for the Southern District of California granted Spectrum’s motion for summary judgment of non-infringement, resolving all claims against Spectrum[1][8].
The court’s decision hinged on claim construction, particularly the interpretation of the term “reagent compartment” in the '187 Patent[1][12].
Federal Circuit Affirmance (February 2025):
The Federal Circuit upheld the district court’s ruling, affirming that the “reagent compartment” required placement within the “containment vessel” (e.g., the sample container), excluding Spectrum’s device, which stored reagents in the lid[9][10].
Genotek’s prior statements in an unrelated IPR proceeding—where it distinguished its patent from prior art with lid-based reagents—were cited as “highly persuasive” evidence of claim scope disavowal[5][9][12].
Remaining Claims:
Spectrum’s counterclaims for antitrust violations and fraudulent procurement of the '187 Patent remain pending, seeking treble damages and fees[3][9][12].
Critical Legal Analysis
Claim Construction & Prosecution History
The court construed “reagent compartment” as a “region or section of the containment vessel”, rejecting Genotek’s broader interpretation[9][12]. This construction aligned with:
Prosecution history: Genotek had deleted an embodiment showing a reagent in the device cap, signaling intent to limit claims to the containment vessel[9][12].
IPR statements: In prior proceedings, Genotek emphasized that its invention’s reagent was “below a plastic cover in a container”, contrasting with lid-based designs[5][9].
Impact of IPR Proceedings
Statements from IPRs challenging unrelated patents were deemed relevant. For example, Genotek’s counsel described the patented technology as “very different” from devices with reagents in lids, undermining their infringement arguments[5][12].
Broader Implications
Strategic Use of IPRs: Parties’ arguments in unrelated IPRs can influence claim construction in district court litigation.
Business Impact: Spectrum’s legal victory removes barriers to its SDNA product line, which became pivotal during the pandemic[3][8]. Genotek faces ongoing litigation risks from Spectrum’s antitrust claims.
Current Status
The Federal Circuit’s affirmance finalized the non-infringement ruling[9][10]. Spectrum continues pursuing claims alleging Genotek engaged in anticompetitive behavior by asserting a fraudulently obtained patent[3][8].
“Spectrum will continue to vigorously pursue its fraud and antitrust claims against DNA Genotek to seek treble damages and fees.”
—Stephen Fanning, Spectrum CEO[3][8]
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.
