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In management’s opinion, based upon the advice of counsel, the outcomes of such actions are not expected, individually or in the aggregate, to have a material adverse effect on the Company's future financial position or results of operations.
−Removed: Spectrum Patent Litigation
−Removed: In March 2021, the Company filed a complaint against Spectrum Solutions, LLC (“Spectrum”) in the United States District Court for the Southern District of California alleging that certain saliva collection devices manufactured and sold by Spectrum infringe a patent held by DNAG.
−Removed: Spectrum filed an answer asserting that its device does not infringe the Company’s patent and that the Company’s patent is invalid.
−Removed: In August 2021, the Company amended its complaint to add a second patent to this litigation.
−Removed: Spectrum responded to the Company’s amended complaint and asserted counterclaims for inequitable conduct and antitrust violations with respect to one of the patents in the litigation and subsequently filed a request for review of the second patent at the Patent and Trademark Office (“PTO”), which was granted by the PTO.
−Removed: The District Court issued multiple pretrial orders, resolving the infringement, antitrust, and inequitable conduct claims without trial.
−Removed: First, the District Court granted Spectrum’s motion for summary judgment of noninfringement.
−Removed: Second, the Court denied Spectrum’s motion to supplement its allegations of alleged antitrust violations, finding that if such an amendment were allowed, Spectrum’s claims would not survive a motion for summary judgment.
−Removed: Spectrum thereafter withdrew its antitrust and inequitable conduct counterclaims.
−Removed: Spectrum did not appeal the District Court’s denial of its motion to amend.
−Removed: The Company appealed the grant of summary judgment to the Court of Appeals on June 8, 2023.
−Removed: On February 14, 2025, the Court of Appeals affirmed the District Court’s judgment.
−Removed: The Court of Appeals mandate issued on March 24, 2025.
−Removed: On February 7, 2024, the PTO issued a Final Written Decision regarding the second patent in the litigation, holding that claims 1, 3–8, 11, and 12 of U.S.
−Removed: 11,002,646 B2 are unpatentable.
−Removed: On March 8, 2024, the Company filed a Request for Rehearing by the Director of the PTO of the Final Written Decision.
−Removed: On March 27, 2024, the Company’s Request for Rehearing was denied.
−Removed: On September 15, 2023, Spectrum filed a separate petition for inter partes review of a third patent, which DNAG did not assert in the District Court.
−Removed: On March 26, 2024, the PTO issued a Decision Granting Institution of Inter Partes Review.
−Removed: On July 2, 2024, the Company filed a Motion to Amend the claims of the third patent and oral argument in this IPR took place on January 24, 2025.
−Removed: On February 19, 2025, the PTO issued a Final Written Decision regarding the third patent in the litigation, granting the Company’s Motion to Amend as to cancelling the original claims, but denying the Company’s Motion to Amend as to adding proposed substitute claims.
NowDiagnostics Litigation
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.