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Item 3. Legal Proceedings

2023-02-16 compared with 2022-02-18 · 56 added, 5 removed, 16 unchanged (79% of the section changed)

Legal Proceedings.

We are regularly subject to claims, lawsuits, arbitration proceedings, administrative actions and other legal and regulatory proceedings involving commercial disputes, competition, intellectual property disputes and other matters, and we may become subject to additional types of claims, lawsuits, arbitration proceedings, administrative actions, government investigations and legal and regulatory proceedings in the future and as our business grows, including proceedings related to product liability or our acquisitions, securities issuances or our business practices, including public disclosures about our business.

We are regularly subject to lawsuits, claims, arbitration proceedings, administrative actions and other legal and regulatory proceedings involving intellectual property disputes, commercial disputes, competition and other matters, and we may become subject to additional types of lawsuits, claims, arbitration proceedings, administrative actions, government investigations and legal and regulatory proceedings in the future and as our business grows, including proceedings related to product liability or our acquisitions, securities issuances or our business practices, including public disclosures about our business.

Our success depends in part on our non-infringement of the patents or proprietary rights of third parties.

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District Court for the District of Delaware alleging that Nanostring's GeoMx Digital Spatial Profiler and associated instruments and reagents infringe U.S.

10,472,669, 10,662,467, 10,961,566, 10,983,113, and 10,996,219.

10,472,669, 10,662,467, 10,961,566, 10,983,113 and 10,996,219 (the "GeoMx Action").

On May 19, 2021, we filed an amended complaint additionally alleging that the GeoMx products infringe U.S.

11,001,878 and 11,008,607.

On July 1, 2021, Nanostring filed a motion to dismiss.

On November 17, 2021, the Court held a hearing and dismissed without prejudice our claims for pre-suit indirect infringement and willful infringement.

On May 4, 2022, we filed an amended complaint in the GeoMx Action additionally alleging that the GeoMx products infringe U.S.

11,293,917 and withdrawing our claim of infringement of U.S.

Nanostring filed its answer to the GeoMx Action on May 18, 2022.

Discovery is in progress.

A Markman hearing is scheduled for October 2022 and trial is scheduled for June 2023.

A Markman hearing is scheduled for February 2023 and trial is scheduled for November 2023.

On February 28, 2022, we filed a second suit against Nanostring in the U.S.

District Court for the District of Delaware alleging that Nanostring's CosMx Spatial Molecular Imager and associated instruments, reagents and services infringe U.S.

10,227,639 and 11,021,737 (the "CosMx Action").

On May 12, 2022, we filed an amended complaint in the CosMx Action additionally alleging that the CosMx products infringe U.S.

11,293,051, 11,293,052 and 11,293,054.

Nanostring filed

its answer to the CosMx Action on May 26, 2022.

Discovery is in progress.

A Markman hearing is scheduled for July 2023 and trial is scheduled for June 2024.

On August 16, 2022, Nanostring filed a counterclaim in the CosMx Action alleging that our Visium products infringe U.S.

We filed our answer to Nanostring's counterclaim in the CosMx Action on August 30, 2022.

On November 23, 2022, we moved to sever claims relating to NanoString’s assertion of U.S.

11,377,689 and consolidate those claims with the patent case NanoString filed against us on October 20, 2022 (discussed below).

On January 24, 2023, the Court granted our motion.

On October 20, 2022, Nanostring filed suit against us in the U.S.

District Court for the District of Delaware alleging that our Visium products infringe U.S.

11,473,142, a continuation of U.S.

11,377,689 (the "Nanostring Action").

On January 24, 2023, the Court severed Nanostring’s claims with respect to U.S.

11,377,689 from the CosMx Action and consolidated those claims with this action.

Discovery is in progress;

no case schedule has been set.

We believe Nanostring's claim in the Nanostring Action is meritless and we intend to vigorously defend ourselves.

On March 9, 2022, we filed suit in the Munich Regional Court in Germany alleging that Nanostring's CosMx Spatial Molecular Imager and associated instruments, reagents and services infringe EP Patent No.

2794928B1 (the "928 Patent") (the "Germany CosMx Action").

Nanostring filed its statement of defense to the Germany CosMx Action on August 26, 2022.

A hearing on infringement is scheduled for March 2023 and a decision is expected around May 2023.

On July 29, 2022, Nanostring filed a nullity action with the German Federal Patent Court challenging the validity of the 928 Patent.

On February 10, 2023, the Federal Patent Court issued a preliminary opinion upholding the validity of certain claims of the 928 Patent directed to in situ analysis.

A hearing on validity is scheduled before the Federal Patent Court in May 2024 and a decision is expected around the end of 2024.

In May 2022, we filed suit against Vizgen, Inc.

("Vizgen") in the U.S.

District Court for the District of Delaware alleging that Vizgen’s MERSCOPE Platform and workflow and Vizgen’s Lab Services program, including associated instruments and reagents, infringe U.S.

11,021,737, 11,293,051, 11,293,052, 11,293,054 and 11,299,767.

On July 25, 2022, Vizgen filed a motion to dismiss our claims for willful and indirect infringement, which the Court denied on September 19, 2022.

Discovery is in progress.

A Markman hearing is scheduled for July 2023 and trial is scheduled for July 2024.

On August 30, 2022, Vizgen filed its answer and counterclaims alleging that our Xenium product infringes U.S.

Vizgen also filed counterclaims alleging that we tortiously interfered with Vizgen's contractual and business relationship with Harvard and that we engaged in unfair practices under Massachusetts state law.

On October 27, 2022, we filed a partial answer and motion to dismiss the infringement counterclaim and the tort counterclaims.

On February 2, 2023, our motion to dismiss was denied.

We believe Vizgen’s claims are meritless and intend to vigorously defend ourselves.

On August 24, 2022, we filed suit against Parse Biosciences, Inc.

("Parse") in the U.S.

District Court for the District of Delaware alleging that Parse’s Evercode Whole Transcriptomics and ATAC-seq products infringe U.S.

10,155,981, 10,697,013, 10,240,197, 10,150,995, 10,619,207, and 10,738,357.

On October 17, 2022, Parse filed a motion to dismiss alleging that the asserted claims are directed to patent ineligible subject matter.

The Court held a hearing on the motion to dismiss on November 22, 2022, and supplemental briefing was submitted on December 15, 2022.

A ruling on the motion to dismiss is expected around March 2023.

Discovery has not yet commenced and no case schedule has been set.

For further discussion of the risks relating to intellectual property and our pending litigation, see the section titled “ Risk Factors—Risks related to litigation and our intellectual property ” under Item 1A.

2 unchanged sentences

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What changed 10-K

Item 3. Legal Proceedings