What changed in this filing

/stocks — the workspaceLOADING

Item 3. Legal Proceedings

2024-02-28 compared with 2023-02-28 · 60 added, 30 removed, 55 unchanged (62% of the section changed)

Legal Proceedings.

Patent Infringement

On July 24, 2020, we filed complaints against (i) Aurobindo Pharma Limited and its affiliate Aurobindo Pharma USA, Inc.

3 unchanged sentences

and its affiliate Cadila Healthcare Limited.

These complaints, which were filed in the United States District Court for the District of Delaware, allege infringement of certain of our Orange Book-listed patents covering NUPLAZID.

These complaints, which were filed in the United States District Court for the District of Delaware, allege infringement of certain of our Orange Book-listed patents covering NUPLAZID (Pimavanserin I Cases).

The cases have been assigned to the Honorable Richard G.

On September 1, 2020, Aurobindo filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity.

On September 22, 2020, we filed our answer to Aurobindo’s counterclaims.

On August 31, 2020, Teva filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity.

On September 21, 2020, we filed our answer to Teva’s counterclaims.

On October 5, 2020, Hetero filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity.

On October 26, 2020, we filed our answer to Hetero’s counterclaims.

On September 30, 2020, MSN filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity regarding certain of our Orange Book-listed patents covering NUPLAZID.

1 unchanged sentence

On November 19, 2020, MSN filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity regarding certain of our Orange Book-listed patents covering NUPLAZID.

On December 10, 2020, we filed our answer to MSN’s counterclaims.

On November 2, 2020, Zydus filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity.

On November 23, 2020, we filed our answer to Zydus’s counterclaims.

On December 8, 2020, the parties’

joint proposed scheduling order was entered by Judge Andrews.

On November 23, 2020, we filed our answer to Zydus’s counterclaims.

On December 8, 2020, the parties’ joint proposed scheduling order was entered by Judge Andrews.

On April 7, 2021, we filed our first amended complaints against Hetero and Teva and our second amended complaint against MSN, to include an additional Orange Book-listed patent covering NUPLAZID.

4 unchanged sentences

On April 22, 2021, Aurobindo filed its answer, affirmative defenses, and counterclaims to our first amended complaint, seeking declaratory judgments of noninfringement and invalidity.

On May 11, 2021, we filed our answer to MSN’s counterclaims.

On May 12, we filed our answer to Teva’s counterclaims.

On May 13, we filed our answer to Zydus’s counterclaims and our answer to Aurobindo’s counterclaims.

A joint trial in the matters is scheduled for May 15, 2023.

On May 11, 2021, we filed our answer to MSN’s counterclaims.

On May 12, we filed our answer to Teva’s counterclaims.

On May 13, we filed our answer to Zydus’s counterclaims and its answer to Aurobindo’s counterclaims.

We entered into an agreement effective April 22, 2021 with Hetero settling all claims and counterclaims in the litigation.

The agreement allows Hetero to launch its generic pimavanserin product on July 27, 2038, subject to certain triggers for earlier launch.

The agreement allows Hetero to launch its generic pimavanserin product on February 27, 2038, subject to certain triggers for earlier launch.

The Hetero case was dismissed by joint agreement on May 3, 2021.

2 unchanged sentences

Also on September 10, 2021, the parties filed their Joint Claim Construction Chart.

On October 1, 2021, we filed our answer to Zydus’s counterclaims.

On November 30, 2021, we filed a stipulation and proposed order to dismiss two of our Orange Book-listed patents covering NUPLAZID against Teva, which was ordered by the Court on December 1, 2021.

1 unchanged sentence

On February 23, 2022, the Court heard oral argument on claim construction.

On April 6, 2022, the Court issued a Memorandum Opinion construing several terms at issue, adopting our construction on two terms, Defendants’

construction on two terms, and one agreed-upon construction.

On April 6, 2022, the Court issued a Memorandum Opinion construing several terms at issue, adopting our construction on two terms, Defendants’ construction on two terms, and one agreed-upon construction.

On February 28, 2022, we filed a stipulation and proposed order to dismiss one patent against MSN, which was ordered by the Court on March 1, 2022.

1 unchanged sentence

On March 22, 2022, we filed a stipulation and proposed order to dismiss seven patents against Aurobindo, which was ordered by the Court on March 22, 2022.

On March 30, 2022, we filed a stipulation

and proposed order to dismiss two patents against Zydus, which was ordered by the Court on March 31, 2022.

On March 30, 2022, we filed a stipulation and proposed order to dismiss two patents against Zydus, which was ordered by the Court on March 31, 2022.

On April 22, 2022, we filed a stipulation and proposed order of non-infringement against Aurobindo regarding certain of our Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on April 22, 2022.

6 unchanged sentences

On June 2, 2022, we filed our third amended complaint against Zydus alleging infringement of certain of our Orange Book-listed patents covering NUPLAZID.

On June 14, 2022, we filed our answer to Teva’s counterclaims.

June 15, 2022, Aurobindo filed its answer, affirmative defenses, and counterclaims to our second amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of our Orange Book-listed patents covering NUPLAZID.

On June 16, 2022, Zydus filed its answer, affirmative defenses, and counterclaims to our third amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of our Orange Book-listed patents covering NUPLAZID.

On July 6, 2022, we filed our answer to Aurobindo’s counterclaims.

On September 7, 2022, the consolidated cases were reassigned to the Honorable Judge Gregory B.

On September 30, 2022, we filed a stipulation and proposed order to stay the claims currently asserted against Teva and for Teva to be bound by the result of the litigation rendered against the remaining Defendants, which was ordered by the Court on October 4, 2022.

On October 21, 2021, we filed complaints against Aurobindo, MSN and Zydus in the United States District Court for the District of Delaware alleging infringement of an additional Orange Book-listed patent covering NUPLAZID.

On October 21, 2022, we filed complaints against Aurobindo, MSN and Zydus in the United States District Court for the District of Delaware alleging infringement of an additional Orange Book-listed patent covering NUPLAZID (Pimavanserin II Cases).

On March 29, 2023, following Aurobindo’s conversion of various patent certifications from Paragraph IV certifications to Paragraph III certifications in connection with the Pimavanserin I Case, we filed a stipulation and proposed order in the Pimavanserin I Case to dismiss the remaining asserted patents against Aurobindo.

This stipulation was ordered by the Court on March 30, 2023.

We entered into an agreement, effective March 31, 2023, with Zydus settling all claims and counterclaims in the Pimavanserin I Cases and Pimavanserin II Cases.

The agreement allows Zydus to launch its generic pimavanserin 10 mg products on September 23, 2036 and 34 mg products on February 27, 2038, subject to certain triggers for earlier launch.

On April 4, 2023, we filed a stipulation and proposed order to dismiss all claims and counterclaims between us and Zydus in the Pimavanserin I Cases and Pimavanserin II Cases, which was ordered by the Court on April 5, 2023.

As a result of the above, only MSN remained as an active defendant in the Pimavanserin I Cases.

On April 6, 2023, we and MSN filed a stipulation and proposed order requesting adjournment of the final pre-trial conference and trial, and requesting resolution of the remaining issue – MSN’s validity challenge of the sole patent in suit – through summary judgment briefing by the parties, which was ordered by the Court on April 10, 2023.

Briefing was completed on June 28, 2023 and oral argument took place on September 27, 2023.

On December 13, 2023, the Court ruled in our favor on the summary judgment motions – denying MSN’s motion for summary judgment of invalidity and granting our cross-motion for no invalidity.

MSN had previously stipulated to infringement of the patent-in-suit.

On January 11, 2024, the District Court entered final judgment in our favor that MSN’s submission of ANDA No.

214925 was an act of infringement in the Pimavanserin I Case.

On January 18, 2024, MSN filed a Notice of Appeal to the United States Court of Appeals for the Federal Circuit from the December 13, 2023 Memorandum Order of the United States District Court for the District of Delaware, and final judgment entered on January 11, 2024.

On February 12, 2024, we filed an Entry of Appearance for the appeal to the United States Court of Appeals for the Federal Circuit.

MSN’s Opening Appeal Brief is due on March 29, 2024.

In connection with the Pimavanserin II cases, MSN and Aurobindo are the remaining defendants.

On December 13, 2023, the Court issued a claim construction order finding in favor of us on all disputed terms of the patent-in-suit.

Fact discovery closes on March 21, 2024.

Trial is scheduled in the matter for December 3, 2024 to December 5, 2024.

Securities Class Action

On April 19, 2021, a purported stockholder of us filed a putative securities class action complaint (captioned Marechal v.

2 unchanged sentences

District Court for the Southern District of California against us and certain of our current executive officers.

The complaint generally alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 by failing to disclose that the materials submitted in support of our sNDA seeking approval of pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis contained statistical and design deficiencies and that the FDA was unlikely to approve the sNDA in our current form.

The complaint seeks unspecified monetary damages and other relief.

On September 29, 2021, the Court issued an order designating lead plaintiff and lead counsel.

On December 10, 2021, lead plaintiff filed an amended complaint.

The amended complaint generally alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, by failing to disclose that the materials submitted in support of its sNDA seeking approval of pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis contained statistical and design deficiencies and that the FDA was unlikely to approve the sNDA in its current form.

The amended complaint seeks unspecified monetary damages and other relief.

Defendants filed a motion to dismiss the amended complaint on February 15, 2022.

Lead plaintiff filed an opposition to Defendants’

motion to dismiss on April 18, 2022, and Defendants filed a reply on June 2, 2022.

On September 27, 2022, the Court issued an order denying Defendants’

motion to dismiss.

On September 27, 2022, the Court issued an order denying Defendants’ motion to dismiss.

Defendants filed their answer to the amended complaint on October 19, 2022, and filed a motion for reconsideration on October 25, 2022.

On February 2, 2023, the Court issued an order denying the motion for reconsideration.

We currently believe that none of the foregoing claims or actions pending against us as of December 31, 2022 is likely to have, individually or in the aggregate, a material adverse effect on our business, liquidity, financial position, or results of operations.

On August 21, 2023, plaintiffs filed a motion for class certification.

Briefing on that motion concluded on January 12, 2024, and the Court will hear oral argument on the motion on February 28, 2024.

The parties are currently engaged in discovery.

The cutoff for fact discovery is June 13, 2024.

Derivative Suit

On December 15, 2023, a purported stockholder of us filed a derivative action (captioned Kanner et al v.

Biggar et al.

23-cv-2293) in the U.S.

District Court for the Southern District of California against certain of our current directors.

We are named as a nominal defendant.

The complaint is based on the same alleged misconduct as the Securities Class Action, and asserts state law claims, on behalf of us, against the individual defendants for breach of fiduciary duty, unjust enrichment, abuse of control, waste of corporate assets, and insider trading.

The complaint also asserts federal claims under sections 10(b), 21D, and 14(a) of the Securities Exchange Act of 1934, as amended.

On December 27, 2023, the action was reassigned to District Judge William Q.

Hayes and Magistrate Judge Michael S.

Berg due to its relation to the Securities Class Action.

On January 30, 2024, the parties jointly requested a stay of the action.

The Court granted that request and the action was stayed on February 20, 2024, pending the outcome of our Demand Review Committee’s investigation into the underlying claims.

We currently believe that none of the foregoing claims or other actions pending against us as of December 31, 2023 is likely to have, individually or in the aggregate, a material adverse effect on our business, liquidity, financial position, or results of operations.

Given the unpredictability inherent in litigation, however, we cannot predict the outcome of these matters.

We are unable to estimate possible losses or ranges of losses that may result from these matters, and therefore we have not accrued any amounts in connection with these matters other than attorneys’

fees incurred to date.

Mine Safety Disclosures .

1 unchanged sentence

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.

What changed 10-K

Item 3. Legal Proceedings