What changed in this filing

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Item 3. Legal Proceedings

2023-02-28 compared with 2022-03-01 · 33 added, 59 removed, 52 unchanged (64% of the section changed)

Legal Proceedings.

Between July 19 and August 3, 2018, following negative publicity about NUPLAZID, three purported stockholders of ours filed putative securities class action complaints (captioned Staublein v.

Acadia Pharmaceuticals, Inc., Case No.

18-cv-01647, Stone v.

Acadia Pharmaceuticals Inc., Case No.

18-cv-01672, and Barglow v.

Acadia Pharmaceuticals Inc., Case No.

18-cv-01812) in the U.S.

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

Thereafter, several putative lead plaintiffs filed motions to consolidate the cases and to appoint a lead plaintiff.

On January 3, 2019, the Court consolidated the cases under the caption In re Acadia Pharmaceuticals Inc.

Securities Litigation, Case No.

18-cv-01647, and took the lead plaintiff motions under submission.

On February 26, 2019, the Court appointed a lead plaintiff and lead counsel.

Lead plaintiff filed a consolidated complaint on April 15, 2019.

The consolidated complaint generally alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 by making materially false and misleading statements regarding our business, operations, and prospects by failing to disclose that adverse events and safety concerns regarding NUPLAZID threatened initial and continuing FDA approval, and by failing to disclose that we engaged in business practices likely to attract regulatory scrutiny.

The consolidated complaint seeks unspecified monetary damages and other relief.

Defendants filed a motion to dismiss the consolidated complaint on June 7, 2019.

On June 1, 2020, the Court granted the motion in part and gave lead plaintiff leave to file an amended complaint.

On July 16, 2020, lead plaintiff filed the amended complaint.

Defendants filed a motion to dismiss the amended complaint on August 28, 2020.

Lead plaintiff opposed the motion on September 15, 2020.

Defendants’

reply in support of the motion to dismiss was filed on November 11, 2020.

On March 29, 2021, the Court granted the defendants’

motion to dismiss with leave to amend.

On April 16, 2021, lead plaintiff filed a third amended complaint.

Defendants filed a motion to dismiss the third amended complaint on May 31, 2021.

The lead plaintiff opposed the motion on July 12, 2021 and Defendants filed their reply in support of their motion on August 11, 2021.

On January 3, 2022, the Court issued an order and judgment dismissing lead plaintiff’s third amended complaint without leave to amend and closing the case.

The deadline to appeal the order and judgment expired on February 2, 2022.

On February 7, 2020, a purported stockholder of ours filed a derivative complaint (captioned Barney v.

Davis et al., Case No.

20-cv-0238) in the U.S.

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

The complaint asserts claims for breach of fiduciary duty, waste of corporate assets, and unjust enrichment arising from allegations similar to those in the federal securities class action described above.

On September 9, 2020, the Court substituted plaintiffs and re-captioned the case Shumacher v.

Davis et al., Case No.

On June 23, 2020, a second derivative complaint (captioned Lazarus v.

Davis et al., Case No.

20-cv-0843) was filed in the U.S.

District Court for the District of Delaware.

On September 9, 2020, the Court transferred the Lazarus case to the U.S.

District Court for the Southern District of California and re-captioned the case Lazarus v.

Davis et al., Case No.

On January 15, 2021, the Court consolidated the cases under the name In re ACADIA Pharmaceuticals Inc.

Stockholder Derivative Litigation, Case No.

20-cv-0238, appointed lead counsel for the plaintiffs, and designated the complaint in the Shumacher case as the operative complaint.

The consolidated case is stayed until the defendants in the federal securities class action answer, or the federal securities class action is dismissed with prejudice and all appeals are exhausted, or any party to the stipulation to stay gives 15 days’

written notice that it no longer consents to the voluntary stay.

As discussed above, the federal securities class action was dismissed with prejudice on January 3, 2022, and the deadline to appeal that dismissal expired on February 2, 2022

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

10 unchanged sentences

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 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.

8 unchanged sentences

On April 8, 2021, we filed our first amended complaint against Zydus and on April 9, 2021, we filed our first amended complaint against Aurobindo.

On April 20, 2021, MSN filed its answer, affirmative defenses, and counterclaims to our second amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of the our Orange Book-listed patents covering NUPLAZID.

On April 21, 2021, Teva filed its answer, affirmative defenses, and counterclaims to our first amended complaint, seeking declaratory judgments of noninfringement and invalidity.

14 unchanged sentences

On January 28, 2022, the parties filed their Joint Claim Construction Brief and Appendix.

On January 31, 2022, a joint motion for claim construction was ordered by the Court, setting a claim construction hearing on February 23, 2022.

A ruling is expected in the near future.

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

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 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.

On March 10, 2022, we filed a stipulation and proposed order to dismiss one patent against Teva, which was ordered by the Court on March 10, 2022.

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 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.

On April 26, 2022, we filed a stipulation and proposed order of non-infringement against MSN regarding certain of our Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on April 26, 2022.

On April 26, 2022, we filed a stipulation and proposed order of non-infringement against Teva regarding certain of our Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on April 27, 2022.

On May 10, 2022, we filed our second amended complaint against Teva to include an additional Orange Book-listed patent covering NUPLAZID.

On May 18, 2022, we filed a stipulation and proposed order of non-infringement against Zydus regarding certain of our Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on May 19, 2022.

On May 24, 2022, Teva 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 1, 2022, we filed our second amended complaint against Aurobindo alleging infringement of certain of our Orange Book-listed patents covering NUPLAZID.

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

Acadia Pharmaceuticals, Inc., Case No.

1 unchanged sentence

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 making materially false and misleading statements regarding our business, operations, and prospects 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 its current form.

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 June 21, 2021, five motions for lead plaintiff and lead counsel were filed.

Thereafter, four of the five movants either withdrew their motions or filed statements of non-opposition.

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

1 unchanged sentence

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.

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

On February 3, 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.

5 unchanged sentences

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