Acadia Pharmaceuticals wins Delaware ruling on NUPLAZID formulation patent

A federal court in Delaware ruled for Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) in a patent case over NUPLAZID (pimavanserin), the company's drug for Parkinson's Disease Psychosis. In a Form 8-K filed May 20, 2025, Acadia said the U.S. District Court for the District of Delaware ruled in its favor on both infringement and validity of the '721 formulation patent. The defendants are Aurobindo Pharma Limited, its affiliate Aurobindo Pharma USA, Inc., MSN Laboratories Private Ltd. and its affiliate MSN Pharmaceuticals, Inc. Acadia is the plaintiff.

What the court decided

Acadia says it announced the ruling on May 16, 2025. The case is called the Pimavanserin II Cases. The 8-K describes the outcome in one sentence: the court ruled for Acadia on infringement and on validity. Infringement asks whether the accused products use the patented formulation. Validity asks whether the patent holds up against a challenge. The 8-K does not describe the court's reasoning, and it does not say whether the defendants will appeal.

The 10-K filed February 27, 2025 gives the case history. The Pimavanserin II cases were filed as additional complaints alleging infringement of another Orange Book-listed patent covering NUPLAZID. MSN and Aurobindo were the remaining defendants after Acadia settled with Zydus. A bench trial ran from December 3 to December 6, 2024, and post-trial briefing was completed on February 12, 2025.

The generic entry dates already set

The 10-K shows that Acadia has already agreed to generic entry dates in other cases. Its agreement with Zydus, effective March 31, 2023, allows Zydus to launch generic pimavanserin 10 mg tablets on September 23, 2036 and 34 mg capsules on February 27, 2038, subject to certain triggers for earlier launch. An agreement with Hetero, effective April 22, 2021, allows Hetero to launch its generic pimavanserin product on February 27, 2038, subject to similar triggers.

A separate appeal is still pending. On January 18, 2024, MSN filed a Notice of Appeal to the United States Court of Appeals for the Federal Circuit from a January 11, 2024 final judgment in the Pimavanserin I Case, which concerned the '740 patent. The 10-K says that appeal is fully briefed and awaiting a date for oral argument. So a win in one case does not close the other.

The franchise behind the patent

The 10-K says net product sales from the company's two commercial products, NUPLAZID and DAYBUE, totaled $957.8 million for 2024, compared with $726.4 million for 2023. DAYBUE is the first and only drug approved for Rett syndrome. The combined figure does not isolate NUPLAZID revenue, so the ruling's effect on sales cannot be read from it alone.

The 10-K also describes a separate securities class action filed April 19, 2021 against Acadia and certain current executive officers in the U.S. District Court for the Southern District of California (City of Birmingham Relief Retirement Systems v. Acadia Pharmaceuticals Inc., Case No. 21-cv-0762). The amended complaint alleges, and the allegations are unproven, that the defendants violated Sections 10(b) and 20(a) of the Exchange Act by failing to disclose statistical and design deficiencies in the sNDA for pimavanserin in dementia-related psychosis. The court granted class certification on March 11, 2024.

A new lease in Princeton

The 8-K also reports two real estate agreements dated May 15, 2025. Acadia entered into a Lease and Lease Agreement, the 210 Lease, with 210 Associates Limited Partnership for about 52,771 rentable square feet of office space at 210 Carnegie Center Drive, Princeton, New Jersey. The term is 12 years and two months. Acadia will pay $1,899,756 upon the rent commencement date during the first year, and base rent is abated for the first two months.

The landlord's maximum contribution toward Acadia's improvements is $5,277,100. Acadia may ask for a supplemental contribution of $2,638,550, which it would repay monthly as additional rent over the initial term, plus 8.00% interest. Under Amendment No. 1 to its lease with Boston Properties Limited Partnership, the current 502 Lease ends five days after the 210 Lease begins.

Signatory

Jennifer J. Rhodes, Executive Vice President, Chief Legal Officer and Secretary, signed the 8-K for Acadia.

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