U.S. Court of Appeals for the Federal Circuit Affirms Prior Delaware District Court Rulings in Favor of Acadia in NUPLAZID® (pimavanserin) Composition of Matter Patent

- Composition of matter patent affirmed, provides protection into 2030

- Builds on recent ruling in favor of Acadia for formulation patent expiring in 2038

SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Court of Appeals for the Federal Circuit affirmed a decision issued by the U.S. District Court for the District of Delaware in December 2023 confirming validity of the NUPLAZID^® (pimavanserin) '740 composition of matter patent. The affirmance came in Acadia’s litigation against MSN Laboratories Pvt. Ltd. and MSN Pharmaceuticals, Inc.

In its affirmance, the Appeals Court applied the precedent established in Allergan USA, Inc. v. MSN Laboratories Private Ltd., MSN Pharmaceuticals, Inc., Sun Pharmaceutical Industries Limited, holding that “a first filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date.”

“We are gratified that the U.S. Federal Appeals Court has affirmed the lower court’s ruling in favor of our composition of matter patent for NUPLAZID, securing protection into 2030 for this patent, and beyond based on the recent favorable ruling for our formulation patent providing patent protection for NUPLAZID 34 mg capsule formulation into 2038,” said Catherine Owen Adams, Chief Executive Officer. “These decisions reinforce our commitment to safeguarding the intellectual property that underpins our innovations in addressing serious, unmet medical needs.”

This follows the U.S. District Court for the District of Delaware ruling in favor of Acadia regarding its ‘721 formulation patent for NUPLAZID which ruled in favor of Acadia on both infringement and validity arguments in its formulation patent litigation against Aurobindo Pharma Limited and other ANDA (Abbreviated New Drug Application) filers.

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis and multiple other programs targeting neuroscience and neuro-rare diseases. For more information, visit us at Acadia.com and follow us on LinkedIn and X.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential,” “continue” and similar expressions (including the negative thereof) intended to identify forward-looking statements. Forward-looking statements contained in this press release, include, but are not limited to, statements about: (i) the impact of the court ruling on our business and our ability to defend ourselves in the future; (ii) the continued patent protection for NUPLAZID; and (iii) the anticipated timing for termination of such protections. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Such risks, uncertainties and other factors include, but are not limited to: our ability to maintain, protect and enhance our intellectual property; the outcome of other existing and potential future lawsuits challenging our intellectual property; and our ability to continue to stay in compliance with applicable laws and regulations. Given the risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties and other factors that may cause our actual results, performance or achievements to differ, please refer to our annual report on Form 10-Q for the quarter ended March 31, 2025 as well as our subsequent filings with the Securities and Exchange Commission from time to time. The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update them after this date, except as required by law.