Mizuho: Acadia's Nuplazid Exclusivity Extended to 2030

Acadia Pharmaceuticals' Federal Court of Appeals ruling in favor of the company upholds the validity of its '740 composition of matter patent, supporting the conclusion that Nuplazid will maintain exclusivity until April 29, 2030. However, Mizuho notes that the stock price has already accounted for this outcome.

Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) has secured a significant legal victory with the U.S. Court of Appeals for the Federal Circuit affirming the validity of its '740 composition of matter patent for NUPLAZID® (pimavanserin). This decision upholds the exclusivity of the patent until April 29, 2030 [1].

The ruling came as part of Acadia's ongoing litigation against MSN Laboratories Pvt. Ltd. and MSN Pharmaceuticals, Inc. The Federal Court of Appeals applied the precedent set in the Allergan USA, Inc. v. MSN Laboratories Private Ltd. case, which held that a first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim with a common priority date [2].

This affirmation follows a previous favorable ruling by the U.S. District Court for the District of Delaware in December 2023, which confirmed the validity of Acadia's '721 formulation patent for NUPLAZID. The court ruled in favor of Acadia on both infringement and validity arguments in its formulation patent litigation against Aurobindo Pharma Limited and other ANDA filers [3].

The legal victory is expected to bolster Acadia's intellectual property portfolio and support its ongoing clinical-stage development efforts focused on various neuroscience and neuro-rare diseases. The company's CEO, Catherine Owen Adams, expressed gratitude for the court's decision, highlighting its commitment to safeguarding intellectual property that underpins its innovations [1].

While the stock price has already accounted for this outcome, the ruling provides additional reassurance for investors about the company's ability to defend its intellectual property and maintain exclusivity for its key products [4].

References:
[1] https://finance.yahoo.com/news/u-court-appeals-federal-circuit-200100101.html
[2] https://www.tipranks.com/news/the-fly/acadia-pharmaceuticals-says-appeals-court-confirms-validity-of-nuplazid-patent-thefly
[3] https://www.lifesciencesipreview.com/americas/fed-circ-affirms-rulings-in-acadias-fight-against-parkinsons-drug-copies
[4] https://www.gurufocus.com/news/2916809/federal-court-upholds-acadia-pharmaceuticals-acad-patent-victory-acad-stock-news