Acadia Pharmaceuticals Clinches Patent Victory for NUPLAZID Composition

Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) secured a critical legal win on Tuesday after the U.S. Court of Appeals for the Federal Circuit upheld the validity of the company’s composition of matter patent for its flagship drug, NUPLAZID (pimavanserin). The decision preserves Acadia’s exclusive rights under the ’740 patent and delivers a setback to challengers MSN Laboratories Private Ltd. and MSN Pharmaceuticals, Inc.

The court’s affirmation confirms a lower court ruling that had sided with Acadia in its patent dispute, cementing the biotech firm’s control over the proprietary formulation of NUPLAZID, a therapy approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

“This ruling reinforces the strength of our intellectual property portfolio and our commitment to defending the innovation behind NUPLAZID,” said Steve Davis, CEO of Acadia Pharmaceuticals, in a statement following the announcement. “We are pleased that the court has once again validated our patent, enabling us to continue focusing on delivering therapies to patients with unmet medical needs.”

The legal battle stemmed from efforts by MSN Laboratories and its U.S. affiliate to invalidate Acadia’s ’740 patent, which they argued was not novel or sufficiently inventive. The appellate court rejected these arguments, siding with the company and affirming the patent’s enforceability until its expiration.

The timing of the ruling coincides with Acadia’s robust financial performance. Over the last twelve months, the company has reported revenues nearing $1 billion, with a notable 60% gross margin—a figure that highlights operational efficiency and pricing power in the specialty pharmaceutical market. According to InvestingPro, Acadia currently boasts a “GREAT” financial health score, with more than ten positive metrics contributing to its investment outlook.

Legal experts suggest this ruling will deter potential generic competition in the near term, securing continued market exclusivity for Acadia and potentially preserving its revenue stream from NUPLAZID. The drug remains the first and only FDA-approved treatment for Parkinson’s disease psychosis, positioning it as a valuable asset in Acadia’s expanding neuroscience pipeline.

With the legal hurdle now cleared, analysts anticipate that Acadia will intensify its strategic investments in late-stage clinical programs and explore additional therapeutic indications for pimavanserin.

The decision not only strengthens Acadia’s intellectual property rights but also underscores the importance of robust patent protection in the competitive pharmaceutical sector, where market exclusivity often dictates the pace of innovation and return on investment.

About Acadia Pharmaceuticals:
Founded in 1993 and headquartered in San Diego, California, Acadia Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address central nervous system disorders. Its lead product, NUPLAZID, is approved in the U.S. and continues to be studied for multiple neuropsychiatric indications.

Landmark Delhi High Court Ruling Prioritizes Access to Life-Saving Drugs Over Patent Protection

In a powerful judgment that resonates with the ongoing global debate on healthcare access versus intellectual property rights, Justice Mini Pushkarna of the Delhi High Court has delivered a standout ruling that places public health and patient affordability at the heart of India’s patent law jurisprudence.

On March 24, 2025, the Court dismissed a patent infringement suit filed by Swiss pharmaceutical giant Hoffman-La Roche against Hyderabad-based Natco Pharma, in a case involving the prohibitively expensive spinal muscular atrophy (SMA) drug, risdiplam, marketed internationally as Evrysdi.

💊 The High Stakes: Life-Saving Medicine or Legal Monopoly?

Spinal muscular atrophy is a rare genetic disorder that progressively weakens muscles used for breathing, walking, and other vital functions. Risdiplam is the only approved oral treatment available in India for SMA, and its cost places it far out of reach for most patients. One bottle reportedly costs ₹6 lakh, with a typical patient requiring 30 bottles a year—a staggering ₹1.8 crore annually.

Natco Pharma has developed a generic version of risdiplam, challenging Roche’s patent rights. Roche, in response, approached the court to halt the sale of Natco’s version, claiming patent infringement and requesting an interim injunction.

⚖️ Justice Pushkarna’s Clear Stand: People First
In a firm and clear ruling, Justice Pushkarna refused the injunction, emphasizing that public health cannot be treated lightly. She wrote:

She also highlighted a critical point in patent law: while pharma companies can be compensated later through damages, there is no mechanism to compensate the public for a lack of access to essential medicine.

This case stands out because the voice of patients was directly heard in court. Two SMA patients intervened to share their lived experiences—stating unequivocally that they could not afford Roche’s drug and had no alternative treatment available.

💸 Big Pharma’s “Patient Assistance” Argument Falls Flat
Roche attempted to soften the blow by pointing to its Patient Assistance Programme (PAP)—an initiative that offers discounted medication to a limited number of patients. But the court saw through the strategy.

Justice Pushkarna called the program “far too limited” and noted that even the proposed reduced prices (revealed in a sealed cover) were insufficient to address widespread affordability. Only a fraction of patients could potentially benefit, leaving many out in the cold.

She also acknowledged budgetary limitations of the National Policy for Rare Diseases (NPRD)—a government scheme that provides up to ₹50 lakh per patient but has only been able to support 1,118 patients, despite India recognizing 63 rare diseases.

🔄 Global Implications & Legal Loopholes
Interestingly, this is not the only battleground for Roche and Natco. In the U.S., Natco is seeking approval to launch its generic risdiplam through an Abbreviated New Drug Application (ANDA), and is currently facing another infringement suit there. Despite being a rare disease drug, Evrysdi clocked $1.8 billion in U.S. sales in 2024, a growth of 18%, thanks to its user-friendly oral format.

Back in India, the patent debate hinges on Roche’s attempt to claim protection under a “species patent”, even though a broader “genus patent” had been filed earlier internationally. Natco argues that Roche is trying to extend its monopoly by segmenting patents, which is not allowed under Indian law if the new invention was already disclosed.

🧠 A Legal Shift in Priorities

The ruling isn’t just about one drug or one company. It signals a broader shift in judicial thinking, where courts are weighing public health more heavily in patent disputes, especially for essential or life-saving medicines.

This isn’t the first time Indian courts have leaned this way. In a 2008 case, Roche sought an injunction against Cipla over its cancer drug erlotinib (Tarceva). The court refused, noting that Cipla’s version was significantly cheaper, and the balance of convenience lay with affordable treatment.

🧬 What This Means for Patients and Policy

This case is likely to become a benchmark in how rare disease drugs are treated in Indian courts, especially when affordability is at stake. It also brings renewed focus on the inadequacy of current government schemes to support patients with ultra-expensive therapies.

For pharmaceutical companies, it’s a wake-up call: patent rights do not guarantee exclusivity if access is denied to the vast majority.

For patients, it is a glimmer of hope—an acknowledgment that their right to live cannot be outweighed by corporate profits.

📝 Final Thoughts
In Justice Pushkarna’s words, “There exists no right for the public to lessen or compensate itself.” This ruling flips the script, putting people before patents, and serves as a reminder that innovation must go hand in hand with access.

India has long been seen as the pharmacy of the developing world, and rulings like this ensure that mantle remains intact.