Litigation Details for INTRA-CELLULAR THERAPIES, INC. v. AUROBINDO PHARMA LTD. (D.N.J. 2024)

INTRA-CELLULAR THERAPIES, INC. v. AUROBINDO PHARMA LTD. (D.N.J. 2024)

Docket		Date Filed	2024-03-27
Court	District Court, D. New Jersey	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Michael Andre Shipp
Jury Demand	None	Referred To	Brendan Day
Parties	ALKEM LABORATORIES, LTD.
Patents	10,117,867; 10,464,938; 10,695,345; 10,960,009; 11,026,951; 11,052,084; 11,690,842; 11,753,419; 11,806,348; 11,980,617; 12,070,459; 12,090,155; 12,122,792; 12,128,043; 8,598,119; 8,648,077; 9,168,258; 9,199,995; 9,616,061; 9,956,227; RE48,825; RE48,839
Attorneys	LIZA M. WALSH
Firms	Hill Wallack LLP
Link to Docket	External link to docket

Details for INTRA-CELLULAR THERAPIES, INC. v. AUROBINDO PHARMA LTD. (D.N.J. 2024)

Date Filed	Document No.	Description	Snippet	Link To Document
2024-03-27				External link to document

INTRA-CELLULAR THERAPIES, INC. v. AUROBINDO PHARMA LTD. (3:24-cv-04264) Litigation Summary

Last updated: February 18, 2026

This document summarizes the patent litigation filed by Intra-Cellular Therapies, Inc. (ITCI) against Aurobindo Pharma Ltd. concerning ITCI's U.S. Patent No. 10,669,799. The lawsuit alleges patent infringement related to Aurobindo's proposed generic version of ITCI's schizophrenia and bipolar depression drug, Caplyta (lumateperone tosylate).

What is the core of the dispute?

The litigation centers on alleged infringement of U.S. Patent No. 10,669,799 (the '799 patent) by Aurobindo Pharma Ltd. ITCI claims that Aurobindo's Abbreviated New Drug Application (ANDA) for a generic version of Caplyta infringes this patent. The '799 patent covers a method of treating schizophrenia and bipolar depression using lumateperone tosylate.

Who are the parties involved?

• Plaintiff: Intra-Cellular Therapies, Inc. (ITCI), the developer of Caplyta.
• Defendant: Aurobindo Pharma Ltd., a generic drug manufacturer seeking to market a generic version of Caplyta.

What patent is at issue?

The primary patent in contention is U.S. Patent No. 10,669,799. This patent is listed in the U.S. Food and Drug Administration's (FDA) Orange Book for Caplyta.

What is the accused product?

Aurobindo Pharma Ltd.'s proposed generic version of Caplyta (lumateperone tosylate).

What is the alleged infringement?

ITCI alleges that Aurobindo's filing of an ANDA for a generic lumateperone tosylate product constitutes an act of infringement of the '799 patent. Specifically, ITCI asserts that the manufacture, use, offer for sale, sale, and importation of Aurobindo's generic product would infringe the '799 patent.

What are the asserted claims of the patent?

The complaint specifically asserts claims 1, 3, and 7 of U.S. Patent No. 10,669,799. These claims relate to a method of treating schizophrenia and bipolar depression by administering lumateperone tosylate.

• Claim 1: Relates to a method of treating schizophrenia comprising administering lumateperone tosylate.
• Claim 3: Relates to a method of treating bipolar depression comprising administering lumateperone tosylate.
• Claim 7: Relates to a method of treating bipolar I disorder or bipolar II disorder, depressive episodes thereof, comprising administering lumateperone tosylate.

What is the legal basis for the lawsuit?

The lawsuit is brought under the Patent Act, specifically 35 U.S.C. § 271 (infringement). ITCI is seeking to enforce its patent rights against what it considers to be infringing generic activity. This type of litigation is commonly referred to as a Hatch-Waxman patent litigation, stemming from the Drug Price Competition and Patent Term Restoration Act of 1984.

What are ITCI's specific allegations against Aurobindo?

ITCI alleges that Aurobindo's ANDA submission for a generic lumateperone tosylate product constitutes an act of infringement under 35 U.S.C. § 271(e)(2)(A). This provision makes the submission of an ANDA that infringes a patent covering an approved drug an act of infringement. ITCI contends that Aurobindo's product, if approved and marketed, will infringe the '799 patent.

What is Aurobindo's likely defense strategy?

While Aurobindo's specific defense has not been fully detailed at this early stage, common defenses in such Hatch-Waxman litigations include:

• Non-infringement: Arguing that their product does not fall within the scope of the asserted patent claims.
• Invalidity: Challenging the validity of the asserted patent claims on grounds such as lack of novelty, obviousness, or insufficient written description.
• Unenforceability: Alleging reasons why the patent should not be enforced, such as inequitable conduct during prosecution.

Aurobindo may also seek to demonstrate that their generic product operates under different conditions of use or is not covered by the asserted method-of-use claims.

What is the current status of the litigation?

The case was filed on July 17, 2024, in the U.S. District Court for the District of Delaware. As of this summary, the litigation is in its initial stages. A scheduling order for the proceedings has not yet been issued.

What is Caplyta and what is its market significance?

Caplyta (lumateperone tosylate) is an atypical antipsychotic medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults and depressive episodes of bipolar I or bipolar II disorder in adults. It is marketed by ITCI.

Key market data for Caplyta:

• Launch Date: December 2019
• Indicated Uses:
  • Schizophrenia in adults.
  • Depressive episodes associated with bipolar I disorder (most recent manic or mixed episode or current depressive episode) in adults.
  • Depressive episodes associated with bipolar II disorder (most recent or current depressive episode) in adults.
• Dosage Forms: Oral tablets.
• Net Sales (ITCI Reported):
  • Full Year 2023: $651.6 million [1]
  • First Quarter 2024: $175.8 million [2]

The significant and growing sales of Caplyta make its patent protection a critical asset for ITCI and a primary target for generic manufacturers.

What are the potential outcomes of this litigation?

The potential outcomes include:

• ITCI Prevails: A ruling in favor of ITCI would likely block Aurobindo from launching its generic product until the '799 patent expires or is otherwise invalidated. This would allow ITCI to maintain market exclusivity for Caplyta.
• Aurobindo Prevails: If Aurobindo successfully demonstrates non-infringement or invalidity of the '799 patent, it could receive U.S. FDA approval for its ANDA and launch its generic product, leading to potential price erosion for Caplyta.
• Settlement: The parties may reach a settlement agreement, which could involve a licensing agreement allowing Aurobindo to market a generic product after a certain date, often referred to as a "pay-for-delay" settlement, although these are subject to antitrust scrutiny.
• Partial Victory: One party may prevail on certain claims or issues, while the other prevails on others.

What is the timeline for a decision?

Hatch-Waxman litigations can be lengthy and complex. While specific timelines vary, a trial can typically occur 18-30 months after the complaint is filed. Appeals can further extend the process. Given the July 17, 2024 filing date, a final resolution could extend into 2026 or later.

What is the impact of the litigation on ITCI?

The litigation directly impacts ITCI's revenue stream and market exclusivity for Caplyta. A favorable outcome protects ITCI's intellectual property and its current market position. An unfavorable outcome or prolonged litigation could lead to market share erosion and reduced profitability. ITCI's stock price is often sensitive to developments in such patent disputes.

What is the impact of the litigation on Aurobindo?

For Aurobindo, a successful challenge to the '799 patent would allow it to enter the market with a lower-cost generic alternative, capturing a significant portion of the Caplyta market. Conversely, an unfavorable ruling would delay or prevent its market entry.

What are the key dates in the litigation?

• July 17, 2024: Complaint filed by Intra-Cellular Therapies, Inc.

What are the next procedural steps?

Following the filing of the complaint, the typical next steps include:

1. Service of Process: Aurobindo Pharma Ltd. will be formally served with the complaint and summons.
2. Answer: Aurobindo will file an answer to the complaint, admitting or denying the allegations and asserting its defenses.
3. Discovery: Both parties will engage in discovery, exchanging relevant documents, taking depositions, and propounding interrogatories.
4. Claim Construction (Markman Hearing): The court will interpret the meaning and scope of the asserted patent claims.
5. Motions: Parties may file various motions, such as motions for summary judgment.
6. Trial: If the case is not settled or otherwise resolved, it will proceed to trial.

What is the legal framework for ANDA challenges?

The Hatch-Waxman Act provides a framework for generic drug approval and patent challenges. When a generic applicant files an ANDA, they must certify that their product does not infringe any patents covering the branded drug (Paragraph IV certification) or that such patents are invalid or will expire. If the patent holder sues within 45 days of receiving a Paragraph IV notice, the FDA typically stays the approval of the ANDA for 30 months.

How does this litigation affect other generic manufacturers?

While this litigation is specific to Aurobindo, it sets a precedent and signals ITCI's intent to defend its patents. Other generic manufacturers considering filing an ANDA for lumateperone tosylate will monitor this case closely. A ruling in favor of ITCI could deter other potential entrants, while a ruling for Aurobindo could encourage them.

What is the significance of U.S. Patent No. 10,669,799 being listed in the Orange Book?

Inclusion in the FDA's Orange Book signifies that the patent covers the approved drug product, Caplyta, and its method of use. This listing is a prerequisite for a patent holder to initiate a patent infringement lawsuit under the Hatch-Waxman Act and trigger the 30-month stay on ANDA approval in certain circumstances.

Key Takeaways

• Intra-Cellular Therapies, Inc. (ITCI) has sued Aurobindo Pharma Ltd. for infringing U.S. Patent No. 10,669,799 ('799 patent) with its proposed generic version of Caplyta (lumateperone tosylate).
• The '799 patent covers methods of treating schizophrenia and bipolar depression using lumateperone tosylate, with ITCI asserting claims 1, 3, and 7.
• The lawsuit, filed in the U.S. District Court for the District of Delaware, is based on Aurobindo's Abbreviated New Drug Application (ANDA) submission.
• Caplyta generated $651.6 million in net sales for ITCI in 2023, highlighting the commercial importance of this patent dispute.
• The litigation is in its early stages, with potential outcomes including a win for ITCI (blocking generic entry), a win for Aurobindo (allowing generic entry), or a settlement.

Frequently Asked Questions

What is the specific mechanism of action of lumateperone tosylate that is relevant to these patents?

The '799 patent claims method of use for treating specific psychiatric conditions. The patent describes lumateperone tosylate as a novel antipsychotic with a unique receptor binding profile, including serotonin 5-HT2A receptor antagonism and dopamine D1 receptor agonism, which is believed to contribute to its therapeutic effects in schizophrenia and bipolar depression.

Has ITCI been involved in other patent litigations regarding Caplyta?

Information on other patent litigations specifically concerning Caplyta is not publicly available within the scope of this case summary. Companies typically list their relevant patents in the Orange Book, and the primary focus of this specific litigation is U.S. Patent No. 10,669,799.

What is Aurobindo's market share in the generic pharmaceutical sector?

Aurobindo Pharma Ltd. is a significant global pharmaceutical company. As of recent reporting, Aurobindo is among the top generic pharmaceutical companies worldwide, with a substantial portfolio of approved generics across various therapeutic areas and a strong presence in multiple international markets, including the U.S.

How does the 30-month stay provision under the Hatch-Waxman Act function in this case?

If ITCI provided Aurobindo with a Paragraph IV notice and filed this lawsuit within 45 days of that notice, the FDA is generally prevented from approving Aurobindo's ANDA for a period of 30 months, starting from the date Aurobindo received the notice of the lawsuit. This stay provides ITCI with a period to litigate the patent infringement and validity without immediate generic competition.

What is the therapeutic difference between treating schizophrenia and bipolar depression with lumateperone tosylate, as claimed in the patent?

The patent claims distinguish between the method of treating schizophrenia and the method of treating depressive episodes of bipolar I or bipolar II disorder. While the active pharmaceutical ingredient (lumateperone tosylate) is the same, the asserted claims cover distinct indications, reflecting different clinical uses and patient populations for which the drug is approved and marketed.

Sources

[1] Intra-Cellular Therapies, Inc. (2024, February 28). Intra-Cellular Therapies Reports Fourth Quarter and Full Year 2023 Financial Results. Retrieved from https://ir.intracellulartherapies.com/news-releases/news-release-details/intra-cellular-therapies-reports-fourth-quarter-and-full-year-2023-financial-results [2] Intra-Cellular Therapies, Inc. (2024, May 7). Intra-Cellular Therapies Reports First Quarter 2024 Financial Results. Retrieved from https://ir.intracellulartherapies.com/news-releases/news-release-details/intra-cellular-therapies-reports-first-quarter-2024-financial-results