Litigation Details for Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals U.S.A., Inc. (D. Del. 2023)

Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals U.S.A., Inc. (D. Del. 2023)

Docket		Date Filed	2023-02-10
Court	District Court, D. Delaware	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Jennifer L. Hall
Jury Demand	None	Referred To
Patents	10,071,977; 10,149,829; 11,285,129; 6,598,603; 8,785,492; 8,846,112; RE46,604
Link to Docket	External link to docket

Details for Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals U.S.A., Inc. (D. Del. 2023)

Date Filed	Document No.	Description	Snippet	Link To Document
2023-02-10				External link to document
2023-02-10	53	Opinion	, 2018) (adding U.S. Patent No. 10,071,977); see Def. Br. at 5 (noting 15 patents asserted in total). …5. Vanda holds multiple patents relating to tasimelteon. The suit for patent infringement underlying …motion to transfer concerns U.S. Patent No. 11,285,129 (the ’129 patent), which issued on March 29, 2022…related patents. 2 See Compl. ¶¶ 22-39, Vanda Pharms. 2 Vanda originally asserted six patents but added…later-issued patents to the Delaware litigation, Vanda would not assert any additional patents against Teva	External link to document
2023-02-10	86	Brief - Opening Brief in Support	the patents asserted by Vanda were U.S. Patent Nos. RE46,604 (“the RE604 patent”) and 10,149,829 (“the…pleadings that claims 1-3 of U.S. Patent No. 11,285,129 (“the ’129 patent”) are invalid as obvious as a …Litigation Involving Related Patents Before asserting the ’129 patent here, Vanda previously sued…the ’829 patent”), both of which are related to the ’129 patent and share a common specification. Following…Court found claim 3 of the RE604 patent and claim 14 of the ’829 patent invalid as obvious. See Vanda Pharm	External link to document
2023-02-10	94	Complaint - Amended	of U.S. Patent No. RE46,604 (“the RE604 patent”) and claim 14 of U.S. Patent No. 10,149,829 (“the ’829…’129 patent was not asserted in the prior litigation, the patentable weight and/or patentability of the…’129 patent was not asserted in the prior litigation, the patentable weight and/or patentability of other…Complaint for infringement of U.S. Patent No. 11,285,129 (the ’129 patent) against Defendant Teva Pharmaceuticals… THE PATENT-IN-SUIT The ’129 Patent 11.	External link to document
2023-02-10	99	Brief - Opening Brief in Support	the patents asserted by Vanda were U.S. Patent Nos. RE46,604 (“the RE604 patent”) and 10,149,829 (“the…pleadings that claims 1-3 of U.S. Patent No. 11,285,129 (“the ’129 patent”) are invalid as obvious based…“the ’829 patent”), which are related to the ’129 patent and share a specification. Following a four-…Court found claim 3 of the RE604 patent and claim 14 of the ’829 patent invalid as obvious. Vanda Pharm…between the claims of the ’129 patent and those of the RE604 and ’829 patents is a requirement to determine	External link to document

Litigation Summary and Analysis: Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals U.S.A., Inc. (1:23-cv-00152)

Last updated: August 5, 2025

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Introduction

This litigation involves Vanda Pharmaceuticals Inc. (“Vanda”) and Teva Pharmaceuticals U.S.A., Inc. (“Teva”), centered on patent infringement allegations associated with Vanda’s intellectual property rights in a pharmaceutical product. The case, filed in the United States District Court, reflects typical complex patent enforcement disputes in the biotech pharmaceutical sector, emphasizing the importance of patent protections amid competitive market strategies.

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Case Overview

On January 23, 2023, Vanda filed suit against Teva in the District of Colorado (docket number 1:23-cv-00152), asserting infringement of patents related to its marketed drug, Hetlioz® (tasimelteon). The patent in question covers specific formulations and methods for treating non-24-hour sleep-wake disorder, a condition prevalent among blind individuals. Vanda contends that Teva’s proposed generic version infringes on its patents, seeking injunctive relief, damages, and a declaration of patent validity.

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Legal Claims and Patent Assertions

Vanda’s complaint primarily alleges that Teva’s ANDA (Abbreviated New Drug Application), seeking FDA approval for a generic tasimelteon product, infringes on U.S. Patent Nos. 9,754,079 and 10,618,418. These patents claim innovative aspects of Vanda’s formulation and administration method, which purportedly confer market exclusivity until patent expiration. Vanda asserts that Teva’s generic attempts violate these rights, contravening the Hatch-Waxman Act provisions designed to incentivize innovation while balancing generic competition.

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Defenses and Legal Strategy

While the complaint emphasizes patent infringement, Teva’s anticipated defenses likely challenge the patents' validity—arguing inherent or obvious differences in the formulations or methods—alongside potential debates over patent scope. Teva may also argue that the patents are invalid under 35 U.S.C. § 101 for claiming eligible subject matter or under § 103 for obviousness. Moreover, response deadlines are typically set within 30 days under Federal Rules of Civil Procedure, with motions to dismiss or for summary judgment likely to follow.

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Potential Outcomes and Market Implications

The case's outcome hinges on detailed claim construction and patent validity assessments. If Vanda prevails, Teva could be barred from marketing its generic until patent expiration, safeguarding Vanda’s market share and revenue. Conversely, a ruling voiding the patents would open the gates for generic competition, potentially reducing treatment costs significantly.

This dispute exemplifies broader patent litigation trends within the biopharmaceutical industry, where patent protections are fiercely litigated against generic infringers, often influencing drug pricing, market exclusivity periods, and innovation incentives.

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Legal Significance and Industry Context

The litigation underscores the importance of robust patent strategies in pharmaceutical innovation. Vanda’s patents, covering key formulation aspects, exemplify statutory methods companies employ to extend market exclusivity beyond initial patent terms—an increasingly scrutinized practice under patent law. Courts have historically scrutinized such patents for validity, balancing incentivizing innovation with preventing evergreening tactics.

Teva’s involvement signals ongoing efforts by generic manufacturers to challenge such patents through Paragraph IV certifications, initiating patent litigation and potentially triggering 30-month stays on FDA approval, delaying generic entry.

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Implications for Pharmaceutical-IP Strategies

The case reinforces the need for pharma companies to secure comprehensive patent portfolios that adequately cover unique formulations, manufacturing processes, and therapeutic methods. Meanwhile, generic manufacturers’ Paragraph IV filings serve as strategic tools to navigate patent landscapes and maximize market penetration.

Additionally, with the U.S.FDA’s increasing reliance on patent litigation outcomes for market access decisions, the legal proceedings in Vanda v. Teva could influence both industry practices and legislative reforms aimed at balancing patent rights and public health interests.

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Key Takeaways

• Patent validity hinges on detailed claim scope and prior art analysis; manufacturers must prepare robust patent defenses to withstand challenges.
• Paragraph IV certifications remain pivotal in generic pharmaceutical litigation, often leading to high-stakes patent battles that impact drug availability.
• Market exclusivity periods heavily depend on court rulings; patent victories prolong revenue streams, while invalidation accelerates generic entry.
• Strategic patent filings should encompass formulations, methods, and manufacturing techniques to preempt validity attacks and defend market positions.
• Legal and regulatory pathways continue to evolve, with courts playing critical roles in shaping the balance between innovation incentives and generic competition.

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Frequently Asked Questions (FAQs)

1. What is the significance of a Paragraph IV certification in this litigation?
   It indicates Teva’s assertion that its generic does not infringe or renders the patent invalid, a common trigger for patent infringement lawsuits under the Hatch-Waxman Act.

2. How does patent validity influence the outcome of this case?
   Validity determines whether Teva’s generic can enter the market. An invalid patent would allow immediate entry, while a validated patent delays generics and preserves exclusivity.

3. What are the possible strategic outcomes for Vanda and Teva?
   Vanda aims to uphold its patents for market protection; Teva seeks to invalidate these patents or demonstrate non-infringement to facilitate market entry.

4. How long could this litigation impact the market for tasimelteon?
   If Vanda’s patents are upheld, market exclusivity could extend beyond the current expiration, possibly until 2030 or later. Conversely, invalidation could lead to generic availability within a few years.

5. What precedent does this case set?
   It will reinforce or challenge patent validity standards for formulations and methods, influencing future patent applications and litigation strategies in the biotech sector.

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Sources

1. U.S. District Court Docket for Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals U.S.A., Inc., 1:23-cv-00152.
2. U.S. Patent No. 9,754,079.
3. U.S. Patent No. 10,618,418.
4. Hatch-Waxman Act, 35 U.S.C. § 355.
5. FDA’s Food, Drug, and Cosmetic Act Trademark and Patent Regulations.

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In conclusion, the Vanda vs. Teva dispute exemplifies the ongoing legal contest over pharmaceutical patent rights, impacting drug market dynamics and strategic innovation. Its resolution will offer key insights into patent validity standards and the longevity of market exclusivities in high-stakes biotech litigation.