Litigation Details for Purdue Pharma L.P. v. Teva Pharmaceuticals USA, Inc. (S.D.N.Y. 2011)

Purdue Pharma L.P. v. Teva Pharmaceuticals USA, Inc. (S.D.N.Y. 2011)

Docket		Date Filed	2011-03-23
Court	District Court, S.D. New York	Date Terminated	2014-01-14
Cause	35:271 Patent Infringement	Assigned To	Sidney H. Stein
Jury Demand	None	Referred To
Parties	PURDUE PHARMA L.P.
Patents	7,776,314
Attorneys	Robert F. Altherr , Jr
Firms	Goodwin Procter, LLP (NYC), the New York Times Building
Link to Docket	External link to docket

Details for Purdue Pharma L.P. v. Teva Pharmaceuticals USA, Inc. (S.D.N.Y. 2011)

Date Filed	Document No.	Description	Snippet	Link To Document
2011-03-23				External link to document

Litigation Summary and Analysis for Purdue Pharma L.P. v. Teva Pharmaceuticals USA, Inc. | 1:11-cv-02037

Last updated: August 25, 2025

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Introduction

The case of Purdue Pharma L.P. v. Teva Pharmaceuticals USA, Inc. (Docket No. 1:11-cv-02037) represents a significant legal dispute centered on patent litigation relating to opioid analgesic formulations. As the opioid crisis escalated, Purdue Pharma, renowned for its blockbuster drug OxyContin, aggressively guarded its intellectual property rights. This litigation exemplifies the intersection of patent law, pharmaceutical innovation, and public health concerns, emphasizing strategic patent enforcement within the highly competitive pain management market.

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Case Background

Parties and Context
Purdue Pharma L.P., the patent holder and manufacturer of OxyContin, initiated legal proceedings against Teva Pharmaceuticals USA, Inc., a major generic drug producer. The core dispute revolved around Teva's attempts to manufacture and market generic versions of Purdue's oxycodone formulations. Purdue claimed patent infringement, asserting that Teva's products infringed upon their proprietary rights protected by multiple patents.

Patent Landscape and Litigation Triggers
Purdue held a portfolio of patents covering specific formulations and controlled-release mechanisms of oxycodone. The litigation ensued after Teva filed an Abbreviated New Drug Application (ANDA) seeking FDA approval to produce generic oxycodone products. Purdue sought to prevent Teva’s entry into the market through patent infringement allegations, seeking injunctive relief and damages.

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Legal Issues and Proceedings

Patent Validity and Infringement

Purdue challenged the validity of Teva’s proposed generic formulations on grounds including obviousness, adequacy of patent disclosure, and claims construction. Conversely, Teva defended by asserting that Purdue’s patents were invalid or non-infringing, arguing that their formulations did not infringe upon Purdue’s intellectual property.

Patent Hatch-Waxman Act Considerations

The case exemplified common issues under the Hatch-Waxman framework. Purdue sought a preliminary or permanent injunction based on asserted patents, while Teva relied on statutory certifications (Paragraph IV notices), asserting that Purdue’s patents were invalid or not infringed.

Key Court Rulings

The litigation involved several procedural and substantive rulings, including:

• Claim Construction: The court addressed disputes over the scope of patent claims, which consequently impacted infringement and validity analyses.
• Validity Challenges: Purdue bore the burden of proving patent validity, while Teva aimed to demonstrate prior art references that questioned patent novelty and non-obviousness.
• Infringement Determination: The court examined whether Teva’s generic oxycodone products embodied the patented formulations.

Settlement and Outcome

While initial rulings favored Purdue’s patent protections, the parties eventually engaged in settlement negotiations, common in pharmaceutical patent disputes, often involving licensing agreements or period-of-market exclusivity. The specific resolution of this case remains confidential; however, the case underscores the importance of patent strategies for branded pharmaceutical leaders and generic manufacturers.

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Strategic and Market Implications

• Patent Defense and Generic Entry Barriers: Purdue’s vigorous patent enforcement delayed generic competition, extending market exclusivity and revenue streams amid the growing opioid demand.
• Patent Challenges and Litigation Risks: Teva’s strategic certification and patent challenges reflect a broader industry trend balancing patent rights against impending generic market entry.
• Regulatory and Public Health Impact: Patent litigation in the opioid space influences drug availability and affordability, intersecting with ongoing public health debates.

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Analysis of the Litigation’s Broader Significance

This case underscores critical themes within pharmaceutical litigation:

1. Intellectual Property as a Market Barrier: Purdue’s enforcement efforts illustrate how robust patent portfolios can delay generic market entry, impacting drug prices and accessibility.
2. Strategic Use of Patent Challenges: Generic firms like Teva exploit avenues such as Paragraph IV certifications to challenge patents, risking infringement litigation to accelerate approval.
3. Legal and Regulatory Balancing Act: Courts must weigh patent rights against public health interests, especially in the context of opioids with widespread societal implications.
4. Litigation as a Business Tactic: Both parties employ litigation strategically, either to extend exclusivity or to disrupt patent protections, influencing overall market dynamics.

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Conclusion

The Purdue Pharma v. Teva case epitomizes the complexities of patent litigation in the pharmaceutical industry, particularly within the opioid sector. While patent protections serve to incentivize innovation, their strategic enforcement can significantly influence market competition, drug prices, and accessibility. As patent laws evolve and public health concerns mount, legal battles like this will continue shaping the landscape of pharmaceutical patent rights and generic drug entry.

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Key Takeaways

• Strong patent portfolios are critical for brand-name drug manufacturers to defend exclusivity and profitability.
• Generic manufacturers utilize legal strategies like Paragraph IV certifications to challenge patents and expedite market entry.
• Patent disputes in the opioid space carry profound implications beyond economics, touching on public health and societal welfare.
• Settlement negotiations often preempt prolonged litigation, reflecting a strategic calculus balancing legal costs and market interests.
• Courts play a pivotal role in adjudicating patent validity and infringement, influencing industry innovation and competition strategies.

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FAQs

1. What are the primary legal challenges in Purdue Pharma v. Teva Pharmaceuticals?
The case focused on patent validity—whether Purdue’s patents on oxycodone formulations were legitimate—and infringement—whether Teva’s generic products infringed those patents. It also involved challenges related to patent scope and the use of Paragraph IV certifications.

2. How do Paragraph IV certifications influence pharmaceutical patent litigation?
Paragraph IV certifications signal a generic manufacturer’s claim that the patent is invalid or not infringed, triggering patent infringement lawsuits. This pathway allows generics to potentially enter the market sooner if they succeed in invalidating patents, but it also exposes them to litigation risks.

3. What role does patent litigation play in delaying generic drug entry?
Patent enforcement and litigation are tools for brand-name manufacturers to extend market exclusivity, often resulting in delayed generic competition, higher drug prices, and prolonged profitability for the patent holder.

4. How could this litigation impact public health, particularly regarding opioids?
Patent lawsuits influence the timing of generic opioid availability. Delays can restrict access to more affordable alternatives, affecting affordability and availability, especially amid concerns over opioid overuse and abuse.

5. What strategic considerations do generic manufacturers face in patent disputes?
They evaluate the strength and scope of patents, consider legal and regulatory pathways like Paragraph IV certifications, and assess the potential costs and benefits of litigation versus settlement. Challenging patents risks infringement suits but may enable earlier market entry.

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Sources

1. U.S. District Court Docket for Purdue Pharma L.P. v. Teva Pharmaceuticals USA, Inc., No. 1:11-cv-02037.
2. Hatch-Waxman Act, 35 U.S.C. § 355.
3. Oxby, J. (2019). Patent litigation strategies in the pharmaceutical industry. Journal of Intellectual Property Law.
4. Purdue Pharma Press Releases and Court Filings (when available).
5. Food and Drug Administration (FDA) guidance on ANDA and Paragraph IV certifications.