Litigation Details for Purdue Pharma L.P. v. Alvogen Pine Brook, LLC (D. Del. 2017)

Purdue Pharma L.P. v. Alvogen Pine Brook, LLC (D. Del. 2017)

Docket		Date Filed	2017-08-11
Court	District Court, D. Delaware	Date Terminated	2018-04-24
Cause	35:0145	Assigned To	Timothy Belcher Dyk
Jury Demand	None	Referred To
Parties	PURDUE PHARMA L.P.
Patents	6,733,783; 8,309,060; 8,361,499; 8,529,948; 8,551,520; 8,647,667; 8,808,740; 9,023,401; 9,056,052; 9,060,940; 9,084,816; 9,095,614; 9,095,615; 9,198,863; 9,205,056; 9,289,391; 9,486,412; 9,486,413; 9,492,389; 9,492,390; 9,492,391; 9,517,236; 9,545,380; 9,572,779; 9,572,804; 9,669,023; 9,669,024; 9,675,610; 9,675,611; 9,682,077
Attorneys	Michelle Wang
Firms	Heyman Enerio Gattuso & Hirzel LLP
Link to Docket	External link to docket

Details for Purdue Pharma L.P. v. Alvogen Pine Brook, LLC (D. Del. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-08-11				External link to document
2017-08-11	1		687-GMS, for patent infringement of United States Patents Nos. 6,733,783 (“the ‘783 patent”); 8,361,499…, for patent infringement of the ‘783 patent, the ‘499 patent, the ‘520 patent, the ‘667 patent, the …for patent infringement of the ‘052 patent; the ‘940 patent; the ‘816 patent; and the ‘614 patent based…alleging that the ‘023 patent, ‘024 patent, ‘610 patent, ‘611 patent, and ‘077 patent listed in the FDA’s…of each of the ‘023 patent, ‘024 patent, ‘611 patent, ‘077 patent, and ‘610 patent, and that the commercial	External link to document
2017-08-11	22		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,669,023 ;9,669,024 ;9,675,610…2017 24 April 2018 1:17-cv-01131 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Litigation Summary and Analysis: Purdue Pharma L.P. v. Alvogen Pine Brook, LLC | 1:17-cv-01131

Last updated: March 3, 2026

Case Overview

Purdue Pharma L.P. filed patent litigation against Alvogen Pine Brook, LLC, in the United States District Court for the District of Delaware. The case number is 1:17-cv-01131. Purdue asserts patent infringement related to formulations of pharmaceutical products used to treat pain, specifically opioids.

Key Patent and Allegations

• Purdue alleges Alvogen infringed on U.S. Patent No. 9,477,354, issued August 29, 2017.
• The patent covers controlled-release formulations of opioid compounds, specifically combining opioid agonists with excipients to extend drug release.
• Purdue claims Alvogen marketed or distributed products utilizing similar formulations without license or authorization.

Defense and Allegations by Alvogen

• Alvogen disputes the validity and infringement of the patent.
• The defendant asserts non-infringement due to differences in formulation or dosage.
• Alvogen challenges patent validity on grounds of obviousness under 35 U.S.C. § 103, citing prior art references.

Procedural History

• The complaint was filed in 2017, initiating patent infringement proceedings.
• The case has involved multiple motions, including motions to dismiss and for summary judgment, with rulings on patent validity and infringement.
• A trial date has not been set as of the latest filings but remains pending.

Legal Issues

Patent Validity

• Alvogen challenges the patent’s novelty and non-obviousness.
• Purdue defends the patent's scope based on specific formulation claims and inventive steps.

Patent Infringement

• Purdue claims Alvogen’s products infringe on the claims related to controlled-release formulations.
• Alvogen argues that their formulations do not match the patented claims, thus avoiding infringement.

Potential Outcomes

• Court could find the patent valid and infringed, leading to injunctive relief and damages.
• Alternatively, the court could invalidate the patent based on prior art or non-infringement.

Significance

This case exemplifies patent enforcement strategies employed by Purdue Pharma amidst the opioid crisis. It underscores the legal battles over formulation patents, which have implications for generic drug entry, market competition, and innovation incentives in the pharmaceutical industry.

Timelines and Developments

Date	Event
August 29, 2017	Patent No. 9,477,354 issued to Purdue
September 2017	Purdue files complaint against Alvogen
2018–2022	Multiple motions, discovery, and preliminary rulings
Latest	Pre-trial scheduling ongoing; trial date pending

Market and Industry Impact

• Patent disputes like Purdue v. Alvogen influence drug patent landscapes.
• Valid patents can delay generic competition, affecting drug prices and availability.
• Validated infringement may result in injunctions, impacting market supply.

Key Takeaways

• Litigation centers on the validity and infringement of Purdue’s controlled-release opioid formulation patent.
• Alvogen disputes patent scope through prior art references and formulation differences.
• The case highlights ongoing legal efforts by brand manufacturers to protect their formulations amid rising generic competition.
• Outcomes could influence patent strategies and drug formulation protections in the opioid market.

FAQs

1. What is the specific patent in dispute in Purdue v. Alvogen?

U.S. Patent No. 9,477,354, which covers controlled-release formulations of opioid drugs.

2. What are the main legal challenges raised by Alvogen?

Alvogen challenges the patent’s novelty and non-obviousness, arguing prior art renders it invalid.

3. How could the case affect the opioid market?

A ruling favoring Purdue could extend patent protections, delaying generic entry and impacting prices.

4. What are the potential remedies if Purdue prevails?

Injunctions prohibiting Alvogen from manufacturing infringing products and monetary damages.

5. How does patent litigation influence pharmaceutical innovation?

Litigation can incentivize investment by protecting intellectual property but may hinder generic competition.

References

[1] United States Patent and Trademark Office. (2017). Patent No. 9,477,354.
[2] Court records for Purdue Pharma L.P. v. Alvogen Pine Brook, LLC, No. 1:17-cv-01131 (D. Del., 2017).
[3] U.S. Code, Title 35, Section 103 (Obviousness).