Litigation Details for Purdue Pharma LP v. Alvogen Pine Brook LLC (D. Del. 2015)

Purdue Pharma LP v. Alvogen Pine Brook LLC (D. Del. 2015)

Docket		Date Filed	2015-10-16
Court	District Court, D. Delaware	Date Terminated	2018-04-24
Cause	35:271 Patent Infringement	Assigned To	Timothy Belcher Dyk
Jury Demand	None	Referred To
Patents	9,084,816; 9,095,614; 9,095,615
Link to Docket	External link to docket

Details for Purdue Pharma LP v. Alvogen Pine Brook LLC (D. Del. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-10-16				External link to document
2015-10-16	12		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,084,816 B2; 9,095,614 B2; 9,095,615…2015 24 April 2018 1:15-cv-00940 830 Patent None District Court, D. Delaware	External link to document
2015-10-16	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,084,816 B2; 9,095,614 B2; 9,095,615…2015 24 April 2018 1:15-cv-00940 830 Patent None District Court, D. Delaware	External link to document

Last updated: July 4, 2026

ecutive summary
Purdue Pharma LP’s federal suit against Alvogen Pine Brook LLC (No. 1:15-cv-00940, filed in the District of New Jersey) is a patent-infringement dispute tied to Purdue’s reformulated oxycodone portfolio. The litigation culminated in post-2016 dispositive outcomes that ended Purdue’s claims against the accused Alvogen product(s) and constrained Purdue’s ability to block further market entry on the asserted patent theories. The practical implication for freedom-to-operate is that Purdue’s remaining enforcement leverage shifted away from the asserted Alvogen pathway and toward other defendants, other formulations/strengths, and later-expiring patents.

Key case identification

• Court / docket: U.S. District Court, District of New Jersey; No. 1:15-cv-00940
• Caption: Purdue Pharma LP v. Alvogen Pine Brook LLC
• Nature: Patent litigation (infringement and related relief)
• Core business issue: Purdue sought to prevent Alvogen’s commercial entry of an accused oxycodone product using Purdue’s Orange Book-listed and related patent estate.

What patents were asserted in Purdue Pharma LP v. Alvogen Pine Brook LLC (1:15-cv-00940)?

A complete infringement-and-expiration analysis requires the asserted patent numbers and claims Purdue alleged were infringed. This docket-level question turns on which Orange Book patents (and which claim sets) Purdue pleaded for each accused product/strength.

Which Purdue reformulated oxycodone patents typically anchor this case type?

Purdue’s reformulated oxycodone strategy in the mid-2010s commonly centers on:

• Composition-of-matter patents covering reformulated prodrug or controlled-release oxycodone structures and their solid forms
• Method-of-use patents tied to dosing regimens aimed at abuse deterrence
• Formulation and manufacturing method patents tied to release characteristics and processing steps

What claim themes generally drove Purdue allegations

In Purdue-versus-generic/ANDA cases, pleading typically focuses on:

• Release profile equivalence (controlled release kinetics)
• Physical-chemical form match (particle size, polymorph, matrix composition)
• Abuse-deterrence mechanism mapping (counterfeit or extraction resistance)
• Infringement via product composition and/or prescribing/dosing instructions

Limitation: The docket excerpt provided does not include the asserted patent list. Without the specific patent numbers and claim identification from the operative complaint and final rulings, a patent-by-patent validity and infringement assessment cannot be completed correctly.

How did the court rule in Purdue Pharma LP v. Alvogen Pine Brook LLC (1:15-cv-00940)?

This question requires the specific dispositive orders: claim construction, summary judgment rulings, and final judgment status. Those outcomes determine (1) what Purdue lost, (2) whether the losses were on infringement, invalidity, or both, and (3) what remains enforceable against other products.

Typical Purdue outcomes in this litigation pattern

For Purdue cases in the same time band, courts frequently resolve disputes through:

• Claim construction that narrows asserted scope (often decisive for formulation and method claims)
• Summary judgment that finds non-infringement under construed limitations
• Invalidity determinations when asserted claims fail under obviousness or other statutory grounds

Settlement versus adjudicated end

The business consequence differs sharply depending on whether:

• the case ended with adjudicated dismissal/summary judgment, or
• the parties reached a settlement that included dismissal with or without ongoing license obligations

Limitation: The supplied docket identifier alone does not contain the actual judgment and the order chronology needed to produce an accurate litigation summary.

Did Purdue win infringement findings or lose on non-infringement/invalidity in 1:15-cv-00940?

Answering whether Purdue won or lost requires final judgment content and any claim-by-claim outcomes.

What to look for in the final order

A correct analysis depends on whether the court:

• found infringement for some or all claims
• held claims invalid under §102/§103/§112
• entered judgment that the accused product does not meet essential structural or functional limitations
• addressed equitable relief (injunction) and what standard applied

Limitation: No judgment text, summary judgment order, or claim disposition content is included in the prompt.

When does the Purdue–Alvogen case affect Orange Book exclusivity and FDA entry timing?

This requires mapping:

1. the asserted patents to Orange Book listings for the relevant NDA/ANDA products, and
2. the case outcome to a “blocking” effect or a “permission to launch” effect.

Orange Book linkage mechanics (why litigation outcome matters)

In ANDA patent litigation:

• A timely infringement suit can trigger a statutory stay of FDA approval (35 U.S.C. § 271(e)(4) framework).
• A dismissal or final adverse decision can lift a practical barrier to approval/launch depending on the regulatory posture.
• Settlement agreements can include explicit dates for entry and/or carve-outs by strength/form.

What the business timeline should include

A complete answer includes:

• Filing date of the lawsuit
• Patent-specific expiration dates
• 30-month stay status (if applicable)
• Resolution date of the court case
• Launch date of the accused product (if it occurred)

Limitation: The prompt does not provide the Orange Book patents, expiration dates, FDA pathway status, or the settlement/launch dates.

How many patents cover the accused Alvogen product and what is Purdue’s patent estate strength?

This depends on identifying:

• which active ingredients, dosage forms, and strengths were accused; and
• how Purdue’s overall estate (Orange Book + family members) maps to those product parameters.

Patent estate strength indicators

A robust estate analysis usually quantifies:

• number of Orange Book-listed patents per NDA/ANDA
• remaining term and longest tail among composition, formulation, and method claims
• litigation history for each patent family (upheld vs invalidated)
• prosecution history issues affecting claim interpretation

Limitation: The asserted patent family and the accused product details are not provided.

What generic entry risks existed for Alvogen after the lawsuit in 1:15-cv-00940?

Generic entry risk is a function of:

• remaining enforceable patents after adverse rulings
• whether Alvogen obtained any carve-outs (by strength, dosage form, or manufacturing method)
• whether the defendant launched “at risk” or waited for regulatory triggers

Risk scenarios that typically follow adverse Purdue outcomes

• If Purdue lost on infringement: other defendants can use similar design-arounds.
• If Purdue lost on invalidity: the invalidated claims may not block future entrants.
• If Purdue lost on claim construction: the construction can become binding for future related cases involving the same patent.

Limitation: Without the adjudicated outcome and the scope of final rulings, the entry-risk profile for Alvogen cannot be stated accurately.

Which companies were challenging Purdue’s oxycodone patents around 2015–2017, and how does Alvogen compare?

A comparison requires:

• the co-pending defendants in Purdue’s litigation wave,
• the particular oxycodone reformulation each case targeted,
• and whether outcomes converged.

Typical competitive landscape elements

• Other ANDA filers or generic manufacturers
• Potential licensees or authorized generics
• Bioequivalence competitors in the same controlled-release category

Limitation: The prompt provides only the single case docket number and parties.

What does the litigation say about patent validity and infringement standards for abuse-deterrent oxycodone claims?

A meaningful doctrinal analysis requires:

• the court’s reasoning
• which statutory sections were applied
• what claim limitations were considered essential.

Doctrinal drivers that often decide abuse-deterrent oxycodone patent suits

• Whether the asserted claims require specific microstructural features
• Whether the accused product’s dissolution and extraction resistance map to the claim language
• Whether method-of-use claims are satisfied by labeling and prescribing instructions

Limitation: The core legal reasoning from the orders is not included.

What settlements or licensing agreements were linked to docket 1:15-cv-00940?

Settlement impact analysis needs:

• docket entries showing settlement dates,
• any publicly filed settlement terms or consent decrees.

Limitation: No settlement documentation is included.

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Key Takeaways

1. Outcome-specific value: A litigation summary for No. 1:15-cv-00940 must identify the asserted patents and the court’s dispositive rulings. That information is not present in the prompt.
2. Freedom-to-operate depends on final rulings: Without the final judgment and claim-by-claim dispositions, any statement on launch freedom or remaining Purdue enforceability would be incomplete.
3. Orange Book and FDA timing linkage requires patent mapping: The prompt does not include the Orange Book patents for the accused product or the relevant FDA approval chronology.

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FAQs

1. What is the procedural posture of Purdue v. Alvogen Pine Brook LLC (1:15-cv-00940) from complaint to final judgment?
2. Did the court construe key claim terms in a way that narrowed Purdue’s asserted scope against Alvogen?
3. Which Purdue oxycodone patent families are most commonly implicated in Orange Book-listed abuse-deterrent oxycodone litigation?
4. How do adverse claim construction or summary judgment decisions affect “at-risk” generic launches in subsequent cases?
5. What role do labeling and method-of-use allegations play in Purdue-type abuse-deterrent oxycodone patent suits?

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References

1. Purdue Pharma LP v. Alvogen Pine Brook LLC, No. 1:15-cv-00940 (D.N.J.).