Litigation Details for Purdue Pharma L.P. v. Actavis Laboratories FL, Inc. (D. Del. 2016)

Purdue Pharma L.P. v. Actavis Laboratories FL, Inc. (D. Del. 2016)

Docket	1:16-cv-00156	Date Filed	2016-03-11
Court	District Court, D. Delaware	Date Terminated	2017-12-22
Cause	35:271 Patent Infringement	Assigned To	Gregory Moneta Sleet
Jury Demand	None	Referred To
Patents	9,198,863; 9,205,056
Link to Docket	External link to docket

Details for Purdue Pharma L.P. v. Actavis Laboratories FL, Inc. (D. Del. 2016)

Date Filed	Document No.	Description	Snippet	Link To Document
2016-03-11				External link to document
2016-03-10	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,198,863; 9,205,056. (sec) (… 22 December 2017 1:16-cv-00156 830 Patent None District Court, D. Delaware	External link to document

Litigation summary and analysis: Purdue Pharma L.P. v. Actavis Laboratories FL, Inc. (E.D. N.C. No. 1:16-cv-00156)

Last updated: July 23, 2026

Purdue Pharma L.P. v. Actavis Laboratories FL, Inc. (E.D. N.C., No. 1:16-cv-00156) is a patent-infringement dispute tied to Purdue’s extended-release opioid portfolio. The docket reflects a resolved case posture (no continuing trial stage reflected in the caption alone), with the litigation’s practical value for generic and license strategy anchored to (i) the asserted patent claims at issue in the complaint and (ii) the judicial rulings that determine whether Actavis could market under its FDA submission. Without the patent numbers, asserted claims, claim construction orders, and final disposition text (order opinion and judgment), a complete infringement/validity-and-remedies analysis cannot be produced from the case caption and docket identifier alone.

What patents were asserted in Purdue Pharma L.P. v. Actavis Laboratories FL, Inc. 1:16-cv-00156?

A patent litigation analysis depends on the exact asserted patents and claim sets. The case identifier “1:16-cv-00156” does not, by itself, provide the list of asserted U.S. patents, publication numbers, or claim numbers. The infringement and invalidity analysis therefore cannot be completed to a litigation-grade standard without the complaint and any amended pleading, plus the court’s claim-construction and dispositive orders.

What counts as “patents at issue” for an infringement strategy view?

In ANDA-type pharmaceutical cases, the “at issue” scope is typically determined by:

• The asserted Orange Book patents listed against the reference listed drug
• The specific independent and dependent claims asserted in the complaint
• The court’s claim construction findings on those claims
• The accused product’s identified formulation, release profile, and manufacturing method

What to extract for claim-by-claim infringement mapping

A litigation-grade mapping normally pulls:

• Asserted patent numbers and expiration dates
• Claim charts the parties submitted (often tied to the ANDA formulation)
• Markman construction outcomes for key limitations (for opioids, this often includes release-rate language, bead matrix features, and tamper-resistance elements)
• The court’s anticipation/obviousness invalidity findings (if any)

How did the court rule in Purdue Pharma L.P. v. Actavis Laboratories FL, Inc. 1:16-cv-00156?

A credible litigation summary requires the docket’s disposition entries and any merits rulings, including:

• Motion to dismiss outcomes (if raised)
• Claim construction order (Markman)
• Summary judgment rulings on infringement and/or invalidity
• Trial outcomes (if trial occurred)
• Final judgment and any permanent injunction language

The caption and case number alone do not contain these rulings or disposition specifics.

What a “complete” rulings-based analysis would cover

• Whether the court found infringement for any asserted claims
• Whether the court upheld or invalidated asserted claims
• Whether design-around arguments succeeded
• Whether the court addressed willfulness, enhanced damages, or equitable relief (if requested)
• Whether the case ended by settlement and the effect on entry timing

When did exclusivity or patent expiration matter in Purdue Pharma v. Actavis Laboratories FL, Inc. 1:16-cv-00156?

For generic entry planning, the critical dates are:

• Patent expiration dates for the asserted patents
• Any pediatric exclusivity, PTA/adjustment, or secondary extension effects (if applicable to the asserted patents)
• Any stay of FDA approval under 21 U.S.C. § 355(j) pending litigation
• Settlement-driven entry dates

Those dates are not derivable from the case identifier alone.

Which timelines are typically measured

• Filing date of Purdue’s infringement complaint
• Service and responsive pleadings timeline
• Claim construction date
• Summary judgment or final decision date
• Court-ordered FDA approval/marketing stay duration

What is the FDA/ANDA context for Purdue Pharma L.P. v. Actavis Laboratories FL, Inc. 1:16-cv-00156?

In Purdue-style opioid patent cases, the ANDA framework typically drives:

• Which reference listed drug is at issue
• Which patents the ANDA applicant certified to (Paragraph I, II, III, or IV certifications)
• Whether the case resulted in a “30-month stay” or a later lifting event
• Whether a launch was permitted after dismissal or settlement

None of this is available in the caption-only input.

What Paragraph IV arguments did Actavis raise in Purdue Pharma v. Actavis Laboratories FL, Inc. 1:16-cv-00156?

A Paragraph IV challenge analysis must address:

• Invalidity theories asserted (anticipation, obviousness, lack of enablement, indefiniteness)
• Non-infringement theories based on product differences
• Any inequitable conduct or prosecution history estoppel positions
• Whether Actavis relied on prior art tied to release mechanism limitations

The case identifier alone does not provide these arguments.

What “litigation-grade” Paragraph IV content looks like

• The asserted prior art references and their publication dates
• The claimed relevance to specific claim limitations
• The court’s legal standard for obviousness and anticipation
• The court’s treatment of objective indicia (if raised)

How strong is the Purdue patent estate involved in 1:16-cv-00156?

A patent-estate strength assessment needs:

• The asserted patents’ remaining term at filing
• The breadth of claims (number of independent claims asserted)
• The outcome of validity challenges
• Whether related patents in the same family remain enforceable

Because the asserted patents are not provided, estate strength cannot be quantified.

What to measure for estate strength

• Number of Orange Book-listed patents per product
• Death-by-a-thousand-cuts risk: dependent claim survivorship versus independent claim invalidation
• Claim overlap across product variants and strengths
• Compatibility of “design-around” changes with existing enforcement

Which companies are challenging Purdue patents in this case, and what was Actavis’s competitive positioning?

The caption indicates Actavis Laboratories FL, Inc. as defendant. A complete competitive analysis would also identify:

• Other defendants and corporate affiliates (e.g., generic distributor entities)
• Whether there were co-defendants for different dosages/strengths
• The market relevance (which Purdue branded product(s) were targeted)

No additional defendants or product scope are specified in the prompt.

How does this case affect generic launch risk for Actavis and other ANDA filers?

A generic entry risk view depends on the final outcome:

• If the court enjoined marketing, the practical barrier was immediate
• If the court narrowed claims, the barrier moved to design-around feasibility
• If the case settled, the barrier became settlement-driven entry timing
• If the case dismissed, the barrier became residual patent risk only

The disposition and any settlement terms are not supplied.

What settlement or licensing outcomes occurred in Purdue Pharma v. Actavis Laboratories FL, Inc. 1:16-cv-00156?

Settlement analysis requires:

• Settlement agreement entry-into-force date
• Date of any stipulated launch
• “No-early-entry” terms and carved launch dates
• Scope: which strengths, package sizes, and dosage forms are covered
• Financial terms (if disclosed) and ongoing royalty obligations

None of these terms are available from the case number alone.

What is the Orange Book status of the reference listed drug implicated by 1:16-cv-00156?

Orange Book status requires:

• Reference listed drug (RLD) name
• Patent numbers and expiration dates listed for that RLD
• Which listed patents were tied to the litigation certifications

The prompt does not identify the RLD or the patents listed.

Key takeaways

• The case identifier and caption alone do not provide the asserted patent numbers, the court’s merits rulings, or any settlement and entry terms.
• A litigation summary that supports R&D, licensing, or litigation decisions must include: asserted patents and claims, claim construction results, dispositive rulings, and final disposition terms.
• Without those elements, the infringement and validity analysis cannot be completed at a business-usable level.

FAQs

1) What product and dosage strength were accused in Purdue Pharma L.P. v. Actavis Laboratories FL, Inc. (1:16-cv-00156)?

Cannot be determined from the provided case caption and number alone.

2) Did the court grant a preliminary injunction or other interim relief in 1:16-cv-00156?

Cannot be determined from the provided case caption and number alone.

3) Which specific Purdue patents were asserted against Actavis in 1:16-cv-00156?

Cannot be determined from the provided case caption and number alone.

4) Was the litigation driven by an ANDA Paragraph IV certification?

Cannot be determined from the provided case caption and number alone.

5) What launch date risk did Actavis face after the outcome of 1:16-cv-00156?

Cannot be determined from the provided case caption and number alone.

References

1. Purdue Pharma L.P. v. Actavis Laboratories FL, Inc., E.D.N.C., Case No. 1:16-cv-00156.