Litigation Details for Unimed Pharmaceuticals LLC v. Perrigo Company (D. Del. 2013)

Unimed Pharmaceuticals LLC v. Perrigo Company (D. Del. 2013)

Docket		Date Filed	2013-02-15
Court	District Court, D. Delaware	Date Terminated	2015-05-05
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Parties	PERRIGO UK FINCO LIMITED PARTNERSHIP
Patents	6,503,894; 8,466,136; 8,466,137; 8,466,138; 8,486,925; 8,729,057; 8,741,881; 8,754,070; 8,759,329
Attorneys	John C. Phillips , Jr.
Firms	Polsinelli PC
Link to Docket	External link to docket

Details for Unimed Pharmaceuticals LLC v. Perrigo Company (D. Del. 2013)

Date Filed	Document No.	Description	Snippet	Link To Document
2013-02-15				External link to document

Litigation summary and analysis for: Unimed Pharmaceuticals LLC v. Perrigo Company (D. Del. 2013)

Last updated: June 25, 2026

Litigation summary and analysis for Unimed Pharmaceuticals LLC v. Perrigo Company (1:13-cv-00236)

Executive summary: Unimed Pharmaceuticals LLC sued Perrigo Company in C.D. Cal. for alleged infringement of Unimed’s Orange Book-listed intellectual property covering prescription ophthalmic products associated with Perrigo’s generic launch plans. The case is styled Unimed Pharmaceuticals LLC v. Perrigo Company, No. 1:13-cv-00236 (filed 2013). The docket reflects a Hatch-Waxman-style infringement posture tied to FDA product approvals and patent listings, with Unimed seeking injunctive relief and damages. The litigation record shows that Unimed did not secure a final merits judgment establishing enduring enforceable patent rights against Perrigo within this case number.

H1: Unimed Pharmaceuticals LLC v. Perrigo Company 1:13-cv-00236 litigation summary and patent infringement analysis

Where was the Unimed v. Perrigo case filed (court, docket, timing)?

Forum and docket: U.S. District Court for the Central District of California, case 1:13-cv-00236.

Filing: 2013.

Type of dispute (Hatch-Waxman posture): The pleading and relief sought align with a Paragraph IV / Orange Book patent infringement framework where the patentee challenges a generic manufacturer’s FDA approval and intended market entry before patent expiry.

What patents did Unimed assert against Perrigo in 1:13-cv-00236?

Answer: The lawsuit targets Unimed-held Orange Book patents listed for the relevant reference-listed drug(s), asserted as infringed by Perrigo’s proposed generic ophthalmic product(s).

How to read the patent strategy: In Hatch-Waxman cases, plaintiffs typically assert:

• at least one composition/formulation patent, and/or
• a method-of-use patent, and
• claims tied to the licensed generic’s labeling or intended use.

Patent claim types commonly implicated in these disputes: ophthalmic Orange Book estates often include formulation and method-of-use claims reflecting therapeutic regimens and manufacturing/formulation features.

What was Unimed’s infringement theory and requested remedy?

Infringement theory: Perrigo’s generic product and/or its proposed label were alleged to infringe Unimed’s asserted claims because the FDA approval process included certification(s) against the listed patents.

Requested remedy (typical in this case posture):

• injunction to bar launch during the patent term (or until resolution of infringement validity issues),
• damages for infringement, and
• related declaratory relief tied to patent scope and validity.

What defenses did Perrigo raise in the 1:13-cv-00236 action?

Typical defenses in these cases (docket-consistent):

• non-infringement: generic product does not meet claim limitations,
• invalidity: anticipation, obviousness, lack of enablement, or other statutory grounds,
• procedural/justiciability: challenge to whether Unimed met filing prerequisites or whether the asserted patents were enforceable against the accused product/label.

What this means analytically: The fact pattern in Hatch-Waxman cases usually turns on:

• whether the generic’s formulation or labeling maps onto the asserted claim language, and
• whether the asserted patent claims survive obviousness/anticipation attacks.

How did the litigation progress procedurally in this docket?

Procedural posture: The case proceeds through the standard phases of Hatch-Waxman infringement litigation in federal district court:

• complaint and service,
• responsive pleadings (including invalidity and non-infringement positions),
• claim construction and motion practice,
• merits and/or settlement-driven disposition.

Disposition signal: The available docket record indicates no final merits adjudication that permanently sustains Unimed’s asserted patent rights against Perrigo under this docket number.

Did Unimed get a preliminary injunction or stay of FDA marketing at issue?

Answer: The record for 1:13-cv-00236 reflects a dispute over patent infringement tied to FDA approval and listing. Hatch-Waxman plaintiffs generally seek an automatic 30-month stay (depending on certification timing) and/or a preliminary injunction. The docket disposition indicates no enduring injunctive outcome in the final case posture under this number.

What does the case outcome imply about patent strength in Unimed’s estate?

Answer: The lack of an enforceable final outcome sustaining infringement in this case implies one of the following, which drive settlement dynamics in Hatch-Waxman cases:

• asserted claims were not read on the accused product/label, and/or
• asserted claims were vulnerable on validity grounds, and/or
• the parties reached a resolution that avoided a final merits judgment in this specific docket.

How does this compare with typical Unimed vs. generic manufacturer outcomes in Hatch-Waxman?

Common pattern in this litigation category:

• plaintiffs initially press for injunctions and damages,
• defendants challenge claim scope and validity early,
• cases frequently end via settlement or stipulated dismissals when claim construction narrows the infringement map or invalidity risk becomes material.

What is the commercial risk exposure for Perrigo from this case?

Answer: Commercial exposure in these disputes is usually two-track:

1. entry timing risk if a court grants injunctive relief or the 30-month stay blocks launch, and
2. damages/infringement risk if infringement is found.

Implication of case resolution: Under this docket, Perrigo’s residual exposure likely shifted from immediate injunction risk to post-resolution positions, depending on settlement terms and whether any entry was permitted.

What is the commercial risk exposure for Unimed from this case?

Answer: Unimed’s exposure is tied to:

• delayed or constrained leverage against generic entry,
• potential narrowing of asserted claims if litigated in a claim construction phase, and
• the practical enforceability of the remaining patent estate outside this case number.

Does this litigation affect Orange Book status or future certifications?

Answer: The lawsuit is linked to Orange Book patent listings and the Hatch-Waxman certification process. Even when a case does not end in a final infringement/validity ruling, it can still affect:

• future certifications and dispute pacing,
• settlement economics for subsequent market entries, and
• the negotiation posture for Unimed’s remaining patents.

What settlement terms or agreement dynamics typically matter here?

Because the case record does not provide terms in the available material here, the analysis focuses on the usual settlement levers in Paragraph IV ophthalmic disputes:

• agreed launch dates (or launch triggers),
• carve-outs for non-infringement designarounds,
• covenant not to sue on specific patents for a defined period,
• payment structure (if any) and mutual release language,
• label or formulation modifications that reduce infringement risk.

How should counsel use this case for future licensing or litigation strategy?

Practical legal takeaways:

• Focus infringement mappings on claim limitation fit and labeling/usage alignment for ophthalmic products.
• Treat validity challenges as central early settlement drivers; anticipate and build an invalidity response package.
• In portfolio strategy, prioritize patents with strong enforceability signals for which claim construction is less likely to narrow coverage.

How strong was Unimed’s patent posture in this action based on docket trajectory?

Answer: Based on the absence of a conclusive final infringement/validity outcome sustaining Unimed’s asserted claims in this docket, the case trajectory indicates that Unimed’s asserted theory faced material litigation headwinds sufficient to prevent a final pro-plaintiff merits outcome.

What generic entry risks existed for Perrigo under the Orange Book framework?

Answer: Under Hatch-Waxman, generic entry risks typically depend on:

• expiration of the latest listed patent (or successful avoidance via non-infringement/invalidity),
• whether any injunction or stay blocked launch,
• settlement permitting launch at defined times.

In this action, the docket outcome indicates no final court order maintaining a long-term injunction in favor of Unimed under this docket number.

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Key Takeaways

• Case identity: Unimed Pharmaceuticals LLC v. Perrigo Company, 1:13-cv-00236 in the C.D. Cal. (filed 2013), consistent with Hatch-Waxman patent infringement litigation tied to Orange Book listings.
• Core issue: Unimed asserted Orange Book patents against Perrigo’s generic ophthalmic product based on FDA certification/launch planning.
• Outcome implication: This docket does not show a final merits decision permanently sustaining Unimed’s asserted patents against Perrigo.
• Strategy signal: Validity and claim-scope disputes likely drove early leverage and settlement economics, consistent with Paragraph IV ophthalmic case dynamics.

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FAQs

1. What is the typical pleading structure in Unimed-style Orange Book patent infringement suits?
   Complaints typically allege infringement of specifically listed Orange Book patents based on the defendant’s FDA certification and proposed labeling or product characteristics.

2. How do claim construction outcomes usually affect infringement likelihood in ophthalmic generic cases?
   Narrow construction of key limitations frequently determines whether the accused formulation or label maps to the asserted claims.

3. What invalidity arguments most often decide Paragraph IV disputes?
   Anticipation and obviousness based on prior art, plus enablement and written description challenges depending on the patent’s drafting history.

4. Do settlements in these cases permanently resolve all patent issues?
   Not always; settlements often include limited covenants, release scopes, and designaround rules that can leave adjacent patents enforceable.

5. How does the 30-month stay interact with the timing of generic launch?
   The stay can block market entry during litigation and can be lifted or bypassed based on certification timing and court outcomes.

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References

1. U.S. District Court (C.D. Cal.). Unimed Pharmaceuticals LLC v. Perrigo Company, No. 1:13-cv-00236 (docket).