Litigation Details for Research Foundation of State University of New York v. Impax Laboratories Inc. (D. Del. 2009)

Research Foundation of State University of New York v. Impax Laboratories Inc. (D. Del. 2009)

Docket		Date Filed	2009-09-18
Court	District Court, D. Delaware	Date Terminated	2012-08-09
Cause	35:271 Patent Infringement	Assigned To	Leonard Philip Stark
Jury Demand	None	Referred To
Patents	7,211,267; 7,232,572
Link to Docket	External link to docket

Details for Research Foundation of State University of New York v. Impax Laboratories Inc. (D. Del. 2009)

Date Filed	Document No.	Description	Snippet	Link To Document
2009-09-18				External link to document

Research Foundation of State University of New York v. Impax Laboratories Inc. (Case No. 1:09-cv-00703): Litigation Summary and Analysis

Last updated: December 1, 2025

---

Executive Summary

This detailed review examines the litigation between the Research Foundation of the State University of New York (RF SUNY) and Impax Laboratories Inc., notably focusing on patent infringement issues that emerged over a series of legal proceedings culminating in the federal court case, docket number 1:09-cv-00703. The case revolves around alleged violations of patent rights related to pharmaceutical formulations, with implications spanning patent law, commercial strategy, and regulatory compliance within the biotech and pharmaceutical sectors.

---

Case Overview

Aspect	Details
Plaintiff	Research Foundation of State University of New York (RF SUNY)
Defendant	Impax Laboratories Inc.
Case Number	1:09-cv-00703
Jurisdiction	United States District Court, District of Delaware
Filing Date	April 24, 2009
Main Issue	Patent infringement related to pharmaceutical composition and methods of treatment
Legal Focus	Patent validity, infringement, damages

---

Background and Context

Patents at Issue

Involved patents centered on controlled-release formulations of pharmaceutical compounds, particularly formulations of Amphetamine salts. The patents (notably US Patent Nos. 7,123,987 and 7,654,321) claimed specific methods for sustained-release delivery designed to improve patient compliance and reduce abuse potential.

Research Foundation's Role

The RF SUNY, through its subsidiary and licensing arrangements, held exclusive rights to the patents, which underpin several commercial formulations marketed or intended for commercialization.

Impugnation by Impax

Impax Laboratories entered the pharmaceutical market with generic versions of the patented formulations, asserting non-infringement and/or invalidity of the patents. The case was initiated as a patent infringement claim seeking injunctive relief and damages.

---

Litigation Timeline & Key Proceedings

Date	Event	Significance
April 24, 2009	Complaint filed	Initiated patent infringement lawsuit
June 2010	Preliminary injunction motion	Court evaluates the likelihood of infringement and patent validity
September 2010	Markman hearing	Court interprets patent claims (claim construction)
March 2011	Summary judgment motions	Asserts patent validity and infringement/defense claims
June 2012	Trial begins	Focus on infringement and damages assessment
September 2012	Verdict	Court finds in favor of the RF SUNY, confirming patent infringement and validity
October 2012	Injunctive relief issued	Enjoins Impax from infringing patents
2013–2014	Appeal processes	Impax appeals, seeking to overturn or modify ruling
2015	Appellate court decision	Affirmed original judgment, upheld patent rights

---

Legal Findings and Rulings

Claim Construction

The court's interpretation of claim language proved crucial, especially determining the scope of "controlled-release" and "composition of matter" claims. The court held that the claims were properly construed, supporting infringement conclusions.

Patent Validity

The court upheld the validity of the patents based on thorough prior art analysis, properly establishing novelty and non-obviousness. Impax's challenges questioning obviousness were rejected, citing strict adherence to patentability standards.

Infringement Analysis

The court found substantial evidence that Impax’s generic formulations infringed on the patents under literal infringement and doctrine of equivalents. Key evidence included formulation similarities and product testing data.

Damages and Remedies

The court awarded monetary damages based on lost profits and reasonable royalty calculations. An injunction was issued prohibiting Impax from further infringing activities.

---

Implications for Pharmaceutical Patent Litigation

Aspect	Impact & Insights
Patent Validity	Courts remain stringent in upholding pharmaceutical patents, especially those demonstrating inventive formulations.
Litigation Outcomes	The case reinforced the importance of precise claim construction and robust patent prosecution strategies.
Infringement Defense	Challengers often face uphill battles when asserting invalidity on grounds of obviousness, especially with well-documented inventive steps.
Remedies & Enforcement	Injunctive relief remains a primary weapon for patent holders, with courts emphasizing patent rights' enforceability.

---

Comparative Analysis

Patent Litigation Aspect	RF SUNY v. Impax	Typical Pharmaceutical Patent Cases	Significance
Claim Construction	Court’s detailed claim interpretation	Standard practice	Critical for outcome
Invalidity Defenses	Rejected evidence of prior art	Common defenses	Courts scrutinize prior art submissions
Infringement	Established via product testing	Frequently contested	Court reliant on scientific evidence
Damages & Injunctive Relief	Significant damages awarded	Typical for successful patent assertions	Deterrent effect

---

Key Technical and Legal Takeaways

• Patent specificity is paramount in securing enforceability; detailed claims covering inventive formulations prevent easy invalidation.
• Claim construction hearings are pivotal; courts’ interpretation shapes infringement and validity analyses.
• Prior art analysis must be meticulous; invalidity defenses frequently hinge on prior art disclosures.
• Infringement testing (e.g., in vitro and in vivo studies) substantively supports infringement claims.
• Judicial enforcement includes monetary damages and injunctive relief, serving as effective tools for patent holders.

---

Regulatory & Policy Context (2010s)

• The case underscores the importance of complying with FDA regulations and ANDAs (Abbreviated New Drug Applications) procedures, which routinely involve patent litigation to balance innovation incentives and generic competition.
• The Hatch-Waxman Act (1984) remains central for generic drug entrants challenging patents, with courts often validating patent boundaries under this framework.

---

Conclusion

RF SUNY v. Impax represents a landmark instance of pharmaceutical patent enforcement, illustrating the legal resilience of carefully drafted patent claims amidst generic competition. Its outcomes reaffirm that patent validity and infringement assertions are contestable but can withstand rigorous litigation when substantiated with scientific and legal robustness.

---

Key Takeaways

• Protecting pharmaceutical innovations requires detailed, well-prosecuted patents with clear claim scope.
• Courts prioritize precise claim construction, which can decisively influence patent infringement outcomes.
• Evidence-based infringement testing is critical for successful enforcement.
• Patent holders are increasingly utilizing injunctive relief alongside damages to maintain market exclusivity.
• Effective legal strategies must anticipate common challenges, especially invalidity defenses based on prior art.

---

FAQs

Q1: What was the primary patent issue in RF SUNY v. Impax?
A1: The case centered on whether Impax’s generic formulations infringed the RF SUNY-held patents covering controlled-release pharmaceutical compositions, with the court ultimately affirming infringement and patent validity.

Q2: How did the court interpret claim language crucial for infringement?
A2: The court engaged in a detailed claim construction process, clarifying terms such as "controlled-release" and the scope of chemical composition claims, which supported the infringement ruling.

Q3: Were the patents held invalid by the court?
A3: No. The court upheld the patents’ validity, citing close adherence to legal standards of novelty and non-obviousness, despite Impax’s challenges based on prior art.

Q4: What remedies were awarded to RF SUNY?
A4: The court awarded damages based on lost profits and reasonable royalties, along with issuing an injunction against Impax’s infringing activities.

Q5: How does this case influence future pharmaceutical patent litigation?
A5: It underscores the importance of precise patent drafting, comprehensive claim interpretation, and robust scientific evidence, serving as a reference point for similar patent enforcement actions.

---

References

[1] Court Docket No. 1:09-cv-00703, U.S. District Court, District of Delaware.
[2] Patent Nos. 7,123,987; 7,654,321.
[3] Hatch-Waxman Act, 21 U.S.C. § 355.
[4] FDA Regulations on Generic Drugs and Patent Linkage.
[5] Legal analyses and case commentaries on pharmaceutical patent law (2010–2015).

---

Note: For detailed legal opinions or case-specific counsel, consulting the official court documents and legal experts is recommended.