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Purdue Pharma v. Endo Pharmaceuticals

Citation: 438 F.3d 1123Docket: 2004-1189

Court: Court of Appeals for the Federal Circuit; January 31, 2006; Federal Appellate Court

Original Court Document: View Document

Narrative Opinion Summary

In a patent infringement case, Purdue Pharma sued Endo Pharmaceuticals alleging that Endo's generic versions of OxyContin infringed Purdue's patents related to controlled release oxycodone formulations. The trial court found that Endo's products infringed Purdue's patents but ruled the patents unenforceable due to inequitable conduct by Purdue during patent prosecution. Purdue appealed the inequitable conduct ruling, while Endo cross-appealed the infringement decision. The appellate court initially affirmed the trial court's decision on inequitable conduct but later vacated it, identifying errors in the trial court's assessment of materiality and intent, and remanded the case for further proceedings. The trial court's interpretation of the patent claims did not require a four-fold dosage range limitation, which Endo argued was necessary. The appellate court affirmed the trial court's infringement ruling, rejecting Endo's claim construction arguments and finding that Purdue did not clearly disavow the four-fold dosage range during prosecution. Consequently, the appellate court vacated the previous judgment of unenforceability and remanded the case, maintaining the infringement determination.

Legal Issues Addressed

Claim Construction in Patent Infringement

Application: The court found no limiting language in the claims requiring a four-fold dosage range for effective pain control, rejecting Endo’s argument and affirming the infringement ruling.

Reasoning: The court reviewed the claim language without deference and found no limiting language specific to controlled release oxycodone formulations that effectively manage pain in 90% of patients over a four-fold dosage range.

Inequitable Conduct in Patent Prosecution

Application: The trial court determined that Purdue's patents were unenforceable due to inequitable conduct, based on Purdue's failure to disclose that its claims of having discovered a superior formulation were based on insight rather than scientific proof.

Reasoning: Despite this, the court also determined that Endo proved, by clear and convincing evidence, that Purdue’s patents were unenforceable due to inequitable conduct during their prosecution.

Materiality and Intent in Inequitable Conduct

Application: The appellate court vacated the trial court's judgment of inequitable conduct, identifying errors in balancing materiality and intent, and remanded for further proceedings to reevaluate the intent findings.

Reasoning: Consequently, the previous opinion was withdrawn, the judgment of inequitable conduct was vacated, and the case was remanded to the trial court for additional proceedings.

Patent Infringement under 35 U.S.C. 271(e)(2)

Application: The trial court found that Endo's generic products would infringe Purdue's patents for controlled release oxycodone formulations.

Reasoning: The court found that Purdue established by a preponderance of the evidence that Endo’s generic products would infringe its patents, specifically interpreting 'controlled release oxycodone formulation' as those controlling pain in 90% of patients within a four-fold dosage range.

Prosecution Disclaimer Doctrine

Application: The trial court erroneously found a disavowal by Purdue regarding the four-fold dosage range, as Purdue's statements did not constitute a necessary feature of the claimed formulations.

Reasoning: Although Purdue referenced the four-fold dosage range to distinguish its formulations from prior art, the statements did not constitute a necessary feature of the claimed formulations but rather described an outcome associated with the oxycodone formulations based on the specified blood plasma concentrations.